Kayne Anderson Energy Infrastructure Fund Provides Unaudited Balance Sheet Information and Announces Its Net Asset Value and Asset Coverage Ratios as of April 30, 2026

HOUSTON, May 01, 2026 (GLOBE NEWSWIRE) — Kayne Anderson Energy Infrastructure Fund, Inc. (the “Company”) (NYSE: KYN) today provided a summary unaudited statement of assets and liabilities and announced its net asset value and asset coverage ratios under the Investment Company Act of 1940 (the “1940 Act”) as of April 30, 2026.

As of April 30, 2026, the Company’s net assets were $2.8 billion, and its net asset value per share was $16.62. As of April 30, 2026, the Company’s asset coverage ratio under the 1940 Act with respect to senior securities representing indebtedness was 676% and the Company’s asset coverage ratio under the 1940 Act with respect to total leverage (debt and preferred stock) was 520%.

STATEMENT OF ASSETS AND LIABILITIES

APRIL 30, 2026   // (UNAUDITED)
 
    (in millions)
Investments   $ 3,921.0  
Cash and cash equivalents     13.1  
Accrued income     7.2  
Current tax asset, net     2.3  
Other assets     1.0  
Total assets     3,944.6  
     
Credit facility     115.0  
Notes     400.0  
Unamortized notes issuance costs     (2.8 )
Preferred stock     153.6  
Unamortized preferred stock issuance costs     (0.9 )
Total leverage     664.9  
     
Payable for securities purchased     1.8  
Other liabilities     15.9  
Deferred tax liability, net     450.6  
Total liabilities     468.3  
     
Net assets   $ 2,811.4  
     

The Company had 169,126,038 common shares outstanding as of April 30, 2026.

Long-term investments were comprised of Midstream Energy Companies (94%), Power Infrastructure Companies (4%) and Other (2%).

The Company’s ten largest holdings by issuer at April 30, 2026 were:

        Amount
(in millions)
% Long-Term
Investments
1. Enterprise Products Partners L.P. (Midstream Energy Company)     $393.8   10.0%  
2. Energy Transfer LP (Midstream Energy Company)     385.0   9.8%  
3. The Williams Companies, Inc. (Midstream Energy Company)     379.5   9.7%  
4. Cheniere Energy, Inc. (Midstream Energy Company)     336.3   8.6%  
5. MPLX LP (Midstream Energy Company)     310.9   7.9%  
6. Enbridge Inc. (Midstream Energy Company)     263.4   6.7%  
7. ONEOK, Inc. (Midstream Energy Company)     261.5   6.7%  
8. Kinder Morgan, Inc. (Midstream Energy Company)     235.4   6.0%  
9. TC Energy Corporation (Midstream Energy Company)     225.3   5.7%  
10. Targa Resources Corp. (Midstream Energy Company)     161.5   4.1%  
               

Portfolio holdings are subject to change without notice. The mention of specific securities is not a recommendation or solicitation for any person to buy, sell or hold any particular security. You can obtain a complete listing of holdings by viewing the Company’s most recent quarterly or annual report.

Kayne Anderson Energy Infrastructure Fund, Inc. (NYSE: KYN) is a non-diversified, closed-end management investment company registered under the Investment Company Act of 1940, as amended, whose common stock is traded on the NYSE. The Company’s investment objective is to provide a high after-tax total return with an emphasis on making cash distributions to stockholders. KYN intends to achieve this objective by investing at least 80% of its total assets in securities of Energy Infrastructure Companies. See Glossary of Key Terms in the Company’s most recent quarterly or annual report for a description of these investment categories and the meaning of capitalized terms.

This press release shall not constitute an offer to sell or a solicitation to buy, nor shall there be any sale of any securities in any jurisdiction in which such offer or sale is not permitted. Nothing contained in this press release is intended to recommend any investment policy or investment strategy or consider any investor’s specific objectives or circumstances. Before investing, please consult with your investment, tax, or legal adviser regarding your individual circumstances.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS: This communication contains statements reflecting assumptions, expectations, projections, intentions, or beliefs about future events. These and other statements not relating strictly to historical or current facts constitute forward-looking statements as defined under the U.S. federal securities laws. Forward-looking statements involve a variety of risks and uncertainties. These risks include but are not limited to changes in economic and political conditions; regulatory and legal changes; energy industry risk; leverage risk; valuation risk; interest rate risk; tax risk; and other risks discussed in detail in the Company’s filings with the SEC, available at 

www.kaynefunds.com

 or 

www.sec.gov

. Actual events could differ materially from these statements or our present expectations or projections. You should not place undue reliance on these forward-looking statements, which speak only as of the date they are made. Kayne Anderson undertakes no obligation to publicly update or revise any forward-looking statements made herein. There is no assurance that the Company’s investment objectives will be attained.

Contact investor relations at 877-657-3863 or [email protected].



Extreme Networks Investigation Continued: Kahn Swick & Foti, LLC Continues to Investigate the Officers and Directors of Extreme Networks, Inc. – EXTR

Extreme Networks Investigation Continued: Kahn Swick & Foti, LLC Continues to Investigate the Officers and Directors of Extreme Networks, Inc. – EXTR

NEW YORK CITY & NEW ORLEANS–(BUSINESS WIRE)–
Former Attorney General of Louisiana, Charles C. Foti, Jr., Esq., a partner at the law firm of Kahn Swick & Foti, LLC (“KSF”), announces that KSF continues its investigation into Extreme Networks, Inc. (NasdaqGS: EXTR).

On January 31, 2024, the Company disclosed disappointing financial results and operational trends for 2Q24 including, among other things, that its revenues for the quarter were $296.4 million, down 7% year-over-year, and that it generated just $186.6 million in product revenue, a decline of 37% year-over-year.

Thereafter, the Company and certain of its executives were sued in a securities class action lawsuit, charging them with failing to disclose material information during the Class Period in violation of federal securities laws. Specifically, the case alleges that Defendants made false and misleading statements about Extreme’s product revenue and backlog between July 27, 2022 and January 30, 2024. Recently, the Court presiding over the case denied the Company’s motion to dismiss the case, allowing the case to move forward.

KSF’s investigation is focusing on whether Extreme’s officers and/or directors breached their fiduciary duties to its shareholders or otherwise violated state or federal laws.

If you have information that would assist KSF in its investigation, or have been a long-term holder of Extreme shares and would like to discuss your legal rights, you may, without obligation or cost to you, call toll-free at 1-833-938-0905 or email KSF Managing Partner Lewis Kahn ([email protected]), or visit https://www.ksfcounsel.com/cases/nasdaqgs-extr/ to learn more.

About Kahn Swick & Foti, LLC

KSF, whose partners include former Louisiana Attorney General Charles C. Foti, Jr., is one of the nation’s premier boutique securities litigation law firms. This past year, KSF was ranked by SCAS among the top 10 firms nationally based upon total settlement value. KSF serves a variety of clients, including public and private institutional investors, and retail investors – in seeking recoveries for investment losses emanating from corporate fraud or malfeasance by publicly traded companies. KSF has offices in New York, Delaware, California, Louisiana, Chicago, New Jersey, and a representative office in Luxembourg.

TOP 10 Plaintiff Law Firms – According to ISS Securities Class Action Services

To learn more about KSF, you may visit www.ksfcounsel.com.

