Ascentage Pharma Presents Multiple Clinical Updates at EHA2026 Congress

  • Poster presentations from ongoing clinical trials of two core assets, olverembatinib and lisaftoclax, highlight global innovation capabilities in hematologic malignancies

ROCKVILLE, Md. and SUZHOU, China, June 14, 2026 (GLOBE NEWSWIRE) — Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855), a global, commercial-stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel therapies to address unmet medical needs in cancer, announced today that seventeen clinical updates from its core assets were presented at the 31st Congress of the European Hematology Association (EHA2026), including eight poster presentations. The presentations featured data from ongoing clinical studies of olverembatinib (HQP1351), the first third-generation BCR-ABL1 inhibitor approved in China, and lisaftoclax (APG-2575), the first approved China-developed Bcl-2 selective inhibitor. The EHA2026 Congress convened in Stockholm, Sweden, from June 11 to 14, 2026.

At the EHA2026 Congress, presentations on olverembatinib comprised key concurrent updates across two therapeutic areas: chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). In CML, olverembatinib demonstrated deep and durable responses in patients with chronic-phase CML (CML-CP) without the T315I mutation, in whom the disease was resistant and/or intolerant to first-line TKI therapy, supporting its potential as a second-line treatment option. For CML-CP patients who have failed treatment with at least two prior TKIs, olverembatinib can be used as a standard treatment option. In addition, olverembatinib showed positive clinical data in CML patients with multiline TKI resistance and co-occurring high-risk genetic mutations. In Ph+ ALL, olverembatinib continued to demonstrate robust clinical response, with updated data from the first-line global registrational Phase III study (POLARIS-1) further validating its deep response rate and manageable safety profile. The chemotherapy-free combination regimen with lisaftoclax yielded encouraging clinical data in subpopulations such as pediatric patients with relapsed/refractory Ph+ ALL.

Updated data from the registrational Phase II study of lisaftoclax in chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) were also presented. Stratified analyses correlating baseline characteristics with prognosis provided important insights that will inform refinement of treatment strategies and optimization of individualized dosing regimens across different patient populations. The real-world data on lisaftoclax in myeloid neoplasms also provides robust evidence for its clinical utility.

Yifan Zhai, MD, Chief Medical Officer of Ascentage Pharma, said: “The clinical updates on olverembatinib and lisaftoclax presented at EHA2026 further validate the therapeutic value of these two key assets in the global hematologic malignancy field. Olverembatinib has the potential to become an important treatment option for CML, while offering new treatment possibilities for Ph+ ALL patients. The updated data from the registrational Phase II study of lisaftoclax in CLL/SLL will help guide individualized dosing strategies across different patient populations. Its real-world data in myeloid malignancies further strengthens our confidence in its clinical application among such patients. We are particularly encouraged by the promising combination data. Looking ahead, we will continue to accelerate the global clinical development of our key assets, while actively exploring more innovative combination treatment strategies to provide meaningful treatment options for patients around the world.”

Key highlights of the selected poster presentations at EHA2026 are as follows (for more information of the Company’s candidates, please visit the official EHA website):

EFFICACY OF OLVEREMBATINIB IN PATIENTS WITH CHRONIC-PHASE CHRONIC MYELOID LEUKEMIA (CP-CML) WITH PRIOR RESISTANCE TO PONATINIB OR ASCIMINIB AND

ASXL1

MUTATIONS

  • Abstract Number: EHA-3991 (PS1727)
  • First Author: Elias Jabbour, MD, Department of Leukemia, The University of Texas MD Anderson Cancer Center
  • Key Highlights: This Phase Ib study performed mutational analyses on 22 patients with ponatinib- and/or asciminib-resistant CP-CML and evaluated the antileukemic activity of olverembatinib across different mutational backgrounds. ASXL1 mutations were present in 40.9% (9/22) of patients. After olverembatinib treatment, 44.4% (4/9) of patients with ASXL1 mutations achieved clinical responses, including 22.2% (2/9) who achieved MMR, one of whom achieved MR4.5. This study provided the first evidence that olverembatinib is active in patients with ponatinib- and/or asciminib-resistant CP-CML, including those harboring challenging genotypes such as ASXL1 mutations, highlighting its potential as a treatment option for patients with multi-line TKI-resistant disease.

UPDATED EFFICACY AND SAFETY OF OLVEREMBATINIB (HQP1351) AS SECOND-LINE THERAPY IN PATIENTS WITH CHRONIC-PHASE CHRONIC MYELOID LEUKEMIA (CP-CML)

  • Abstract Number: EHA-3388 (PS1733)
  • First Author: Weiming Li, MD, Department of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Key Highlights: This single-arm, multicenter, open-label Phase II study evaluated olverembatinib as a second-line treatment in patients with CP-CML without the T315I mutation. Among 42 evaluable patients, the complete cytogenetic response (CCyR) rate was 76.2% and the major molecular response (MMR) rate was 47.6%. Responses deepened over time with longer treatment duration, and olverembatinib exhibited manageable tolerability with no treatment-related deaths. These findings support the potential of olverembatinib to induce durable and deep responses in patients with CP-CML without the T315I mutation whose disease was resistant and/or intolerant to first-line TKI therapy, further supporting its role as a second-line treatment option.

THE EFFICACY AND SAFETY OF SWITCHING TO OLVEREMBATINIB OR CONTINUING ORIGINAL TKI THERAPY IN CML-CP PATIENTS TREATED WITH AT LEAST TWO PRIOR TKIS: A PROSPECTIVE, MULTICENTER, CONTROLLED TRIAL

  • Abstract Number: EHA-4595 (PS1728)
  • First Author: Bingbing Wen, the Second People’s Hospital of Shenzhen
  • Key Highlights: This prospective, multicenter, controlled trial enrolled 105 patients with CML-CP who had received at least two prior TKIs for ≥18 months and failed to achieve MMR. Patients were assigned in a 1:2 ratio to either switch to olverembatinib (40 mg orally every other day) or continue their most recent TKI therapy. Results showed that the 6-month MMR rate was significantly higher in the olverembatinib group than in the control group (54.3% vs 10.0%; P<0.001). At 12 months, the cumulative incidence of MMR was 57.14% in the olverembatinib group compared with 21.43% in the control group (P<0.0001). Common grade 3/4 hematologic treatment-emergent adverse events (TEAEs) included thrombocytopenia (42.86%) and anemia (17.14%). Grade 3/4 non-hematologic adverse events were rare. Notably, 78.57% of adverse events related to prior TKI therapy improved after patients switched to olverembatinib. These findings support olverembatinib as a potential standard of care for patients with CML-CP previously treated with at least two TKIs.

UPDATED RESULTS OF POLARIS-1 (PART 1), A GLOBAL REGISTRATIONAL PHASE 3 STUDY: OLVEREMBATINIB COMBINED WITH LOW-INTENSITY CHEMOTHERAPY IN NEWLY DIAGNOSED PH+ ALL

  • Abstract Number: EHA-3437 (PS1479)
  • First Author: Suning Chen, The First Affiliated Hospital of Soochow University
  • Key Highlights: This global, multicenter, registrational Phase III study (POLARIS-1 Part 1) is evaluating the efficacy and safety of olverembatinib in combination with reduced-intensity chemotherapy in patients with newly diagnosed Ph+ ALL. A total of 55 patients were enrolled. By the end of induction, the CR/CRi rate reached 94.4% and the MRD-negative CR rate reached 63.0%. MRD-negativity rates increased over time, reaching 93.1% by the end of cycle 9. The regimen demonstrated a manageable safety profile, with no meaningful differences in efficacy or safety observed between the 30 and 40mg dose groups. Encouraging activity was also observed in patients with adverse prognostic genotypes, including IKZF1plus. These findings suggest that olverembatinib combined with low-intensity chemotherapy may induce rapid, deep, and sustained MRD-negative responses in patients with newly diagnosed Ph+ ALL, while maintaining a favorable safety profile, and provide important evidence supporting its use in the frontline setting.

SAFETY AND PRELIMINARY EFFICACY OF OLVEREMBATINIB (HQP1351) COMBINED WITH LISAFTOCLAX (APG-2575) IN PEDIATRIC PATIENTS WITH RELAPSED/REFRACTORY (R/R PH+ ALL): RESULTS OF A PHASE 1B STUDY

  • Abstract Number: EHA-4691 (PS1473)
  • First Author: Jingliao Zhang, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
  • Key Highlights: This open-label, dose-escalation Phase Ib study evaluated olverembatinib in combination with lisaftoclax in pediatric patients with relapsed/refractory (R/R) Ph+ ALL who are resistant or intolerant to at least one prior TKI. A total of 17 patients were enrolled, with a median age of 13 years, and 40% harbored ABL1 mutations, including T315I. Among nine efficacy-evaluable patients, the combination achieved an overall response rate (ORR) of 88.9%, an MRD-negativity rate of 66.7% (8/12 at cycle 2 day 28), and 93.3% of patients (14/15 at cycle 2 day 28) achieved MMR or better. Both agents were detectable in cerebrospinal fluid (CSF), providing evidence of CNS penetration, and demonstrated activity across ABL1 mutation subgroups. The regimen showed a manageable safety profile with no treatment-related deaths. These findings support the potential of this chemotherapy-free oral dual-targeted regimen to induce rapid and deep remissions, and may provide a novel treatment option for pediatric patients with R/R Ph+ ALL.

