FDA Approves Omeros’ YARTEMLEA® – First and Only Therapy Indicated for TA-TMA




FDA Approves Omeros’ YARTEMLEA® – First and Only Therapy Indicated for TA-TMA

– Omeros to Host Conference Call Monday, December 29, 2025 at 4:30 p.m. ET – 

• First and only approved option: YARTEMLEA^® is the only approved treatment for hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) and is indicated for adults and children ages two years and older.
• High complete response (CR) rates: YARTEMLEA-treated patients achieved CR rates of 61% in the pivotal trial and 68% in the Expanded Access Program (EAP) among those with evaluable patient-level response data; CR defined as improvement in key laboratory values plus either improved organ function or transfusion independence.
• Strong survival benefit: 100-day survival from TA-TMA diagnosis, based on all-cause mortality, was 73% in the pivotal trial and 74% in evaluable EAP patients; all patients met international harmonization criteria for high-risk TA-TMA.
• Safety profile and Prescribing Information highlights: The only approved TA-TMA therapy, YARTEMLEA has no Boxed Warning and no Risk Evaluation and Mitigation Strategy (REMS), and vaccinations are not required prior to treatment. Serious infections and other adverse reactions, regardless of causality, have occurred in patients treated with YARTEMLEA; see Important Safety Information for details.

SEATTLE–(BUSINESS WIRE)–Omeros Corporation (NASDAQ: OMER) today announced that the U.S. Food and Drug Administration (FDA) has approved YARTEMLEA^® (narsoplimab-wuug) for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA), an often-fatal complication of stem-cell transplantation driven by activation of the lectin pathway of complement. YARTEMLEA is the first and only approved lectin pathway inhibitor. YARTEMLEA selectively inhibits MASP-2, the effector enzyme of the lectin pathway, blocking pathway activation while preserving classical and alternative complement functions important for host defense. YARTEMLEA is approved for use in adults and in children ages two years and older.

“This approval is a long-awaited breakthrough in hematopoietic cell transplantation and TA-TMA care,” stated Miguel-Angel Perales, M.D., Chief of the Adult Bone Marrow Transplantation Service at Memorial Sloan Kettering Cancer Center. “Until now, we’ve lacked an effective TA-TMA therapy and relied largely on supportive measures such as modifying calcineurin inhibitors, which can significantly increase the risk of life-threatening graft-versus-host disease. Based on a compelling data package, narsoplimab delivers robust response rates and improved survival in TA-TMA, with a favorable benefit-risk profile and a safety profile consistent with that seen in patients undergoing hematopoietic stem cell transplantation. As the first and only drug approved for TA-TMA, narsoplimab is a practice-changing advance for patients facing this devastating complication.”

Approval of YARTEMLEA was based on results from a single-arm, open-label study in adults with TA-TMA (the TA-TMA Study; N=28), supported by additional data from an expanded access program (EAP; N=221 adult and pediatric patients). In the EAP, 19 patients (13 adult and 6 pediatric) had evaluable patient-level response data.

Efficacy was assessed by TMA complete response (CR), defined as improvement in key laboratory markers of TMA (platelet counts and LDH levels) together with either improved organ function or transfusion independence. CR was achieved in 17/28 patients (61%) in the TA-TMA Study and 13/19 evaluable EAP patients (68%). Across the TA-TMA Study and the EAP, 100-day survival from the time of TMA diagnosis (based on all-cause mortality) was 73% (95% confidence interval CI: 52, 86) and 74% (95% CI: 48, 88), respectively. All patients met international harmonization criteria for high-risk TA-TMA, classifying each patient as having a poor prognosis and high risk of death.

In peer-reviewed publications, treatment with YARTEMLEA was associated with a three- to fourfold lower risk of mortality compared with an external control cohort.¹ In the EAP, YARTEMLEA was used both as first-line therapy and in high-risk TA-TMA patients who had failed or discontinued one or more prior regimens, namely off-label complement inhibitors and/or defibrotide. In these previously refractory high-risk patients, YARTEMLEA was associated with 50 percent one-year survival, compared with historical one-year survival rates reported as less than 20 percent.^{2 3 4 5}

“Just as in adults, YARTEMLEA’s indication to treat TA-TMA in children two years of age and older is tremendously important,” said Michelle Schoettler, M.D., Assistant Professor of Pediatric Oncology and Hematopoietic Cellular Therapy at Emory University. “Peer-reviewed clinical publications in TA-TMA have steadily advanced our understanding of the disease in children – its biology, diagnostic criteria, and increasing recognition – and have revealed the limitations and risks of relying on off-label options in this setting. Across the published pediatric experience, YARTEMLEA has produced strong and consistent benefit, including in very high-risk children with organ dysfunction and in those who have failed prior complement-inhibition therapy. When used first-line, YARTEMLEA has been associated with approximately 75 percent one-year survival; and even in children refractory to one or more off-label complement inhibitors, one-year survival is approximately triple historical rates that have remained below 20 percent. My clinical experience with YARTEMLEA through the expanded access program, including in very young patients, has reinforced that it needs to be readily available for children when TA-TMA emerges. With this approval, effective TA-TMA therapy can become the pediatric standard instead of the exception – and that will save children’s lives.”

All patients in the TA-TMA Study had multiple risk factors for poor outcomes, and adverse reactions were reported regardless of causality or relatedness to YARTEMLEA. The most common adverse reactions (≥20%) were viral infections, sepsis, hemorrhage, diarrhea, vomiting, nausea, neutropenia, pyrexia, fatigue, and hypokalemia. Serious adverse reactions occurred in 61% of YARTEMLEA-treated patients; those reported in >5% included acute kidney injury, confusional state, acute respiratory failure, neutropenic sepsis, septic shock, pulmonary edema, and vomiting. Fatal adverse reactions were reported in 7% of patients, including neutropenic sepsis and septic shock. No new clinically significant safety signals were identified in patients treated with YARTEMLEA in the EAP.

Following FDA approval of YARTEMLEA, Omeros is finalizing preparations for its U.S. product launch planned for January 2026. Dedicated U.S. billing and reimbursement codes are now in place, including:

• Diagnosis Code: ICD-10-CM code M31.11 specific to the diagnosis of “Hematopoietic Stem Cell Transplantation-Associated Thrombotic Microangiopathy”
• Procedure Codes: ICD-10-PCS codes XW03357 and XW04357 for introduction of narsoplimab monoclonal antibody into a peripheral vein or into a central vein, respectively

The YARTEMLEAssist™ patient support program is expected to be available in the first quarter of 2026. Providers and patient representatives can call 1-844-YARTEM1 (1-844-927-8361) for personalized services, including identifying potential financial assistance options.

“FDA’s approval of YARTEMLEA marks a defining milestone for Omeros and, more importantly, for patients and families facing TA-TMA,” said Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. “After years of work and close collaboration with the transplant community, we can now offer the first FDA-approved therapy for this frequently fatal complication, with robust response data and a benefit-risk profile that supports confident use in both adults and children. With our U.S. launch planned for January 2026, our focus is on ensuring rapid, reliable access so that YARTEMLEA can be used when TA-TMA is recognized and time is critical. We are deeply grateful to the patients, caregivers, investigators, and clinical teams who made this approval possible, and we are committed to bringing YARTEMLEA to every eligible patient who needs it.”

TA-TMA can occur after both autologous and allogeneic hematopoietic stem cell transplantation, with higher prevalence following allogeneic transplant. Approximately 30,000 allogeneic transplants are performed each year in the U.S. and Europe. Recent studies estimate that TA-TMA develops in up to 56 percent of allogeneic transplant recipients.

A marketing authorization application for YARTEMLEA for the treatment of TA-TMA is currently under review by the European Medicines Agency with a decision expected in mid-2026.

Important Safety Information for YARTEMLEA^®

WHAT IS YARTEMLEA^®?

YARTEMLEA is a MASP-2 inhibitor indicated for the treatment of adults and children ages two years and older with hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA).

IMPORTANT SAFETY INFORMATION

Contraindications

None.

Warnings and Precautions

Serious and life-threatening infections have occurred in patients treated with YARTEMLEA.