CONNECT WITH US: Facebook || Instagram || YouTube || TikTok || LinkedIn

Kahn Swick & Foti, LLC

Lewis Kahn, Managing Partner

[email protected]

1-877-515-1850

1100 Poydras St., Suite 960

New Orleans, LA 70163

KEYWORDS: Louisiana New York United States North America

INDUSTRY KEYWORDS: Professional Services Class Action Lawsuit

MEDIA:

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Soleno Therapeutics 96 Hour Deadline Alert: Kahn Swick & Foti, LLC Reminds Investors With Losses In Excess Of $100,000 of Deadline in Class Action Lawsuit Against Soleno Therapeutics, Inc. – SLNO

Soleno Therapeutics 96 Hour Deadline Alert: Kahn Swick & Foti, LLC Reminds Investors With Losses In Excess Of $100,000 of Deadline in Class Action Lawsuit Against Soleno Therapeutics, Inc. – SLNO

NEW YORK CITY & NEW ORLEANS–(BUSINESS WIRE)–Kahn Swick & Foti, LLC (“KSF”) and KSF partner, the former Attorney General of Louisiana, Charles C. Foti, Jr., remind investors that they have until May 5, 2026 to file lead plaintiff applications in a securities class action lawsuit against Soleno Therapeutics, Inc. (“Soleno” or the “Company”) (NasdaqCM: SLNO), if they purchased or otherwise acquired the Company’s securities between March 26, 2025 and November 4, 2025, inclusive (the “Class Period”). This action is pending in the United States District Court for the Northern District of California.

What You May Do

If you purchased securities of Soleno and would like to discuss your legal rights and how this case might affect you and your right to recover for your economic loss, you may, without obligation or cost to you, contact KSF Managing Partner Lewis Kahn toll-free at 1-877-515-1850 or via email ([email protected]), or visit https://www.ksfcounsel.com/cases/nasdaqcm-slno/ to learn more. If you wish to serve as a lead plaintiff in this class action by overseeing lead counsel with the goal of obtaining a fair and just resolution, you must request this position by application to the Court by May 5, 2026.

About the Lawsuit

Soleno and certain of its executives are charged with failing to disclose material information during the Class Period, violating federal securities laws.

The alleged false and misleading statements and/or omissions include, but are not limited to, that: (i) The Phase 3 clinical trial program for DCCR, the Company’s only commercial product (for the treatment of hyperphagia in individuals afflicted with Prader-Willi syndrome or “PWS”), systematically minimized, mischaracterized, and/or failed to disclose substantial evidence of potential safety concerns associated with its administration, including indications of excessive fluid retention among clinical trial participants; (ii) as a result, the administration of DCCR to treat hyperphagia in individuals with PWS posed materially greater safety risks than disclosed by the Company; and (iii) consequently, DCCR had materially lower commercial viability and undisclosed risks related to the likelihood of significant and widespread adverse events after its commercial launch, including risks related to patient discontinuation rates, lower patient adoption, prescriber reluctance, adverse regulatory action, and potential reputational and legal fallout.

The case is City of Pontiac Police and Fire Retirement System v. Soleno Therapeutics, Inc., No. 26-cv-01979.

About Kahn Swick & Foti, LLC

KSF, whose partners include former Louisiana Attorney General Charles C. Foti, Jr., is one of the nation’s premier boutique securities litigation law firms. This past year, KSF was ranked by SCAS among the top 10 firms nationally based upon total settlement value. KSF serves a variety of clients, including public and private institutional investors, and retail investors – in seeking recoveries for investment losses emanating from corporate fraud or malfeasance by publicly traded companies. KSF has offices in New York, Delaware, California, Louisiana, Chicago, and a representative office in Luxembourg.

TOP 10 Plaintiff Law Firms – According to ISS Securities Class Action Services

To learn more about KSF, you may visit www.ksfcounsel.com.

CONNECT WITH US: Facebook || Instagram || YouTube || TikTok || LinkedIn

Kahn Swick & Foti, LLC

Lewis Kahn, Managing Partner

[email protected]

1-877-515-1850

1100 Poydras St., Suite 960

New Orleans, LA 70163

KEYWORDS: Louisiana New York United States North America

INDUSTRY KEYWORDS: Professional Services Class Action Lawsuit

MEDIA:

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DigitalBridge Prices $300 Million Financing Facility, to Repay Outstanding Series 2021-1 Notes

DigitalBridge Prices $300 Million Financing Facility, to Repay Outstanding Series 2021-1 Notes

BOCA RATON, Fla.–(BUSINESS WIRE)–
DigitalBridge Group, Inc. (NYSE: DBRG) (the “Company”) today announced two of its subsidiaries, DigitalBridge Issuer, LLC and DigitalBridge Co-Issuer, LLC (together, the “Co-Issuers”) have priced an offering of $300 million aggregate principal amount of Series 2026-1 6.326% Secured Fund Fee Revenue Notes, Class A-2 (the “Class A-2 Notes”). Interest payments on the Class A-2 Notes are payable on a quarterly basis. The anticipated repayment date of the Class A-2 Notes is June 2031. The Class A-2 Notes are expected to be issued by the Co-Issuers in a securitization transaction.

The proceeds from the sale of the Class A-2 Notes, net of the payment of certain offering expenses and the deposits into certain reserve accounts, will be used to repay the outstanding securitization notes of the Co-Issuers.

Additionally, and concurrent with the issuance of the Class A-2 Notes, the Co-Issuers expect to issue Series 2026-1 Secured Fund Fee Revenue Variable Funding Notes, Class A-1 Notes (the “VFN Notes” and, together with the Class A-2 Notes, the “Series 2026-1 Notes”), which will allow the Co-Issuers to borrow up to $100 million on a revolving basis.

The closing of the sale of the Series 2026-1 Notes is expected to occur on May 11, 2026, subject to satisfaction of various closing conditions. There can be no assurance regarding the timing of the closing or that the sale of the Series 2026-1 Notes will be completed.

This press release does not constitute an offer to sell or the solicitation of an offer to buy the Series 2026-1 Notes or any other security, nor will there be any sale of any securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction. The Series 2026-1 Notes have not been, and will not be, registered under the Securities Act of 1933, as amended (the “Securities Act”), or any state securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state securities laws.

About DigitalBridge

DigitalBridge (NYSE: DBRG) is a leading global alternative asset manager dedicated to investing in digital infrastructure. With a heritage of more than 30 years investing in and operating businesses across the digital ecosystem, including cell towers, data centers, fiber, small cells, and edge infrastructure, DigitalBridge manages infrastructure assets on behalf of its limited partners and shareholders. The firm is headquartered in Boca Raton, Florida, with offices across North America, Europe, the Middle East, and Asia. For more information, visit www.digitalbridge.com.

Forward Looking Statement

This press release may contain forward-looking statements within the meaning of the federal securities laws. Forward-looking statements relate to expectations, beliefs, projections, future plans and strategies, anticipated events or trends and similar expressions concerning matters that are not historical facts. In some cases, you can identify forward-looking statements by the use of forward-looking terminology such as “may,” “will,” “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” or “potential” or the negative of these words and phrases or similar words or phrases which are predictions of or indicate future events or trends and which do not relate solely to historical matters. Forward-looking statements involve known and unknown risks, uncertainties, assumptions and contingencies, many of which are beyond our control, and may cause actual results to differ significantly from those expressed in any forward-looking statement. Factors that might cause such a difference include, without limitation, whether the Co-Issuers will consummate the sale of the Series 2026-1 Notes and expected use of proceeds from the sale of the Class A-2 Notes, whether the issuance size of the VFN Notes will increase and other risks and uncertainties, including those detailed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, Quarterly Report on Form 10-Q for the quarter ended March 31, 2026 and its other reports filed from time to time with the U.S. Securities and Exchange Commission. All forward-looking statements reflect the Company’s good faith beliefs, assumptions and expectations, but they are not guarantees of future performance. The Company cautions investors not to unduly rely on any forward-looking statements. The forward-looking statements speak only as of the date of this press release. The Company is under no duty to update any of these forward-looking statements after the date of this press release, nor to conform prior statements to actual results or revised expectations, and the Company does not intend to do so.