REAL-WORLD EFFICACY AND SAFETY OF LISAFTOCLAX IN MYELOID NEOPLASMS: A MULTICENTER STUDY

  • Abstract Number: EHA-5454 (PF562)
  • First Author: Chen Cao, Qilu Hospital of Shandong University
  • Key Highlights: This multicenter real-world (retrospective) study evaluated the efficacy and safety of the novel BCL-2 inhibitor lisaftoclax in patients with myeloid neoplasms. A total of 30 patients (median age 63) were enrolled, including 25 patients with acute myeloid leukemia (AML, 83%), 3 with myelodysplastic syndromes (MDS, 10%), and 2 with chronic myelomonocytic leukemia (CMML, 7%). In patients with AML, the CR/CRi rate reached 72%, with the highest response observed in the ELN low-risk subgroup (87%). Among patients achieving CR/CRi, the MRD-negativity rate was 61%. The CR/CRi rate was 100% in patients with NPM1 mutations and 83% in patients with IDH2 mutations. Among the three patients with MDS, two achieved CRi. Regarding safety, grade≥3 treatment-emergent adverse events (TEAEs) were primarily hematologic adverse events, including thrombocytopenia (27%), anemia (23%), and neutropenia (20%). Overall safety was manageable. These findings demonstrate promising efficacy and manageable safety of lisaftoclax in the real-world treatment of myeloid neoplasms, particularly AML.

CORRELATION OF BASELINE CHARACTERISTICS WITH PROGNOSIS IN PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA/SMALL LYMPHOCYTIC LYMPHOMA (CLL/SLL) TREATED WITH LISAFTOCLAX (APG-2575) IN A PIVOTAL PHASE 2 STUDY

  • Abstract Number: EHA-3984 (PS1713)
  • First Author: Keshu Zhou, Henan Cancer Hospital
  • Key Highlights: This correlative analysis from the pivotal Phase II study (NCT05147467) evaluated associations between baseline characteristics and prognosis in patients with R/R CLL/SLL treated with lisaftoclax. The study enrolled 77 patients with R/R CLL/SLL refractory to BTKis who received lisaftoclax 600 mg once daily. Among 72 evaluable patients, the median progression-free survival (PFS) was 23.9 months and the Independent Review Committee (IRC)-assessed ORR was 62.5%. Further analyses showed that TP53 mutation/del(17p), complex karyotype (CK), and mutations in SF3B1, KIT, BLM, and SETD2 were associated with significantly shorter PFS. Complex karyotype and tumor size were identified as independent risk factors for shorter PFS. These findings demonstrate that lisaftoclax has clinical activity in patients with R/R CLL/SLL refractory to BTKi therapy. Additionally, these data may help to identify patients with poorer prognosis based on baseline risk characteristics, supporting future risk stratification and risk-adapted combination treatment strategies.

*Olverembatinib and lisaftoclax are currently under investigation and have not yet been approved by
the US FDA.

About Ascentage Pharma
Ascentage Pharma Group International (NASDAQ: AAPG; HKEX: 6855) (“Ascentage Pharma” or the “Company”) is a global, commercial stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer. The Company has built a rich pipeline of innovative drug products and candidates that include inhibitors targeting key proteins in the apoptotic pathway, such as Bcl-2 and MDM2-p53, next-generation kinase inhibitors, and protein degraders.

The Company’s first approved product, olverembatinib, is the first novel third-generation BCR-ABL1 inhibitor approved in China for the treatment of patients with CML in chronic phase (CML-CP) with T315I mutations, CML in accelerated phase (CML-AP) with T315I mutations, and CML-CP that is resistant or intolerant to first and second-generation TKIs. It is covered by the China National Reimbursement Drug List (NRDL). Ascentage Pharma is currently conducting an FDA- and EMA-cleared registrational Phase III trial, called POLARIS-2, of olverembatinib for CML, as well as an FDA- and EMA-cleared registrational Phase III trials for patients with newly diagnosed Ph+ ALL, called POLARIS-1, and SDH-deficient GIST patients, called POLARIS-3.

The Company’s second approved product, lisaftoclax, is a novel Bcl-2 inhibitor for the treatment of various hematologic malignancies. Lisaftoclax has been approved by China’s National Medical Products Administration (NMPA) for the treatment of adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously received at least one systemic therapy including Bruton’s tyrosine kinase (BTK) inhibitors. The Company is currently conducting four global registrational Phase III trials: the FDA- and EMA- cleared GLORA study of lisaftoclax in combination with BTK inhibitors in patients with CLL/SLL previously treated with BTK inhibitors for more than 12 months with suboptimal response; the GLORA-2 study in patients with newly diagnosed CLL/SLL; the GLORA-3 study in newly diagnosed, elderly and unfit patients with AML; and the FDA- and EMA-cleared GLORA-4 study in patients with newly diagnosed higher risk MDS.

Leveraging its robust R&D capabilities, Ascentage Pharma has built a portfolio of global intellectual property rights and entered into global partnerships and other relationships with numerous leading biotechnology and pharmaceutical companies, such as Takeda, AstraZeneca, Merck, Pfizer, and Innovent, in addition to research and development relationships with leading research institutions, such as Dana-Farber Cancer Institute, Mayo Clinic, National Cancer Institute and the University of Michigan. For more information, visit https://ascentage.com/

Cautionary Note Regarding Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical facts, contained in this press release may be forward-looking statements, including statements that express Ascentage Pharma’s opinions, expectations, beliefs, plans, objectives, assumptions or projections regarding future events or future results of operations or financial condition. These forward-looking statements are subject to a number of risks and uncertainties as discussed in Ascentage Pharma’s filings with the SEC, including those set forth in the sections titled “Risk factors” and “Cautionary note regarding forward-looking statements” in its Annual Report on Form 20-F for the year ended December 31, 2025, filed with the SEC on April 29, 2026, the sections headed “Forward-looking Statements” and “Risks Factors” in the prospectus of the Company for its Hong Kong initial public offering dated October 16, 2019, and other filings with the SEC and/or The Stock Exchange of Hong Kong Limited where the Company’s ordinary shares are listed it has made or it makes from time to time that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. The forward-looking statements contained in this presentation do not constitute profit forecast by the Company’s management.

As a result of these factors, you should not rely on these forward-looking statements as predictions of future events. The forward-looking statements contained in this press release are based on Ascentage Pharma’s current expectations and beliefs concerning future developments and their potential effects and speak only as of the date of such statements. Ascentage Pharma does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Contact Information

Investor Relations:

Stella Yang
Ascentage Pharma
[email protected]
+1 (301) 792-6286
Ascentage Pharma
[email protected]
+1 (301) 792-6286

Stephanie Carrington
ICR Healthcare
[email protected]
+1 (646) 277-1282

Media Relations:

Sean Leous
ICR Healthcare
[email protected]
+1 (646) 866-4012



ComEd Reaches 99% Restoration Following Multi-Day Severe Storm Event

ComEd Reaches 99% Restoration Following Multi-Day Severe Storm Event

Crews in final stages of repairs following worst storms since 2020 and remain committed to completing service restoration for all customers

CHICAGO–(BUSINESS WIRE)–
ComEd crews have nearly completed the restoration of power to customers impacted by multiple rounds of severe storms that moved through northern Illinois beginning Wednesday afternoon. With 99% of affected customers now restored, crews are in the final stages of repairs and remain committed to completing service restoration for all remaining customers.

Multiple bands of severe weather moved through ComEd’s northern Illinois service territory on Wednesday and Thursday, bringing intense rain, frequent lightning, and high wind gusts — with speeds reaching roughly 80 mph at peak — causing significant damage to ComEd’s infrastructure and resulting in widespread outages across the service territory. At least two tornadoes were confirmed on Thursday, including one in Streator, Illinois, approximately 100 miles southwest of Chicago, and another near Dwight, Illinois, about 80 miles southwest of Chicago, with additional damage assessments ongoing.

Large trees fell across equipment and blocked access to neighborhoods with restoration needs, and hundreds of utility poles were broken and had to be completely replaced. That type of work is complex and takes more time to do safely, even with crews working around the clock. In total, crews replaced nearly 500 poles and used more than 295,000 feet of cable wire during the restoration effort.

Across the two days of severe weather, more than 674,600 ComEd customers experienced outages. Late Saturday evening, isolated thunderstorms produced localized strong wind gusts that caused additional tree and limb damage, resulting in an additional 6,425 outages.

“Our crews have worked tirelessly — around the clock and under challenging conditions — to safely restore power to our customers, and their dedication throughout this storm event has been extraordinary,” said David Perez, executive vice president and COO of ComEd. “We are incredibly grateful for their hard work and commitment over the duration of this event. We also want to sincerely thank our customers for their patience and understanding as we worked through the most significant storm damage our service territory has experienced since the 2020 Derecho. We will not rest until the final customers are restored.”

More than 3,000 ComEd employees and 2,200 contractors were mobilized during the peak of the response, supported by roughly 400 mutual assistance personnel who arrived Friday to bolster ComEd staff and contractors in their restoration efforts.

Public Safety Reminders

Public safety remains paramount, and ComEd encourages customers to take the following precautions:

  • If a downed power line is spotted, please immediately call ComEd at 1-800-EDISON1 (1-800-334-7661). Spanish-speaking customers should call 1-800-95-LUCES (1-800-955-8237).

  • Never approach a downed power line. Always assume a power line is energized and extremely dangerous.

  • In the event of an outage, do not approach ComEd crews working to restore power to ask about restoration times. Crews may be working on live electrical equipment, and the perimeter of the work zone may be hazardous.

ComEd urges customers to contact the company immediately if they experience a power outage. Customers can text OUT to 26633 (COMED) to report an outage and receive restoration information and can follow the company on X @ComEd or on Facebook at Facebook.com/ComEd. Customers can also call 1-800-EDISON1 (1-800-334-7661), or report outages via the website at ComEd.com/report. Spanish-speaking customers should call 1-800-95-LUCES (1-800-955-8237).

