Posts

Posted on

Dr. Reddy’s Announces the First-to-Market Launch of Bosutinib Tablets 400mg, a Generic Equivalent of Bosulif®, in the United States

Dr. Reddy’s Announces the First-to-Market Launch of Bosutinib Tablets 400mg, a Generic Equivalent of Bosulif®, in the United States

HYDERABAD, India & PRINCETON, N.J.–(BUSINESS WIRE)–
Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, along with its subsidiaries together referred to as “Dr. Reddy’s”) today announced the first-to-market launch of Bosutinib Tablets 400mg, a generic equivalent of Bosulif®, in the United States, expanding its oncology portfolio and reinforcing its commitment to improving patient access to affordable, high-quality medicines. Dr. Reddy’s has collaborated with MSN Laboratories Private Limited (“MSN”), a leading pharmaceutical company in India, on this product. Dr. Reddy’s holds the exclusive marketing rights for the product in the United States. MSN is responsible for the development and manufacturing of the product.

Bosutinib Tablets (400mg) was a first-to-file product and is eligible for 180-days of generic drug exclusivity for this strength, in the U.S.

Milan Kalawadia, CEO- North America, Dr. Reddy’s Laboratories, Inc. said: “This launch highlights our commitment to leading with timely market entry for high-priority therapies while broadening access for both patients and healthcare providers. With this launch, we remain focused on strengthening our oncology portfolio and partnering across the healthcare system to ensure that critical treatments are both accessible and affordable.”

Bharat Reddy, Executive Director, MSN Laboratories added: “The successful development and commercialization of Bosutinib Tablets demonstrates MSN’s strong scientific, regulatory, and manufacturing capabilities in complex oncology products. We remain committed to delivering high-quality, affordable medicines globally through efficient development and reliable manufacturing excellence.”

The Bosulif® brand (400mg) had U.S. sales of approximately $253.8 million for the latest 12-month period ended April 2026, according to IQVIA National Sales Perspectives data.

Bosulif® is a registered trademark of Wyeth LLC.

RDY-0626-887

…………………………………………………………………………………………………………………………………………………………………………………………………………

About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is a global pharmaceutical company headquartered in Hyderabad, India. Established in 1984, we are committed to providing access to affordable and innovative medicines. Driven by our purpose of ‘Good Health Can’t Wait’, we offer a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Our major markets include – USA, India, Russia & CIS countries, China, Brazil and Europe. As a company with a history of deep science that has led to several industry firsts, we continue to plan ahead and invest in businesses of the future. As an early adopter of sustainability and ESG actions, we released our first Sustainability Report in 2004. Our current ESG goals aim to set the bar high in environmental stewardship; access and affordability for patients; diversity; and governance. For more information, log on to: www.drreddys.com.

About MSN Laboratories: MSN Laboratories is a research-driven pharmaceutical company with integrated capabilities across APIs and finished dosage formulations. The company is recognized for its strong expertise in product development, regulatory execution, and world-class manufacturing infrastructure with USFDA approved facilities in Hyderabad, India and in New Jersey, USA. MSN serves global markets with a focus on quality, affordability, and operational excellence across multiple therapeutic segments, including oncology.

………………………………………………………………………………………………………………………………………………………

Disclaimer: This press release may include statements of future expectations and other forward-looking statements that are based on the management’s current views and assumptions and involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. In addition to statements which are forward-looking by reason of context, the words “may”, “will”, “should”, “expects”, “plans”, “intends”, “anticipates”, “believes”, “estimates”, “predicts”, “potential”, or “continue” and similar expressions identify forward-looking statements. Actual results, performance or events may differ materially from those in such statements due to without limitation, (i) general economic conditions such as performance of financial markets, credit defaults , currency exchange rates, interest rates, persistency levels and frequency / severity of insured loss events, (ii) mortality and morbidity levels and trends, (iii) changing levels of competition and general competitive factors, (iv) changes in laws and regulations and in the policies of central banks and/or governments, (v) the impact of acquisitions or reorganization, including related integration issues, and (vi) the susceptibility of our industry and the markets addressed by our, and our customers’, products and services to economic downturns as a result of natural disasters, epidemics, pandemics or other widespread illness, including coronavirus (or COVID-19), and (vii) other risks and uncertainties identified in our public filings with the Securities and Exchange Commission, including those listed under the “Risk Factors” and “Forward-Looking Statements” sections of our Annual Report on Form 20-F for the year ended March 31, 2025. The company assumes no obligation to update any information contained herein.

INVESTOR RELATIONS

AISHWARYA SITHARAM

[email protected]

MEDIA RELATIONS

PRIYA K

[email protected]

KEYWORDS: New Jersey United States India North America Asia Pacific

INDUSTRY KEYWORDS: Biotechnology Pharmaceutical Health Oncology

MEDIA:

Logo
Logo
Posted on

Results from Incyte’s Pivotal Phase 3 frontMIND Trial of Tafasitamab (Monjuvi®/Minjuvi®) Combination Presented at the 2026 European Hematology Association (EHA) Congress Plenary Showed Prolonged Progression Free Survival

Results from Incyte’s Pivotal Phase 3 frontMIND Trial of Tafasitamab (Monjuvi®/Minjuvi®) Combination Presented at the 2026 European Hematology Association (EHA) Congress Plenary Showed Prolonged Progression Free Survival

– frontMIND study evaluating tafasitamab (Monjuvi®/Minjuvi®) in patients with previously untreated high-risk diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) selected for the prestigious Plenary Abstracts Session at EHA 2026

– Results showed tafasitamab and lenalidomide plus R-CHOP (Tafa-Len-R-CHOP) significantly prolonged progression-free survival (PFS), reducing risk of disease progression or death by 25%

– Positive trends toward PFS benefit with Tafa-Len-R-CHOP were observed acrossprespecified subgroups, including in patients with centrally confirmed lymphoma subtypes and both cell-of-origin (COO) molecular subtypes

– The frontMIND data support global regulatory applications for tafasitamab and lenalidomide in addition to R-CHOP for previously untreated DLBCL and HGBL

WILMINGTON, Del.–(BUSINESS WIRE)–
Incyte (Nasdaq:INCY) today announced positive results from the pivotal Phase 3 frontMIND trial evaluating the efficacy and safety of tafasitamab (Monjuvi®/Minjuvi®), a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody, and lenalidomide added to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone; Tafa-Len-R-CHOP) versus R-CHOP, the current standard of care, as a first-line treatment for adults with previously untreated diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL). Eligible patients had an International Prognostic Index (IPI) score of 3-5, or, for patients ≤60 years of age, an age-adjusted IPI (aaIPI) of 2-3.

These data are being highlighted in a prestigious Plenary Abstracts Session at the European Hematology Association (EHA) 2026 Congress, being held June 11 – 14, 2026, in Stockholm, Sweden (Abstract # S101. Plenary Abstract Session. June 13, 6:00 – 7:30 a.m. ET [12:00-1:30 p.m. CEST]). frontMIND results were also recently published in The Lancet.

“These frontMIND data reinforce the potential of Tafa-Len-R-CHOP to meaningfully change the first-line treatment landscape for patients with high-risk DLBCL or HGBL, for which outcomes have remained unchanged for decades,” said Steven Stein, M.D., Executive Vice President, Chief Medical Officer and Head of Late-stage Development, Incyte. “With encouraging efficacy observed across prespecified subgroups regardless of cell-of-origin (COO) molecular subtype, we believe these findings position this therapy as a compelling potential new standard of care and support our continued efforts to bring it to patients who are in need of other efficacious treatment options.”

The results, which build on previously reported topline data and also recently announced at the 2026 American Society of Clinical Oncology Annual Meeting, showed Tafa-Len-R-CHOP resulted in statistically significant and clinically meaningful improvements in progression-free survival (PFS).

Efficacy Data

  • A 25% reduction in risk of disease progression or death demonstrated with Tafa-Len-R-CHOP compared with R-CHOP (HR 0.75 [P=0.0194]; 95% CI: 0.59, 0.96; median follow-up of 35.2 months).

  • PFS increase of 8.2% at 2 years (71.1% with Tafa-Len-R-CHOP vs. 62.9% with R-CHOP) and a PFS increase of 6.6% at 3 years (67.3% with Tafa-Len-R-CHOP vs. 60.7% with R-CHOP).

  • Tafa-Len-R-CHOP trends toward PFS advantage were broadly consistent across prespecified subgroups, including patients with centrally confirmed lymphoma subtypes and across COO molecular subtypes (ABC [Activated B-cell-like] and GCB [Germinal Center B-cell-like]).

  • Tafa-Len-R-CHOP significantly improved event-free survival (EFS) compared to R-CHOP (HR 0.79 [P=0.0260] 95% CI: 0.64, 0.97; median follow-up of 35.4 months).

  • Interim overall survival (OS) analysis demonstrated a positive trend toward improvement (HR=0.85 [P=0.2703] 95% CI: 0.63, 1.14, median follow-up of 35.9 months).

  • Minimal residual disease (MRD)-negativity rate was 81.3% with Tafa-Len-R-CHOP and 66.7% with R-CHOP.