Investors:

Severin White

Managing Director

(212) 547-2777

[email protected]

Media:

Joele Frank, Wilkinson Brimmer Katcher

Jon Keehner

(212) 355-4449

[email protected]

KEYWORDS: Florida United States North America

INDUSTRY KEYWORDS: Technology Mobile/Wireless Fintech Telecommunications Professional Services Networks Internet Hardware Asset Management

MEDIA:

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Zentalis Pharmaceuticals Announces Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)

SAN DIEGO, May 01, 2026 (GLOBE NEWSWIRE) — Zentalis® Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical oncology innovator advancing late-stage development of investigational first-in-class WEE1 inhibitor azenosertib as a biomarker-driven treatment approach for ovarian cancer, today announced that on May 1, 2026, the Compensation Committee of Zentalis’ Board of Directors granted non-qualified stock options to purchase an aggregate of 26,000 shares of the Company’s common stock to one (1) newly hired employee. The stock options were granted under the Zentalis Pharmaceuticals, Inc. 2022 Employment Inducement Incentive Award Plan (2022 Inducement Plan) as an inducement material to such individual’s entering into employment with Zentalis in accordance with Nasdaq Listing Rule 5635(c)(4).

The 2022 Inducement Plan is used exclusively for the grant of equity awards to individuals who were not previously employees of Zentalis, or following a bona fide period of non-employment, as an inducement material to each such individual’s entering into employment with Zentalis, pursuant to Nasdaq Listing Rule 5635(c)(4).

The stock options have an exercise price of $4.09 per share, which is equal to the closing price of Zentalis’ common stock on The Nasdaq Global Market on the date of grant. The stock options have a 10-year term and will vest over four years, with 25% of the options vesting on the first anniversary of the vesting commencement date and the remaining 75% of the options vesting in equal monthly installments over the three years thereafter.

Vesting of the stock options is subject to the employee’s continued service to Zentalis on each vesting date.

About Zentalis Pharmaceuticals

Zentalis is a clinical oncology innovator developing a treatment approach for ovarian cancer and multiple tumor types. Leveraging therapeutics development and biomarker expertise, Zentalis is advancing monotherapy and combination studies of its first-in-class WEE1 inhibitor, azenosertib. Focused on translating WEE1 science into clinical practice, we aim to equip physicians with a targeted, non-chemo, orally available medicine that enhances treatment experience, choice, and outcomes. Our mission: to unburden cancer patients with more convenience and care.​

For more information, please visit www.zentalis.com. Follow Zentalis on LinkedIn at www.linkedin.com/company/zentalis-pharmaceuticals.

ZENTALIS

®

 and its associated logo are trademarks of Zentalis and/or its affiliates. All website addresses and other links in this press release are for information only and are not intended to be an active link or to incorporate any website or other information into this press release.

Contact: 
Aron Feingold
VP, Investor Relations & Corporate Communications
[email protected]



Incyte Announces FDA Approval of Jakafi XR™ (ruxolitinib) Extended-Release Tablets for the Treatment of Myelofibrosis, Polycythemia Vera and Graft-Versus-Host Disease

Incyte Announces FDA Approval of Jakafi XR™ (ruxolitinib) Extended-Release Tablets for the Treatment of Myelofibrosis, Polycythemia Vera and Graft-Versus-Host Disease

  • Jakafi XR is a once-daily, film-coated, extended-release formulation of Jakafi®(ruxolitinib)
  • Once-daily Jakafi XR was shown to provide consistent, day-long exposure comparable to twice-daily Jakafi
  • Jakafi XR will be available for pharmacy orders by May 8

WILMINGTON, Del.–(BUSINESS WIRE)–
Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Jakafi XR™ (ruxolitinib) extended-release tablets for the treatment of adults with intermediate- or high-risk myelofibrosis (MF); adults with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea; as well as adults and children aged 12 years and older with steroid-refractory acute graft-versus-host disease (GVHD) or chronic GVHD after failure of one or two lines of systemic therapy.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260501334677/en/

“The approval of Jakafi XR reinforces Incyte’s leadership in hematology and our focus on meeting the evolving needs of patients with myeloproliferative neoplasms (MPNs) and GVHD,” said Bill Meury, Chief Executive Officer, Incyte. “Jakafi XR offers appropriate patients and physicians a once-daily option, expanding choice without changing the well-established role of Jakafi in clinical practice.”

FDA approval was based on a clinical study which demonstrated that a single 55 mg Jakafi XR tablet taken once-daily (QD) is bioequivalent to a single 25 mg Jakafi tablet, the immediate-release (IR) dosage form, taken twice-daily (BID). This means that, based on key measures of steady-state drug exposure, it delivers the same active ingredient at comparable levels throughout the day, indicating the potential for similar clinical benefit.1

The safety of Jakafi XR has been established from adequate and well-controlled studies of Jakafi in adult patients with myelofibrosis, polycythemia vera, and adult and pediatric patients with acute and chronic graft-versus-host-disease. The most common adverse reactions associated with Jakafi in these studies include:

  • For certain patients with MF and PV: low platelet or red blood cell counts, bruising, dizziness, headache and diarrhea;

  • For patients with acute GVHD: low platelet counts, low red or white blood cell counts, infections and swelling;

  • And for patients with chronic GVHD: low red blood cell or platelet counts and infections, including viral infections.2

“Patients living with chronic conditions like MPNs and GVHD often struggle with managing complex treatment regimens or have multiple conditions,” said Naveen Pemmaraju, M.D., Professor of Leukemia, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center. “Since its initial approval in 2011, ruxolitinib has helped transform the treatment landscape for patients with MPNs and GVHD. With the approval of Jakafi XR, appropriate patients now have the choice of a single daily tablet.” Researchers at UT MD Anderson have led several clinical trials in the development of ruxolitinib.

Incyte is committed to supporting patients and removing barriers to access medicines. Eligible patients in the U.S. who are prescribed Jakafi XR have access to IncyteCARES (Connecting to Access, Reimbursement, Education and Support), a comprehensive program offering personalized patient support, including financial assistance and ongoing education and additional resources. More information about IncyteCARES is available by visiting www.incytecares.com or calling 1-855-452-5234, Monday through Friday, from 8 a.m. to 8 p.m. ET.

About Myelofibrosis

Myelofibrosis (MF) is a part of a group of rare, chronic blood cancers called myeloproliferative neoplasms, or MPNs. MF occurs when a bone marrow defect results in an abnormal production of blood cells, causing scar tissue to form, which can lead to severe anemia, weakness, fatigue and an enlarged spleen and liver. MF can result from a progression of other bone marrow diseases, including polycythemia vera and essential thrombocythemia, or it can occur on its own.3

About Polycythemia Vera

Polycythemia Vera (PV) is a part of a group of rare, chronic blood cancers called myeloproliferative neoplasms, or MPNs.3 PV occurs when bone marrow produces too many red blood cells, white blood cells and often platelets. Increased red blood cells and platelets can cause the blood to thicken, leading to an increased risk of blood clotting complications, including deep vein thrombosis, stroke or heart attack.4

About Graft-Versus-Host Disease

Graft-versus-host disease (GVHD) is a condition that can occur after an allogeneic stem cell transplant (the transfer of stem cells from a donor) in which the donated cells initiate an immune response and attack the transplant recipient’s organs, leading to significant morbidity and mortality. There are two major forms of GVHD: acute, which generally occurs within 100 days of transplant, and chronic, which generally occurs after 100 days of transplant. Both forms can affect multiple organ systems, including the skin, gastrointestinal (digestive) tract and liver.5

About Jakafi XR™ (ruxolitinib) Extended-Release Tablets

Jakafi XR™ (ruxolitinib) extended-release tablets are a once-daily (QD) formulation of ruxolitinib, a first-in-class JAK1/JAK2 inhibitor, approved by the U.S. FDA for the treatment of intermediate- or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential thrombocythemia myelofibrosis in adults; polycythemia vera in adults who have had an inadequate response to or are intolerant of hydroxyurea; steroid-refractory acute graft-versus-host disease in adult and pediatric patients 12 years and older; and chronic graft-versus-host disease after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.

It is not known if Jakafi XR is safe or effective in children for treatment of myelofibrosis or polycythemia vera.

Jakafi XR and the Jakafi XR logo are trademarks of Incyte.