With ComEd’s Outage Tracker, customers can report outages, check estimated time of restoration, view crew status updates, and explore our outage map. Visit ComEd.com/OutageTracker.

ComEd’s mobile app for iPhone and Android® smart phones gives customers the ability to report power outages and manage their accounts; download the app at ComEd.com/app.

ComEd is a unit of Chicago-based Exelon Corporation (NASDAQ: EXC), a Fortune 200 company and one of the nation’s largest utility companies, serving nearly 11 million electricity and natural gascustomers. ComEd powers the lives of more than 4 million customers across northern Illinois, or 70percent of the state’s population. For more information, visit ComEd.com, and connect with the company on Facebook, Instagram, LinkedIn, X and YouTube.

ComEd Media Relations

312-394-3500

KEYWORDS: Illinois United States North America

INDUSTRY KEYWORDS: Energy Utilities Oil/Gas

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CEL-SCI Corporation Announces Pricing of Offering

CEL-SCI Corporation Announces Pricing of Offering

VIENNA, Va.–(BUSINESS WIRE)–
CEL-SCI Corporation (“CEL-SCI” or the “Company”) (NYSE American: CVM), a clinical stage cancer immunotherapy company, today announced the pricing of a best-efforts offering of 2,500,000 shares of common stock at an offering price of $1.00 per share. Total gross proceeds from the offering, before deducting the placement agent’s fees and offering expenses, are expected to be $2.5 million. The offering is expected to close on June 16, 2026, subject to satisfaction of customary closing conditions.

The Company intends to use the proceeds for the continued development of Multikine*, general corporate purposes, and working capital.

ThinkEquity is acting as the sole placement agent for the offering.

The securities will be offered and sold pursuant to a shelf registration statement on Form S-3 (File No. 333-288515), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the “SEC”) on July 3, 2025, and declared effective on August 12, 2025. The offering will be made only by means of a written prospectus. A final prospectus supplement and accompanying prospectus describing the terms of the offering will be filed with the SEC on its website at www.sec.gov. Copies of the prospectus supplement and the accompanying prospectus relating to the offering may also be obtained, when available, from the offices of ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About CEL-SCI Corporation

CEL-SCI believes that boosting a patient’s immune system before surgery, radiotherapy and chemotherapy have damaged it, should provide the greatest possible impact on survival. Multikine is designed to help the immune system “target” the tumor at a time when the immune system is still relatively intact and thereby thought to be better able to mount an attack on the tumor.

Multikine (Leukocyte Interleukin, Injection), given right after diagnosis and before surgery, has been dosed in over 740 patients and received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck.

The Company has operations in Vienna, Virginia, and near/in Baltimore, Maryland.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this press release, the words “intends,” “believes,” “anticipated,” “plans” and “expects,” and similar expressions, are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Factors that could cause or contribute to such differences include an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company’s potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI’s filings with the Securities and Exchange Commission, including but not limited to its report on Form 10-K for the year ended September 30, 2025. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

* Multikine (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI has registered for this investigational therapy. This proprietary name is subject to FDA review in connection with the Company’s future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use.

Gavin de Windt

CEL-SCI Corporation

(703) 506-9460

KEYWORDS: United States North America Virginia

INDUSTRY KEYWORDS: Oncology Health Other Health Clinical Trials Pharmaceutical Biotechnology

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Zymeworks Presents New Phase 1 Data for Folate Receptor Alpha-Targeting ADC ZW191 at ESMO Gynaecological Cancers Congress 2026

  • ZW191 demonstrates compelling anti-tumor activity in platinum-resistant ovarian cancer patients regardless of FRα expression level
  • Confirmed objective response rate (cORR) of 78.6% in FRα-positive (≥75% at PS2+) platinum-resistant ovarian cancer patients and 47.4% in FRα-negative patients (<75% at PS2+) across all dose levels studied
  • Median duration of response was not reached at the time of data cutoff, and median progression-free survival was 7.6 months across ovarian and endometrial cancer cohorts
  • Patient recruitment in dose optimization cohorts completed, with favorable tolerability profile and broad therapeutic window supporting continued clinical development

VANCOUVER, British Columbia, June 14, 2026 (GLOBE NEWSWIRE) — Zymeworks Inc. (Nasdaq: ZYME), a biotechnology company managing a portfolio of licensed healthcare assets while developing a diverse pipeline of novel, multifunctional biotherapeutics, today presented new clinical data from the dose-escalation portion of its ongoing Phase 1 study evaluating ZW191, a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC), at the European Society for Medical Oncology (ESMO) Gynaecological Cancers Congress 2026.

The presentation highlights compelling anti-tumor activity in patients with platinum-resistant ovarian cancer (PROC) and in patients with endometrial cancer, including patients with both positive and negative FRα expression. The results further support the potential of ZW191 to address limitations of currently available and investigational FRα-targeted therapies and broaden treatment opportunities for patients with gynecologic cancers.

“We are highly encouraged by these data, which continue to demonstrate the differentiated profile of ZW191 and its potential to deliver meaningful clinical benefit across a broad population of patients with ovarian and endometrial cancers,” said Sabeen Mekan, M.D., Senior Vice President and Chief Medical Officer of Zymeworks. “The response rate observed in FRα-positive ovarian cancer patients compares favorably with currently available therapies, while maintaining meaningful activity in patients with negative FRα expression. Together these encouraging data on durability, progression-free survival, and manageable safety profile further strengthen our confidence in the program and reinforce the ability of our ADC platform to generate differentiated therapeutics.”

The analysis included efficacy data by FRα expression level from Part 1 of the ongoing Phase 1 study as of the March 9, 2026, data cutoff. FRα expression was assessed by immunohistochemistry and categorized using the Proportion and Staining Intensity, defined as the percentage of cells with 2+/3+ staining. Tumors were categorized as FRα-negative (<75%) or FRα-positive (≥75%).

Key Findings

Among response-evaluable PROC patients, ZW191 demonstrated a cORR of 78.6% in patients with FRα-positive tumors and 47.4% in patients with FRα-negative tumors across all dose levels. Disease control rates were 100.0% and 89.5%, respectively. Confirmed ORR in the overall PROC population was 58.8% across all dose levels studied and 65.2% in dose range of 6.4-9.6 mg/kg. These findings demonstrate meaningful anti-tumor activity across both FRα-positive and FRα-negative tumors as well as in the overall population.

In endometrial cancer patients with FRα-negative tumors, ZW191 demonstrated a cORR of 40.0% and a disease control rate of 80.0% across all doses evaluated.

Across both ovarian and endometrial cancer cohorts, responses were observed early and continued to deepen over time. Median duration of response was not reached at the time of data cutoff, and median progression-free survival was 7.6 months.

ZW191 continued to demonstrate a favorable tolerability profile. Treatment-emergent adverse events (TEAEs) occurred in 98% of patients, with grade ≥3 TEAEs reported in 55% of patients. The most common grade ≥3 adverse events were neutropenia (24%), anemia (20%), and thrombocytopenia (12%). Serious TEAEs occurred in 35% of patients, and 20% of patients discontinued treatment due to adverse events. Overall, the safety profile was manageable and consistent with continued clinical development.

“These results further demonstrate the potential of ZW191 to provide meaningful clinical benefit for patients with difficult-to-treat gynecologic cancers,” said Kosei Hasegawa, M.D., Ph.D., Saitama Medical University International Medical Center and presenting author. “The robust activity observed in FRα-positive ovarian cancer, together with encouraging responses in tumors with lower FRα expression, suggests ZW191 could expand the benefit of FRα-targeted therapy to a broader patient population.”

Part 2a, the dose optimization portion of the Phase 1 study evaluating ZW191 in ~60 PROC patients randomized to either 6.4 mg/kg every three weeks or 9.6 mg/kg every three weeks, has completed enrollment. Data from Part 2a will be presented at a future medical meeting and are expected to inform dose selection for potential future development.

ZW191’s differentiated profile, including its novel FRα-targeting antibody, ZD06519 payload, and high drug-to-antibody ratio, supports its potential to address key limitations of current therapies and broaden the applicability of FRα-targeted treatment approaches across multiple tumor types.

About ZW191

ZW191 is an antibody-drug conjugate engineered to target a protein called folate receptor-⍺ found in ~75% of high-grade serous ovarian carcinomas1, over 50% of endometrial cancers2,3 and ~70% of lung adenocarcinomas4. ZW191’s differentiated design strongly supports its ability to internalize into FR⍺-expressing cells with the potential to release bystander active topoisomerase-1 inhibitor (ZD06519), a novel proprietary payload developed by Zymeworks to kill tumor cells.

About Zymeworks Inc. 

Zymeworks is a global biotechnology company managing a portfolio of licensed healthcare assets and developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, including cancer, inflammation, and autoimmune disease. Zymeworks’ asset and royalty aggregation strategy focuses on optimizing positive future cash flows from an emerging portfolio of licensed products such as Ziihera® (zanidatamab-hrii) and other licensed products and product candidates, such as pasritamig. In addition, Zymeworks is also building a portfolio of healthcare assets that can generate strong cash flows, while supporting the development of innovative medicines. Zymeworks engineered and developed Ziihera, a HER2-targeted bispecific antibody using Zymeworks’ proprietary Azymetric™ technology and has entered into separate agreements with BeOne Medicines Ltd. (formerly BeiGene, Ltd.) and Jazz Pharmaceuticals Ireland Limited granting each exclusive rights to develop and commercialize zanidatamab in different territories. Zymeworks is rapidly advancing a robust pipeline of product candidates, leveraging its expertise in both antibody drug conjugates and multispecific antibody therapeutics targeting novel pathways in areas of significant unmet medical need. Zymeworks’ complementary therapeutic platforms and fully integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly differentiated antibody-based therapeutics. These capabilities have been further leveraged through strategic partnerships with global biopharmaceutical companies. For information about Zymeworks, visit www.zymeworks.com and follow @ZymeworksInc on X.