“A key goal in frontline treatment is to potentially prevent relapse, and spare patients from requiring additional therapies later. This is particularly meaningful for high-risk DLBCL and HGBL patients, where new treatment approaches are needed,” said Dr. Georg Lenz, University Hospital Münster and principal investigator of the frontMIND study. “The frontMIND results are especially encouraging because the addition of tafasitamab and lenalidomide improved outcomes without compromising delivery of the R-CHOP backbone, which remains fundamental to achieving better outcomes for patients.”

Safety Data

Tafa-Len-R-CHOP was generally well tolerated, and safety was consistent with the expected safety profile of adding Tafa-Len to R-CHOP. Safety findings included:

  • The most common treatment-emergent adverse events (TEAEs) for Tafa-Len-R-CHOP were neutropenia (70.7%), anemia (46.3%) and peripheral neuropathy (40.6%).

  • Any grade TEAEs were similar in both treatment arms (98.6% vs 97.1%).

  • More Grade ≥3 TEAEs occurred with Tafa-Len-R-CHOP (86.7%) vs R-CHOP (76.1%).

  • The most common Grade 3 TEAEs for Tafa-Len-R-CHOP group were anemia (22.8%), thrombocytopenia (13.1%) and neutropenia (12.4%) vs. anemia (15.9%), febrile neutropenia (8.7%) and thrombocytopenia (6.7%) for R-CHOP.

  • Incremental safety events observed with Tafa-Len-R-CHOP were well managed and did not interfere with the delivery of the R-CHOP backbone.

  • Rates of TEAEs leading to discontinuation of all study treatment were similar between the two groups (5.2% for Tafa-Len-R-CHOP and 5.4% for R‑CHOP) – a higher rate of fatal TEAEs was observed with Tafa-Len-R-CHOP (5.9% vs 3.8% with R-CHOP), however there were fewer overall deaths with Tafa-Len-R-CHOP (82 [18.5%]) compared to R-CHOP (97 [21.7%]), consistent with the positive trend observed in overall survival.

The frontMIND data support global regulatory applications for tafasitamab and lenalidomide in addition to R-CHOP for previously untreated DLBCL and HGBL.

About DLBCL

Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin lymphoma (NHL) in adults worldwide, representing 40% of all cases.1 It is characterized as an aggressive, fast-growing type of lymphoma that can emerge in lymph nodes or extranodal sites such as the gastrointestinal tract, skin and brain.2 Each year, approximately 24,000 people in the U.S. and up to 36,000 people in Europe are diagnosed with DLBCL.3,4 With about 40% of these patients not responding to initial therapy or relapsing thereafter5,6, there is a high medical need for new, effective therapies, particularly for high-risk patients.

About frontMIND

The frontMIND trial (NCT04824092) is a randomized, double-blind, placebo-controlled, global Phase 3 study in patients with previously untreated high-risk diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL).

The study enrolled 899 adults (≥18 to ≤80 years) and is evaluating the efficacy and safety of tafasitamab and lenalidomide added to R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone) compared with R-CHOP.

The primary endpoint of the study is investigator-assessed progression-free survival (PFS) using the Lugano 2014 criteria. Key secondary endpoints include event-free survival (EFS) by investigator assessment and overall survival (OS).

For more information about the frontMIND trial, please visit https://www.clinicaltrials.gov/study/NCT04824092.

About Tafasitamab (Monjuvi®/Minjuvi®)

Tafasitamab (Monjuvi®/Minjuvi®) is a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody. Tafasitamab incorporates an XmAb® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). Incyte licenses exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc.

In the U.S., Monjuvi® (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). Additionally, Monjuvi received accelerated approval in the United States in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).

Monjuvi is not indicated and is not recommended for the treatment of patients with relapsed or refractory marginal zone lymphoma outside of controlled clinical trials.

In Europe, Minjuvi® (tafasitamab) received conditional Marketing Authorization from the European Medicines Agency in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory DLBCL who are not eligible for ASCT. In addition, in December 2025, the EMA approved Minjuvi, in combination with lenalidomide and rituximab, for the treatment of adult patients with relapsed or refractory FL (Grade 1-3a) after at least one line of systemic therapy.

In Japan, Minjuvi is approved in combination with rituximab and lenalidomide for adult patients with relapsed or refractory follicular lymphoma (2L+ FL).

XmAb® is a registered trademark of Xencor, Inc.

Monjuvi and Minjuvi are registered trademarks of Incyte.

IMPORTANT SAFETY INFORMATION

What are the possible side effects of MONJUVI?

MONJUVI may cause serious side effects, including:

  • Infusion reactions. Your healthcare provider will monitor you for infusion reactions during your infusion of MONJUVI. Tell your healthcare provider right away if you get fever, chills, flushing, headache, or shortness of breath during an infusion of MONJUVI.
  • Low blood cell counts (platelets, red blood cells, and white blood cells). Low blood cell counts are common with MONJUVI, but can also be serious or severe. Your healthcare provider will monitor your blood counts during treatment with MONJUVI. Tell your healthcare provider right away if you get a fever of 100.4°F (38°C) or above, or any bruising or bleeding.
  • Infections. Serious infections, including infections that can cause death, have happened in people during treatment with MONJUVI and after the last dose. Tell your healthcare provider right away if you get a fever of 100.4°F (38°C) or above, or develop any signs and symptoms of an infection.

The most common side effects of MONJUVI include:

  • Feeling tired or weak

  • Diarrhea

  • Cough

  • Fever

  • Swelling of lower legs or hands

  • Respiratory tract infection

  • Decreased appetite

These are not all the possible side effects of MONJUVI. Your healthcare provider will give you medicines before each infusion to decrease your chance of infusion reactions. If you do not have any reactions, your healthcare provider may decide that you do not need these medicines with later infusions. Your healthcare provider may need to delay or completely stop treatment with MONJUVI if you have severe side effects.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before you receive MONJUVI, tell your healthcare provider about all of your medical conditions, including if you:

  • Have an active infection or have had one recently.

  • Are pregnant or plan to become pregnant. MONJUVI may harm your unborn baby. You should not become pregnant during treatment with MONJUVI. Do not receive treatment with MONJUVI in combination with lenalidomide if you are pregnant because lenalidomide can cause birth defects and death of your unborn baby.

  • You should use an effective method of birth control (contraception) during treatment and for at least 3 months after your final dose of MONJUVI.

  • Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with MONJUVI.

  • Are breastfeeding or plan to breastfeed. It is not known if MONJUVI passes into your breastmilk. Do not breastfeed during treatment for at least 3 months after your last dose of MONJUVI.

You should also read the lenalidomide Medication Guide for important information about pregnancy, contraception, and blood and sperm donation.

Tell your healthcare provider about all the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Please see the full Prescribing Information for Monjuvi, including Patient Information, for additional Important Safety Information.

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.

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 whether and when tafasitamab may provide a successful treatment option for patients with DLBCL and HGBL, the potential and promise suggested by the Phase 3 frontMIND results, the potential for Tafa-Len-R-CHOP to become a new standard of care option in the first-line treatment of DLBCL, Incyte’s plans to advance its global regulatory filings for tafasitamab 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 Incyte’s ability to demonstrate the efficacy and safety of its products and product candidates; 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; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; Incyte’s ability to achieve commercial success for its marketed products and product candidates, if approved; Incyte’s ability to obtain and maintain protection of intellectual property for its products and technology; Incyte’s reliance on third parties and partners; the acceptance of Incyte’s products in the marketplace; market competition, sales, marketing, manufacturing and distribution requirements; 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 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. Wang S. Epidemiology and etiology of diffuse large B-cell lymphoma. Semin Hematol. 2023 Nov;60(5):255-266.

  2. Skrabek, P., et al. (2019). Emerging Therapies for the Treatment of Relapsed or Refractory Diffuse Large B Cell Lymphoma. Current Oncology, 26(4), 253-265.

  3. Chihara D, et al. Clin Lymphoma Myeloma Leuk. 2022;22(12):e1092-e1099.

  4. GLOBOCAN 2020 Cancer Today.

  5. Swerdlow SH, et al. Blood. 2016;127(20):2375-2390.

  6. Kanas G, et al. Leuk Lymphoma. 2021;63:54-63.

 

Media

[email protected]


Investors

[email protected]

KEYWORDS: Delaware Europe United States North America

INDUSTRY KEYWORDS: Oncology FDA Health Clinical Trials Pharmaceutical Biotechnology

MEDIA:

Logo
Logo
Posted on

Defiance ETFs Announces Temporary Trading Halt of the Defiance Daily 2X Space ETF (SPCL) on Cboe BZX Exchange, Inc.

MIAMI, June 12, 2026 (GLOBE NEWSWIRE) — Defiance ETFs, a leader in thematic and leveraged exchange-traded funds, today announced that trading in shares of the Defiance Daily 2X Space ETF (Cboe BZX: SPCL) was temporarily halted by Cboe BZX Exchange, Inc. (the “Exchange”).

Trading was temporarily halted at 10:45 A.M. EDT today.

SPCL’s trading halt was the result of the Exchange exercising its broad discretionary authority to halt trading in a listed ETF, as authorized by Exchange rules. According to the Exchange, it currently anticipates lifting the temporary halt of trading in SPCL shares and resuming trading no earlier than Monday, June 15, 2026.

During this temporary halt, investors are advised that while shares of SPCL cannot be bought or sold on the secondary market, the underlying portfolio assets remain secure and are not impacted by this temporary halt of trading initiated by the Exchange.