About Jakafi® (ruxolitinib)

Jakafi® (ruxolitinib) is a JAK1/JAK2 inhibitor approved by the U.S. FDA for the treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea; intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF in adults; steroid-refractory acute GVHD in adult and pediatric patients 12 years and older; and chronic GVHD after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.

It is not known if Jakafi is safe or effective in children for treatment of myelofibrosis or polycythemia vera.

Jakafi is marketed by Incyte in the U.S. and by Novartis as Jakavi® (ruxolitinib) outside the U.S. Jakafi and the Jakafi logo are registered trademarks of Incyte. Jakavi is a registered trademark of Novartis AG in countries outside the United States.

IMPORTANT SAFETY INFORMATION

JAKAFI or JAKAFI XR can cause serious side effects, including:

Low blood counts: JAKAFIor JAKAFI XRmay cause low platelet, red blood cell, and white blood cell counts. If you develop bleeding, stop taking JAKAFI or JAKAFI XR and call your healthcare provider. Your healthcare provider will do a blood test to check your blood counts before you start and regularly during your treatment. Your healthcare provider may change your dose or stop your treatment based on the results of your blood tests.

Tell your healthcare provider right away if you develop or have worsening symptoms such as:

  • unusual bleeding

  • bruising

  • tiredness

  • shortness of breath

  • a fever

Infection: You may be at risk for developing a serious infection during treatment with JAKAFI or JAKAFI XR. Tell your healthcare provider if you develop any of the following symptoms of infection:

  • chills

  • nausea

  • vomiting

  • aches

  • weakness

  • fever

  • painful skin rash or blisters

Worsening of symptoms after interrupting or stopping treatment. Signs and symptoms of myelofibrosis may worsen after you stop treatment.

Do not interrupt or stop treatment without talking to your healthcare provider. Tell your healthcare provider right away if you have any of the following after stopping treatment:

  • fever

  • trouble breathing

  • weakness

  • night sweats

  • feeling dizzy or lightheaded

  • pain in left upper stomach area or left shoulder

Cancer: Some people have had certain types of non-melanoma skin cancers during treatment with JAKAFI or JAKAFI XR. Your healthcare provider will regularly check your skin during your treatment. Tell your healthcare provider if you develop any new or changing skin lesions during treatment.

Increases in cholesterol: You may have changes in your blood cholesterol levels during treatment with JAKAFI or JAKAFI XR. Your healthcare provider will do blood tests to check your cholesterol levels about every 8 to 12 weeks after you start taking JAKAFI or JAKAFI XR and as needed.

Increased risk of major cardiovascular events such as heart attack, stroke or death in people who have cardiovascular risk factors and who are current or past smokers while using another JAK inhibitor to treat rheumatoid arthritis:

Get emergency help right away if you get any symptoms of a heart attack or stroke during treatment with JAKAFI or JAKAFI XR, including:

  • discomfort in the center of your chest that lasts for more than a few minutes or that goes away and comes back

  • severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw

  • pain or discomfort in your arms, back, neck, jaw, or stomach

  • shortness of breath with or without chest discomfort

  • breaking out in a cold sweat

  • nausea or vomiting

  • feeling lightheaded

  • weakness in one part or on one side of your body

  • slurred speech

Increased risk of blood clots: Blood clots in the veins of your legs (deep vein thrombosis, DVT) or lungs (pulmonary embolism, PE) have happened in people taking another JAK inhibitor for rheumatoid arthritis and may be life-threatening.

Tell your healthcare provider right away if you have any signs and symptoms of blood clots during treatment with JAKAFI or JAKAFI XR, including:

  • swelling, pain, or tenderness in one or both legs

  • sudden, unexplained chest or upper back pain

  • shortness of breath or difficulty breathing

Possible increased risk of new (secondary) cancers: People who take another JAK inhibitor for rheumatoid arthritis have an increased risk of new (secondary) cancers, including lymphoma and other cancers. People who smoke or who smoked in the past have an added risk of new cancers.

The most common side effects of JAKAFI or JAKAFI XR include:

  • for certain types of polycythemia vera (PV) – low platelet or red blood cell counts, bruising, dizziness, headache, and diarrhea

  • for certain types of myelofibrosis (MF) – low platelet or red blood cell counts, bruising, dizziness, headache, and diarrhea

  • for acute GVHD – low platelet counts, low red or white blood cell counts, infections, and swelling

  • for chronic GVHD – low red blood cell or platelet counts and infections, including viral infections

These are not all the possible side effects. Ask your pharmacist or healthcare provider for more information. Call your doctor for medical advice about side effects.

Before taking JAKAFI or JAKAFI XR, tell your healthcare provider about:

  • all the medications, vitamins, and herbal supplements you are taking

  • your medical conditions, including if you

    • have or had low white or red blood cell counts

    • have an infection

    • have or had tuberculosis (TB) or have been in close contact with someone who has TB

    • had shingles (herpes zoster)

    • have or had hepatitis B

    • have a high level of fat in your blood (high blood cholesterol or triglycerides)

    • have or have had a blood clot, heart attack, other heart problems, or stroke

    • are a current or past smoker

    • had cancer

    • have or had liver or kidney problems or are on dialysis. If you are on dialysis, JAKAFI or JAKAFI XR should be taken after your dialysis

    • have any other medical condition

Women should not take JAKAFI or JAKAFI XR while pregnant or planning to become pregnant. Do not breastfeed during treatment with JAKAFI or JAKAFI XR and for 2 weeks after the final dose.

How should I take JAKAFI or JAKAFI XR?

  • Take exactly as your healthcare provider tells you.

  • Do not change your dose or stop taking JAKAFI or JAKAFI XR without first talking to your healthcare provider. If you stop treatment, symptoms of your condition may return.

  • If you miss a dose, take your next dose at your regular time. Do NOT take 2 doses at the same time.

  • You may have regular blood tests during your treatment. Based on the results, your healthcare provider may change your dose or stop JAKAFI or JAKAFI XR.

  • IF YOU ARE PRESCRIBED JAKAFI:

    • Take JAKAFI 2 times a day or exactly as your healthcare provider tells you, with or without food.

    • JAKAFI may also be given through certain nasogastric tubes.

    • Tell your healthcare provider if you cannot take JAKAFI by mouth. Your healthcare provider will decide if you can take JAKAFI through a nasogastric tube. Ask your healthcare provider to give you specific instructions on how to properly take JAKAFI through a nasogastric tube.

  • IF YOU ARE PRESCRIBED JAKAFI XR:

    • Take JAKAFI XR 1 time a day with or without food.

    • Swallow JAKAFI XR whole. Do not split, crush, or chew.

Please see the Full Prescribing Information, including Patient Information, which includes a more complete discussion of the risks associated with JAKAFI or JAKAFI XR at Jakafi.com.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You may also report side effects to Incyte Medical Information at 1-855-463-3463.

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 and Autoimmunity.

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

Incyte is a registered trademark of Incyte.

Forward-Looking Statements

Except for the historical information set forth herein, the matters set forth in this release, including statements regarding when Jakafi XR will be available in pharmacies; Incyte’s leadership in hematology and its commitment to supporting the MPN and GVHD communities, Incyte’s focus on advancing innovative treatments that help address the needs of patients, the potential for Jakafi XR to provide a successful treatment option for patients and offer patients and their providers choice and flexibility and Incyte’s intent to work closely with payers and providers to help ensure access to Jakafi XR, contain predictions, estimates, and other forward-looking statements.

These forward-looking statements are based on Incyte’s current expectations and are subject to risks and uncertainties that may cause actual results to differ materially, including risks and uncertainties regarding research and development of products and product candidates, determinations made by the FDA, EMA and other regulatory agencies, Incyte’s dependence on its relationships with and changes in the plans of its collaboration partners; the efficacy or safety of Incyte’s products, the acceptance of Incyte’s products in the marketplace; market competition, unexpected variations in the demand for Incyte’s products; the effects of announced or unexpected price regulation or limitations on reimbursement or coverage for Incyte’s products, sales, marketing, manufacturing and distribution requirements, including Incyte’s ability to successfully commercialize and build commercial infrastructure for newly approved products and any additional products that become approved; greater than expected expenses, including expenses relating to litigation or strategic activities, variations in foreign currency exchange rates; and other risks detailed in Incyte’s reports filed with the Securities and Exchange Commission, including its annual report on Form 10-K 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

_________________________

1 Gong X, et al. ASH 2025. Poster 5045.

2 Data on File. Incyte Corporation.

3 Blood Cancer United. Myelofibrosis (MF). https://bloodcancerunited.org/blood-cancer/myeloproliferative-neoplasms-mpns/myelofibrosis-mf. Accessed May 2026.