Cautionary Note Regarding Forward-Looking Statements

This press release includes “forward-looking statements” or information within the meaning of the applicable securities legislation, including Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements in this press release include, but are not limited to, statements that relate to the potential safety profile and therapeutic effects of ZW191; Zymeworks’ development of product candidates; status of studies and the related data; anticipated clinical data presentations; Zymeworks’ implementation of its long-term strategy; and other information that is not historical information. When used herein, words such as “plan”, “believe”, “expect”, “may”, “continue”, “anticipate”, “potential”, “will”, “on track”, “progress”, “preserve”, “intend”, “could”, and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Zymeworks’ current expectations and various assumptions. Zymeworks believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Zymeworks may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various factors, including, without limitation: any of Zymeworks’ or its partners’ product candidates, including ZW191, may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; Zymeworks may not achieve milestones or receive additional payments or royalties under its collaborations; regulatory agencies may impose additional requirements or delay the initiation of clinical trials; the impact of new or changing laws and regulations; market conditions, including the impact of tariffs; potential negative impacts of FDA regulatory delays and uncertainty around recent policy developments, changes in the leadership of federal agencies such as the FDA, staff layoffs, budget cuts to agency programs and research, and changes in drug pricing controls; the impact of global and regional geopolitical or public health developments on Zymeworks’ business, research and clinical development plans and timelines and results of operations, including impact on its clinical trial sites, collaborators, and contractors who act for or on Zymeworks’ behalf; zanidatamab may not be successfully commercialized; Zymeworks’ business strategy related to anticipated and potential future milestones and royalty streams and existing and potential new partnerships may not be successfully implemented; Zymeworks’ evolution of its business strategy may not deliver meaningful shareholder returns; Zymeworks may be unsuccessful in actively managing and/or aggregating revenue generating assets alongside its active R&D operations; ongoing and future clinical trials may not demonstrate safety and efficacy of any of Zymeworks’ or its collaborators’ product candidates, including ZW191; Zymeworks’ assumptions and estimates regarding its financial condition, future financial performance and estimated cash runway may be incorrect; inability to maintain or enter into new partnerships or strategic collaborations; and the factors described under “Risk Factors” in Zymeworks’ quarterly and annual reports filed with the Securities and Exchange Commission (copies of which may be obtained at www.sec.gov and www.sedarplus.ca).

Although Zymeworks believes that such forward-looking statements are reasonable, there can be no assurance they will prove to be correct. Investors should not place undue reliance on forward-looking statements. The above assumptions, risks and uncertainties are not exhaustive. Forward-looking statements are made as of the date hereof and, except as may be required by law, Zymeworks undertakes no obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances, or to reflect the occurrences of unanticipated events.

Contacts:

Investor Inquiries:
Shrinal Inamdar
Vice President, Investor Relations
(604) 678-1388
[email protected]   

Media Inquiries:
Diana Papove
Vice President, Corporate Communications
(604) 678-1388
[email protected]

1 Köbel, M., Madore, J., Ramus, S. et al., Br J Cancer 111, 2297–2307 (2014).
May B, Conway N, Truong T, Linhart S, et al. FRα, B7-H4, & HER2 Expression in Endometrial Cancer: Assessing the Promise of Antibody Drug Conjugate Therapies. Presented at: SGO 2025 Winter Meeting; January 30 – February 1, 2025; Whistler, British Columbia, Canada.
3 Senol S, Ceyran AB, Aydin A, Zemheri E, Ozkanli S, Kösemetin D, Sehitoglu I, Akalin I. Folate receptor α expression and significance in endometrioid endometrium carcinoma and endometrial hyperplasia. Int J Clin Exp Pathol. 2015 May 1;8(5):5633-41.
4 O’Shannessy DJ, et al., Oncotarget. 2012 Apr; 3(4):414-25.



Phreesia Deadline: PHR Investors with Losses in Excess of $100K Have Opportunity to Lead Phreesia, Inc. Securities Fraud Lawsuit

PR Newswire

NEW YORK, June 14, 2026 /PRNewswire/ —

Rosen Law Firm Logo

Why: Rosen Law Firm, a global investor rights law firm, reminds purchasers of common stock of Phreesia, Inc. (NYSE: PHR) between May 8, 2025 and March 30, 2026, inclusive (the “Class Period”), of the important July 13, 2026 lead plaintiff deadline.

So what: If you purchased Phreesia common stock during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement.

What to do next: To join the Phreesia class action, go to https://rosenlegal.com/cases/phreesia-inc/join or call Phillip Kim, Esq. toll-free at 866-767-3653 or email [email protected] for information on the class action. A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than July 13, 2026. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation.

Why Rosen Law: We encourage investors to select qualified counsel with a track record of success in leadership roles. Often, firms issuing notices do not have comparable experience, resources, or any meaningful peer recognition. Many of these firms do not actually handle securities class actions, but are merely middlemen that refer clients or partner with law firms that actually litigate the cases. Be wise in selecting counsel. The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm has achieved, at that time, the largest ever securities class action settlement against a Chinese Company. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017. The firm has been ranked in the top 4 each year since 2013 and has recovered hundreds of millions of dollars for investors. In 2019 alone the firm secured over $438 million for investors. In 2020, founding partner Laurence Rosen was named by law360 as a Titan of Plaintiffs’ Bar. Many of the firm’s attorneys have been recognized by Lawdragon and Super Lawyers.

Details of the case: According to the lawsuit, throughout the Class Period, defendants made false and/or misleading statements and/or concealed material adverse facts concerning the true state of Phreesia’s slowing demand and reduced visibility in key revenue streams, notably, the weakened pharmaceutical marketing commitments in its Network Solutions segment. When the true details entered the market, the lawsuit claims that investors suffered damages. 

To join the Phreesia class action, go to https://rosenlegal.com/cases/phreesia-inc/join or call Phillip Kim, Esq. toll-free at 866-767-3653 or email [email protected] for information on the class action.

No Class Has Been Certified. Until a class is certified, you are not represented by counsel unless you retain one. You may select counsel of your choice. You may also remain an absent class member and do nothing at this point. An investor’s ability to share in any potential future recovery is not dependent upon serving as lead plaintiff.

Follow us for updates on LinkedIn: https://www.linkedin.com/company/the-rosen-law-firm, on Twitter: https://twitter.com/rosen_firm or on Facebook: https://www.facebook.com/rosenlawfirm/.

Attorney Advertising. Prior results do not guarantee a similar outcome.

Contact Information:
     Laurence Rosen, Esq.
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     The Rosen Law Firm, P.A.
     275 Madison Avenue, 40th Floor
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Oshkosh Defense Highlights Proven, Adaptable Tactical Mobility Solutions for Europe at Eurosatory 2026

Oshkosh Defense Highlights Proven, Adaptable Tactical Mobility Solutions for Europe at Eurosatory 2026

PARIS–(BUSINESS WIRE)–
As European and allied forces accelerate modernization efforts in response to evolving operational threats, Oshkosh Defense LLC, an Oshkosh Corporation [NYSE: OSK] business, will showcase proven tactical mobility solutions at Eurosatory 2026 designed to support interoperability, distributed operations and future battlefield requirements, without the risk and long development timelines of entirely new vehicle programs.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260614504023/en/

Oshkosh Defense Hybrid Electric Joint Light Tactical Vehicle (eJLTV).

Oshkosh Defense Hybrid Electric Joint Light Tactical Vehicle (eJLTV).

For decades, Oshkosh Defense has supported allied military forces with heavy, medium and light tactical vehicle platforms designed to operate across coalition environments. Today, as NATO and European partners prioritize readiness, sustainment resilience and operational flexibility, Oshkosh Defense continues to evolve its proven platforms to meet emerging mission requirements. At Eurosatory 2026, Oshkosh Defense will feature its hybrid electric Joint Light Tactical Vehicle (eJLTV), an advanced capability demonstrator built on the combat-proven JLTV platform currently fielded by the United States and allied nations worldwide. With more than 24,000 JLTVs produced, the platform provides a mature, interoperable foundation capable of adapting to future operational requirements while maintaining commonality across coalition forces. The eJLTV demonstrates how allied forces can modernize tactical mobility capabilities while reducing transition risk, leveraging existing sustainment infrastructure and preserving operational familiarity for deployed forces. The platform integrates hybrid electric capability, onboard exportable power generation, silent watch and silent drive functionality to support distributed operations, next-generation battlefield systems and evolving operational energy requirements.

By building on a fielded and combat-proven platform, Oshkosh Defense offers allied customers a scalable path toward future capability integration without sacrificing reliability, survivability or interoperability. The JLTV platform also creates opportunities for localized sustainment, long-term fleet support and regional operational integration aligned with allied modernization priorities.

“European and allied forces are modernizing under real operational pressure, and they also need solutions that can be fielded, sustained and integrated quickly,” said Pat Williams, Chief Programs Officer at Oshkosh Defense. “The eJLTV demonstrates how Oshkosh Defense can evolve a combat-proven platform to support future power, interoperability and distributed operational requirements without forcing customers to accept the risk and timelines associated with entirely new vehicle programs.”

