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
e-mail: pr@QIAGEN.com

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

Sinovac: Antigua Court Makes Interim Order Giving Board Control of the Company until the Trial of the Disputed 2025 Shareholder Meeting




Sinovac: Antigua Court Makes Interim Order Giving Board Control of the Company until the Trial of the Disputed 2025 Shareholder Meeting

BEIJING–(BUSINESS WIRE)–Sinovac Biotech Ltd. (NASDAQ: SVA) (SINOVAC or the Company), a leading provider of biopharmaceutical products in China, today announced that the Antigua High Court has ordered that the directors Mr. Simon Anderson, Mr. Shan Fu, Mr. Shuge Jiao, Mr. Yuk Lam Lo, Mr. Yumin Qiu, Mr. Yu Wang, Mr. Andrew Y. Yan and Mr. Yin Weidong (collectively, the Board), will comprise the Board of the Company until the trial listed in late April/early May 2026.

The Antigua High Court decision arises from a hearing that took place on 27 October 2025, at which applicants SAIF Partners IV L.P., OrbiMed Partners Master Fund Limited and 1Globe Capital LLC each sought injunctions to confirm the composition of their respective favoured Boards, pending determination of a dispute over the outcome of the Company’s Special Shareholders Meeting on 8 July 2025 (the SSM Dispute).

The hearing of the SSM Dispute has been scheduled to take place in the Antigua High Court in late April/early May 2026, with judgment to be delivered by the Court thereafter.

A Board meeting was held on 17 December 2025 to reiterate its unwavering commitment to shareholder value creation, to work diligently with the management and the advisors of the Company, to make efforts to restore trading of the Company’s shares on NASDAQ, to explore opportunities to properly and legally resolve the Company’s ongoing disputes, and to take all necessary steps, including to facilitate to reach agreements among all parties, to ensure the stable operations of the Company and to create greater value for shareholders through cooperation.

Mr. Andrew Y. Yan, Chairman of the Board of SINOVAC, stated, “The current Board is committed to the long-term and sustainable development of the Company. The Board and its Audit Committee will collaborate closely with the auditors to complete audit. The Board trusts and supports the CEO and management team in continuing to implement the Company’s current development strategy, maintaining operational stability, continuously enhancing shareholder value through sustained business growth, and collaboratively promoting the comprehensive development of the Company.”

About SINOVAC

Sinovac Biotech Ltd. (SINOVAC) is a China-based global biopharmaceutical company, with a mission of “supply vaccines to eliminate human diseases”, the company specializes in the research, development, manufacturing and commercialization of vaccines and related biological products that protect against human infectious diseases.

The company’s diversified portfolio includes vaccines for influenza, viral hepatitis, varicella, Hand-Foot-Mouth disease (HFMD), poliomyelitis, pneumococcal disease, etc., of which 3 vaccines have been prequalified by WHO, including inactivated hepatitis A vaccine Healive®, Sabin-strain inactivated polio vaccine (sIPV), and varicella vaccine.

SINOVAC has a leading edge in developing vaccines to combat infectious disease outbreaks and was among the first to initiate R&D during major public health emergencies, including SARS, H5N1, H1N1, and COVID-19. The company developed the world’s first inactivated SARS vaccine (Phase I completed), China’s first H5N1 influenza vaccine (Paneflu®), the world’s first H1N1 influenza vaccine (Panflu.1®), and CoronaVac®, the most widely used inactivated COVID-19 vaccine globally.

Beyond its marketed portfolio, the company is advancing a robust pipeline that includes combination vaccines, recombinant protein vaccines and next-generation platforms such as mRNA technologies and antibodies.

With a long-standing commitment to innovation and global health, SINOVAC is expanding its global footprint by strengthening partnerships with research institutions, international organizations, and local partners. Through broader market presence, technological cooperation, and localized production, the company aims to accelerate vaccine development and supply, enhance regional access to high-quality products, and better address unmet medical needs while improving preparedness for future pandemics.