Defiance ETFs believes the temporary halt of trading in SPCL shares was in response to today’s significant market price volatility surrounding SpaceX’s completion of its initial public offering, and the commencement of trading in shares of SpaceX Class A common stock on Nasdaq (NASDAQ: SPCX).

Defiance ETFs will issue an update as soon as the Exchange authorizes the resumption of trading in shares of SPCL. For real-time updates on the status of SPCL, please monitor the Exchange’s Issuer Portal (SPCL) or contact your financial advisor.

For full fund details, the prospectus, holdings, and performance current to the most recent month-end, visit defianceetfs.com/spcl or call 833.333.9383.

An investment in SPCL is not a direct investment in the underlying securities. The Fund is not suitable for all investors. The Fund is designed to be utilized only by knowledgeable investors who understand the potential consequences of seeking daily leveraged (2X) investment results, understand the risks associated with the use of leverage, and are willing to monitor their portfolios frequently. The Fund is not intended to be used by, and is not appropriate for, investors who do not intend to actively monitor and manage their portfolios. The Fund pursues daily leveraged investment objectives, which means it is riskier than alternatives that do not use leverage. The Fund magnifies the performance of the Target Portfolio and is designed strictly for short-term use. For periods longer than a single day, the Fund’s performance will be the result of compounded daily returns, which is very likely to differ from 200% of the return of the Target Portfolio over the same period. It is possible that investors could lose their entire principal within a single trading day.

Important Disclosures

Defiance ETFs LLC is the ETF sponsor. The Fund’s investment adviser is Tidal Investments LLC (“Tidal” or the “Adviser”).

The Fund’s investment objectives, risks, charges, and expenses must be considered carefully before investing. The prospectus and summary prospectus contain this and other important information and can be obtained by calling 833.333.9383 or by visiting defianceetfs.com/spcl. Please read the prospectus and summary prospectus carefully before investing.

An investment in the Fund involves a high degree of risk. An investor could lose the full principal value of his or her investment within a single day.

Strategy and Reconstitution Risk. The Fund is actively managed and, per its recently amended Prospectus, may reconstitute its portfolio to consist of exposure to a single Space Company security in response to a “Material Space Event” – defined to include an initial public offering of a company, such as SpaceX, which the Adviser determines to be a significant participant in the space economy. SpaceX’s IPO, a Material Space Event, will result in the Fund holding all or a predominant portion of its portfolio in instruments providing exposure to SpaceX shares, subjecting existing and future Shareholders to a substantially more concentrated and potentially more volatile investment portfolio due to such an event. Fund investment results following a reconstitution in response to a Material Space Event may differ materially from prior results and the Fund may as a result temporarily deviate from its daily targeted exposure level. The Fund’s prospectus does not require the Adviser to provide advance notice before a reconstitution; however, the Fund’s Target Portfolio is published daily on its website at www.defianceetfs.com/spcl.

An investment in the Fund is not an investment in SpaceX. The Fund seeks to obtain exposure to SpaceX Class A common stock, and to other Space Company securities, through derivatives, not by holding the underlying securities directly. Fund holdings are subject to change at any time and should not be considered a recommendation to buy or sell any security.

Focused Portfolio and Concentration Risk. The Fund may seek exposure to one or a limited number of Space Company securities, including SpaceX. Given the Fund’s exposure is concentrated in a one or a limited number of underlying stocks, such as SpaceX, the Fund is subject to the price movements, business results, regulatory developments, and other risks specific to SpaceX or other Space Companies. The Fund is significantly less diversified than traditional ETFs, and its performance is more volatile than a fund seeking exposure to a broader market sector or seeking to track a broad-based securities index.

Leverage, Compounding and Daily Reset Risk. The Fund seeks daily investment results equal to 200% of the daily performance of a Target Portfolio consisting of one or a limited number of Space Company securities, which may include or consistent entirely of SpaceX Class A common stock due to the Material Space Event. The Fund obtains exposure in excess of its net assets through leverage, which magnifies both gains and losses. The Fund’s returns over periods longer than a single day will likely differ, in amount and possibly direction, from its stated daily target. For periods longer than a single day, the Fund will lose money if its Target Portfolio performance is flat, and it is possible that the Fund will lose money even if its Target Portfolio’s performance increases. The Fund is intended for short-term use and is not appropriate for investors who do not intend to actively monitor and manage their portfolios.

Newly Public Company Risk. SpaceX has recently completed, or is in the process of completing, its initial public offering. The first day of trading in a newly public company’s securities frequently involves extraordinary market activity and may differ significantly from subsequent trading days. For example, trading in SpaceX common stock may be characterized by substantial price volatility, rapid price movements, significant differences between the IPO price and the opening market price, wide bid-ask spreads, trading imbalances, limited liquidity, trading halts, and other market disruptions. These conditions may make it difficult for market participants to value SpaceX common stock and may contribute to significant fluctuations in the market price of the Fund’s Shares.

SpaceX-Specific Risks. The Fund’s exposure to SpaceX stock will subject it to risks specific to SpaceX, including its expected status as a controlled company with voting power concentrated in founder Elon Musk through Class B common stock (10 votes per share), the Fund’s dependence on Mr. Musk’s services and reputation, and the execution risk associated with unproven or novel technologies such as the Starship program, next-generation Starlink satellites, and orbital AI initiatives.

Initial Trading Day IPO Exposure Risk. The Fund expects to seek exposure to the performance of SpaceX common stock measured from the opening market price of SpaceX common stock on its first day of exchange trading. The Fund will not seek to provide exposure to the difference between the IPO offering price and the opening market price of SpaceX common stock. There can be no assurance that the Fund will be able to obtain, maintain, or rebalance its desired level of exposure to the performance of SpaceX common stock during its in initial day of trading.

Derivatives Capacity Constraints Risk. Because SpaceX will be a newly public company, the markets for swap agreements, options contracts, and other instruments that the Fund may use to obtain leveraged exposure may be limited, illiquid, volatile, costly, or unavailable. Counterparties may impose exposure limits, exchanges may impose position limits or other restrictions, and market participants may be unwilling or unable to provide the Fund with the desired level of exposure. These constraints may increase tracking error, cause the Fund to return substantially less than its desired daily leveraged exposure to the performance of SpaceX stock, or prevent the Fund from achieving its investment objective. These risks may be particularly pronounced during the period immediately following an IPO, when trading volumes, liquidity conditions, derivatives availability, counterparty capacity, price discovery, and market volatility may be highly uncertain.

Derivatives and Non-Diversification Risk. The Fund uses swap agreements and/or listed options contracts to obtain economic exposure to its Target Portfolio securities, which are subject to counterparty, liquidity, valuation, correlation, and leverage risks, as well as the risk that a derivative will not perform as expected. The Fund is classified as non-diversified and may invest a larger portion of its assets providing exposure to a single issuer.

Tax Risk. The Fund’s use of swaps and other derivatives may produce taxable income, including ordinary income and short-term capital gains, which are generally taxable at higher rates than long-term capital gains.

Past performance does not guarantee future results. Fund holdings and exposures are subject to change at any time and should not be considered recommendations to buy or sell any security.

Defiance Daily 2X Space ETF is distributed by Foreside Fund Services, LLC.

About Defiance ETFs

Founded in 2018, Defiance is a leading ETF issuer specializing in thematic, income, and leveraged ETFs. Our first-mover leveraged single-stock ETFs empower investors to take amplified positions in high-growth companies, providing precise leverage exposure without the need to open a margin account.

Media Contact: Brenda Hentschel | [email protected] | 201.705.3758

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/e7d44c46-c91a-4fa4-9361-fe178f1ad310



Posted on

Arcadia Biosciences (RKDA) Announces Closing of $4 Million Private Placement Priced At-The-Market Under Nasdaq Rules

DALLAS, June 12, 2026 (GLOBE NEWSWIRE) — Arcadia Biosciences, Inc.® (Nasdaq: RKDA), a producer and marketer of innovative wellness products, announced today the closing of its previously announced private placement priced at-the-market under Nasdaq rules for the purchase and sale of 3,883,496 shares of its common stock (or pre-funded warrants in lieu thereof), Series A-1 preferred investment options to purchase up to an aggregate of 3,883,496 shares of common stock and Series A-2 preferred investment options to purchase up to an aggregate of 3,883,496 shares of common stock at a purchase price of $1.03 per share of common stock (or pre-funded warrant in lieu thereof) and associated preferred investment options.

H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

The Series A-1 preferred investment options have an exercise price of $0.91 per share, will be exercisable beginning on the effective date of stockholder approval of the issuance of the shares of common stock upon exercise of the Series A-1 preferred investment options and will expire five years from the effective date of stockholder approval. The Series A-2 preferred investment options have an exercise price of $0.91 per share, are exercisable immediately upon issuance and will expire twenty-four months from the effective date of the Resale Registration Statement (as defined below).

The aggregate gross proceeds to the company from the offering were approximately $4 million before deducting placement agent fees and other offering expenses. Arcadia intends to use the net proceeds from the offering for working capital and general corporate purposes.

The securities described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Act”), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the Series A-1 preferred investment options and Series A-2 preferred investment options, have not been registered under the Act or applicable state securities laws. Accordingly, the securities may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements. Pursuant to a registration rights agreement, the Company has agreed to file one or more registration statements with the SEC covering the resale of the unregistered securities to be issued in the offering (the “Resale Registration Statement”).