Attendees can experience the eJLTV and learn more about Oshkosh Defense’s portfolio of advanced tactical mobility solutions and technologies at Eurosatory 2026 in Booth A320 in the USA Pavilion.

About Oshkosh Defense

Oshkosh Defense, an Oshkosh Corporation business [NYSE: OSK], delivers adaptable, connected, and survivable systems critical to the modernization and readiness of the U.S. and its allied forces. As a trusted mobility integrator, Oshkosh brings advanced vehicles, intelligent systems, and mission-critical technologies together into unified solutions built for evolving operational demands. Combining defense expertise with commercial scale, Oshkosh accelerates innovation from development through deployment. And because the mission does not end at fielding, Oshkosh provides global sustainment, lifecycle support, and aftermarket solutions that keep fleets ready while advancing the future of defense mobility.

Learn more at OshkoshDefense.com.

About Oshkosh Corporation

At Oshkosh (NYSE: OSK), we make innovative, purpose-built vehicles and equipment to help everyday heroes advance communities around the world. Headquartered in Wisconsin, Oshkosh Corporation employs over 18,000 team members worldwide, all united behind a common purpose: to make a difference in people’s lives. Oshkosh products can be found in more than 150 countries under the brands of JLG®, Pierce®, MAXIMETAL, Oshkosh® S-Series™, McNeilus®, IMT®, Jerr-Dan®, Frontline™ Communications, Oshkosh® Airport Products, Oshkosh AeroTech™, Oshkosh® Defense and Pratt Miller. For more information, visit oshkoshcorp.com.

Forward Looking Statements

This news release contains statements that the Company believes to be “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact, including, without limitation, statements regarding the Company’s future financial position, business strategy, targets, projected sales, costs, earnings, capital expenditures, debt levels and cash flows, and plans and objectives of management for future operations, are forward-looking statements. When used in this news release, words such as “may,” “will,” “expect,” “intend,” “estimate,” “anticipate,” “believe,” “should,” “project” or “plan” or the negative thereof or variations thereon or similar terminology are generally intended to identify forward-looking statements. These forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties, assumptions, and other factors, some of which are beyond the Company’s control, which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These factors include risks related to the Company’s ability to successfully execute on its strategic road map and meet its long-term financial goals. Additional information concerning these and other factors is contained in the Company’s filings with the Securities and Exchange Commission. All forward-looking statements speak only as of the date of this news release. The Company assumes no obligation, and disclaims any obligation, to update information contained in this news release. Investors should be aware that the Company may not update such information until the Company’s next quarterly earnings conference call, if at all.

Media Contact:

Alexandra Hittle, Communications Director

[email protected]

+1.920.410.1929

KEYWORDS: Wisconsin Europe United States North America France

INDUSTRY KEYWORDS: EV/Electric Vehicles Other Defense Contracts Off-Road Trucks & SUVs Aftermarket Automotive Defense Other Manufacturing Engineering Government Technology Automotive Manufacturing Military Manufacturing

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Oshkosh Defense Hybrid Electric Joint Light Tactical Vehicle (eJLTV).
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Mirum Pharmaceuticals and Incyte Announce Positive Pivotal Phase 2 Results from PROGRESS Study of Zilurgisertib in Fibrodysplasia Ossificans Progressiva

Mirum Pharmaceuticals and Incyte Announce Positive Pivotal Phase 2 Results from PROGRESS Study of Zilurgisertib in Fibrodysplasia Ossificans Progressiva

Cohort 1 results presented at ENDO 2026 demonstrate meaningful reductions in total heterotopic ossification (HO) lesion volume, new HO lesions and flare activity in adolescents and adults with FOP

U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for zilurgisertib in FOP under Priority Review

FOSTER CITY, Calif. & WILMINGTON, Del.–(BUSINESS WIRE)–
Mirum Pharmaceuticals, Inc. (Nasdaq:MIRM) and Incyte (Nasdaq:INCY) today announced pivotal Phase 2 results from Cohort 1 of the PROGRESS study evaluating zilurgisertib, an investigational oral activin receptor-like kinase 2 (ALK2) inhibitor, in adolescents and adults (≥12 years of age) with fibrodysplasia ossificans progressiva (FOP). Results were shared in a late-breaking rapid-fire presentation at ENDO 2026, the Endocrine Society’s annual meeting.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260614539468/en/

Results from Cohort 1 of the PROGRESS study demonstrated a consistent treatment effect across measures of disease activity and durability through Week 48. During the open-label extension, no new HO lesions were observed among patients who continued to receive zilurgisertib or among placebo-treated patients who crossed over to active treatment at Week 24.

“The findings presented at ENDO represent an important milestone for the zilurgisertib program and further strengthen the growing body of clinical evidence supporting its potential as a treatment for FOP,” said Steven Stein, M.D., Executive Vice President, Chief Medical Officer and Head of Late-Stage Development at Incyte.

“People living with FOP and their families urgently need additional treatment options,” said Joanne Quan, M.D., Chief Medical Officer at Mirum Pharmaceuticals. “These results reinforce our confidence in the potential of zilurgisertib and our commitment to working with Incyte to bring this important program forward as we prepare for potential commercialization and support the FOP community.”

Cohort 1 of the PROGRESS study evaluated zilurgisertib 100 mg once-daily in 63 adolescents and adults (≥12 years of age) with FOP. Patients were randomized 1:1 to receive zilurgisertib (n=32) or placebo (n=31) during a 24-week, placebo-controlled, double-blind period, followed by an open-label extension period. Baseline demographics and disease characteristics were generally balanced between treatment groups, with a mean age of approximately 21 years and evidence of recent disease activity prior to enrollment. A total of 61 patients had 48-week whole-body CT scan data available at the time of the open-label extension analysis.

Key efficacy findings included:

  • Fewer patients receiving zilurgisertib developed new HO lesions at Week 24, with an 81% reduction versus placebo (p=0.0986).

  • 99.9% reduction in total volume of new HO lesions in patients receiving zilurgisertib versus placebo at Week 24 (nominal p-value<0.0001).

  • Reduction in total existing HO lesion volume compared with an increase observed in placebo-treated patients at Week 24 (nominal p-value=0.004).

  • Among patients receiving zilurgisertib, no new HO lesions were observed and total HO lesion volume continued to decrease from Week 24 to Week 48.

  • Among patients who crossed over from placebo to zilurgisertib, no new HO lesions were observed and total HO lesion volume decreased from Week 24 to Week 48.

Key Efficacy Findings (Week 24 Placebo-Controlled Period and Week 48 Crossover)

Endpoint

 

Zilurgisertib (ZGB)

(n=32)

Week 24

Placebo

(n=31)

Week 24

Key Finding

Open-Label Extension

Week 48

Number (%) of patients who developed new HO lesions

 

1 (3.1)

5 (16.7)

81% reduction vs placebo

 

No patients with new HO lesions observed at Week 48 (n=61)

P-value

0.0986

 

Mean (SD) total number of new HO lesions

0.06 (0.35)

0.23 (0.63)

Fewer new lesions vs placebo

No new lesions observed (n=61)

Mean (SD) new lesion volume, cm³

 

0.003 (0.02)

6.57 (20.70)

99.9% reduction vs placebo

 

No new lesions observed (n=61)

P-value

<0.0001*

 

Mean (SD) change in total lesion volume, cm³

-3.24 (19.86)

24.64 (51.94)

Reduction vs increase on placebo

 

Continued reduction from Week 24

  • -6.37 (19.43) ZGB (n=32)

  • -5.32 (20.91) crossover (n=29)

P-value

0.004*

 

Mean (SD) new flares (annualized)

2.34 (6.06)

4.55 (7.71)

Lower flare activity vs placebo

Low flare activity maintained

  • 1.01 (3.26) ZGB (n=32)

  • 1.22 (2.54) crossover (n=30)

*Nominal P-value

Zilurgisertib was generally well-tolerated during the 24-week placebo-controlled period of the study. Data showed:

  • Most adverse events were mild or moderate in severity.

  • No adverse events led to treatment discontinuation or dose reduction.

  • Serious adverse events and Grade ≥3 adverse events occurred at low rates in both treatment groups.

  • The most commonly reported adverse events among patients receiving zilurgisertib were FOP flare-up or aching/pain due to FOP (25%), headache (21.9%), upper respiratory tract infection (21.9%), arthralgia (18.8%), epistaxis (12.5%), and nausea (12.5%).

The full abstract is available on the Endocrine Society’s ENDO 2026 website. Detailed analyses are also posted on the Publications & Presentations section of Mirum’s website.

The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for zilurgisertib for the treatment of FOP in patients 12 years of age and older and granted Priority Review. The Prescription Drug User Fee Act (PDUFA) target action date for zilurgisertib is September 26, 2026.

About Zilurgisertib

Zilurgisertib is an investigational, oral, small molecule, activin receptor-like kinase 2 (ALK2) inhibitor in development for the treatment of Fibrodysplasia Ossificans Progressiva (FOP). Zilurgisertib is designed to inhibit the ALK2 receptor, which is abnormally active in most patients with FOP and leads to bone formation in soft tissues, a process known as heterotopic ossification (HO). FOP is an ultra-rare genetic disease that affects approximately 300 patients in the U.S. and 900 worldwide, with diagnosis typically occurring in early childhood. Zilurgisertib was evaluated in the PROGRESS pivotal Phase 2 study, which formed the basis of a new drug application (NDA). The FDA has accepted the NDA for zilurgisertib in FOP under Priority Review with a Prescription Drug User Fee Act (PDUFA) date of September 26, 2026.

Mirum Pharmaceuticals, Inc. licensed zilurgisertib from Incyte for worldwide development and commercialization.