• In clinical trials in patients with TA-TMA, serious infections (regardless of causality) were reported in 36% (10/28) of patients receiving YARTEMLEA. Reported serious infections included sepsis, viral infections, pneumonia, bacteremia, fungal infection, gastroenteritis, respiratory tract infection, and urosepsis.
• If YARTEMLEA is administered to patients with active infections, monitor closely for worsening infection and treat promptly.

Adverse Reactions

The most common adverse reactions (≥20%), regardless of causality or relatedness to YARTEMLEA, were viral infections, sepsis, hemorrhage, diarrhea, vomiting, nausea, neutropenia, pyrexia, fatigue, and hypokalemia.

Use in Specific Populations

Pregnancy: Available data on the use of YARTEMLEA in pregnant women are insufficient to inform a drug-associated risk of major birth defects and miscarriage or adverse maternal or fetal outcomes.

Lactation: There are no data on the presence of YARTEMLEA in human milk, the effects on the breastfed child, or the effects on milk production.

Pediatric Use: The safety and effectiveness of YARTEMLEA for treatment of TA-TMA have been established in pediatric patients 2 years of age and older. The safety and effectiveness of YARTEMLEA have not been established in pediatric patients younger than 2 years of age.

Geriatric Use: Clinical studies of YARTEMLEA did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently than younger patients.

To report suspected adverse reactions, contact Omeros Corporation at 1-844-YARTEM1 (1-844-927-8361), or contact FDA at 1-800-FDA-1088 or through FDA MedWatch.

Please see Full Prescribing Information for YARTEMLEA.

About YARTEMLEA^®

YARTEMLEA^® (narsoplimab-wuug), a fully human monoclonal antibody, is the first and only approved inhibitor of the lectin pathway of complement. YARTEMLEA inhibits mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway. In hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA), MASP-2 inhibition prevents lectin pathway-mediated cellular injury, including endothelial damage in small blood vessels, and thrombus formation. By selectively blocking activation of the lectin pathway, YARTEMLEA preserves classical and alternative pathway activity, including functions essential to the adaptive immune response.

YARTEMLEA is approved by the U.S. FDA for the treatment of TA-TMA in adults and in children ages two years and older. A marketing authorization application for YARTEMLEA for TA-TMA is under review by the European Medicines Agency (EMA) with a decision expected in mid-2026.

YARTEMLEA has received breakthrough therapy and orphan drug designations from the FDA for TA-TMA, and the EMA has granted it orphan drug designation in hematopoietic stem-cell transplantation.

YARTEMLEA is the first and only approved therapy for TA-TMA.

About Hematopoietic Stem Cell Transplant-Associated Thrombotic Microangiopathy

Hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) is a severe and often-fatal complication of hematopoietic stem cell transplantation in adults and children. TA-TMA is driven by systemic endothelial injury triggered by conditioning regimens, immunosuppressants, infection, graft-versus-host disease, and other transplant-related factors, with activation of the lectin pathway of complement playing a central role in disease pathogenesis.

TA-TMA can occur following both autologous and allogeneic transplant, with higher prevalence after allogeneic procedures. Approximately 30,000 allogeneic transplants are performed annually in the U.S. and Europe. Recent studies estimate that TA-TMA develops in up to 56 percent of allogeneic transplant recipients. Mortality in severe TA-TMA can exceed 90 percent, and survivors frequently face long-term renal complications, including dialysis dependence.

YARTEMLEA^® is the only approved treatment for TA-TMA.

Conference Call and Webcast

Monday, December 29, 2025 at 4:30 p.m. Eastern Time

Omeros management will host a conference call on December 29, 2025 at 4:30 p.m. Eastern Time to discuss the approval of YARTEMLEA^®.

Live webcast: Access the live webcast at https://investor.omeros.com/upcoming-events.

Conference call (phone): To join by phone, participants must register at https://register-conf.media-server.com/register/BI860d4c7c1e5d4bb1a77988a530e78171 to receive a unique PIN. After registering, you may either:

1. dial in using the conference line and PIN provided at the registration site; or
2. select the “Call Me” option to receive an automated call to the phone number that you provide.

If you lose your PIN or registration confirmation email, please re-register to receive a new PIN.

Replay: A replay will be made available at https://investor.omeros.com/archived-events.

About Omeros Corporation

Omeros is an innovative biotechnology company that discovers, develops, and commercializes first-in-class small-molecule and protein therapeutics for large-market and orphan indications, with particular emphasis on complement-mediated diseases, cancers, and addictive or compulsive disorders. Omeros’ lead lectin pathway inhibitor YARTEMLEA^®, which inhibits the pathway’s effector enzyme MASP-2, is FDA-approved for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) in adult and pediatric patients ages two years and older, with a planned U.S. launch in January 2026. A marketing authorization application for YARTEMLEA in TA-TMA is currently under review by the European Medicines Agency, with a decision expected in mid-2026. OMS1029, Omeros’ long-acting MASP-2 inhibitor, has successfully completed Phase 1 clinical trials.

Under a recently announced asset purchase and licensing agreement, Novo Nordisk acquired global rights to zaltenibart (formerly OMS906), a MASP-3 inhibitor in clinical development for PNH and other alternative pathway indications, along with associated intellectual property and related assets. Omeros’ pipeline also includes OMS527, a phosphodiesterase 7 inhibitor in clinical development for cocaine use disorder and fully funded by the National Institute on Drug Abuse, as well as a growing portfolio of novel molecular and cellular oncology programs. For more information about Omeros and its programs, visit www.omeros.com.

References

1. Matsui H, Arai Y, Kanda J, et al. Survival in adults with high risk TA-TMA – a comparative analysis of narsoplimab versus supportive care. Blood Adv. 2025. doi:10.1182/bloodadvances.2025017540.
2. Schoettler ML, Pusarla SK, Nangia N, et al. Narsoplimab results in excellent survival in adults and children with hematopoietic cell transplant associated thrombotic microangiopathy (TA-TMA). Am J Hematol. 2025;100(11):2040-2051. doi:10.1002/ajh.70044.
3. Schoettler ML, French K, Harris A, et al. D-dimer and sinusoidal obstructive syndrome-novel poor prognostic features of thrombotic microangiopathy in children after hematopoietic cellular therapy in a single institution prospective cohort study. Am J Hematol. 2024;99(3):370-379. doi:10.1002/ajh.27186.
4. Benítez Carabante MI, Bueno D, Alonso García L, et al. Use of eculizumab in pediatric patients with high-risk transplantation-associated thrombotic microangiopathy: outcomes and risk factors associated with response and survival. A retrospective study on behalf of the spanish group for hematopoietic transplantation and cellular therapy (GETH-TC). Transplant Cell Ther. 2024 Jun;30(6):601.e1-601.e13. doi: 10.1016/j.jtct.2024.03.019.
5. Acosta-Medina AA, Sridharan M, Go RS, et al. Clinical outcomes and treatment strategies of adult transplant-associated thrombotic microangiopathy: external validation of harmonizing definitions and high-risk criteria. Am J Hematol. 2025;100(5):830-839. doi:10.1002/ajh.27651.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which are subject to the “safe harbor” created by those sections for such statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “likely,” “look forward to,” “may,” “objective,” “plan,” “potential,” “predict,” “project,” “should,” “slate,” “target,” “will,” “would,” and similar expressions and variations thereof. Forward-looking statements, including statements regarding the marketing authorization application for YARTEMLEA^® in Europe, prospects for obtaining EMA approval of YARTEMLEA in any indication, plans and expectations regarding the commercial launch of YARTEMLEA in the U.S., and in the EU following any EMA approval, our ability to consummate licensing, partnering or other transactions and the benefits, if any, we would receive from any such transactions, expectations regarding the sufficiency and availability of our capital resources to fund current and planned operations, including the commercialization of YARTEMLEA, plans for development of zaltenibart or other products under the asset purchase and license agreement, and the potential therapeutic benefits of zaltenibart and its commercial prospects, are based on management’s beliefs and assumptions and on information available to management only as of the date of this press release. Omeros’ actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, unfavorable or unexpected regulatory conclusions or interpretations related to the clinical data, external registry data, statistical analyses or other information and data included in the YARTEMLEA MAA, inability to respond satisfactorily to information requests during regulatory review of the YARTEMLEA MAA, potential differences between the diagnostic criteria used in our pivotal trial and in the external registry, and whether the EMA determines the registry used in our statistical analysis is sufficiently representative of TA-TMA patients, unanticipated or unexpected outcomes or requirements of regulatory processes in relevant jurisdictions, our financial condition and results of operations, including our ability to raise additional capital for our operations or complete other transactions on favorable terms or at all, regulatory processes and oversight, challenges associated with manufacture or supply of our products to support clinical trials, regulatory inspections and/or commercial sale following any marketing approval, changes in reimbursement and payment policies by government and commercial payers or the application of such policies, intellectual property claims, competitive developments, litigation, and the risks, uncertainties, and other factors described under the heading “Risk Factors” in our Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 31, 2025 and in subsequently filed Quarterly Reports on Form 10-Q. Given these risks, uncertainties, and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, whether because of new information, future events or otherwise, except as required by applicable law.