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

About Arcadia Biosciences, Inc.

Since 2002, Arcadia Biosciences (Nasdaq: RKDA) has been innovating high-value, healthy ingredients to meet consumer demands for healthier choices. With its roots in agricultural innovation, Arcadia cultivates next-generation wellness products. For more information, visit www.arcadiabio.com.

Safe Harbor Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements relate to future events or future results of operations concerning the company and its products, including, but not limited to, statements concerning the following matters: the receipt of any required stockholder approvals; and the anticipated use of proceeds from the offering. Undue reliance should not be placed on any forward-looking statements. Forward-looking statements are only predictions and are subject to known and unknown risks and uncertainties that could cause actual results to differ materially from the results anticipated by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risks set forth in filings that the company makes with the Securities and Exchange Commission from time to time, including in Arcadia’s Annual Report on Form 10-K for the year ended December 31, 2025 (the 2025 Form 10-K), and other filings that the company makes with the SEC. Forward-looking statements concerning anticipated future activities also assume that the company has sufficient funding to continue its operations and planned activities, which may not be the case. As described in greater detail in the 2025 Form 10-K, the company may require additional funding in the future to continue its operations and planned activities. There are no assurances that required funding will be available at all or will be available in sufficient amounts or on reasonable terms. The company may seek to raise additional funds through equity or debt financings, through transactions involving its other assets, or through other transactions. Any sale of additional equity securities could result in dilution to company stockholders. Reported results should not be considered as an indication of future performance. Forward-looking statements made in this press release speak only as of the date hereof, and except as required by law, Arcadia Biosciences, Inc. disclaims any obligation to update these forward-looking statements or to reflect events or circumstances arising after the date of this press release.

Arcadia Biosciences Contact
:

T.J. Schaefer
[email protected]



Posted on

Belite Bio Completes Rolling Submission of New Drug Application to U.S. Food and Drug Administration for Tinlarebant for the Treatment of Stargardt Disease Type 1

SAN DIEGO, June 12, 2026 (GLOBE NEWSWIRE) — Belite Bio, Inc (NASDAQ: BLTE) (“Belite Bio®” or the “Company”), a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announced the completion of its rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tinlarebant. Tinlarebant is an investigational, once-daily oral therapy for the treatment of Stargardt disease type 1 (STGD1), a rare, inherited retinal disease caused by mutations in the ABCA4 gene that leads to progressive and irreversible vision loss. STGD1 affects an estimated 53,000 people in the U.S. alone, and there are currently no approved treatment options for the disease.

The rolling NDA was initiated in April 2026 and was submitted under Breakthrough Therapy Designation (BTD), which was granted by the FDA due to the high unmet need among patients living with STGD1. The completed application will undergo the 60-day review period with the FDA, and if accepted, a Prescription Drug User Fee Act (PDUFA) target action date will be assigned.

“The completion of our NDA submission marks a pivotal moment for Belite Bio and represents an important step forward for those affected by Stargardt disease who have long faced a future of progressive vision loss without an approved treatment option,” said Dr. Tom Lin, Chairman and Chief Executive Officer of Belite Bio. “We are immensely grateful to everyone who made this milestone possible, including the patients, families, and investigators who participated in our clinical trials, and the entire Belite team. We look forward to honoring them by working with the FDA to advance tinlarebant through the regulatory review process, while continuing to focus on our commercial preparedness activities in anticipation of a timely and efficient launch following potential approval.”

“Stargardt disease places a profound burden on patients, often affecting them early in life and steadily diminishing central vision during critical years of education and independence,” said Dr. Hendrik Scholl, Chief Medical Officer of Belite Bio. “We believe that the results from the Phase 3 DRAGON trial, which demonstrated tinlarebant’s ability to significantly reduce the growth rate of retinal lesions as compared to placebo, underscore its benefit and pave the way for it to potentially become the first approved therapy for this devastating disease.”

About Tinlarebant (a/k/a LBS-008)

Tinlarebant is a novel oral therapy that is intended to reduce the accumulation of vitamin A-based toxins (known as bisretinoids) that cause retinal disease in STGD1 and also contribute to disease progression in geographic atrophy (GA), or advanced dry age-related macular degeneration (AMD). Bisretinoids are by-products of the visual cycle, which is dependent on the supply of vitamin A (retinol) to the eye. Tinlarebant works by reducing and maintaining levels of serum retinol binding protein 4 (RBP4), the sole carrier protein for retinol transport from the liver to the eye. By modulating the amount of retinol entering the eye, tinlarebant reduces the formation of bisretinoids. Tinlarebant has been granted Breakthrough Therapy Designation, Fast Track Designation, and Rare Pediatric Disease Designation in the U.S., Orphan Drug Designation in the U.S., Europe, Japan, and Switzerland, and Sakigake Designation in Japan for the treatment of STGD1.

About Belite Bio

Belite Bio is a clinical-stage drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical need, such as Stargardt disease type 1 (STGD1) and geographic atrophy (GA) in advanced dry age-related macular degeneration (AMD), in addition to specific metabolic diseases. Belite Bio’s lead candidate, tinlarebant, is an oral therapy intended to reduce the accumulation of bisretinoid toxins in the eye. The Company has completed a Phase 3 trial (DRAGON) in adolescent and adult subjects with STGD1, which met its primary endpoint, and the drug is currently being evaluated in a Phase 2/3 trial (DRAGON II) in adolescent and adult subjects with STGD1 and a Phase 3 trial (PHOENIX) in subjects with GA. For more information, follow us on X, Instagram, LinkedIn, and Facebook, or visit us at www.belitebio.com.

Important Cautions Regarding 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, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements relate to future expectations, plans and prospects, as well as other statements regarding matters that are not historical facts. These statements include but are not limited to statements regarding the estimated STGD1 patient population in the U.S., Belite Bio’s advancement of regulatory milestones and planned commercialization of its product candidates, Belite Bio’s commercial preparedness and the timing and execution of a potential product launch following regulatory approval, the ability of tinlarebant to treat STGD1 and GA, the timing for the FDA to review Belite Bio’s NDA for tinlarebant, the potential acceptance by the FDA and the potential assignment of the PDUFA target action date, as well as any other statements regarding matters that are not historical facts, and any other statements containing the words “may”, “will”, “expect”, “believe”, “target”, “plan”, “intend”, “continue”, “hope”, “potential”, “anticipate”, “estimate”, “look forward”, and other similar expressions. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors related to Belite Bio’s business, including but not limited to Belite Bio’s ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may not support further development or regulatory approval; expectations for the timing of initiation, enrollment and completion of, and data relating to, its clinical trials; the timing to complete any ancillary clinical trials and/or to receive the interim/final data of such clinical trials; the timing to communicate with and submit trial data to regulatory authorities for drug approval in various jurisdictions; the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approval of Belite Bio’s drug candidates; Belite Bio’s ability to successfully commercialize tinlarebant, if approved, including its ability to build out commercial infrastructure, achieve market acceptance, and execute a timely product launch; timing for Belite Bio to share additional data at upcoming medical meetings; the potential efficacy of tinlarebant to set a new benchmark for future research in inherited retinal disorders, as well as those risks more fully discussed in the “Risk Factors” section in Belite Bio’s filings with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Belite Bio, and Belite Bio undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

Media and Investor Relations Contact:

Jennifer Wu / [email protected]
Argot Partners / [email protected]



Posted on

ComEd Continues Power Restoration Following Two Powerful Storms

ComEd Continues Power Restoration Following Two Powerful Storms

Crews focus on remaining outages as weather clears across northern Illinois

CHICAGO–(BUSINESS WIRE)–
ComEd crews continue restoring power to customers impacted by multiple rounds of severe storms that moved through northern Illinois beginning Wednesday afternoon. With the most volatile weather now past the region, crews are focused on completing repairs and restoring service to remaining pockets of customers affected by storm damage.

Multiple bands of severe weather brought intense rain, frequent lightning and high wind gusts, causing significant damage to ComEd’s power infrastructure and resulting in widespread outages across the service territory. At least two tornadoes were confirmed on Thursday, including one in Streator, Illinois, and another near Dwight, Illinois, with additional damage assessments ongoing.

Across the two days of severe weather, approximately 684,000 ComEd customers experienced outages. As of 6pm June 12, ComEd has restored power to roughly 582,000 customers, representing significant progress following both storm systems.

“Our crews have been working long hours under challenging conditions to safely restore power as quickly as possible,” said David Perez, executive vice president and COO of ComEd. “While we’re encouraged by the progress being made and the improving weather outlook, we will continue our work until every customer is restored.”

The most severe impacts from Wednesday evening’s storms were felt on Chicago’s South Side, in Joliet and in the communities of Crestwood, Lockport and Alsip. Of the approximately 548,200 customers impacted Wednesday, about 71,000 remain without power, meaning more than 87 percent have been restored.

A second round of storms moved through the region Thursday afternoon and evening, causing outages for roughly 136,600 customers, primarily on Chicago’s South Side and in Oak Lawn, Joliet, Markham, Bridgeview, Justice and Streator. Approximately 26,000 customers remain without power from Thursday’s storms, reflecting a restoration rate of about 81 percent.

The storms caused extensive tree damage and downed power lines, with one tornado touching down in Streator, approximately 100 miles southwest of Chicago, damaging homes and other structures. Another tornado was identified near Dwight, about 80 miles southwest of Chicago.