4 Blood Cancer United. Polycythemia vera (PV) https://bloodcancerunited.org/blood-cancer/myeloproliferative-neoplasms-mpns/polycythemia-vera-pv. Accessed May 2026.

5 National Library of Medicine. The European Blood and Marrow Transplantation Textbook for Nurses: Under the Auspices of EBMT. https://www.ncbi.nlm.nih.gov/books/NBK543657/. Accessed May 2026.

 

Media

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Investors

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KEYWORDS: Delaware Europe United States North America

INDUSTRY KEYWORDS: Oncology Health FDA Stem Cells Pharmaceutical Cardiology Biotechnology

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ComEd Reconciliation Filing to Match Cost with Revenues for 2025 and Would Lead to Lower Monthly Bills for Customers

ComEd Reconciliation Filing to Match Cost with Revenues for 2025 and Would Lead to Lower Monthly Bills for Customers

Proposals to ICC would help to lower monthly customer bills in 2027

CHICAGO–(BUSINESS WIRE)–
ComEd has initiated the annual reconciliation process, which matches actual costs of service with revenues. For 2025, ComEd is submitting two reconciliation filings with the Illinois Commerce Commission (ICC), which if approved would lead to a net decrease in charges on 2027 bills relative to this year’s charges.

The first, a revenue reconciliation filed March 20, compares revenues billed last year and the amount approved in ComEd’s current Multi-year Rate Plan. That filing is expected to result in refunds for most residential customers. The second filing, a cost reconciliation submitted today, reflects a true-up of actual 2025 costs associated with customer programs, grid maintenance, and electric service delivery.

“Reconciliation proceedings are a valuable means for ensuring that electricity rates are reasonable and aligned with prudently incurred costs,” said Gil Quiniones, president and CEO, ComEd. “Sometimes this process leads to a credit for customers and sometimes it results in a charge, but it always reflects our commitment to transparency, efficiency and delivering value to the communities we serve.”

If approved by the ICC, the revenue reconciliation filed in March will return $128 million to customers for excess revenues billed during the 2025 service year, reducing the average monthly residential customer bill by $1.09. The refund is driven by higher electricity usage due to weather or load among residential and business customers – not higher rates – and reflects a record stretch of 90-degree-plus days last summer.

In the cost reconciliation filed today, ComEd seeks recovery of $234.3 million in prudently incurred costs associated with operating the grid, supporting customer-driven projects, and implementing state-mandated programs such as beneficial electrification. If approved, the cost reconciliation will decrease charges on the average monthly residential customer bills relative to 2026 by about $.13. When combined with the revenue reconciliation, residential customers would see a total decrease in charges on the average monthly bill of $1.22 from January through December 2027.

ComEd’s annual cost reconciliation is governed by the prior multi-year grid plan that established its current rate structure and is separate from the multi-year grid plan filed in January covering its planned investments for 2028-2031. The reconciliations provide an opportunity to update customers, stakeholders, and elected officials on the latest actions by ComEd to operate responsibly and to keep customer bills as low as possible.

ComEd’s 4.2 million customers are feeling the strain of higher everyday costs, including on their energy bills. While ComEd does not own power plants or control wholesale energy prices, recent PJM capacity auctions are driving higher capacity charges. As a result, beginning June 1, the average residential customer will see an increase of about $2 to $3 per month related to capacity.

Last year’s PJM capacity auction reflects the growing imbalance between supply and demand in the energy market, which results in higher capacity charges passed along to customers. ComEd is actively working with the state of Illinois, PJM, and all other stakeholders to bring long-term solutions to help reduce cost pressures while continuing to deliver safe, reliable power at the lowest possible cost for customers.

In its 2025 annual report of electricity rates for utilities in the top 20 metropolitan areas, the Edison Electric Institute showed ComEd’s rates to be 1.1% below the average of 20.26 cents per kWh.

ComEd has helped families and businesses across northern Illinois save a total of $13 billion on their energy bills through its award-winning ComEd Energy Efficiency Program. It has also introduced other initiatives to help keep customer bills as low as possible, including:

  • the Low-Income Discount (LID) program, which offers qualifying income-eligible ComEd customers percentage-based discounts on their electric bills based on income level up to 300% of the federal poverty level. These discounts are intended to reduce energy costs to 3% to 6% of total household income.

  • the ComEd Delivery Time-of-Day pricing rate, which helps households save money by shifting energy use to times when electricity prices are lower and demand is reduced.

  • the $10 million Customer Relief Fund, which provided bill relief last year to more than 30,000 ComEd customers. Later this year, ComEd plans an extension of the program, which is launched in collaboration with its parent company, Exelon.

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 more than 10.7 million electricity and natural gas customers. ComEd powers the lives of more than 4.2 million customers across northern Illinois, or 70 percent 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 Other Energy Utilities Oil/Gas

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Eupraxia Pharmaceuticals Appoints Dr. Jeymi Tambiah as Chief Medical Officer

VANCOUVER, British Columbia, May 01, 2026 (GLOBE NEWSWIRE) — Eupraxia Pharmaceuticals Inc. (“Eupraxia” or the “Company”) (NASDAQ:EPRX) (TSX:EPRX), a clinical-stage biotechnology company leveraging its proprietary Diffusphere™ technology designed to optimize local, controlled drug delivery for applications with significant unmet need, today announced the appointment of Dr. Jeymi Tambiah as Chief Medical Officer (CMO) as well as the retirement of Dr. Mark Kowalski, Eupraxia’s current CMO.

Dr. Jeymi Tambiah (MB ChB, FRCS, MS, FAPCR, FFPM), is a Board Certified Cardiothoracic Surgeon physician scientist who practiced at Guys and St Thomas’ Hospitals prior to entering the biopharmaceutical industry in 2008. Dr. Tambiah brings over 18 years of experience in clinical development, medical and regulatory strategy, and product commercialization across pharmaceutical and biotechnology organizations.

“I am excited to welcome Dr. Tambiah at such a pivotal development stage for Eupraxia as we advance EP-104GI in Eosinophilic Esophagitis. His extensive development and leadership experience will help drive the late-stage development and expansion of our Gastroenterology pipeline. Jeymi’s deep clinical, regulatory and operational experience add additional core strength to Eupraxia’s executive leadership,” said Dr. James A. Helliwell, Chief Executive Officer of Eupraxia. “I also want to thank Dr. Kowalski for his important contributions in helping bring the company to this clinical stage. On behalf of all of us, I want to thank him for his leadership and wish him the very best in his retirement and his support as a senior consultant through the transition”.

Dr. Tambiah has a strong track record of leading cross functional teams and advancing immunology programs, including novel therapeutics, through key late stage clinical and regulatory milestones.

“Eupraxia is at an exciting development stage with EP-104GI in EOE with several key data catalysts in the near term and the opportunity to expand into other important areas in gastroenterology. With so much opportunity to drive programs in areas of high unmet need into late-stage clinical development, combined with the additional possibilities of the Diffusphere™ platform, I am thrilled to join Eupraxia and work with the team to bring therapies like these to patients,” said Dr Tambiah.

Dr. Tambiah earned his MBChB from the University of Manchester, his Master of Surgery from Imperial College London and trained as a Cardiothoracic Surgery specialist at the London Chest Hospital and at Guys and St Thomas’ Hospitals in the UK. He also completed his Doctorate in Vascular Immunology at Imperial College and is a Fellow of the Royal College of Physicians and Surgeons.