Contacts

Jennifer Cook Williams

Cook Williams Communications, Inc.

Investor and Media Relations

IR@omeros.com

PharmaEssentia USA Announces Appointment of Jeffrey Williams as Independent Director




PharmaEssentia USA Announces Appointment of Jeffrey Williams as Independent Director

Seasoned global finance and governance leader joins Board to support the company’s continued global expansion

BURLINGTON, Mass.–(BUSINESS WIRE)–PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation (TWSE: 6446), a global biopharmaceutical innovator based in Taiwan leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, announced the appointment of Jeffrey R. Williams as Independent Director.

“We are pleased to welcome Jeffrey to our Board of Directors for PharmaEssentia USA,” said Ko-Chung Lin, Ph.D., Founder and Chief Executive Officer. “Jeffrey’s global governance and financial acumen, along with his deep understanding of the East Asian market, will be instrumental as we continue to strengthen our international footprint and deliver innovation to patients worldwide.”

Mr. Williams is a seasoned corporate and nonprofit director with decades of experience in global finance, governance, and philanthropy, with a career deeply rooted in East Asia. He has served as an Independent Director of PharmaEssentia Corporation in Taiwan since May 2024 and brings valuable regional insight to the PharmaEssentia USA Board.

He currently serves as Director of UBS SDIC Fund Management Company, UBS Asset Management (China), and Koo Foundation Cancer Center Hospital. He is also a Trustee of the CMB Foundation, a trustee of Carleton-Willard Homes, and a Council Member of the Asian Corporate Governance Association.

Mr. Williams earned both his A.B. in East Asian Languages and Civilizations and his M.B.A. from Harvard University.

“Having had the opportunity to work closely with PharmaEssentia’s leadership team in Taiwan, I’ve seen firsthand the company’s dedication to scientific excellence and patient impact,” said Mr. Williams. “I’m honored to now extend that partnership to the USA Corporation and look forward to helping guide the company’s continued expansion as it brings innovative therapies to patients around the world.”

About PharmaEssentia

PharmaEssentia USA Corporation, located in Burlington, Massachusetts, is a subsidiary of PharmaEssentia Corporation (TWSE: 6446). PharmaEssentia Corporation, headquartered in Taipei, Taiwan, is a global and rapidly growing biopharmaceutical innovator. Leveraging deep expertise and proven scientific principles, PharmaEssentia aims to deliver effective new biologics for challenging diseases in the areas of hematology, oncology, and immunology with one approved product and a diversifying pipeline. Founded in 2003 by a team of Taiwanese-American executives and renowned scientists from U.S. biotechnology and pharmaceutical companies, today PharmaEssentia is expanding its global presence with operations in the U.S., Japan, China, and Korea, along with a world-class biologics production facility in Taichung, Taiwan.

For more information about PharmaEssentia USA, visit the website, LinkedIn or X (formerly Twitter).

Contacts

Media Contact
Muriel Huang

Director, Investor Relations and Corporate Communication

muriel_huang@pharmaessentia.com

Repare Therapeutics Announces Acquisition of Polθ ATPase Inhibitor, RP-3467, by Gilead Sciences for Up To $30 Million in Total Consideration




Repare Therapeutics Announces Acquisition of Polθ ATPase Inhibitor, RP-3467, by Gilead Sciences for Up To $30 Million in Total Consideration

CAMBRIDGE, Mass. & MONTREAL–(BUSINESS WIRE)–Repare Therapeutics Inc. (“Repare” or the “Company”) (Nasdaq: RPTX), a clinical-stage precision oncology company, today announced a definitive asset purchase agreement for Gilead Sciences, Inc. to acquire Repare’s polymerase theta (Polθ) ATPase inhibitor, RP-3467 (the “Gilead Agreement”).

“We are pleased to announce this transaction which combines Gilead’s leading expertise in oncology research and development with RP-3467, a potential best-in-class Polθ ATPase inhibitor,” said Steve Forte, President, Chief Executive Officer and Chief Financial Officer of Repare. “This marks the third and most significant portfolio transaction for Repare this year.”

Under the terms of the Gilead Agreement, Repare will receive up to $30 million in total consideration, including a $25 million upfront payment, subject to customary holdbacks and adjustments, and an additional $5 million payment upon completion of specified technology transfer activities.

On November 14, 2025, Repare announced that it had entered into a definitive arrangement agreement (the “Arrangement Agreement”) with XenoTherapeutics, Inc. and Xeno Acquisition Corp. (jointly, “Xeno”), pursuant to which Xeno will acquire (the “Arrangement Transaction”) all of the issued and outstanding common shares of Repare (the “Common Shares”). Under the terms of the Arrangement Agreement, Repare shareholders will receive a cash payment per Common Share that will be determined based upon Repare’s cash balance at closing of the Arrangement Transaction (the “Arrangement Closing”) after deducting certain transaction costs and the aggregate amount of outstanding liabilities (the “Closing Net Cash Amount”).

The upfront portion of the consideration payable under the Gilead Agreement has increased Repare’s cash balance and, therefore, has also increased the estimated Closing Net Cash Amount. Based on Repare’s revised estimate of the Closing Net Cash Amount, it is now currently estimated that each Repare shareholder will receive a cash payment of approximately US$2.20 per Common Share at the Arrangement Closing.

About RP-3467.

RP-3467 is a highly potent, small molecule inhibitor of Polθ that is a synthetic lethality target associated with BRCA mutations and other genomic alterations. RP-3467 is being evaluated in the POLAR Phase 1 clinical trial to evaluate its safety, pharmacokinetics, pharmacodynamics and preliminary activity alone or in combination with olaparib in adults with locally advanced or metastatic epithelial ovarian cancer, metastatic breast cancer, metastatic castration-resistant prostate cancer or pancreatic adenocarcinoma.

About Repare Therapeutics Inc.

Repare Therapeutics is a clinical-stage precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics. Repare Therapeutics has developed highly targeted cancer therapies focused on genomic instability, including DNA damage repair. For more information, please visit www.reparerx.com and follow @Reparerx on X (formerly Twitter) and LinkedIn.

Additional Information and Where to Find It

The Company has filed and furnished to its shareholders of record the close of business on November 21, 2025 (the “Record Date”) a definitive proxy statement on Schedule 14A, as well as other relevant documents concerning the proposed transaction with Xeno. The proxy statement contains important information about the proposed transaction with Xeno and related matters, including information related to a special meeting of Shareholders to be held on January 16, 2026 by the Company seeking required approvals from the shareholders in connection with such transaction. Investors and security holders of the Company are urged to carefully read the entire proxy statement (including any amendments or supplements thereto) because it contains important information about the proposed transaction with Xeno and the matters to be voted on at the special meeting.

Investors and security holders of the Company are able to obtain a free copy of the proxy statement, as well as other relevant filings containing information about the Company and the proposed transaction, including materials that will be incorporated by reference into the proxy statement, without charge, at the Securities and Exchange Commission’s (“SEC”) website (http://www.sec.gov) or from the Company by contacting the Company’s Investor Relations at (857) 412-7018, by submitting a contact form on the Company’s website at https://www.reparerx.com/contact/, or by going to the Company’s Investor Relations page on its website at https://ir.reparerx.com/investor-relations and clicking on the link titled “SEC Filings.”