More than 200 ComEd crews and over 3,000 personnel were mobilized during the peak of the response, supported by additional mutual assistance crews arriving Friday. Prior to storms hitting the area, ComEd strategically positioned crews and equipment across the service territory to enable faster response once outages occurred.

To support restoration efforts, ComEd established base camps at Joliet Junior College, Daley College in Chicago and Cherry Valley Mall in Rockford, among other sites. ComEd also activated its Mobile Command Center to enhance coordination across impacted areas. In addition, four ComEd Care Vans were deployed to Worth, Alsip, Palos Hills and Joliet to provide resources to customers.

Public safety is 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 new 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 gas customers. ComEd powers the lives of more than 4 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: United States North America Illinois

INDUSTRY KEYWORDS: Energy Utilities Oil/Gas

MEDIA:

Logo
Logo
Posted on

PICS INVESTOR NOTICE: PicS N.V. Investors with Substantial Losses Have Opportunity to Lead Class Action Lawsuit

PR Newswire

SAN DIEGO, June 12, 2026 /PRNewswire/ — Robbins Geller Rudman & Dowd LLP announces that purchasers of PicS N.V. (NASDAQ: PICS) Class A common stock in and/or traceable to PicS N.V.’s January 30, 2026 initial public offering (“IPO”), have until August 4, 2026 to seek appointment as lead plaintiff of the PicS N.V. class action lawsuit.  Captioned FirstFire Global Opportunities Fund, LLC v. PicS N.V., No. 26-cv-04793 (S.D.N.Y.), the PicS N.V. class action lawsuit charges PicS N.V. and certain of PicS N.V.’s top executive officers, directors, controlling shareholders, and underwriters of the IPO with violations of the Securities Act of 1933.

Robbins Geller Rudman & Dowd LLP

If you suffered substantial losses and wish to serve as lead plaintiff of the

PicS N.V.

class action lawsuit, please provide your information here:


https://www.rgrdlaw.com/cases-pics-n-v-class-action-lawsuit-pics.html

You can also contact attorneys

Ken Dolitsky

or

Michael Albert

of Robbins Geller by calling 800/851-7783 or via e-mail at

[email protected]

.

CASE ALLEGATIONS: PicS N.V. operates one of the largest digital banks in Brazil.  In the IPO, PicS N.V. sold approximately 22.9 million shares of Class A common stock to the public at $19 per share, generating gross proceeds of $434.3 million.

The PicS N.V. class action lawsuit alleges that defendants in the IPO’s offering documents made false and/or misleading statements and/or failed to disclose that: (i) PicS N.V. had conducted an evaluation of its credit evaluation procedures in December 2025 and determined that such procedures were deficient and in need of enhancement; (ii) as a result of the new procedures PicS N.V. had implemented in December 2025, PicS N.V. had reclassified approximately R$590 million of exposures previously classified as Stage 2 to Stage 3, leading to an incremental ECL charge of R$88 million in the three months ended December 31, 2025; (iii) PicS N.V. had experienced a heightened, but unreported, Stage 3 formation rate of more than 7% in the fourth quarter of 2025 that deviated substantially from the historical results and trends provided in the offering documents; (iv) the IPO’s offering documents had materially overstated the quality and ability of PicS N.V.’s credit models and user data to inform PicS N.V.’s underwriting practices and to allow PicS N.V. to timely and effectively monitor, assess, and identify adverse credit events, credit risks, and credit deterioration across its portfolio; and (v) PicS N.V. suffered from degradations in customer credit quality and heightened risks of default and loan impairment as a result of its entrance into materially riskier business lines leading up to the IPO, resulting in undisclosed adverse financial and operational trends such as heightened incidents of default, which predated the IPO and were internally projected by PicS N.V. to continue to worsen following the IPO, materially impairing PicS N.V.’s business, operations, and financial results.

By June 4, 2026, PicS N.V. Class A common stock fell to a low of less than $9 per share,

representing a more than 50% decline from the $19 per share IPO price.  The price of PicS N.V. Class A common stock has remained substantially below the IPO price as of the date of the filing of the complaint.

The plaintiff is represented by Robbins Geller, which has extensive experience in prosecuting investor class actions including actions involving financial fraud.  You can view a copy of the complaint by clicking here.

THE LEAD PLAINTIFF PROCESS: The Private Securities Litigation Reform Act of 1995 permits any investor who purchased PicS N.V. Class A common stock in and/or traceable to the IPO to seek appointment as lead plaintiff in the PicS N.V. class action lawsuit.  A lead plaintiff is generally the movant with the greatest financial interest in the relief sought by the putative class who is also typical and adequate of the putative class.  A lead plaintiff acts on behalf of all other class members in directing the PicS N.V. class action lawsuit.  The lead plaintiff can select a law firm of its choice to litigate the PicS N.V. class action lawsuit.  An investor’s ability to share in any potential future recovery is not dependent upon serving as lead plaintiff of the PicS N.V. class action lawsuit.

ABOUT ROBBINS GELLER: Robbins Geller Rudman & Dowd LLP is one of the world’s leading law firms representing investors in securities fraud and shareholder litigation.  Our Firm has been ranked #1 in the ISS Securities Class Action Services rankings for four out of the last five years for securing the most monetary relief for investors.  In 2024, we recovered over $2.5 billion for investors in securities-related class action cases – more than the next five law firms combined, according to ISS.  With 200 lawyers in 10 offices, Robbins Geller is one of the largest plaintiffs’ firms in the world, and the Firm’s attorneys have obtained many of the largest securities class action recoveries in history, including the largest ever – $7.2 billion – in In re Enron Corp. Sec. Litig.  Please visit the following page for more information:


https://www.rgrdlaw.com/services-litigation-securities-fraud.html

Past results do not guarantee future outcomes. 

Services may be performed by attorneys in any of our offices. 

Contact:

          Robbins Geller Rudman & Dowd LLP

          Ken Dolitsky

          Michael Albert

          655 W. Broadway, Suite 1900, San Diego, CA 92101

          800/851-7783

          [email protected]

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/pics-investor-notice-pics-nv-investors-with-substantial-losses-have-opportunity-to-lead-class-action-lawsuit-302797732.html

SOURCE Robbins Geller Rudman & Dowd LLP

Posted on

ROMA Green Finance Establishes Dedicated Artificial Intelligence and High-Performance Computing Infrastructure Investment Vertical

New vertical extends ROMA’s sustainable-finance mandate into energy-efficient, behind-the-meter-powered digital infrastructure; Company is evaluating a pipeline of distributed, sub-50 MW AI/HPC investment opportunities, subject to diligence, definitive documentation, and board approval.

ROMA, HONG KONG, June 12, 2026 (GLOBE NEWSWIRE) — ROMA Green Finance Limited (Nasdaq: ROMA) (“ROMA” or the “Company”) today announced the establishment of a dedicated investment vertical focused on Artificial Intelligence and High-Performance Computing (AI/HPC) infrastructure. The vertical extends the Company’s sustainable-finance and ESG advisory mandate into low-carbon, energy-efficient digital infrastructure.

The vertical targets distributed, sub-50 MW compute assets paired with on-site behind-the-meter (BTM) power generation in low-cost energy jurisdictions. ROMA believes this approach is differentiated from large-scale hyperscale development and is defensible on ESG grounds through improved energy efficiency, reduced grid dependence, and disciplined, partnership-led capital deployment.

Strategic Highlights

  • Extends ROMA’s sustainable-finance and ESG advisory mandate into energy-efficient digital infrastructure.
  • Targets distributed, sub-50 MW AI/HPC compute assets paired with on-site behind-the-meter (BTM) power generation in low-cost energy jurisdictions.
  • Pursues a capital-disciplined, asset-light, partnership-led strategy intended to differentiate the Company from hyperscale developers.
  • The Company is evaluating a pipeline of potential investments; any specific transaction will be publicly disclosed if and when a definitive agreement is reached that would be material to the Company.
  • All investment activity is subject to due diligence, the execution of definitive documentation, and board approval.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and the safe-harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements include, without limitation, statements regarding the matters described in this release, including timing, scope, and anticipated benefits. Words such as “anticipate,” “believe,” “expect,” “intend,” “plan,” “target,” “may,” “will,” and similar expressions are intended to identify forward-looking statements.

These statements are based on the Company’s current expectations and are subject to known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially. The transaction(s) described herein, where applicable, are governed by a non-binding letter of intent, remain subject to due diligence, the negotiation and execution of definitive documentation, and any required corporate, regulatory, and third-party approvals, and may not be completed on the terms described or at all. The Company undertakes no obligation to update any forward-looking statement except as required by law. Additional information concerning risks and uncertainties is contained in the Company’s filings furnished to or filed with the U.S. Securities and Exchange Commission, including on Form 6-K and the Company’s Annual Report on Form 20-F.