About the PROGRESS Study

PROGRESS is a global, randomized, double-blind, placebo-controlled Phase 2 study evaluating the efficacy and safety of zilurgisertib in patients with fibrodysplasia ossificans progressiva (FOP). PROGRESS Cohort 1 enrolled patients 12 years of age and older who were randomized 1:1 to receive zilurgisertib 100 mg once daily or placebo during a 24-week double-blind treatment period, followed by an open-label extension. Additional PROGRESS cohorts will evaluate the efficacy and safety of zilurgisertib in patients ages 6 to <12 years of age (Cohort 2) and in patients ages 2 to <12 years of age (Cohort 3).

The primary endpoint of the study is the proportion of Cohort 1 patients with new heterotopic ossification (HO) lesions at Week 24 as assessed by whole-body CT scan data. Key secondary endpoints include the number and total volume of new HO lesions, changes in total HO lesion volume and flare activity through Week 24.

About Mirum Pharmaceuticals

Mirum Pharmaceuticals (NASDAQ: MIRM) is a leading rare disease company with a global footprint of approved products and a broad pipeline of investigational medicines. Purpose-built to bring forward breakthrough medicines for people with overlooked conditions, Mirum focuses on rare liver and rare genetic diseases, where it has built deep expertise and strong connections to patient communities. The company’s commercial portfolio includes LIVMARLI® (maralixibat) for Alagille syndrome (ALGS) and progressive familial intrahepatic cholestasis (PFIC), CHOLBAM® (cholic acid) for bile-acid synthesis disorders, and CTEXLI® (chenodiol) for cerebrotendinous xanthomatosis (CTX).

Mirum’s clinical-stage pipeline includes volixibat, an IBAT inhibitor in late-stage development for primary sclerosing cholangitis (PSC) and primary biliary cholangitis (PBC), brelovitug, a fully human monoclonal antibody in late-stage development for chronic hepatitis delta virus (HDV), zilurgisertib, an ALK2 inhibitor under regulatory review with the FDA for fibrodysplasia ossificans progressiva (FOP), and MRM-3379, a PDE4D inhibitor being evaluated for Fragile X syndrome (FXS).

Mirum’s success is driven by a team dedicated to advancing high impact medicines through strategic development, disciplined execution and purposeful collaboration across the rare disease ecosystem. Learn more at www.mirumpharma.com and follow Mirum on Facebook, LinkedIn, Instagram and X.

About Incyte®

Incyte is redefining what’s possible in biopharmaceutical innovation. Through deep scientific expertise and a relentless focus on patients, we have built an established portfolio of first-in-class medicines and an extensive portfolio of next-generation medicines across our key franchises: Hematology, Oncology and Inflammation & Autoimmunity.

To learn more, visit Incyte.com and Investor.Incyte.com. Follow us on social media: LinkedIn, X and Instagram.

Mirum Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things,the Company’s planned participation at a scientific congress, Mirum’s continued advancement of zilurgisertib with Incyte, the likelihood of a FDA approval pathway for zilurgisertib and the potential benefit of zilurgisertib in real world settings versus scientific presentations of data. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “expected,” “will,” “could,” “would,” “guidance,” “potential,” “continue” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Mirum’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with Mirum’s business in general, the impact of geopolitical and macroeconomic events, and the other risks described in Mirum’s Annual Report for the year ended December 31, 2025, filed with the Securities and Exchange Commission on February 25, 2026, and subsequent filings with the Securities and Exchange Commission, which are available at www.sec.gov. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Mirum undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

Incyte Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the presentation of data from the PROGRESS study; the potential for zilurgisertib to become a treatment option for people living with FOP; expectations regarding ongoing and future clinical trials for zilurgisertib, including the timing of such trials; and Incyte’s aspirations and goals as set forth under the heading “About Incyte.”

Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including the sufficiency of clinical trial data to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials and the ability to enroll subjects in accordance with planned schedules; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; the efficacy or safety of Incyte’s and its partners’ products; the ability of Incyte and its partners to achieve commercial success for their marketed products and product candidates, if approved; Incyte’s and its partners’ ability to obtain and maintain protection of intellectual property for their products and technology; Incyte’s reliance on third parties and partners; the acceptance of Incyte’s and its partners’ products in the marketplace; market competition, sales, marketing, manufacturing and distribution requirements; greater than expected expenses, including expenses relating to litigation or strategic activities; and those risks and uncertainties discussed in greater detail in Incyte’s reports filed with the U.S. Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2025, and its quarterly report on Form 10-Q for the quarter ended March 31, 2026. Incyte disclaims any intent or obligation to update these forward-looking statements.

Mirum and the Mirum logo are trademarks of Mirum Pharmaceuticals, Inc.

Mirum Investor Contact:

Andrew McKibben

[email protected]

Mirum Media Contact:

Meredith Kiernan

[email protected]

Incyte Investor Contact:

[email protected]

Incyte Media Contact:

[email protected]

KEYWORDS: Delaware Illinois California United States North America

INDUSTRY KEYWORDS: Health FDA Clinical Trials Research Science Pharmaceutical Biotechnology

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Crinetics Presents Full Results From Phase 2 Trial of Atumelnant in Congenital Adrenal Hyperplasia (CAH) in Oral Presentation at ENDO 2026

Data show investigational atumelnant drove sustained androgen reductions while enabling lowering of glucocorticoid supplementation to physiologically normal levels in adults with classic CAH

New results from the Phase 1b/2a ACTH-dependent Cushing’s syndrome trial also presented, showing atumelnant rapidly lowered early morning cortisol and normalized urinary free cortisol levels even at lower dose

SAN DIEGO, June 14, 2026 (GLOBE NEWSWIRE) — Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) presented data today from the open-label, Phase 2 congenital adrenal hyperplasia (CAH) adult study of investigational atumelnant, a novel, once-daily oral adrenocorticotropic hormone (ACTH) receptor antagonist candidate being developed for the treatment of classic CAH and ACTH-dependent Cushing’s syndrome. The findings were included in an oral presentation titled “Once Daily Atumelnant (CRN04894) Enables Lowering of Glucocorticoid Doses with Sustained Androgen Reduction in Adults with Congenital Adrenal Hyperplasia” at Endocrine Society’s Annual Meeting, ENDO 2026.

“Atumelnant is designed to block the effect of excess ACTH, the fundamental driver of symptoms and complications of CAH and ADCS,” said Dr. Alan Krasner, M.D., Chief Endocrinologist, Crinetics. “Based on promising results from phase 2 clinical trials presented today, we are advancing atumelnant into late phase clinical development. The data suggest atumelnant could represent a uniquely effective and simple to use oral therapy for many patients who need new options.”

“It’s exciting to see that glucocorticoid dose reduction did not impact the atumelnant-induced decline in androstenedione in adults with classic CAH who participated in this Phase 2 trial,” said Dr. Umasuthan Srirangalingam, Consultant Physician in Endocrinology and Diabetes at University College London Hospitals NHS Foundation Trust and TouCAHn Investigator. “We are looking forward to learning more about the full potential of atumelnant in the treatment of CAH from adult and pediatric Phase 3 trials that are already underway.”

At ENDO 2026, findings from Cohort 4 of the Phase 2 CAH trial were presented for the first time, including the percent change from baseline in morning serum A4, 11-OHA4, and 11-KT with GC reduction. Participants in Cohort 4 received dosing of 80 mg once daily in the morning. Beginning at week 2 of treatment, each participant’s previous GC dose was reduced stepwise by 5-10 mg HC equivalents, independent of A4 measurement, to target <11 mg/m2/day HC equivalents.

Phase 2 CAH Cohort 4 Results

  • At week 12, the mean percentage change from baseline in A4 morning serum levels in Cohort 4 was -67%.
  • Seven out of eight participants (88%) who completed 12 weeks of treatment achieved a physiologic daily dose of GC.
  • Reductions in pre-GC serum 11-OHA4 and 11-KT were rapid and sustained, with mean change from baseline of -64% and -56% at week 12, respectively.
  • Morning dosing of atumelnant resulted in similar androgen reductions as seen in previous cohorts with evening administration.

Atumelnant was generally well tolerated with no treatment-related severe or serious adverse events to date, irrespective of disease severity or dose level.

Initial findings from the adult Phase 2 trial in CAH, including A4 reduction levels compared to baseline for cohorts 1-3, in which participants did not change previous GC doses, were presented at ENDO 2025.

Topline results from Cohort 4 were announced in January 2026.

Previously Reported A4 Reductions for Cohorts 1-3 (no GC reduction)

Atumelnant, Dosed Once Daily Mean A4 Change from Baseline
40 mg (n=11) -58%
80 mg (n=11) -70%
120 mg (n=6) -80%

New Phase 1b/2a ADCS Trial Results

Data presented at ENDO 2026 include findings from a cohort dosed with atumelnant 40 mg once daily (n=6). Findings include:

  • Atumelnant rapidly lowered early morning serum cortisol in all participants.
  • Atumelnant also rapidly lowered UFC. At the end of the 10-day dosing period, UFC remained ≤ upper limit of normal (ULN) in 3/6 participants.
  • Most AEs were mild to moderate and consistent with symptoms of adrenal insufficiency. Most improved with initiation of GC replacement.