About Eupraxia Pharmaceuticals Inc. 

Eupraxia is a clinical-stage biotechnology company focused on the development of locally delivered, extended-release products that have the potential to address therapeutic areas with high unmet medical need. Diffusphere™, a proprietary, polymer-based micro-sphere technology, is designed to facilitate targeted drug delivery of both existing and novel drugs. The technology is designed to support extended duration of effect and delivery of drugs in a hyper-localized fashion, targeting only the tissues that physicians are wanting to treat. We believe the potential for fewer adverse events may be achieved through the precision targeting and the stable and flat delivery of the active ingredient when using the Diffusphere™ technology, versus the peaks and troughs seen with more traditional drug delivery methods. The precision of Eupraxia’s Diffusphere™ technology platform has the potential to augment and transform existing FDA-approved drugs to improve their safety, tolerability, efficacy and duration of effect. The potential uses in therapeutic areas may go beyond pain and inflammatory gastrointestinal disease, where Eupraxia currently is developing advanced treatments, to also be applicable in oncology, infectious disease and other critical disease areas.

Eupraxia’s EP-104GI is currently in a Phase 1b/2 trial, the RESOLVE trial, for the treatment of EoE. EP-104GI is administered as an injection into the esophageal wall, providing local delivery of drug. This is a unique treatment approach for EoE. Eupraxia also completed a Phase 2b clinical trial (SPRINGBOARD) of EP-104IAR for the treatment of pain due to knee osteoarthritis. The trial met its primary endpoint and three of the four secondary endpoints. In addition, Eupraxia is developing a pipeline of later and earlier-stage long-acting formulations. Potential pipeline indications include candidates for other inflammatory joint indications and oncology, each designed to improve on the activity and tolerability of currently approved drugs. For further details about Eupraxia, please visit the Company’s website at: www.eupraxiapharma.com.

Notice Regarding Forward-looking Statements and Information 

This news release includes forward-looking statements and forward-looking information within the meaning of applicable securities laws. Often, but not always, forward-looking information can be identified by the use of words such as “plans”, “is expected”, “expects”, “suggests”, “indicates”, “scheduled”, “intends”, “contemplates”, “anticipates”, “believes”, “proposes”, “potential” or variations (including negative and grammatical variations) of such words and phrases, or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Forward-looking statements in this news release include statements regarding the Company’s expectations around the benefits of Dr. Tambiah’s appointment as CMO; the interpretation of the 36-week data from the RESOLVE trial, including tissue health and symptom response; the Company’s expected timing of reporting additional data from the RESOLVE trial, including the Phase 2b portion thereof; the Company’s product candidates, including their expected benefits with respect to safety, tolerability, efficacy and duration of effect and their potential use in therapeutic areas beyond pain and inflammatory gastrointestinal disease; the expectations regarding the advancement of the Company’s product candidates through clinical development; the results of clinical trials of the Company’s product candidates; the potential for the Company’s technology to impact the drug delivery process; the potential market opportunity for the Company’s product candidates; and potential pipeline indications. Such statements and information are based on the current expectations of Eupraxia’s management, and are based on assumptions, including but not limited to: future research and development plans for the Company proceeding substantially as currently envisioned; industry growth trends, including with respect to projected and actual industry sales; the Company’s ability to obtain positive results from the Company’s research and development activities, including clinical trials; and the Company’s ability to protect patents and proprietary rights. Although Eupraxia’s management believes that the assumptions underlying these statements and information are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this news release may not occur by certain dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting Eupraxia, including, but not limited to: risks and uncertainties related to the Company’s limited operating history; the Company’s novel technology with uncertain market acceptance; if the Company breaches any of the agreements under which it licenses rights to its product candidates or technology from third parties, the possibility that the Company could lose license rights that are important to its business; the Company’s current license agreement may not provide an adequate remedy for its breach by the licensor; the possibility that the Company’s technology may not be successful for its intended use; the fact that the Company’s future technology will require regulatory approval, which is costly and the Company may not be able to obtain it; the possibility that the Company may fail to obtain regulatory approvals or only obtain approvals for limited uses or indications; the possibility that the Company’s clinical trials may fail to demonstrate adequately the safety and efficacy of its product candidates at any stage of clinical development; the possibility that the Company may be required to suspend or discontinue clinical trials due to side effects or other safety risks; the fact that the Company completely relies on third parties to provide supplies and inputs required for its product candidates and services; the potential impact of tariffs on the cost of the Company’s active pharmaceutical ingredients and clinical supplies of EP-104IAR and EP-104GI; the fact that the Company relies on external contract research organizations to provide clinical and non-clinical research services; the possibility that the Company may not be able to successfully execute its business strategy; the fact that the Company will require additional financing, which may not be available; the fact that any therapeutics the Company develops will be subject to extensive, lengthy and uncertain regulatory requirements, which could adversely affect the Company’s ability to obtain regulatory approval in a timely manner, or at all; the impact of health pandemics or epidemics on the Company’s operations; the Company’s restatement of its consolidated financial statements, which may lead to additional risks and uncertainties, including loss of investor confidence and negative impacts on the Company’s common share price; and other risks and uncertainties described in more detail in Eupraxia’s public filings on SEDAR+ (sedarplus.ca) and EDGAR (sec.gov). Although Eupraxia has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements and information, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement or information can be guaranteed. Except as required by applicable securities laws, forward-looking statements and information speak only as of the date on which they are made and Eupraxia undertakes no obligation to publicly update or revise any forward-looking statement or information, whether as a result of new information, future events or otherwise.   

For investor and media inquiries, please contact: 

James Meikle, Eupraxia Pharmaceuticals Inc. 
236-330-7084 
[email protected] 

or 

Kevin Gardner, on behalf of: 
Eupraxia Pharmaceuticals Inc. 
617-283-2856 
[email protected] 

SOURCE Eupraxia Pharmaceuticals Inc. 



Celcuity’s Phase 3 VIKTORIA-1 Trial Achieves Primary Endpoint With Clinically Meaningful Improvement in Progression-Free Survival in PIK3CA Mutant Cohort

Detailed data for the gedatolisib triplet and doublet regimens will be presented at a late-breaking abstract oral session at the 2026 ASCO Annual Meeting

MINNEAPOLIS, May 01, 2026 (GLOBE NEWSWIRE) — Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced positive topline results from the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial evaluating gedatolisib plus fulvestrant with or without palbociclib in patients with hormone receptor positive (“HR+”), human epidermal growth factor receptor 2 negative (“HER2-”), PIK3CA mutant locally advanced or metastatic breast cancer (“ABC”), following progression on or after treatment with a CDK4/6 inhibitor and an aromatase inhibitor. Detailed results will be presented in a late-breaking abstract (“LBA”) oral session at the American Society of Clinical Oncology (“ASCO”) Annual Meeting, taking place May 29 – June 2, 2026, in Chicago, Illinois.

The primary efficacy analysis of gedatolisib combined with fulvestrant and palbociclib (the “gedatolisib triplet”) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (“PFS”) compared to alpelisib, a PI3Kα inhibitor, and fulvestrant. The secondary endpoint comparing gedatolisib plus fulvestrant (the “gedatolisib doublet”) versus alpelisib plus fulvestrant, which was not part of the primary efficacy analysis in the hierarchical order, also demonstrated a statistically significant and clinically meaningful improvement in PFS compared to alpelisib and fulvestrant. Both gedatolisib regimens were generally well tolerated, with manageable safety profiles, and no new safety signals.

Celcuity intends to submit these data to the U.S. Food and Drug Administration (the “FDA”) as a supplemental New Drug Application (“sNDA”) and to submit VIKTORIA-1 data to other regulatory authorities following the sNDA submission.