Participants in the Solicitation

The Company and certain of its directors, executive officers and employees may be deemed to be “participants” in the solicitation of proxies from the Company’s shareholders with respect to the transaction with Xeno. Information regarding the identity of the Company’s directors and executive officers, and their direct and indirect interests, by security holdings or otherwise, in the Company’s securities is set forth in the definitive proxy statement on Schedule 14A filed with the SEC on December 12, 2025. Information regarding subsequent changes to the holdings of the Company’s securities by the Company’s directors and executive officers can be found in filings on Forms 3, 4, and 5, which are available on the Company’s website at www.reparerx.com or through the SEC’s website at www.sec.gov. Additional information regarding the identity of the participants in the proxy solicitation and a description of their direct and indirect interests in the transaction with Xeno, by security holdings or otherwise, is contained in the proxy statement and other relevant materials filed with the SEC in connection with the transaction with Xeno. Copies of these documents may be obtained, free of charge, from the SEC or the Company as described in the preceding paragraph.

Forward Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and securities laws in Canada. All statements in this press release other than statements of historical facts are “forward-looking statements. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding: the Company’s transaction with Gilead, including the receipt of the future payments under the terms of the asset purchase agreement and the potential benefits of the transaction; the Company’s transaction with Xeno, including the Closing Net Cash at the closing of the arrangement with Xeno, the expected cash payment to be received by Company’s shareholders at the Arrangement Closing and statements regarding the special meeting; the potential therapeutic benefits of RP-3467; and the progress and results of the POLAR Phase 1 clinical trial. These forward-looking statements are based on the Company’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties that could cause the Company’s clinical development programs, future results or performance to differ materially from those expressed or implied by the forward-looking statements. Many factors may cause differences between current expectations and actual results, including: the Company’s ability to successfully pursue a strategic transaction on attractive terms, or at all; the potential that success in preclinical testing and earlier clinical trials does not ensure that later clinical trials will generate the same results or otherwise provide adequate data to demonstrate the efficacy and safety of a product candidate; the impacts of macroeconomic conditions, including tariffs and other trade policies, the conflict in Ukraine and the conflict in the Middle East, fluctuations in inflation and uncertain credit and financial markets, on the Company’s business, clinical trials and financial position; unexpected safety or efficacy data observed during preclinical studies or clinical trials; clinical trial site activation or enrollment rates that are lower than expected; the Company’s ability to realize the benefits of its collaboration and license agreements; changes in expected or existing competition; changes in the regulatory environment; the uncertainties and timing of the regulatory approval process; and unexpected litigation or other disputes. Other factors that may cause the Company’s actual results to differ from those expressed or implied in the forward-looking statements in this press release are identified in the section titled “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024 filed with the Securities and Exchange Commission (“SEC”) and the Québec Autorité des Marchés Financiers (“AMF”) on March 3, 2025, and in other filings made with the SEC and AMF from time to time, including the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2025. The Company expressly disclaims any obligation to update any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law. For more information, please visit reparerx.com and follow Repare on X (formerly Twitter) at @RepareRx and on LinkedIn at https://www.linkedin.com/company/repare-therapeutics/.

Contacts

Investor Relations & Media:
Matthew DeYoung

Investor Relations and Media

Argot Partners

investor@reparerx.com

Number of Shares and Voting Rights of Innate Pharma as of December 18, 2025




Number of Shares and Voting Rights of Innate Pharma as of December 18, 2025

MARSEILLE, France–(BUSINESS WIRE)–#immunotherapy–Regulatory News:

Pursuant to the article L. 233-8 II of the French “Code de Commerce” and the article 223-16 of the French stock-market authorities (Autorité des Marchés Financiers, or “AMF”) General Regulation, Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) releases its total number of shares outstanding as well as its voting rights as of December 18, 2025:

About Innate Pharma

Innate Pharma S.A. is a global, clinical-stage biotechnology company developing immunotherapies for cancer patients. Leveraging its expertise on antibody-engineering and innovative target identification, Innate Pharma is developing innovative and differentiated next-generation antibody therapeutics.

Innate Pharma is advancing a portfolio of differentiated potential first and/or best-in-class assets, focused on areas of high unmet medical need, including IPH4502, a differentiated Nectin-4 ADC developed in solid tumors, lacutamab, an anti-KIR3DL2 antibody developed in cutaneous T cell lymphomas and peripheral T cell lymphomas, and monalizumab, an anti-NKG2A antibody developed in collaboration with AstraZeneca in non-small cell lung cancer.

Innate Pharma has established collaborations with leading biopharmaceutical companies, including Sanofi and AstraZeneca, as well as renowned academic and research institutions, to advance innovation in immuno-oncology.

Headquartered in Marseille, France with a US office in Rockville, MD, Innate Pharma is listed on Euronext Paris and Nasdaq in the US.

Learn more about Innate Pharma at www.innate-pharma.com and follow us on LinkedIn and X.

Information about Innate Pharma shares

Disclaimer on forward-looking information and risk factors

This press release contains certain forward-looking statements, including those within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995. The use of certain words, including “anticipate,” “believe,” “can,” “could,” “estimate,” “expect,” “may,” “might,” “potential,” “intend,” “should,” “will,” or the negative of these and similar expressions, is intended to identify forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. These risks and uncertainties include, among other things, the uncertainties inherent in research and development, including related to safety, progression of and results from its ongoing and planned clinical trials and preclinical studies, review and approvals by regulatory authorities of its product candidates, the Company’s reliance on third parties to manufacture its product candidates, the Company’s commercialization efforts and the Company’s continued ability to raise capital to fund its development. For an additional discussion of risks and uncertainties, which could cause the Company’s actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors (“Facteurs de Risque”) section of the Universal Registration Document filed with the French Financial Markets Authority (“AMF”), which is available on the AMF website http://www.amf-france.org or on Innate Pharma’s website, and public filings and reports filed with the U.S. Securities and Exchange Commission (“SEC”), including the Company’s Annual Report on Form 20-F for the year ended December 31, 2024, and subsequent filings and reports filed with the AMF or SEC, or otherwise made public by the Company. References to the Company’s website and the AMF website are included for information only and the content contained therein, or that can be accessed through them, are not incorporated by reference into, and do not constitute a part of, this press release.

In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by the Company or any other person that the Company will achieve its objectives and plans in any specified time frame or at all. The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in Innate Pharma in any country.

Contacts

For additional information, please contact:

Innate Pharma
Stéphanie Cornen

stephanie.cornen@innate-pharma.fr

Investor Relations
investors@innate-pharma.fr

Medias
communication@innate-pharma.com

FDA Approves Genentech’s Lunsumio VELO™ for Subcutaneous Use in Relapsed or Refractory Follicular Lymphoma




FDA Approves Genentech’s Lunsumio VELO™ for Subcutaneous Use in Relapsed or Refractory Follicular Lymphoma

– Lunsumio VELO reduces administration time from 2-4 hours to approximately one minute –

– Availability of Lunsumio VELO allows treatment aligned to people’s clinical needs and personal preferences –

– Approval supported by data demonstrating compelling complete response rate in third-line or later follicular lymphoma, which typically becomes harder to treat after each relapse –

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved CD20xCD3 bispecific Lunsumio VELO^™ (mosunetuzumab-axgb), as a subcutaneous (SC) formulation, for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy, based on results from the Phase I/II GO29781 study. Based on the study results, Lunsumio VELO is approved under accelerated approval. Full approval for this regimen may be contingent on verification and confirmation of benefit in a confirmatory trial.

“Since follicular lymphoma often requires lifelong management, reducing the burden of care for these individuals is of paramount importance,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “With this FDA approval, treatment can now be administered in just one minute, which significantly reduces the time patients spend in the clinic and helps to align care with their individual needs and preferences.”

Lunsumio VELO reduces administration time with an approximately one-minute injection, compared with a 2-4 hour intravenous (IV) infusion. Like Lunsumio administered intravenously, Lunsumio VELO can be administered outpatient and is a fixed-duration treatment given for a defined period, which could be as short as six months. By contrast, treat-to-progression treatment options are designed to be given to patients indefinitely until disease progression or until treatment can no longer be tolerated.

“This approval is a significant step in broadening access to effective treatments for people living with follicular lymphoma,” said Dr. Ian Flinn, M.D., Ph.D., Tennessee Oncology and One Oncology. “With its manageable cytokine release syndrome profile and reduced administration time, Lunsumio VELO enables oncologists to deliver advanced care in community practice settings.”