Atumelnant ENDO 2026 presentations can be found at: https://crinetics.com/news-events/endo-2026/

About Atumelnant

Atumelnant, Crinetics’ second investigational compound, is the first once-daily, oral adrenocorticotropic hormone (ACTH) receptor antagonist that acts selectively at the melanocortin type 2 receptor (MC2R) on the adrenal gland. Diseases associated with excess ACTH can have significant impact on physical and mental health. Atumelnant has exhibited strong binding affinity for MC2R in preclinical models and has demonstrated suppression of adrenally derived glucocorticoids and androgens that are under the control of ACTH. Data from a 12-week Phase 2 study demonstrated compelling treatment benefits of atumelnant, evidenced by the rapid, substantial and sustained statistically significant reductions in key CAH disease related biomarkers, including androstenedione and 17-hydroxyprogesterone, in a diverse population. Atumelnant is in development for congenital adrenal hyperplasia and ACTH-dependent Cushing’s syndrome, with the Phase 3 CALM-CAH trial and a Phase 1/2b trial in ADCS currently enrolling patients.

About the Phase 2 TouCAHn Trial (CAH)

The TouCAHn trial is an open-label, global, Phase 2 study designed to evaluate the efficacy, safety, and pharmacokinetics of atumelnant when administered for 12 weeks in people with classic CAH (21-hydroxylase deficiency). A total of 38 participants were enrolled, with a median A4 of 980.8 (range=116-2755) ng/dL were enrolled in four cohorts: (40 mg, n=11; 80 mg, n=11; 120 mg, n=6; 80 mg morning dosing with GC reduction, n=10).

Primary endpoints included change from baseline in morning serum androstenedione (A4) levels and incidence of treatment-emergent adverse events. Percent change-from-baseline in GC daily dose was an exploratory endpoint for Cohort 4.

About the Phase 1b/2a Study in ACTH-dependent Cushing’s Syndrome

The Phase 1b/2a, is the first-in-disease, open-label, multiple-ascending dose exploratory study to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamic biomarker responses associated with atumelnant over a 10-day inpatient treatment period in participants with ACTH-dependent Cushing’s syndrome.

The study is being conducted in collaboration with the National Institutes of Health and led by Dr. Lynnette Nieman. Participants received oral atumelnant once daily for 10 days, followed by monitoring during four wash-out days.

About Crinetics Pharmaceuticals 

Crinetics Pharmaceuticals is a global pharmaceutical company committed to transforming the treatment of endocrine diseases and endocrine-related tumors through science rooted in patient needs. Crinetics is focused on discovering, developing, and commercializing novel therapies, with a core expertise in targeting G-protein coupled receptors (GPCRs) with small molecules that have specifically tailored pharmacology and properties.

Crinetics’ first commercial product, PALSONIFY™ (paltusotine), is the first once-daily, oral treatment approved by the U.S. FDA and EMA for the treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option. Paltusotine is also in clinical development for carcinoid syndrome associated with neuroendocrine tumors. Crinetics’ deep pipeline of 10+ disclosed programs includes late-stage investigational candidate atumelnant, which is currently in development for congenital adrenal hyperplasia and ACTH-dependent Cushing’s syndrome, and CRN09682, a nonpeptide drug conjugate candidate that is being developed to treat somatostatin receptor 2 (SST2) expressing neuroendocrine tumors and other SST2 expressing solid tumors. Additional discovery programs are focused on a variety of endocrine targets such as thyroid stimulating hormone (TSH), parathyroid hormone (PTH), somatostatin receptor 3 (SST3), growth hormone (GH), glucagon-like peptide-1 (GLP-1), and glucose-dependent insulinotropic polypeptide (GIP), as well as GPCR-targeted oncology indications.

Forward-Looking Statements 

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this press release are forward-looking statements, including statements regarding the plans and timelines for the clinical development of atumelnant for congenital adrenal hyperplasia and ACTH-dependent Cushing’s syndrome and paltusotine for the treatment of carcinoid syndrome; or the potential for our development candidates to transition to clinical development. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential,” “upcoming” or “continue” or the negative of these terms or other similar expressions. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including, without limitation, we may not be able to obtain, maintain and enforce our patents and other intellectual property rights, and it may be prohibitively difficult or costly to protect such rights; geopolitical events may disrupt Crinetics’ business and that of the third parties on which it depends, including delaying or otherwise disrupting clinical studies and preclinical studies, manufacturing and supply chain, or impairing employee productivity; unexpected adverse side effects, complications and/or drug interactions or inadequate efficacy of the Company’s product candidates that may limit their development, regulatory approval and/or commercialization; the Company’s dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; regulatory developments or political changes, including policies related to pricing and pharmaceutical drug reimbursement, in the United States and foreign countries; the timing and outcome of research, development and regulatory review is uncertain, and Crinetics’ drug candidates may not advance in development or be approved for marketing; Crinetics may use its capital resources sooner than expected or our cash burn rate may accelerate; any future impacts to our business resulting from geopolitical developments outside our control; and the other risks and uncertainties described in the Company’s periodic filings with the Securities and Exchange Commission (SEC). The events and circumstances reflected in the company’s forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Additional information on risks facing Crinetics can be found under the heading “Risk Factors” in Crinetics’ periodic filings with the SEC, including its annual report on Form 10-K for the year ended December 31, 2025. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by applicable law, Crinetics does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
 

Media: 

Natalie Badillo 
Head of Corporate Communications 
[email protected] 
(858) 345-6075 

Investors: 

Gyathri Diwakar 
Head of Investor Relations 
[email protected] 
(858) 345-6340 



Crinetics Presents Long Term Data at ENDO 2026 Confirming PALSONIFY™ (paltusotine) Provides Durable, Consistent Acromegaly Control

Data from up to two years of treatment in PATHFNDR-1 and PATHFNDR-2 open-label extension studies show PALSONIFY maintained lower IGF-1 levels and stable symptoms

Treatment also resulted in stable or reduced pituitary tumor volumes for up to 48 weeks

Additional ENDO highlights include long-term ACROBAT data demonstrating PALSONIFY and cabergoline combination improves biochemical control of acromegaly

SAN DIEGO, June 14, 2026 (GLOBE NEWSWIRE) — Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced new long-term data from its clinical development program evaluating novel PALSONIFYTM (paltusotine) in acromegaly during an oral presentation at the Endocrine Society’s Annual Meeting, ENDO 2026. Notably, pooled data from the open-label extension (OLE) trials of PATHFNDR-1 and PATHFNDR-2 show that after two years of treatment, PALSONIFY was effective and well-tolerated in patients who were switched from standard-of-care monthly injectable somatostatin receptor ligands (SRLs) and those who were medically untreated, respectively, when oral, once-daily PALSONIFY was initiated.

“To assess acromegaly disease control while on medication, endocrinologists carefully monitor control of IGF-1 levels, control of acromegaly symptoms, and stabilization of pituitary tumors,” said Dr. Alan Krasner, M.D., Chief Endocrinologist, Crinetics. “At this year’s ENDO meeting, long-term safety and efficacy data from the PATHFNDR OLE trials will be presented. These studies indicate that Palsonify is well tolerated and maintains control of all three aspects of disease control with long-term follow-up. Since its launch late last year, we are learning that Palsonify is already making a meaningful difference in the lives of many people with acromegaly, and we hope these data will be helpful for patients and for their health care providers.”


Pooled OLE Efficacy and Safety Results

PATHFNDR-1 Data

The PATHFNDR-1 Phase 3 trial enrolled adults with acromegaly who were biochemically controlled on monthly injectable SRLs. Following a 36-week randomized, placebo-controlled period, 53 of 57 participants (93%) entered the ongoing single-arm open-label extension (OLE) trial.

Baseline mean IGF-1 levels for OLE participants (n=53) was 0.91x Upper Limit of Normal (ULN). These levels remained stable at both 48 weeks (n=50) and 96 weeks (n=47) of the study: 0.82x ULN and 0.81, respectively. Symptoms associated with acromegaly, as measured by the Acromegaly Symptom Diary (ASD), remained stable from baseline at assessed timepoints. Additionally, pituitary tumor volumes were reported as stable in all patients at week 48, relative to OLE baseline.

PATHFNDR-2 Data

The PATHFNDR-2 trial evaluated once-daily oral PALSONIFY in adults with biochemically uncontrolled acromegaly (baseline IGF-1 > 1.3 × ULN). After a 24-week randomized controlled (RC period, 103 of 106 completers (97.2%) entered the ongoing OLE, along with 11 additional patients who were eligible for the RC phase but enrolled directly into the OLE.

Baseline mean IGF-1 levels for OLE participants (n=114) was 1.64×ULN. These levels decreased from baseline at both 48 weeks (n=98) and 72 weeks (n=78) of the study: 1.06×ULN and 0.96×ULN, respectively.

Relative to OLE baseline, pituitary tumor volume was reduced by >20% in 7 of 83 PATHFNDR-2 patients with available MRI scans at OLE Week 24. Tumor volume was reported as stable in the other 76 participants.

In both OLEs, median ASD scores were stable at the timepoints assessed. Symptoms associated with acromegaly, as measured by the Acromegaly Symptom Diary (ASD), remained stable from baseline at assessed timepoints.

No new safety signals were found. In the pooled OLE population (n=167), the most common adverse events (incidence>10%) were diarrhea (15.6%), arthralgia (11.4%), headache (11.4%), and urinary tract infection (10.2%). Four patients (2.4%) discontinued from an OLE due to adverse events as of this analysis.

These results were included in an oral presentation at ENDO 2026 titled “Efficacy and Safety of Once-Daily Oral Paltusotine in Patients with Acromegaly: Up to 2 Years in the PATHFNDR-1 and PATHFNDR-2 Open-Label Extension Studies.”

Additionally, an analysis was presented at ENDO 2026 that evaluated the safety and efficacy of PALSONIFY in combination with oral cabergoline in patients with acromegaly who have been followed for up to four years in ACROBAT Advance, an ongoing, single-arm, open-label extension phase 2 study. IGF-I levels on paltusotine monotherapy were similar to parent study baseline values (on injected SRL), but for those in whom IGF-1 had not yet normalized, it further improved when oral cabergoline was added. Combination therapy was well tolerated.