“Patients with PIK3CA mutant HR+/HER2- advanced breast cancer whose disease has progressed while on or after treatment with a CDK4/6 inhibitor typically derive modest benefit from subsequent therapies that target only PI3Kα or AKT,” said Sara Hurvitz, MD, Senior Vice President, Clinical Research Division, Fred Hutch Cancer Center, Smith Family Endowed Chair in Women’s Health and Professor and Head, Division of Hematology and Oncology, University of Washington, School of Medicine and co-principal investigator for the trial. “VIKTORIA-1 represents the first Phase 3 study to demonstrate that comprehensively blocking the PI3K/AKT/mTOR, or PAM, pathway can significantly improve outcomes for patients with PIK3CA mutations compared to therapies only targeting a single component of this pathway.”

HR+/HER2- breast cancer is the most common subtype of breast cancer, accounting for approximately 70% of all breast cancers.2 Among this breast cancer subtype, approximately 40% have PIK3CA mutations.

“These positive topline results demonstrate the potential for gedatolisib to become a transformative new medicine for the treatment of patients with PIK3CA mutant HR+/HER2-advanced breast cancer,” said Igor Gorbatchevsky, MD, Chief Medical Officer of Celcuity. “When considered alongside previously presented data from the VIKTORIA-1 PIK3CA wild-type cohort, the gedatolisib regimens have now demonstrated the potential to improve the standard of care in the second-line setting regardless of the PIK3CA status of a patient’s tumor.”

The FDA has granted Priority Review of Celcuity’s New Drug Application (“NDA”) for gedatolisib in patients with HR+/HER2-/PIK3CA wild-type (“WT”) ABC and assigned a Prescription Drug User Fee Act (“PDUFA”) goal date of July 17, 2026.

“We believe the results from the VIKTORIA-1 study validate our pioneering approach to targeting cancers involving the PI3K/AKT/mTOR pathway. Researchers have sought for nearly 20 years to develop a drug that blockades this pathway comprehensively without inducing unacceptable levels of toxicity,” commented Brian Sullivan, Chairman, CEO and co-founder of Celcuity.

Mr. Sullivan added, “The implications of these results may extend beyond HR+/HER2- advanced breast cancer patients in the second-line setting, and we are working urgently to explore the development of gedatolisib for additional groups of patients whose cancers involve the PI3K/AKT/mTOR pathway.”

Presentation Details

Presenting Author: Sara Hurvitz, MD, Senior Vice President, Clinical Research Division, Fred Hutchinson Cancer Center, Professor and Head, Division of Hematology and Oncology, University of Washington, Department of Medicine

Title: A randomized, open-label, phase 3 study of gedatolisib + fulvestrant ± palbociclib vs standard of care in HR+/HER2−/PIK3CA-mutant advanced breast cancer (VIKTORIA-1 Study 2)

Abstract: LBA1008

Session Type/Title: Oral Abstract Session – Breast Cancer—Metastatic

Date and Time: June 2, 2026, 9:45 AM-12:45 PM CDT 

Late-breaking abstracts accepted for an Oral Abstract Session at the ASCO Annual Meeting will be published online via the ASCO website on the day of presentation.

About HR+/HER2- Breast Cancer

Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.1 More than two million breast cancer cases were diagnosed globally in 2022.1 While survival rates are high for those diagnosed with early breast cancer, approximately 30% of patients who are diagnosed with or who progress to metastatic disease are expected to live five years after their diagnosis.2 HR+/HER2- breast cancer is the most common subtype of breast cancer, accounting for approximately 70% of all breast cancers.2 Among this breast cancer subtype, approximately 40% have PIK3CA mutations.13

Three interconnected signaling pathways, estrogen, cyclin D1-CDK4/6 and PI3K/AKT/mTOR (“PAM”), are primary oncogenic drivers of HR+/HER2- breast cancer.3 Therapies inhibiting these pathways are approved and used in various combinations for ABC. Currently approved inhibitors of the PAM pathway for breast cancer target a single PAM pathway component, such as PI3Kα, AKT or mTORC1.4,5,6,7 However, resistance to CDK4/6 inhibitors and current endocrine therapies develops in many patients with advanced disease.8  Optimizing the inhibition of the PAM pathway is an active area of focus for breast cancer research.

About the VIKTORIA-1 Phase 3 Trial

VIKTORIA-1 is a Phase 3 open-label, randomized clinical trial to evaluate the efficacy and safety of gedatolisib in combination with fulvestrant, with or without palbociclib, in adults with HR+/HER2- ABC whose disease progressed on or after prior CDK4/6 therapy in combination with an aromatase inhibitor. The clinical trial is fully enrolled. The trial enrolled subjects regardless of PIK3CA status while enabling separate evaluation of subjects according to their PIK3CA status. Detailed results from the PIK3CA WT cohort of VIKTORIA-1 have been previously reported. For the PIK3CA mutant cohort, subjects who met eligibility criteria and had confirmed PIK3CA mutations were randomly assigned (3:3:1) to receive a regimen of either the gedatolisib triplet, alpelisib and fulvestrant, or the gedatolisib doublet.

About Gedatolisib

Gedatolisib is an investigational, multi-target PAM inhibitor that potently targets all four class I PI3K isoforms, mTORC1 and mTORC2 to induce comprehensive blockade of the PAM pathway.9,10,11 As a multi-target PAM inhibitor, gedatolisib’s mechanism of action is highly differentiated from currently approved single-target inhibitors of the PAM pathway.11 Inhibition of only a single PAM component gives tumors an escape mechanism through cross-activation of the uninhibited targets. Gedatolisib’s comprehensive PAM pathway inhibition ensures full suppression of PAM activity by eliminating adaptive resistance cross-activation that occurs with single-target inhibitors. Unlike single-target inhibitors of the PAM pathway, gedatolisib has demonstrated equal potency and comparable cytotoxicity in PIK3CA-mutant and -wild-type breast tumor cells in nonclinical studies and early clinical data.11,12

About Celcuity

Celcuity is a clinical-stage biotechnology company pursuing the development of targeted therapies for the treatment of multiple solid tumor indications. The company’s lead therapeutic candidate is gedatolisib, a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PAM pathway. Its mechanism of action and pharmacokinetic properties are differentiated from other currently approved and investigational therapies that target PI3Kα, AKT, or mTORC1 alone or together. A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant, with or without palbociclib, in patients with HR+/HER2- ABC, has reported detailed results for the PIK3CA WT cohort and topline results for the PIK3CA mutant cohort.  A Phase 3 clinical trial, VIKTORIA-2, evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with endocrine treatment resistant HR+/HER2- ABC, is ongoing. A Phase 1/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration-resistant prostate cancer, is ongoing. More detailed information about Celcuity’s active clinical trials can be found at ClinicalTrials.gov. Celcuity is headquartered in Minneapolis. Further information about Celcuity can be found at www.celcuity.com. Follow us on LinkedIn and X.

Forward Looking Statements

This press release contains statements that constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 including statements relating to the potential therapeutic benefits of gedatolisib; the size, design and timing of our clinical trials; our interpretation of clinical trial data; the status and timing of the FDA’s review of our NDA for gedatolisib, including the PDUFA goal date assigned by the FDA; the ability of our data to support the filing of an sNDA with the FDA and comparable filings with other regulatory authorities; our intent to present data at the 2026 ASCO Annual Meeting; the market opportunity for gedatolisib; our expectations regarding the timing of and our ability to obtain FDA approval to commercialize gedatolisib; our strategy, marketing and commercialization plans, including the benefits of strategic decisions regarding studies and trials; other expectations with respect to gedatolisib, including expectations regarding potential benefits to additional groups of patients whose cancers involve the PAM pathway; our anticipated use of cash; and the strength of our balance sheet. Words such as, but not limited to, “look forward to,” “believe,” “expect,” “anticipate,” “estimate,” “intend,” “confidence,” “encouraged,” “potential,” “plan,” “targets,” “likely,” “may,” “will,” “would,” “should” and “could,” and similar expressions or words identify forward-looking statements. The forward-looking statements included in this press release are based on management’s current expectations and beliefs which are subject to a number of risks, uncertainties and factors, including that our topline clinical results are based on an ongoing analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial; unforeseen delays in our clinical trials or the FDA’s review of our NDA for gedatolisib; our ability to obtain and maintain regulatory approvals to commercialize gedatolisib, and the market acceptance of gedatolisib; the development of therapies and tools competitive with gedatolisib; and our ability to access capital upon favorable terms. In addition, all forward-looking statements are subject to other risks detailed in our Annual Report on Form 10-K for the year ended December 31, 2025, as such risks may be updated in our subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by these cautionary statements, and we undertake no obligation to revise or update this press release to reflect events or circumstances after the date hereof.