Safe Harbor Statement

This announcement contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and as defined in the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “may,” “will,” “expect,” “anticipate,” “aim,” “estimate,” “intend,” “plan,” “believe,” “potential,” “continue,” “is/are likely to” or other similar expressions. Such statements are based upon current expectations and current market and operating conditions and relate to events that involve known or unknown risks, uncertainties and other factors, all of which are difficult to predict and many of which are beyond the Company’s or Board’s control, which may cause actual results, performance or achievements to differ materially from those in the forward-looking statements. Further information regarding these and other risks, uncertainties or factors is included in the Company’s filings with the U.S. Securities and Exchange Commission. The Company and Board do not undertake any obligation to update any forward-looking statement as a result of new information, future events or otherwise, except as required under law.

Contacts

Investor and Media Contact
Sinovac Biotech Ltd.

Email: ir@sinovac.com

KEYTRUDA® (pembrolizumab) Plus Padcev® (enfortumab vedotin-ejfv) Significantly Improved Event-Free Survival, Overall Survival and Pathologic Complete Response Rates for Cisplatin-Eligible Patients with MIBC When Given Before and After Surgery




KEYTRUDA® (pembrolizumab) Plus Padcev® (enfortumab vedotin-ejfv) Significantly Improved Event-Free Survival, Overall Survival and Pathologic Complete Response Rates for Cisplatin-Eligible Patients with MIBC When Given Before and After Surgery

First and only immunotherapy plus ADC regimen, used perioperatively, to extend survival for cisplatin-eligible patients with MIBC

RAHWAY, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced positive topline results from the Phase 3 KEYNOTE-B15 trial (also known as EV-304) in patients with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin-based chemotherapy. The trial showed KEYTRUDA^® (pembrolizumab) plus Padcev ^® (enfortumab vedotin-ejfv), given as neoadjuvant and adjuvant treatment (before and after surgery), demonstrated a statistically significant and clinically meaningful improvement in event-free survival (EFS), overall survival (OS) and pathologic complete response (pCR) rates versus neoadjuvant chemotherapy and surgery.

“The persistent risk of recurrence in cis-eligible patients with muscle-invasive bladder cancer, despite recent advances, underscores the continued need for effective perioperative treatments,” said Dr. Matthew Galsky, Lillian and Howard Stratton Professor of Medicine, director of genitourinary medical oncology, Mount Sinai Tisch Cancer Center, and KEYNOTE-B15 principal study investigator. “The strength of these data demonstrates that pembrolizumab plus enfortumab vedotin—given before and after surgery—has the potential to significantly improve survival outcomes.”

The trial, evaluating Merck’s KEYTRUDA, an anti-PD-1 therapy, plus Padcev, an antibody-drug conjugate (ADC), was conducted in collaboration with Pfizer and Astellas and builds on the clinical success of this combination in locally advanced or metastatic urothelial cancer (la/mUC) and cisplatin-ineligible MIBC.

“For people living with muscle-invasive bladder cancer, treatment decisions often need to be made earlier, when the opportunity to change the course of the disease is greatest,” said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. “These results reinforce our conviction that moving KEYTRUDA into earlier stages of cancer care can make a meaningful difference for patients. By exploring combinations with ADCs in the perioperative setting, we aim to improve survival expectations for people facing muscle-invasive bladder cancer.”

The safety profile of KEYTRUDA plus Padcev in this study was consistent with the known safety profiles of each agent. No new safety signals were identified with the combination. The companies plan to share these results with regulatory authorities worldwide for potential regulatory filings and will present the data at an upcoming medical meeting.

KEYTRUDA plus Padcev is currently approved for the treatment of adult patients with la/mUC in the U.S., the European Union (EU), Japan and several other countries around the world. KEYTRUDA plus Padcev is also approved in the U.S. for the treatment of adult patients with MIBC who are ineligible for cisplatin-based chemotherapy. KEYTRUDA as monotherapy is also approved in the U.S., EU, Japan and other countries for the treatment of certain patients with la/mUC or a type of non-muscle-invasive bladder cancer (NMIBC).