Investor & Media Contact

Clarie Luk, CEO, [email protected], (+852) 2529-6878



Posted on

OpenText to Create 400 Jobs with €105 Million Investment in Cork and Galway to Expand Agentic AI and Sovereign Cloud in Europe

PR Newswire

Taoiseach Micheál Martin TD and CEO of IDA Ireland Michael Lohan join OpenText to announce new Cork Centre of Excellence for EMEA

Investment marks the largest in Ireland by a Canadian-headquartered technology company, advancing R&D in agentic AI, sovereign cloud and cyber resilience for EMEA clients

DUBLIN, June 12, 2026 /PRNewswire/ — OpenText™ (NASDAQ/TSX: OTEX), a Waterloo, Ontario, Canada headquartered global leader in data management for enterprise AI, today announced a €105 million investment that will create 400 new jobs across the company’s sites in Ireland over the next three years. The commitment, which doubles OpenText’s investment in Ireland, will significantly expand the company’s agentic AI, cybersecurity, sovereign cloud, and digital operations capabilities in service of European, Middle East & African (EMEA) economies and public sectors.

Taoiseach Micheál Martin and Michael Lohan, CEO of IDA Ireland join OpenText to announce creation of 400 new jobs in Cork and Galway as part of €105m investment in expanding agentic AI, sovereign cloud and cybersecurity in Europe. Pictured (L to R): Anne Marie Tierney Le Roux, Head of Technology at IDA Ireland; Michael Lohan CEO of IDA Ireland; Taoiseach Micheál Martin TD; Thomas Jenkins, Chairman of OpenText; and Shannon Bell, Chief Digital Officer & Chief Information Officer of OpenText. 

This is the single largest investment into Ireland by a technology company headquartered in Canada, supported by the Irish government through IDA Ireland. The €105 million investment is directed at operations and R&D across three areas foundational to trusted enterprise AI — agentic AI, sovereign cloud, and cybersecurity — that will create high-skilled roles at OpenText in Cork and Galway. Irish-based developers and researchers will design, deploy, secure and operate these AI & cloud capabilities for EMEA markets.

OpenText announced the investment today in Dublin alongside Taoiseach Micheál Martin TD and Michael Lohan, CEO of IDA Ireland, marking a significant milestone in Canada-Ireland technology and economic collaboration.

“OpenText’s investment in Ireland is a strong endorsement of the deep and growing economic partnership between Ireland and Canada,” said Taoiseach Micheál Martin. “It reflects the strength of our longstanding relationship and will help create new opportunities for innovation, trade and high-value job creation between our two countries. Furthermore, as Ireland prepares to take up the EU Presidency, investments of this scale underline our role in shaping Europe’s competitiveness in AI, digital infrastructure and innovation and reflect the kind of international partnership that will be central to Europe’s future growth and resilience.”

“Organisations across Europe are looking for trusted partners that can help them deploy AI securely, govern it responsibly, and operate with confidence across increasingly complex digital environments,” said Shannon Bell, EVP, Chief Digital Officer and CIO, OpenText. “This investment expands our EMEA R&D and operations capacity to deliver the trusted AI, cybersecurity, and cloud capabilities our clients already rely on globally, while giving European organisations greater regional support and flexibility across the cloud environments of their choice.”

Speaking of the announcement Michael Lohan, CEO of IDA Ireland said, “AI is one of the most significant growth drivers in the global economy today, and OpenText’s decision to invest in Ireland reflects our strength as a strategic location for world-leading companies seeking talent, innovation and a trusted environment in which to scale international operations. Particularly welcome is the creation of high-skilled roles across two regional locations, which highlights the depth of talent available throughout the country. This investment will strengthen Ireland’s leadership in AI and transformational technology and IDA Ireland looks forward to continuing to work closely in partnership with OpenText as it grows its business in Ireland and deepens its European presence.”

Scaling Trusted AI Operations for EMEA

OpenText’s expanded European operations will increase regional capacity for organisations operating in highly regulated and mission-critical environments, including organisations requiring greater control over data governance, cyber resilience, and cloud deployment models.

The investment is part of OpenText’s cloud-of-choice strategy to enable clients with the flexibility to operate across hybrid public cloud, private cloud, and sovereign cloud environments based on their operational, regulatory, and security requirements.

Investing in AI Innovation and Europe-based Talent

For more than 35 years, OpenText has helped organisations manage, protect, and innovate with their most important human, machine and transactional data. The Ireland expansion represents a significant step in the company’s global strategy to support trusted enterprise AI through secure data management, cybersecurity, sovereign cloud, and operational resilience.

OpenText intends to explore opportunities for university and research collaboration in Ireland as part of its long-term innovation and talent strategy, including potential partnerships focused on AI, cybersecurity, and secure digital operations.

R&D Across Three Foundational AI Areas

In agentic AI, OpenText research will advance how agents are orchestrated and governed including multi-agent collaboration, system boundary enforcement, and knowledge sharing across sovereign zones.

In data sovereignty, developers will build continuous compliance mechanisms that give organisations verifiable control over where data lives and how it is governed as AI environments become more dynamic.

In cybersecurity, research will focus on threat detection and response built natively for regulated environments, including federated intelligence sharing that strengthens collective resilience without exposing sensitive operational data across jurisdictions.

About OpenText

OpenText™ is a global leader in data management for enterprise AI, helping organisations protect, govern, and activate their data with confidence. Our technologies turn data into information with context to form the knowledge base for enterprise AI. Learn more at www.opentext.com. 

About IDA Ireland

IDA Ireland is the national investment development agency responsible for attracting multinationals and high growth scale-ups.  We partner with companies worldwide to provide financial assistance, on-the-ground support and no-cost advice to help them establish and transform their operations in Ireland.  With over 75 years of experience, the agency supports more than 1,800 client companies which directly employ over 300,000 people.  

Cautionary Statement Regarding Forward-Looking Statements

Certain statements in this press release may contain words considered forward-looking statements or information under applicable securities laws, including statements about Open Text Corporation (“OpenText” or the “Company) on the Company’s strategy and future investments, including amount and associated benefits, timing thereof, potential new jobs created, increase in capacity, and focus of research and development. These statements are based on OpenText’s current expectations, estimates, forecasts and projections about the operating environment, economies and markets in which the company operates. These statements are subject to important assumptions, risks and uncertainties that are difficult to predict, and the actual outcome may be materially different. OpenText’s assumptions, although considered reasonable by the company at the date of this press release, may prove to be inaccurate and consequently its actual results could differ materially from the expectations set out herein. For additional information with respect to risks and other factors which could occur, see OpenText’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and other securities filings with the SEC and other securities regulators. Readers are cautioned not to place undue reliance upon any such forward-looking statements, which speak only as of the date made. Unless otherwise required by applicable securities laws, OpenText disclaims any intention or obligations to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Further, readers should note that we may announce information using our website, press releases, securities law filings, public conference calls, webcasts and the social media channels identified on the Investors section of our website (https://investors.opentext.com). Such social media channels may include the Company’s or our CEO’s blog, X, formerly known as Twitter, account or LinkedIn account. The information posted through such channels may be material. Accordingly, readers should monitor such channels in addition to our other forms of communication. 

OTEX-G

Copyright © 2026 OpenText. All Rights Reserved. Trademarks owned by OpenText. One or more patents may cover this product(s). For more information, please visit https://www.opentext.com/patents. 

OpenText

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/opentext-to-create-400-jobs-with-105-million-investment-in-cork-and-galway-to-expand-agentic-ai-and-sovereign-cloud-in-europe-302799400.html

SOURCE Open Text Corporation

Posted on

TRUQAP® (capivasertib) combination approved in the US as first and only targeted treatment for PTEN-deficient metastatic hormone-sensitive prostate cancer

TRUQAP® (capivasertib) combination approved in the US as first and only targeted treatment for PTEN-deficient metastatic hormone-sensitive prostate cancer

Based on results of CAPItello-281 which prospectively defined PTEN-deficient disease and showed TRUQAP combination reduced risk of radiographic disease progression or death by 19%

First-in-class AKT inhibitor moves into second tumor type to address an aggressive form of prostate cancer associated with poor prognosis

WILMINGTON, Del.–(BUSINESS WIRE)–
AstraZeneca’s TRUQAP® (capivasertib)in combination with abiraterone and prednisone has been approved in the US as the first and only targeted treatment for adult patients with PTEN-deficient metastatic androgen pathway modulation-naïve or sensitive (mAPMN/S) prostate cancer, previously referred to as metastatic hormone-sensitive prostate cancer (mHSPC), as detected by a US Food and Drug Administration (FDA)-authorized test.1

The approval by the US FDA was based on positive results from the CAPItello-281 Phase III trial, presented at the 2025 European Society for Medical Oncology (ESMO) Congress and published in Annals of Oncology.2

Prostate cancer is the second most prevalent cancer in men and the fifth leading cause of male cancer death globally, with more than 1.4 million people diagnosed each year.3 Of these, approximately 200,000 patients worldwide, including 35,000 in the US, are diagnosed with mAPMN/S prostate cancer annually.4 One in four of these patients have PTEN-deficient tumors, which fuels the growth of cancer cells and defines an aggressive form of the disease associated with poor outcomes.4-7 PTEN deficiency is an independent risk factor regardless of other clinical characteristics, and can be identified by immunohistochemistry testing at time of diagnosis.7

Daniel George, MD, Director of Genitourinary Oncology at Duke Cancer Institute and investigator for the CAPItello-281 trial, said: “Patients with PTEN-deficient metastatic hormone-sensitive prostate cancer, now called metastatic androgen pathway modulation-naïve or sensitive prostate cancer, experience faster progression and worse prognosis than those without PTEN deficiency. Keeping patients with this form of prostate cancer in remission and free from disease progression as long as possible is a high priority. Today’s landmark approval of the capivasertib combination as the first and only targeted treatment option for these patients represents a significant clinical advance with the potential to improve their lives and change the course of disease.”

Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: “CAPItello-281 showed that for the first time, we can target a key driver of this disease to bring meaningful benefit to the one in four patients with this form of prostate cancer who urgently need biomarker-directed therapies. Today’s approval makes clear the importance of testing for actionable biomarkers, including PTEN deficiency, in prostate cancer.”

Results from the primary analysis of the CAPItello-281 Phase III trial showed a statistically significant 19% reduction in the risk of radiographic disease progression or death and a clinically meaningful improvement in median radiographic progression-free survival (rPFS) of 7.5 months with TRUQAP in combination with abiraterone and androgen deprivation therapy (ADT) versus treatment with abiraterone and ADT with placebo (based on a hazard ratio [HR] of 0.81; 95% confidence interval [CI] 0.66–0.98; p=0.034). Median rPFS was 33.2 months for the TRUQAP combination versus 25.7 months for the comparator arm.2 While overall survival (OS) data were immature at the time of the primary analysis, results for OS numerically favored the TRUQAP combination versus the comparator arm. The trial will continue as planned to further assess OS as a key secondary endpoint.

The safety profile of TRUQAP in combination with abiraterone and ADT in CAPItello-281 was broadly consistent with the known profile of each medicine. Grade 3 or higher adverse events occurred in 67% of patients treated with the TRUQAP combination, with rash (12.3%) and hyperglycemia (10.3%) the most frequently reported.2

Concurrently with this approval, the FDA also approved a companion diagnostic test to detect PTEN deficiency in tumors of patients with prostate adenocarcinoma.

A regulatory application for the TRUQAP combination in this setting is under review in the EU based on the CAPItello-281 Phase III trial.

IMPORTANT SAFETY INFORMATION ABOUT TRUQAP®(capivasertib) tablets

TRUQAP is contraindicated in patients with severe hypersensitivity to TRUQAP or any of its components.

Hyperglycemia

TRUQAP can cause severe hyperglycemia, including diabetic ketoacidosis and fatal outcomes

Metastatic HR-Positive, HER2-Negative Breast Cancer

– In CAPItello-291, increased fasting glucose (FG) from baseline occurred in 37% of patients treated with TRUQAP, including 11% of patients with Grade 2 (FG >160 to 250 mg/dL), 2% with Grade 3 (FG >250 to 500 mg/dL), and 1.1% with Grade 4 (FG >500 mg/dL) events

– The median time to first occurrence of hyperglycemia was 15 days (range: 1 to 367). Dose reduction for hyperglycemia was required in 0.6% of patients and permanent discontinuation was required in 0.6% of patients. Diabetic metabolic decompensation occurred in 0.6% of patients, including diabetic ketoacidosis in 0.3%

– In the study, 12% (43/355) of patients who received TRUQAP had an anti-hyperglycemic medication regimen either initiated or changed, including treatment with insulin in 4.8% (17/355) of patients

PTEN-Deficient Metastatic Androgen Pathway Modulation-Naïve or -Sensitive Prostate Cancer

– In CAPItello-281, increased fasting glucose (FG) from baseline occurred in 69% of patients treated with TRUQAP, including 25% of patients with Grade 2 (FG >160 to 250 mg/dL), 12% with Grade 3 (FG >250 to 500 mg/dL), and 1.2% of patients with Grade 4 (FG >500 mg/dL) events

– The median time to first occurrence of hyperglycemia was 71 days (range: 1 to 1454). Dose reduction for hyperglycemia was required in 8.7% of patients and permanent discontinuation was required in 2.4% of patients. Diabetic ketoacidosis occurred in 1.2% of patients

– In the study, 41% (204/503) of patients who received TRUQAP had an anti-hyperglycemic medication regimen either initiated or changed, including treatment with insulin in 16% (81/503) of patients

The safety of TRUQAP has not been established in patients with Type 1 diabetes or Type 2 diabetes that is uncontrolled or requiring insulin at baseline as these patients were excluded from clinical studies. Before initiating treatment with TRUQAP, test fasting glucose levels (FPG or FBG), HbA1C levels, and optimize fasting glucose. After initiating treatment with TRUQAP, monitor or self-monitor FG levels on Day 3 or 4 of the dosing week during weeks 1, 2, 4, 6, and 8; then monthly while on treatment with TRUQAP; and as clinically indicated. Monitor HbA1C levels every 3 months during treatment with TRUQAP and as clinically indicated. Patients with a history of well-controlled Type 2 diabetes mellitus may require intensified anti-hyperglycemic treatment and close monitoring of FG levels.

For patients who experience hyperglycemia during treatment with TRUQAP, monitor FG at least twice weekly, on days on and off TRUQAP, until FG decreases to baseline levels. During treatment with anti-diabetic medications, monitor FG at least once a week for 2 months, followed by once every 2 weeks, or as clinically indicated. Consider consultation with a healthcare practitioner with expertise in the treatment of hyperglycemia and initiation of FG monitoring at home for patients who have risk factors for hyperglycemia or who experience hyperglycemia. Advise patients on the signs and symptoms of hyperglycemia and counsel patients on lifestyle changes.

Withhold TRUQAP immediately when ketoacidosis is suspected. If ketoacidosis is confirmed, permanently discontinue TRUQAP. Withhold TRUQAP in clinical situations known to increase the risk of severe hyperglycemia or ketoacidosis (eg, suspected serious infection or acute illness). Based on the severity of hyperglycemia, withhold, reduce dose, or permanently discontinue TRUQAP.

Diarrhea

TRUQAP can cause severe diarrhea associated with dehydration

Metastatic HR-Positive, HER2-Negative Breast Cancer

– In CAPItello-291, diarrhea occurred in 72% of patients. Grade 3 or 4 diarrhea occurred in 9% of patients

– The median time to first occurrence was 8 days (range: 1 to 519). In the study, dose reductions were required in 8% of patients, and 2% of patients permanently discontinued TRUQAP due to diarrhea. In patients with Grade ≥2 diarrhea (n=93) with at least 1 grade improvement (n=89), median time to improvement from the first event was 4 days (range: 1 to 154)

– In the 257 patients with diarrhea, 59% required anti-diarrheal medications to manage symptoms

PTEN-Deficient Metastatic Androgen Pathway Modulation-Naïve or -Sensitive Prostate Cancer

– In CAPItello‑281, diarrhea of any grade occurred in 264 (52%) patients. Grade 3 occurred in 31 (6%) patients and Grade 4 occurred in 1 (0.2%) patient

– The median time to first occurrence was 12 days (range: 3 to 48). In the study, dose reductions were required in 26 (5%) patients and 6 (1.2%) patients discontinued TRUQAP due to diarrhea

– In the 264 patients with diarrhea, anti-diarrheal medication was required in 64% (170/264) of patients to manage diarrhea symptoms

Monitor patients for signs and symptoms of diarrhea. Advise patients to increase oral fluids and start anti-diarrheal treatment at the first sign of diarrhea while taking TRUQAP. Withhold, reduce dose, or permanently discontinue TRUQAP based on severity.

Cutaneous Adverse Reactions

TRUQAP can cause cutaneous adverse reactions, which can be severe, including erythema multiforme (EM), palmar-plantar erythrodysesthesia (PPE), and drug reaction with eosinophilia and systemic symptoms (DRESS).

Metastatic HR-Positive, HER2-Negative Breast Cancer

– In CAPItello-291, cutaneous adverse reactions occurred in 58% of patients. Grade 3 or 4 cutaneous adverse reactions occurred in 17% of patients receiving TRUQAP. EM occurred in 1.7% of patients, and DRESS occurred in 0.3% of patients

– The median time to onset of cutaneous adverse reactions was 13 days (range: 1 to 575 days). Dose reduction was required in 7% of patients and 7% of patients permanently discontinued TRUQAP due to cutaneous adverse reactions

– Among the 204 patients with cutaneous adverse reactions, 44% (90/204) required corticosteroid treatment. Of these, 37% (76/204) were treated with topical corticosteroids and 19% (39/204) with systemic corticosteroids. In patients with Grade ≥2 cutaneous adverse reaction (n= 116) with at least 1 grade improvement (n=104), median time to improvement from the first event was 12 days (range: 2 to 544)

PTEN-Deficient Metastatic Androgen Pathway Modulation-Naïve or -Sensitive Prostate Cancer

– In CAPItello-281, cutaneous adverse reactions occurred in 53% of patients. Grade 3 cutaneous adverse reactions occurred in 84 (17%) patients and Grade 4 occurred in 1 (0.2%) patients

– The median time to onset of rash was 13 days (range: 11 to 63 days). In the study, dose reduction was required in 58 (12%) patients and 38 (8%) patients discontinued TRUQAP due to rash

– Among the 265 patients with cutaneous adverse reactions, 80% (212/265) required treatment and 91% (242/265) recovered in the study. Of these, 54% (115/212) were treated with topical corticosteroids and 25% (54/212) with systemic corticosteroids

Monitor patients for signs and symptoms of cutaneous adverse reactions. Early consultation with a dermatologist is recommended. Withhold, reduce dose, or permanently discontinue TRUQAP based on severity.

Embryo-Fetal Toxicity

Based on findings from animals and mechanism of action, TRUQAP can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TRUQAP and for 1 month after the last dose.