The FDA approval is supported by the primary analysis of the GO29781 study that evaluated Lunsumio VELO in patients with third-line or later (3L+) FL. Results showed the objective response rate and complete response rate in patients treated with Lunsumio VELO were 75% (95% confidence interval [CI]: 64–83%) and 59% (95% CI: 48–69%), respectively. The median duration of response was 22.4 months (95% CI: 16.8–22.8). The most common adverse reactions (≥20%) were injection site reactions, fatigue, rash, cytokine release syndrome (CRS), COVID-19 infection, musculoskeletal pain and diarrhea. The CRS rate was 30% and events were mostly low grade (Grade 1–2, 28%; Grade 3, 2.1%), occurred during Cycle 1, and all resolved after a median duration of two days (range: 1–15). CRS can be severe and life-threatening.

Lunsumio IV was the first bispecific antibody approved for 3L+ FL. Long-term data from the SC and IV arms of the GO29781 study were presented at the 67th American Society of Hematology Annual Meeting and Exposition.

These data have been submitted to other healthcare authorities around the world. Recently, the European Commission granted conditional marketing authorization of Lunsumio SC for the treatment of adult patients with R/R FL after two or more lines of systemic therapy.

Genentech continues to advance its bispecific antibody program in lymphoma, with ongoing Phase III studies evaluating Lunsumio and Lunsumio VELO in earlier lines of treatment. This includes the SUNMO study investigating Lunsumio VELO in combination with Polivy^® (polatuzumab vedotin-piiq) in second-line or later large B-cell lymphoma, and the MorningLyte study investigating Lunsumio VELO in combination with lenalidomide in previously untreated FL.

Genentech is committed to helping patients get the medicine their doctor prescribed. For people who qualify, Genentech plans to offer patient assistance programs through Genentech Access Solutions. More information is also available at 866-4ACCESS/866-422-2377 or http://www.Genentech-Access.com.

About the GO29781 Study

The GO29781 [NCT02500407] study is a Phase I/II, multicenter, open-label, dose-escalation and expansion study evaluating the safety, efficacy, and pharmacokinetics of mosunetuzumab-axgb administered both as an intravenous (IV) and subcutaneous (SC) treatment, in people with relapsed or refractory B-cell non-Hodgkin lymphoma. The efficacy of Lunsumio VELO was established on the basis of objective response rate and duration of response.

About Follicular Lymphoma (FL)

Follicular lymphoma (FL) is the most common slow-growing (indolent) form of non-Hodgkin lymphoma, accounting for about one in five cases. It typically responds well to treatment but is often characterized by periods of remission and relapse. The disease typically becomes harder to treat each time a patient relapses and early progression can be associated with poor long-term prognosis. It is estimated that, in the United States, approximately 13,000 new cases of FL will be diagnosed in 2025 and more than 110,000 people are diagnosed with FL each year worldwide.

About Lunsumio VELO^™ (mosunetuzumab-axgb)

Lunsumio VELO^™ is a subcutaneous formulation of mosunetuzumab-axgb, a CD20xCD3 T-cell-engaging bispecific antibody designed to target CD20 on the surface of B cells and CD3 on the surface of T cells. This dual-targeting activates and redirects a patient’s existing T cells to engage and eliminate target B cells by releasing cytotoxic proteins into the B cells. Lunsumio VELO is being investigated as a monotherapy and in combination with other medicines, for the treatment of people with B-cell non-Hodgkin lymphomas, including follicular lymphoma, large B-cell lymphoma, and other indications.

Lunsumio and Lunsumio VELO U.S. Indication

LUNSUMIO (mosunetuzumab-axgb) or LUNSUMIO VELO is a prescription medicine used to treat adults with follicular lymphoma whose cancer has come back or did not respond to previous treatment, and who have already received two or more treatments.

It is not known if LUNSUMIO or LUNSUMIO VELO is safe and effective in children.

The conditional approval for this use is based on response rate. There are ongoing studies to establish how well the drug works.

Important Safety Information

What is the most important information I should know about LUNSUMIO or LUNSUMIO VELO?

LUNSUMIO or LUNSUMIO VELO can cause Cytokine Release Syndrome (CRS), a serious side effect that is common during treatment with LUNSUMIO or LUNSUMIO VELO, and can also be severe or life-threatening.

Get medical help right away if you develop any signs or symptoms of CRS at any time, including:

• fever of 100.4°F (38°C) or higher
• chills
• low blood pressure
• fast or irregular heartbeat
• tiredness or weakness
• difficulty breathing
• headache
• confusion
• feeling anxious
• dizziness or light-headedness
• nausea
• vomiting

Due to the risk of CRS, you will receive LUNSUMIO or LUNSUMIO VELO on a “step-up dosing schedule.”

• The step-up dosing schedule is when you receive smaller “step-up” doses before receiving higher doses of LUNSUMIO or LUNSUMIO VELO during your first cycle of treatment
• If your dose of LUNSUMIO or LUNSUMIO VELO is delayed for any reason, you may need to repeat the “step-up dosing schedule”
• You may receive medicines to help reduce your risk of CRS before your dose

Your healthcare provider will check you for CRS during treatment with LUNSUMIO or LUNSUMIO VELO and may treat you in a hospital if you develop signs and symptoms of CRS. Your healthcare provider may temporarily stop or completely stop your treatment with LUNSUMIO or LUNSUMIO VELO, if you have severe side effects.

What are the possible side effects of LUNSUMIO or LUNSUMIO VELO?

LUNSUMIO or LUNSUMIO VELO can cause serious side effects, including:

• Neurologic problems. LUNSUMIO or LUNSUMIO VELO can cause serious and life-threatening neurologic problems. Your healthcare provider will check you for neurologic problems during treatment with LUNSUMIO or LUNSUMIO VELO. Your healthcare provider may also refer you to a healthcare provider who specializes in neurologic problems. Tell your healthcare provider right away if you develop any signs or symptoms of neurologic problems during or after treatment with LUNSUMIO or LUNSUMIO VELO, including:
  • headache
  • numbness and tingling of the arms, legs, hands, or feet
  • dizziness
  • confusion and disorientation
  • difficulty paying attention or understanding things
  • forgetting things or forgetting who or where you are
  • trouble speaking, reading or writing
  • sleepiness or trouble sleeping
  • tremors
  • loss of consciousness
  • seizures
  • muscle problems or muscle weakness
  • loss of balance or trouble walking
  • tiredness
• Serious infections. LUNSUMIO or LUNSUMIO VELO can cause serious infections that may lead to death. Your healthcare provider will check you for signs and symptoms of infection before and during treatment. Tell your healthcare provider right away if you develop any signs or symptoms of infection during treatment with LUNSUMIO or LUNSUMIO VELO, including:
  • fever of 100.4°F (38°C) or higher
  • cough
  • chest pain
  • tiredness
  • shortness of breath
  • painful rash
  • sore throat
  • pain during urination
  • feeling weak or generally unwell
• Hemophagocytic lymphohistiocytosis (HLH). LUNSUMIO or LUNSUMIO VELO can cause overactivity of the immune system, a condition called hemophagocytic lymphohistiocytosis. HLH can be life-threatening and has led to death in people treated with LUNSUMIO or LUNSUMIO VELO. Your healthcare provider will check you for HLH especially if your CRS lasts longer than expected. Signs and symptoms of HLH include:
  • fever
  • enlarged spleen
  • easy bruising
  • low blood cell counts
  • liver problems
• Low blood cell counts. Low blood cell counts are common during treatment with LUNSUMIO or LUNSUMIO VELO and can also be serious or severe. Your healthcare provider will check your blood cell counts during treatment with LUNSUMIO or LUNSUMIO VELO. LUNSUMIO or LUNSUMIO VELO can cause the following low blood cell counts:
  • low white blood cell counts (lymphopenia [for LUNSUMIO VELO only] and neutropenia). Low white blood cells can increase your risk for infection
  • low red blood cell counts (anemia). Low red blood cells can cause tiredness and shortness of breath
  • low platelet counts (thrombocytopenia). Low platelet counts can cause bruising or bleeding problems
• Growth in your tumor or worsening of tumor-related problems (tumor flare). LUNSUMIO or LUNSUMIO VELO can cause serious or severe worsening of your tumor. Tell your healthcare provider if you develop any of these signs or symptoms of tumor flare during your treatment with LUNSUMIO or LUNSUMIO VELO:
  • chest pain
  • cough
  • trouble breathing
  • tender or swollen lymph nodes
  • pain or swelling at the site of the tumor

Your healthcare provider may temporarily stop or permanently stop treatment with LUNSUMIO or LUNSUMIO VELO if you develop severe side effects.