Crinetics’ ENDO 2026 presentations can be found at: https://crinetics.com/news-events/endo-2026/

PALSONIFY™ (paltusotine) INDICATION:

PALSONIFY is a somatostatin receptor agonist indicated for the treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS:

  • Cholelithiasis and Its Complications: Cholelithiasis, including related complications such as acute cholecystitis and pancreatitis, have been reported. Monitor patients periodically. Discontinue PALSONIFY if complications of cholelithiasis occur and treat appropriately.
  • Hyperglycemia and Hypoglycemia: Hyperglycemia, diabetes mellitus, or hypoglycemia, may occur. Monitor blood glucose levels when PALSONIFY treatment is initiated or when dosage is altered. Adjust antidiabetic treatment accordingly.
  • Cardiovascular Abnormalities: Cardiac conduction abnormalities and other ECG changes such as PR interval prolongation, bradycardia, sinus arrest, and atrioventricular block may occur in patients with acromegaly and were reported in PALSONIFY clinical trials. Dosage adjustments of concomitant drugs that have bradycardic effects may be necessary.
  • Thyroid Function Abnormalities: Somatostatin analogs may suppress the secretion of thyroid-stimulating hormone, which may result in hypothyroidism. Periodic assessment of thyroid function is recommended.
  • Steatorrhea and Malabsorption of Dietary Fats: Somatostatin analog treatment may result in malabsorption of dietary fats and subsequent symptoms of steatorrhea, loose stools, abdominal bloating, and weight loss. If new or worsening symptoms are reported with PALSONIFY, evaluate patients for potential pancreatic exocrine insufficiency and manage accordingly.
  • Vitamin B12 Deficiency: Vitamin B12 deficiency may occur. Monitor vitamin B12 levels, if clinically indicated.

ADVERSE REACTIONS:

Most common adverse reactions (>5%) are diarrhea, abdominal pain, nausea, decreased appetite, sinus bradycardia, hyperglycemia, palpitations, and gastroenteritis.

DRUG INTERACTIONS:

  • Strong or Moderate CYP3A4 Inducers: may decrease PALSONIFY exposure. May require an increased dosage of PALSONIFY.
  • Proton Pump Inhibitors: may decrease PALSONIFY exposure. May require an increased dosage of PALSONIFY. Avoid concomitant use of proton pump inhibitors in patients who are already on PALSONIFY 60 mg.
  • Cyclosporine: may decrease cyclosporine exposure. May require cyclosporine dosage adjustment when used with PALSONIFY; follow therapeutic monitoring recommendations.

Please report adverse events to Crinetics Pharmaceuticals at 1-833-CRN-INFO (1-833-276-4636) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.ww.fda.gov/medwatch.

Please see 

Full Prescribing Information

 including 

Patient Information

.

About
PALSONIFY™ (Paltusotine) 

PALSONIFY, a selectively-targeted somatostatin receptor type 2 (SST2) nonpeptide agonist, is the first and only once-daily, oral therapy approved for the treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option. In Phase 3 studies, once-daily, oral PALSONIFY maintained IGF-1 levels and symptom control in patients with acromegaly who were switched from monthly injectable medications (PATHFNDR-1) and rapidly decreased IGF-1 levels and symptom burden in medically untreated acromegaly patients (PATHFNDR-2). IGF-1 is the primary biomarker endocrinologists use to manage acromegaly patients. Paltusotine is also in Phase 3 clinical development for carcinoid syndrome associated with neuroendocrine tumors (CAREFNDR). Results from a Phase 2 study in carcinoid syndrome demonstrated rapid and sustained reductions in flushing episodes and bowel movement frequency, which are the most common symptoms of carcinoid syndrome.

PALSONIFY is approved in the U.S. for the first-line treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option. It is also approved for use in the EU for the medical treatment of adult patients with acromegaly.

About Crinetics Pharmaceuticals 
Crinetics Pharmaceuticals is a global pharmaceutical company committed to transforming the treatment of endocrine diseases and endocrine-related tumors through science rooted in patient needs. Crinetics is focused on discovering, developing, and commercializing novel therapies, with a core expertise in targeting G-protein coupled receptors (GPCRs) with small molecules that have specifically tailored pharmacology and properties.

Crinetics’ first commercial product, PALSONIFY™ (paltusotine), is the first once-daily, oral treatment approved by the U.S. FDA and EMA for the treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option. Paltusotine is also in clinical development for carcinoid syndrome associated with neuroendocrine tumors. Crinetics’ deep pipeline of 10+ disclosed programs includes late-stage investigational candidate atumelnant, which is currently in development for congenital adrenal hyperplasia and ACTH-dependent Cushing’s syndrome, and CRN09682, a nonpeptide drug conjugate candidate that is being developed to treat somatostatin receptor 2 (SST2) expressing neuroendocrine tumors and other SST2 expressing solid tumors. Additional discovery programs are focused on a variety of endocrine targets such as thyroid stimulating hormone (TSH), parathyroid hormone (PTH), somatostatin receptor 3 (SST3), growth hormone (GH), glucagon-like peptide-1 (GLP-1), and glucose-dependent insulinotropic polypeptide (GIP), as well as GPCR-targeted oncology indications.

Forward-Looking Statements 
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this press release are forward-looking statements, including statements regarding the plans and timelines for the clinical development of atumelnant for congenital adrenal hyperplasia and ACTH-dependent Cushing’s syndrome and PALSONIFY for carcinoid syndrome, including the therapeutic potential and clinical benefits or safety profile thereof; and the therapeutic potential for our development candidates. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential,” “upcoming” or “continue” or the negative of these terms or other similar expressions. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including, without limitation, initial or topline data that we report may change following completion or a more comprehensive review of the data related to the clinical studies and such data may not accurately reflect the complete results of a clinical study, and the FDA and other regulatory authorities may not agree with our interpretation of such results; geopolitical events may disrupt Crinetics’ business and that of the third parties on which it depends, including delaying or otherwise disrupting its clinical studies and preclinical studies, manufacturing and supply chain, or impairing employee productivity; the success of Crinetics’ clinical studies and nonclinical studies; regulatory developments in the United States and foreign countries; clinical studies and preclinical studies may not proceed at the time or in the manner expected, or at all; the timing and outcome of research, development and regulatory review is uncertain, and Crinetics’ drug candidates may not advance in development or be approved for marketing; and the other risks and uncertainties described in the Company’s periodic filings with the Securities and Exchange Commission (SEC). The events and circumstances reflected in the company’s forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Additional information on risks facing Crinetics can be found under the heading “Risk Factors” in Crinetics’ periodic filings with the SEC, including its annual report on Form 10-K for the year ended December 31, 2025 and quarterly report on Form 10-Q for the quarter ended March 31, 2026. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by applicable law, Crinetics does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Contact:  

Media:  
Natalie Badillo  
Head of Corporate Communications  
[email protected]  
(858) 345-6075   

Investors:  
Gayathri Diwakar  
Head of Investor Relations  
[email protected]  
(858) 345-6340  



VRRM Investors Have Opportunity to Lead Verra Mobility Corporation Securities Fraud Lawsuit

PR Newswire

NEW YORK, June 14, 2026 /PRNewswire/ —

Rosen Law Firm Logo

Why: Rosen Law Firm, a global investor rights law firm, announces a class action lawsuit on behalf of purchasers of common stock of Verra Mobility Corporation (NASDAQ: VRRM) between February 24, 2026 and May 26, 2026, inclusive (the “Class Period”). A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than August 4, 2026.

So what: If you purchased Verra Mobility common stock during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement.

What to do next: To join the Verra Mobility class action, go to https://rosenlegal.com/cases/verra-mobility-corporation-2026/join or call Phillip Kim, Esq. toll-free at 866-767-3653 or email [email protected] for information on the class action. A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than August 4, 2026. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation.

Why Rosen Law: We encourage investors to select qualified counsel with a track record of success in leadership roles. Often, firms issuing notices do not have comparable experience, resources, or any meaningful peer recognition. Be wise in selecting counsel. The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm has achieved, at that time, the largest ever securities class action settlement against a Chinese Company. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017. The firm has been ranked in the top 4 each year since 2013 and has recovered hundreds of millions of dollars for investors. In 2019 alone the firm secured over $438 million for investors. In 2020, founding partner Laurence Rosen was named by law360 as a Titan of Plaintiffs’ Bar. Many of the firm’s attorneys have been recognized by Lawdragon and Super Lawyers.

Details of the case: According to the complaint, defendants provided overwhelmingly positive statements to investors while, at the same time, disseminating materially false and misleading statements and/or concealing material adverse facts concerning the true state of Verra’s relationship with Avis Budget Group (“Avis”), and in particular obtaining a contract extension with Avis. Further, the Company minimized concerns that major rent-a-cars could replace Verra with in-house solutions or outsourced alternatives. When the true details entered the market, the lawsuit claims that investors suffered damages. 

To join the Verra Mobility class action, go to https://rosenlegal.com/cases/verra-mobility-corporation-2026/join or call Phillip Kim, Esq. toll-free at 866-767-3653 or email [email protected] for information on the class action.

No Class Has Been Certified. Until a class is certified, you are not represented by counsel unless you retain one. You may select counsel of your choice. You may also remain an absent class member and do nothing at this point. An investor’s ability to share in any potential future recovery is not dependent upon serving as lead plaintiff.

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Attorney Advertising. Prior results do not guarantee a similar outcome.

Contact Information:
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