References:

  1. Sung H, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021;10.3322/caac.21660.
  2. National Cancer Institute. Surveillance, Epidemiology and End Results Program (Accessed July 2025).
    https://seer.cancer.gov/statfacts/html/breast-subtypes.html
  3. Alves, C. L., & Ditzel, H. J. Drugging the PI3K/AKT/mTOR Pathway in ER+ Breast Cancer. Int J Mol Sci, 2023;24(5),4522. https://doi.org/10.3390/ijms24054522
  4. United States Package Insert, US FDA, ITOVEBI
  5. United States Package Insert, US FDA, PIQRAY
  6. United States Package Insert, US FDA, TRUCAP
  7. United States Package Insert, US FDA, AFINITOR
  8. Lloyd M R, et al. Mechanisms of Resistance to CDK4/6 Blockade in Advanced Hormone Receptor-positive, HER2-negative Breast Cancer and Emerging Therapeutic Opportunities. Clin Cancer Res. 2022;28(5):821-30
  9. Venkatesan, A. M., et al. Bis(morpholino-1,3,5-triazine) derivatives: potent adenosine 5′-triphosphate competitive phosphatidylinositol-3-kinase/mammalian target of rapamycin inhibitors: discovery of compound 26 (PKI-587), a highly efficacious dual inhibitor. J Med Chem, 2010;53(6), 2636-2645. https://doi.org/10.1021/jm901830p
  10. Mallon, R., et al. Antitumor efficacy of PKI-587, a highly potent dual PI3K/mTOR kinase inhibitor. Clin Cancer Res, 2011;17(10), 3193-3203. https://doi.org/10.1158/1078-0432.CCR-10-1694
  11. Rossetti, S., et al. Gedatolisib shows superior potency and efficacy versus single-node PI3K/AKT/mTOR inhibitors in breast cancer models. NPJ Breast Cancer, 2024;10(1), 40. https://doi.org/10.1038/s41523-024-00648-0
  12. Layman, R., et al. Gedatolisib in combination with palbociclib and endocrine therapy in women with hormone receptor-positive, HER2-negative advanced breast cancer: results from the dose expansion groups of an open-label, phase 1b study. Lancet Oncol, 2024;25(4), 474-487. https://doi.org/10.1016/S1470-2045(24)00034-2
  13. Anderson, E. et al. A Systematic Review of the Prevalence and Diagnostic Workup of PIK3CA Mutations in HR+/HER2– Metastatic Breast Cancer, Int J Breast Cancer. 2020 Jun 20;2020:3759179

Contacts: 

For Investors: 
Brian Sullivan, [email protected]
Vicky Hahne, [email protected]  
(763) 392-0123  
Jodi Sievers, [email protected]
(415) 494-9924

For Media:
Sam Brown LLC
Laura Morgan, [email protected]
(951) 333-9110



Trident Announces Receipt of Nasdaq Determination Letter and Intent to Request Hearing

SINGAPORE, May 01, 2026 (GLOBE NEWSWIRE) — Trident Digital Tech Holdings Ltd (“Trident” or the “Company,” NASDAQ: TDTH), a leading catalyst for digital transformation in technology optimization services and Web 3.0 activation based in Singapore, today announced that it received a letter dated April 28, 2026 from the Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that since its listed securities did not have a closing bid price of at least US$1.00 for a minimum of 10 consecutive business days during the 180 calendar days ended April 27, 2026, the Company has not regained compliance with Nasdaq Listing Rule 5550(a)(2), which requires listed securities to maintain a minimum bid price of US$1.00 per share.

The Company is not eligible for a second 180-day period to regain compliance with Nasdaq Listing Rule 5550(a)(2) because the Company does not comply with the US$5,000,000 minimum stockholders’ equity initial listing requirement for the Nasdaq Capital Market, and has received a letter from Nasdaq on March 26, 2026 indicating that, based upon the Company’s market value of listed securities for the 34 consecutive business day period from February 5, 2026 through March 20, 2026, the Company did not maintain the minimum market value of listed securities of US$35,000,000 required for continued listing on the Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(b)(2). The Company is afforded a period until September 22, 2026, in which to regain compliance with Nasdaq Listing Rule 5550(b)(2).

Accordingly, unless the Company requests an appeal of Nasdaq’s determination to a Hearings Panel by May 5, 2026, the Company’s securities will be scheduled for delisting from the Nasdaq Capital Market and will be suspended at the opening of business on May 7, 2026, and a Form 25-NSE will be filed with the Securities and Exchange Commission, which will remove the Company’s securities from listing and registration on the Nasdaq Capital Market.

The Company intends to timely request a hearing before the Hearings Panel to present its plan for regaining compliance with Nasdaq Listing Rule 5550(a)(2) and request continued listing pending its return to compliance. A hearing request will stay the suspension of the Company’s securities and the filing of the Form 25-NSE pending the Hearings Panel’s decision. 

In connection with its plan to regain compliance, on April 7, 2026, the Company announced its plan to change the ratio of its ADS to Class B ordinary shares from the previous ratio of one (1) ADS to eight (8) Class B ordinary shares to a new ratio of one (1) ADS to two hundred and forty (240) Class B ordinary shares. Effective April 24, 2026, the Company effected a 1-for-30 reverse share split.

About Trident

Trident is a leading catalyst for digital transformation in digital optimization, technology services, and Web 3.0 activation worldwide, based in Singapore. The Company offers commercial and technological digital solutions designed to optimize its clients’ experience with their end-users by promoting digital adoption and self-service.

Tridentity, the Company’s flagship product, is an innovative and highly secure blockchain-based identity solution designed to provide secure single sign-on authentication capabilities to integrated third-party systems across various industries. Tridentity aims to offer unparalleled security features, ensuring the protection of sensitive information and preventing potential threats, thus promising a new secure era in the global digital landscape in general, and in South Asia etc.

Beyond Tridentity, the Company’s mission is to become the global leader in Web 3.0 activation, notably connecting businesses to a reliable and secure technological platform, with tailored and optimized customer experiences, with a strong focus on Africa and other high growth markets. For more information, visit: https://tridentity.me/

Safe Harbor Statement

This announcement contains statements that may constitute “forward-looking” statements pursuant to the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “aims,” “future,” “intends,” “plans,” “believes,” “estimates,” “likely to,” and similar statements. The Company may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission (the “SEC”), in its annual report to shareholders, in announcements and other written materials, and in oral statements made by its officers, directors, or employees to third parties. Statements that are not historical facts, including statements about the Company’s beliefs, plans, and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. A number of factors could also cause actual results to differ materially from those contained in any forward-looking statement, including but not limited to the following: potential adverse reactions or changes to business relationships; adverse changes in general economic or market conditions; and actions by third parties, including government agencies; the Company’s strategies, future business development, and financial condition and results of operations; the expected growth of the digital solutions market; the political, economic, social and legal developments in the jurisdictions that the Company operates in or in which the Company intends to expand its business and operations; the Company’s ability to maintain and enhance its brand. Further information regarding these and other risks is included in the Company’s filings with the SEC. All information provided in this announcement is as of the date of this announcement, and the Company does not undertake any obligation to update any forward-looking statement, except as required under applicable law.

Investor Relations Inquiries:

Skyline Corporate Communications Group, LLC
Scott Powell, President
1177 Avenue of the Americas, 5th Floor
New York, New York 10036
Office: (646) 893-5835
Email: [email protected]