The most common side effects of LUNSUMIO include: CRS, tiredness, rash, headache, fever, muscle pain, cough, itching, and numbness, tingling, or pain in the hands or feet (nerve damage).

The most common side effects of LUNSUMIO VELO include: injection site reactions, tiredness, rash, CRS, COVID-19, muscle and joint pain, and diarrhea.

The most common severe abnormal blood test results with LUNSUMIO include: decreased phosphate, increased glucose, and increased uric acid levels.

The most common severe abnormal blood test results with LUNSUMIO VELO include: decreased white blood cell counts and increased uric acid levels.

Before receiving LUNSUMIO or LUNSUMIO VELO, tell your healthcare provider about all of your medical conditions, including if you:

• have ever had an infusion reaction after receiving LUNSUMIO
• have an infection or have had an infection in the past which lasted a long time or keeps coming back
• have or have had Epstein-Barr Virus
• are pregnant or plan to become pregnant. LUNSUMIO or LUNSUMIO VELO may harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with LUNSUMIO or LUNSUMIO VELO
  
  Females who are able to become pregnant:
  • your healthcare provider should do a pregnancy test before you start treatment with LUNSUMIO or LUNSUMIO VELO
  • use an effective method of birth control (contraception) during your treatment and for 3 months after the last dose of LUNSUMIO or LUNSUMIO VELO
• are breastfeeding or plan to breastfeed. It is not known if LUNSUMIO or LUNSUMIO VELO passes into your breast milk. Do not breastfeed during treatment and for 3 months after the last dose of LUNSUMIO or LUNSUMIO VELO

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

What should I avoid while receiving LUNSUMIO or LUNSUMIO VELO?

Do not drive, operate heavy machinery, or do other dangerous activities if you develop dizziness, confusion, tremors, sleepiness, or any other symptoms that impair consciousness until your signs and symptoms go away. These may be signs and symptoms of CRS or neurologic problems.

These are not all of the possible side effects of LUNSUMIO or LUNSUMIO VELO. Talk to your healthcare provider for more information about the benefits and risks of LUNSUMIO or LUNSUMIO VELO.

You may report side effects to the FDA at (800) FDA-1088 or https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program. You may also report side effects to Genentech at (888) 835-2555.

Please see Important Safety Information, including Serious Side Effects, as well as the LUNSUMIO full Prescribing Information and Medication Guide and LUNSUMIO VELO full Prescribing Information and Medication Guide and on https://www.Lunsumio.com.

About Polivy^® (polatuzumab vedotin-piiq)

Polivy is a first-in-class anti-CD79b antibody-drug conjugate (ADC). The CD79b protein is expressed specifically in the majority of B cells, an immune cell impacted in some types of non-Hodgkin lymphoma (NHL), making it a promising target for the development of new therapies. Polivy binds to cancer cells such as CD79b and destroys these B cells through the delivery of an anti-cancer agent, which is thought to minimize the effects on normal cells. Polivy is being developed by Genentech using Pfizer ADC technology and is currently being investigated for the treatment of several types of NHL.

Polivy U.S. Indication

Polivy is a prescription medicine used with other medicines (a rituximab product, cyclophosphamide, doxorubicin, and prednisone) as a first treatment for adults who have moderate to high risk diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL).

Polivy is a prescription medicine used with other medicines, bendamustine and a rituximab product, to treat DLBCL in adults who have progressed after at least 2 prior therapies.

Important Safety Information

Possible serious side effects

Everyone reacts differently to Polivy therapy, so it’s important to know what the side effects are. Some people who have been treated with Polivy have experienced serious to fatal side effects. Your doctor may stop or adjust your treatment if any serious side effects occur. Be sure to contact your healthcare team if there are any signs of these side effects.

• Nerve problems in your arms and legs: This may happen as early as after your first dose and may worsen with every dose. Your doctor will monitor for signs and symptoms, such as changes in your sense of touch, numbness or tingling in your hands or feet, nerve pain, burning sensation, any muscle weakness, or changes to your walking pattern
• Infusion-related reactions: You may experience fever, chills, rash, breathing problems, low blood pressure, or hives within 24 hours of your infusion
• Low blood cell counts: Treatment with Polivy can cause severe low blood cell counts. Your doctor will monitor your blood counts throughout treatment with Polivy
• Infections: If you have a fever of 100.4°F (38°C) or higher, chills, cough, or pain during urination, contact your healthcare team. Your doctor may also give you medication before giving you Polivy, which may prevent some infections
• Rare and serious brain infections: Your doctor will monitor closely for signs and symptoms of these types of infections. Contact your doctor if you experience confusion, dizziness or loss of balance, trouble talking or walking, or vision changes
• Tumor lysis syndrome: Caused by the fast breakdown of cancer cells. Signs include nausea, vomiting, diarrhea, and lack of energy
• Potential harm to liver: Some signs include tiredness, weight loss, pain in the abdomen, dark urine, and yellowing of your skin or the white part of your eyes. You may be at higher risk if you already had liver problems or you are taking other medication

Side effects seen most often

The most common side effects during treatment were

• Nerve problems in arms and legs
• Nausea
• Tiredness or lack of energy
• Diarrhea
• Constipation
• Hair loss
• Redness and sores of the lining of the mouth, lips, throat, and digestive tract

Polivy may lower your red or white blood cell counts and increase uric acid levels.

Polivy may not be for everyone. Talk to your doctor if you are

• Pregnant or think you are pregnant: Data have shown that Polivy may harm your unborn baby
• Planning to become pregnant: Women should avoid getting pregnant while taking Polivy. Women should use effective contraception during treatment and for 3 months after their last Polivy treatment. Men taking Polivy should use effective contraception during treatment and for 5 months after their last Polivy treatment
• Breastfeeding: Women should not breastfeed while taking Polivy and for 2 months after the last dose

These may not be all the side effects. Talk to your healthcare provider for more information about the benefits and risks of Polivy treatment.

You may report side effects to the FDA at (800) FDA-1088 or https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program. You may also report side effects to Genentech at (888) 835-2555.

Please see the full Prescribing Information and visit https://www.Polivy.com for additional Important Safety Information.

About Genentech in hematology

For more than 20 years, Genentech has been developing medicines with the goal to redefine treatment in hematology. Today, we’re investing more than ever in our effort to bring innovative treatment options to people with diseases of the blood. For more information visit http://www.gene.com/hematology.

About Genentech

Founded nearly 50 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.

Contacts

Media Contact: Kristen Ingram (650) 467-6800

Advocacy Contact: Catherine Creme Henry (202) 258-8228

Investor Contacts: Loren Kalm (650) 225-3217

Bruno Eschli +41 616875284

GenSight Biologics Announces the Granting of Compassionate Use Authorization (CUA/AAC) for GS010/LUMEVOQ® in France




GenSight Biologics Announces the Granting of Compassionate Use Authorization (CUA/AAC) for GS010/LUMEVOQ® in France

• French medicines agency ANSM has granted authorization for named patient early access program for GS010/LUMEVOQ^®, a gene therapy indicated for the treatment of ND4-LHON.

PARIS–(BUSINESS WIRE)–Regulatory News:

GenSight Biologics (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today announced that the French medicines safety agency ANSM (Agence nationale de sécurité du médicament et des produits de santé) has granted compassionate use authorization (Autorisation d’Accès Compassionnel, or AAC) for the use of the GS010/LUMEVOQ^® gene therapy¹.

The AAC Program in France is a national scheme that enables patients suffering from serious, rare or disabling diseases to benefit from a treatment that does not have marketing authorization, when there are an unmet medical need and no appropriate therapy. To be eligible for an AAC program, the candidate treatment must present a favorable benefit-risk ratio. Requests for AAC may be initiated only by healthcare professionals, who submit named patient requests to the ANSM, which then evaluates and authorizes the access requests. Patients for whom applications for treatment with GS010 are submitted must meet specific eligibility criteria, including the length of time since the onset of their vision loss.