Advise male patients with female partners of reproductive potential to use effective contraception during treatment with TRUQAP and for 4 months after the last dose.

TRUQAP is used in combination with fulvestrant or abiraterone. Refer to the full Prescribing Information of fulvestrant or abiraterone for pregnancy and contraception information.

ADVERSE REACTIONS

Metastatic HR-Positive, HER2-Negative Breast Cancer

– Among the 355 patients who received TRUQAP in CAPItello-291, the most common (≥20%) adverse reactions, including laboratory abnormalities, were diarrhea (72%), cutaneous adverse reactions (58%), increased random glucose (57%), decreased lymphocytes (47%), decreased hemoglobin (45%), increased fasting glucose (37%), nausea and fatigue (35% each), decreased leukocytes (32%), increased triglycerides (27%), decreased neutrophils (23%), increased creatinine (22%), vomiting (21%), and stomatitis (20%)

– In the 155 patients with PIK3CA/AKT1/PTEN alterations treated with TRUQAP + fulvestrant, dose reductions due to adverse reactions were reported in 21% of patients. Permanent TRUQAP discontinuation due to an adverse reaction occurred in 10% of patients. Dose interruptions of TRUQAP occurred in 39% of patients

PTEN-Deficient Metastatic Androgen Pathway Modulation-Naïve or -Sensitive Prostate Cancer

– Among the 503 patients who received TRUQAP in CAPItello-281, the most common (≥20%) adverse reactions including laboratory abnormalities were increased fasting glucose (70%), decreased hemoglobin (61%), decreased lymphocytes (58%), cutaneous adverse reactions (53%), diarrhea (53%), decreased potassium (51%), increased creatinine (49%), increased non-fasting glucose (49%), increased alanine aminotransferase (38%), increased triglycerides (37%), increased aspartate aminotransferase (36%), decreased sodium (30%), and fatigue (26%)

– In the 503 patients treated with TRUQAP + abiraterone and prednisone, dose reductions due to adverse reactions were reported in 32% of patients. Permanent TRUQAP discontinuation due to an adverse reaction occurred in 20% of patients. Dose interruptions of TRUQAP occurred in 65% of patients

DRUG INTERACTIONS

Strong CYP3A Inhibitors: Avoid concomitant use with a strong CYP3A inhibitor. If concomitant use cannot be avoided, reduce the dose of TRUQAP and monitor patients for adverse reactions.

Moderate CYP3A Inhibitors: When concomitantly used with a moderate CYP3A inhibitor, reduce the dose of TRUQAP and monitor patients for adverse reactions.

Strong or Moderate CYP3A Inducers: Avoid concomitant use of TRUQAP with strong or moderate CYP3A inducers.

INDICATIONS AND USAGE

– TRUQAP in combination with fulvestrant is indicated for the treatment of adult patients with hormone receptor (HR)‑positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN alteration as detected by an FDA-authorized test following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy

– TRUQAP in combination with abiraterone and prednisone is indicated for the treatment of adult patients with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer that is PTEN-deficient as detected by an FDA-authorized test

Please see full Prescribing Information, including Patient Information for TRUQAP.

Notes

Prostate cancer

In the US, prostate cancer is the most common cancer in men, with more than 300,000 new cases of the disease diagnosed annually, and more than 36,000 deaths.8

Metastatic prostate cancer is associated with a significant mortality rate, with only one third of patients surviving five years after diagnosis.9 Development of prostate cancer is often driven by male sex hormones called androgens, including testosterone.10

Metastatic androgen pathway modulation-naïve or sensitive prostate cancer

mAPMN/S prostate cancer, previously referred to as mHSPC or metastatic castration-sensitive prostate cancer (mCSPC) reflects new, redefined terminology for clinical trials and regulatory indications in prostate cancer.1 In patients with mAPMN/S prostate cancer, prostate cancer cells need high levels of androgens to drive cancer growth.5,10 Hormone therapies, such as androgen deprivation therapies, are widely used to block the action of male sex hormones and lower the levels of androgens in the body.5,10 However, resistance to these therapies is common and there is a need to extend their use to delay disease progression and castration resistance, where the prostate cancer grows and spreads to other parts of the body despite the use of these therapies.5,6,11

mAPMN/S prostate cancer is an aggressive form of the disease associated with poor outcomes and survival.5,6 Globally, approximately 200,000 patients are diagnosed with mAPMN/S prostate cancer each year, with 35,000 patients diagnosed with the disease in the US.4 One in four of these patients have PTEN-deficient tumors.4

PTEN-loss or deficiency fuels the growth of cancer cells, leading to dysregulation of the PI3K/AKT pathway, and is associated with poor outcomes in patients with prostate cancer.12,13

CAPItello-281

CAPItello-281 is a Phase III, double-blind, randomized trial evaluating the efficacy and safety of TRUQAP® (capivasertib) in combination with abiraterone and ADT versus abiraterone and ADT in combination with placebo in the treatment of patients with newly diagnosed PTEN-deficient mAPMN/S prostate cancer.

The global trial enrolled 1,012 adult patients with histologically confirmed newly diagnosed APMN/S prostate adenocarcinoma and PTEN deficiency as confirmed by central testing. The primary endpoint of the CAPItello-281 trial is rPFS as assessed by investigator, with OS as a key secondary endpoint.

TRUQAP® (capivasertib)

TRUQAP® (capivasertib) is a first-in-class, potent, adenosine triphosphate (ATP)-competitive inhibitor of all three AKT isoforms (AKT1/2/3). TRUQAP 400 mg is administered twice daily according to an intermittent dosing schedule of four days on and three days off. This was chosen in early phase trials based on tolerability and the degree of target inhibition.

TRUQAP in combination with fulvestrant is approved in the US, EU, Japan, China and a number of other countries for the treatment of adult patients with HR-positive (or estrogen receptor-positive), HER2-negative locally advanced or metastatic breast cancer with one or more biomarker alterations (PIK3CA, AKT1 or PTEN) following recurrence or progression on or after an endocrine-based regimen based on the results from the CAPItello-291 trial. TRUQAP is also approved in Australia for the treatment of adult patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer following recurrence or progression on or after an endocrine based regimen based on these trial results.

TRUQAP is currently being evaluated in combination with established treatments for the 1st-line treatment of HR-positive breast cancer in the Phase III CAPItello-292 trial.

TRUQAP was discovered by AstraZeneca subsequent to a collaboration with Astex Therapeutics (and its collaboration with the Institute of Cancer Research and Cancer Research Technology Limited).

AstraZeneca in oncology

AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyze changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

AstraZeneca

AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca-us.com and follow the Company on social media @AstraZeneca.

References

  1. Armstrong A, et al. Trial Design and Objectives for Patients With Prostate Cancer: Recommendations From the Prostate Cancer Working Group 4. J Clin Oncol. 2026;44:1249-1265.

  2. Fizazi K, et al. Capivasertib plus abiraterone in PTEN-deficient metastatic hormone sensitive prostate cancer: CAPItello-281 phase III study. Ann Oncol 2026; 37(1):53-68.

  3. Bray F, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 Apr 4. doi: 10.3322/caac.21834.

  4. Cerner CancerMPact database. Accessed June 2026.

  5. American Society of Clinical Oncology Educational Book. Metastatic Hormone-Sensitive Prostate Cancer: Toward an Era of Adaptive and Personalized Treatment. Available at: https://ascopubs.org/doi/pdf/10.1200/EDBK_390166. Accessed June 2026.

  6. Hussain M, et al. Metastatic Hormone-Sensitive Prostate Cancer and Combination Treatment Outcomes A Review. JAMA Oncol. 2024;10(6):807-820.

  7. Jamaspishvili T, et al. Clinical implications of PTEN loss in prostate cancer. Nat Rev Urol. 2018 April;15(4): 222–234.

  8. American Cancer Society. Key Statistics for Prostate cancer. Available at: https://www.cancer.org/cancer/types/prostate-cancer/about/key-statistics.html. Accessed June 2026.

  9. Chowdhury S, et al. Real-World Outcomes in First-Line Treatment of Metastatic Castration-Resistant Prostate Cancer: The Prostate Cancer Registry. Target Oncol. 2020;15(3):301-315.

  10. National Cancer Institute. Hormone Therapy for Prostate Cancer Fact Sheet. Available at: https://www.cancer.gov/types/prostate/prostate-hormone-therapy-fact-sheet. Accessed June 2026.

  11. Cancer Research UK. Hormone therapy for metastatic prostate cancer. Available at: https://www.cancerresearchuk.org/about-cancer/prostate-cancer/metastatic-cancer/treatment/hormone-therapy-for-metastatic-prostate-cancer. Accessed June 2026.

  12. Cuzick J, et al. Prognostic value of PTEN loss in men with conservatively managed localised prostate cancer. Br J Cancer. 2013;108(12):2582-2589.

  13. Gasmi A, et al. Overview of the Development and Use of Akt Inhibitors in Prostate Cancer. J Clin Med. 2021;11(1):160.

 US-113586 Last Updated 6/26

Media Inquiries

Lauren-Jei McCarthy

+1 347 918 7001

US Media Mailbox: [email protected]

KEYWORDS: United States North America Delaware

INDUSTRY KEYWORDS: FDA Seniors Men Clinical Trials Biotechnology Health Consumer Pharmaceutical Oncology

MEDIA:

Logo
Logo