About Leber Hereditary Optic Neuropathy (LHON)

LHON is a rare, maternally inherited mitochondrial genetic disease, characterized by the degeneration of retinal ganglion cells, which results in precipitous and usually irreversible vision loss and typically leads to legal blindness. The ND4 mitochondrial mutation is the most common of the mutations that cause LHON and is associated with the worst prognosis among the leading mutations.

About GenSight Biologics

GenSight Biologics S.A. is a clinical-stage biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders. GenSight Biologics’ pipeline leverages two core technology platforms, the Mitochondrial Targeting Sequence (MTS) and optogenetics. Thanks to its gene therapy-based approach, GenSight Biologics’ candidates are designed to be administered as a single intravitreal injection per eye.

About GS010/LUMEVOQ^® (lenadogene nolparvovec)

GS010/LUMEVOQ^® (lenadogene nolparvovec) targets Leber Hereditary Optic Neuropathy (LHON) by leveraging a mitochondrial targeting sequence (MTS) proprietary technology platform, arising from research conducted at the Institut de la Vision in Paris.

¹ GS010/LUMEVOQ has not received marketing authorization in any country and is not commercially available.

Contacts

GenSight Biologics
Chief Financial Officer

Jan Eryk Umiastowski

jeumiastowski@gensight-biologics.com

QIAGEN Announces Details for Completion of Synthetic Share Repurchase of up to Approximately $500 Million




QIAGEN Announces Details for Completion of Synthetic Share Repurchase of up to Approximately $500 Million

• Return of approximately $500 million – maximum approved by shareholders – set to be completed on January 7, 2026

• Capital return to be conducted through synthetic share repurchase – combines a fast direct capital repayment to shareholders with a reverse stock split that enhances EPS

• QIAGEN delivers well ahead of schedule on its commitment to return at least $1 billion through end-2028, considering additional ways to increase returns in 2026 and beyond

VENLO, Netherlands–(BUSINESS WIRE)–$QGEN #QIAGEN–QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced details for completion of plans to return approximately $500 million to shareholders through a synthetic share repurchase that combines a direct capital repayment to QIAGEN shareholders with a reverse stock split.

QIAGEN announced in November 2025 plans for the repurchase, which comes after QIAGEN has returned about $650 million to shareholders since the start of 2024 through a synthetic share repurchase and the implementation of the first annual dividend payment in June 2025.

With the completion of this synthetic share repurchase in January 2026, QIAGEN will have delivered well ahead of schedule on its commitment to return at least $1 billion to shareholders by the end of 2028, and is considering additional measures to increase returns in 2026 and beyond.

Shareholders at the Annual General Meeting in June 2025 gave virtually unanimous approval for resolutions to implement the $500 million repurchase. This approach is designed to return cash to shareholders in a faster and more efficient way than through a traditional open-market repurchase program. It also enhances earnings per share (EPS) through the reduction in outstanding shares.

The repayment from existing cash reserves is expected to lead to an approximately 5% reduction in the number of issued shares (based on current share price).

The terms of the synthetic share repurchase are as follows:

• Every 20 issued QIAGEN shares will be consolidated into 19 QIAGEN shares, leading to a reduction of approximately 10.9 million shares from the level of 217.7 million shares as of December 18, 2025.

• Following the implementation of the consolidation, QIAGEN will repay capital to shareholders of record $2.29 per pre-consolidation share. (As the par-value of QIAGEN shares is denominated in euros, the amount of the capital decrease and repayment in the respective notarial deeds will be denominated in euros. The payment, however, will be made in U.S. dollars.)

The last day of trading of the pre-split shares on the New York Stock Exchange and the Frankfurt Stock Exchange is planned to be Wednesday, January 7, 2026.

Beginning on Thursday, January 8, 2026, the consolidated QIAGEN shares, excluding the entitlement to the capital repayment, are expected to begin trading on the Frankfurt Stock Exchange (QIA) and on the NYSE (QGEN) under the Company’s current ticker symbols.

The consolidated QIAGEN shares will carry the following new security identifiers:

ISIN: NL0015002SN0

CUSIP: N72482 156

WKN: A41HBE

Technical details regarding settlement mechanics

Shareholders holding their QIAGEN shares in brokerage accounts in the United States will have their holdings automatically consolidated in line with the consolidation ratio described above, whereby any fractional shares are planned to be sold and proceeds deposited in their account, effective as of close of business at 4:00 p.m. EST on Wednesday, January 7, 2026 (the “Effective Date” and the last trading day of the prior ISIN / CUSIP / WKN).

The capital repayment is planned to be made via Depository Trust Company to the respective brokerage accounts of the shareholders in the subsequent days. Unsettled market trades as of the Effective Date are planned to be reconciled by Depository Trust Company and settled in line with market practice.

For shareholders who hold their QIAGEN shares in Germany and elsewhere in Europe directly or indirectly via Clearstream Banking AG, these holdings are expected to be consolidated through their banks, brokers and custodians as of close of business European time on Wednesday, January 7, 2026. The capital repayment for these shareholders is expected to also be made in the subsequent days. Any fractional shares will be sold and deposited in their account.

Shareholders holding their QIAGEN shares in registered form directly at Equiniti (formerly American Stock Transfer and Trust Company (“AST”)) are planned to have their holdings automatically consolidated in line with the consolidation ratio described above by processing in the register held by Equiniti, effective as of the Effective Date, and receive the capital repayment in their bank account known to the Company.

Shareholders are advised to consult with their bank or broker with any questions on the reverse stock split and the capital repayment.

Shareholders with questions about their tax status are advised to consult with their local tax advisor.

About QIAGEN

QIAGEN N.V., a Netherlands-based holding company, is a global leader in Sample to Insight solutions that enable customers to extract and analyze molecular information from biological samples containing the building blocks of life. Our Sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies prepare these biomolecules for analysis, while bioinformatics support the interpretation of complex data to deliver actionable insights. Automation solutions integrate these steps into streamlined, cost-effective workflows. QIAGEN serves more than 500,000 customers worldwide in the Life Sciences (academia, pharmaceutical R&D and industrial applications such as forensics) and Molecular Diagnostics (clinical healthcare). As of September 30, 2025, QIAGEN employed approximately 5,700 people across over 35 locations. For more information, visit https://www.qiagen.com.

Forward-Looking Statement

Certain statements in this press release may constitute forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. These statements, including those regarding QIAGEN’s products, development timelines, marketing and/or regulatory approvals, financial and operational outlook, growth strategies, capital allocation strategies, collaborations and operating results (such as expected net sales and adjusted diluted earnings), the CEO transition plan, the acquisition of Parse Biosciences, including the timing and expected benefits thereof, and the synthetic share repurchase, including the timing and expected befits thereof, are based on current expectations and assumptions. However, they involve uncertainties and risks. These risks include, but are not limited to: challenges in managing a successful CEO transition and successor search while providing operational continuity and continued advancement of company strategy; challenges in managing growth and international operations (including the effects of currency fluctuations, tariffs, tax laws, regulatory processes and logistical dependencies); variability in operating results and the commercial development of products for customers in the Life Sciences and clinical healthcare markets; changes in relationships with customers, suppliers or strategic partners; competition and rapid technological advancement; developments or changes in the securities markets and fluctuations in the trading volume and market price of QIAGEN’s shares and the successful implementation of the synthetic share repurchase; QIAGEN’s ability to successfully close, integrate and achieve the expected benefits of its acquisition of Parse Biosciences, including fluctuating demand for QIAGEN’s products due to factors such as economic conditions, customer budgets and funding cycles; obtaining and maintaining regulatory approvals for our products; difficulties in successfully adapting QIAGEN’s products into integrated solutions and producing these products; and protecting product differentiation from competitors. Additional risks and uncertainties may arise from market acceptance of new products, integration of acquisitions, governmental actions, global or regional economic developments, natural disasters, political or public health crises, and other “force majeure” events. There is also no guarantee that anticipated benefits from restructuring programs and acquisitions will materialize as expected. For a more complete discussion of risks and uncertainties, please refer to the “Risk Factors” section in our most recent Annual Report on Form 20-F and other reports filed with or furnished to the U.S. Securities and Exchange Commission.

Source: QIAGEN N.V.

Category: Corporate

Contacts

Contacts QIAGEN:

Investor Relations
e-mail: ir@QIAGEN.com

Public Relations
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Copley Equity Partners Completes Acquisition of Vital Delivery Solutions




Copley Equity Partners Completes Acquisition of Vital Delivery Solutions

BOSTON & WILLISTON, Vt.–(BUSINESS WIRE)–Copley Equity Partners (“Copley Equity” or “Copley”) is pleased to announce that it has acquired Vital Delivery Solutions (“Vital” or “VDS”), a leading New England–based provider of healthcare logistics and courier services. Financial terms of the transaction were not disclosed.

Founded in 1987, VDS has built a strong reputation for providing reliable, time-sensitive delivery and warehousing services. From a single route nearly four decades ago, VDS has grown its operations to over 200 daily routes, supported by a fleet of nearly 250 company vehicles and a team of roughly 300 professional drivers serving clients including healthcare facilities, laboratories, and pharmacies, among others.

Under Copley’s ownership, VDS will continue to operate under its trusted brand and white-glove service model — leveraging its robust fleet, advanced dispatch technology, and 24/7 operational capability — while gaining access to Copley’s resources and strategic guidance to expand both service offerings and geographic coverage.

“We are thrilled to join forces with Copley Equity Partners,” said Matt Kozlowski, CEO of Vital Delivery Solutions. “This partnership represents a fantastic opportunity to accelerate our growth, expand our capacity, and continue delivering the reliable, high-quality service our customers expect.”

“This acquisition reflects our confidence in VDS’ proven track record, operational excellence, and critical role in supporting healthcare and time-sensitive delivery needs across New England,” said Peter Trovato, Managing Partner at Copley.

Sean Sullivan, Principal at Copley, added, “We are excited to partner with Matt and the VDS leadership team to build upon their success and support VDS as it expands deeper into healthcare, laboratory, and other mission-critical delivery routes.”

VDS management team will remain in place, and Copley will work closely with them to support continued growth through enhanced operational capabilities, potential service expansion, and strategic investments.

BellMark Partners acted as transaction advisor to Vital Delivery Solutions. KeyBank acted as lender to support the transaction.

About Vital Delivery Solutions

Since 1987, Vital Delivery Solutions has provided same-day, next-day, and specialty courier services throughout New England. With a large fleet of company-owned vehicles and an experienced team of uniformed drivers, VDS serves a wide variety of industries including healthcare, laboratories, pharmacies, banking, critical-parts delivery, and residential shipments. VDS also offers secure, climate-controlled warehousing with facilities in Vermont and New Hampshire.

About Copley Equity Partners

Established in 2012, Copley Equity Partners is a Boston-based private equity firm and family office that partners with growing, lower-middle-market companies across a range of industries. The firm works collaboratively with management teams to support growth, operational excellence, and long-term value creation.

Contacts

Vital Delivery Solutions

Matt Kozlowski, (802) 862 7662

info@shipvds.com

Copley Equity Partners

Sean Sullivan, (617) 249 5354

info@copleyequity.com

Croma-Pharma Introduces New Medical Device for the Preparation of Autologous PRP | Fluid- PRF




Croma-Pharma Introduces New Medical Device for the Preparation of Autologous PRP | Fluid- PRF

LEOBENDORF, Austria–(BUSINESS WIRE)–#aestheticmedicine–Croma-Pharma, a global player in minimally invasive aesthetic medicine, proudly announces the launch of its new medical device that is used for the preparation of autologous Platelet-Rich Plasma (PRP) | Fluid-Platelet-Rich Fibrin (Fluid-PRF).¹

This launch represents continued progress in Croma’s mission to provide healthcare professionals state-of-the-art tools for their practice.

With its innovative design and optimized separation technology, Exprecell™ enables the efficient preparation of autologous blood concentrates, without the use of anticoagulants, resulting in the formation of Fluid-PRF, a biologically active concentrate that retains the regenerative properties of platelets and leukocytes, yet stays liquid for a defined period.¹

What makes Exprecell™ special?

• MDR certification: Exprecell™ is MDR-certified, meeting stringent EU regulatory requirements to ensure the safe, controlled and standardized preparation of autologous Platelet-Rich Plasma (PRP) | Fluid-Platelet-Rich Fibrin (Fluid-PRF).¹
• Flexibility: Compatibility with Luer-Lock syringes allows flexible system integration and secure fluid transfer in a syringe of choice.
• Safety: A closed system design limits exposure to external contaminants.
• Usability, design, handling: Designed for a soft-single-spin process, enabling autologous PRP |Fluid-PRF preparation from whole blood with 5-minute spin time at 420xg.^1*

Available Now

Exprecell™ is now available for healthcare professionals in the EU, UK & Switzerland. With this launch, Croma-Pharma further extends its commitment to providing a comprehensive and innovative portfolio to healthcare professionals.

About Croma

CROMA-PHARMA GmbH is a global player and challenger in the dynamically growing minimally invasive aesthetics market, and one of Europe’s leading manufacturers of premium-quality hyaluronic acid (HA) syringes.

Founded in 1976 by the pharmacist couple Gerhard and Karin Prinz, Croma has evolved from a family pharmacy into a globally operating Austrian company headquartered near Vienna, where it also runs its state-of-the-art, fully automated HA manufacturing plant. The company employs around 500 people, making its products available in over 80 countries worldwide. Croma offers a comprehensive and innovative aesthetics portfolio covering all key treatment categories in minimally invasive aesthetic medicine. Its range includes botulinum toxin, a broad selection of hyaluronic acid fillers, lifting threads (PDO threads), Polynucleotide injectables and HA skin booster. With this full-face approach, Croma provides aesthetic professionals and their patients with safe, effective, and reliable solutions from a single trusted source. Building on its heritage in ophthalmology and orthopaedics, Croma transferred its pharmaceutical expertise and stringent quality standards to aesthetic applications. The company exceeded over 110 million syringes produced in 2025, reinforcing its position as one of Europe’s foremost HA manufacturers.

References:

*For full instructions, please refer to the IFU.

1 Data on file

The healthcare professional confirms having informed the patient of a likely risk of the medical device in line with its intended use. For risks and adverse events associated with the use of the medical device consult the instructions of use. CE 2797

EPR112025

Contacts

Press contact:
CROMA-PHARMA GmbH

Victoria Szafraniec

Global Digital Media & PR Manager

Cromazeile 2

A-2100 Leobendorf

Phone: +43 676 846 868 494

Mail: victoria.szafraniec@croma.at
Web: www.cromapharma.com

Simulations Plus Announces First Quarter Fiscal Year 2026 Earnings and Conference Call Date




Simulations Plus Announces First Quarter Fiscal Year 2026 Earnings and Conference Call Date

Conference call to be on Thursday, January 8, 2026, at 5 p.m. ET

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–Simulations Plus, Inc. (Nasdaq: SLP) (“Simulations Plus”, “SLP”), a global leader in model-informed and AI-accelerated drug development that advances biopharma innovation, today announced that it will report first quarter fiscal 2026 financial results after the market close on Thursday, January 8, 2026.

Management will host a conference call that same day at 5:00 p.m. Eastern Time to discuss the results. Investment professionals and all current and prospective shareholders are invited to join the live webcast by registering here. The conference call can also be accessed by dialing 1-877-451-6152 (domestic) or 201-389-0879 (international) or by clicking on this Call me™ link to request a return call. The webcast can be accessed on the investor relations page of the Simulations Plus website at www.simulations-plus.com/investorscorporate-profile/corporate-profile/ where it will also be available for replay approximately one hour following the call.

About Simulations Plus, Inc.

Simulations Plus is a global leader in model-informed and AI-accelerated drug development. We create value for our clients by accelerating the discovery, development, and commercialization of pharmaceuticals and other products through innovative science-based software and consulting solutions. For more information, visit www.simulations-plus.com.

Environmental, Social, and Governance (ESG)

We focus our Environmental, Social, and Governance (ESG) efforts where we can have the most positive impact. To learn more about our latest initiatives and priorities, please visit our website.

Contacts

Financial Profiles
Lisa Fortuna

310-622-8251

slp@finprofiles.com