Three additional Phase 3 studies are currently evaluating KEYTRUDA across all stages of bladder cancer, including non-muscle-invasive, muscle-invasive and metastatic. Two of these studies are in MIBC including KEYNOTE-866 (NCT03924856) and KEYNOTE-992 (NCT04241185). KEYTRUDA is also being evaluated in combination with Bacillus Calmette-Guerin (BCG) in patients with NMIBC in KEYNOTE-676 (NCT03711032).

About KEYNOTE-B15/EV-304

KEYNOTE-B15, also known as EV-304, is an open-label, randomized Phase 3 trial (ClinicalTrials.gov, NCT04700124) evaluating perioperative KEYTRUDA in combination with Padcev and surgery (radical cystectomy and pelvic lymph node dissection) versus neoadjuvant chemotherapy (gemcitabine plus cisplatin) and surgery in patients with MIBC who are cisplatin-eligible. The trial enrolled 808 patients who were randomized to receive either:

• Four cycles (each cycle length is 21 days) of neoadjuvant KEYTRUDA intravenous (IV) infusion plus enfortumab vedotin IV infusion, followed by surgery, followed by 13 cycles of adjuvant KEYTRUDA IV infusion plus five cycles of enfortumab vedotin IV infusion, or;
• Four cycles (each cycle is 21 days) of standard of care neoadjuvant chemotherapy followed by surgery.

The primary endpoint is EFS, defined as the time from randomization to the first occurrence of the following events: radiographic disease progression precluding radical cystectomy and pelvic lymph node dissection, failure to undergo surgery in participants with residual disease, gross residual disease left behind at time of surgery, local or distant recurrence based on blinded independent central review or death due to any cause. The key secondary endpoints are OS and pCR rate.

About bladder cancer

In 2022, bladder cancer changed the lives of more than 600,000 people around the world. According to some clinical practice guidelines, about 25% of newly diagnosed bladder cancer cases are MIBC. The standard of care for patients with MIBC is neoadjuvant cisplatin-based chemotherapy followed by surgery, which is shown to prolong survival. However, nearly half of patients who undergo this standard treatment experience recurrence.

About Merck’s early-stage cancer clinical program

Finding cancer at an earlier stage may give patients a greater chance of long-term survival. Many cancers are considered most treatable and potentially curable in their earliest stage of disease. Building on the strong understanding of the role of KEYTRUDA in later-stage cancers, Merck is evaluating our portfolio of medicines and pipeline candidates in earlier disease states, with more than 30 ongoing registrational studies across multiple types of cancer.

About KEYTRUDA^® (pembrolizumab) injection for intravenous use, 100 mg

KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 1,600 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient’s likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA^® (pembrolizumab) Indications in the U.S.

Urothelial Cancer

KEYTRUDA, in combination with enfortumab vedotin, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma:

• who are not eligible for any platinum-containing chemotherapy, or
• who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

KEYTRUDA, in combination with enfortumab vedotin, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, is indicated for the treatment of adult patients with muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin containing chemotherapy.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

See additional selected KEYTRUDA indications in the U.S. after the Selected Important Safety Information.

Selected Important Safety Information for KEYTRUDA

Severe and Fatal Immune-Mediated Adverse Reactions

KEYTRUDA is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death receptor-1 (PD-1) or the programmed death ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions.

Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Early identification and management are essential to ensure safe use of anti–PD-1/PD-L1 treatments. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. For patients with TNBC treated with KEYTRUDA in the neoadjuvant setting, monitor blood cortisol at baseline, prior to surgery, and as clinically indicated. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.

Withhold or permanently discontinue KEYTRUDA depending on severity of the immune-mediated adverse reaction. In general, if KEYTRUDA requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose adverse reactions are not controlled with corticosteroid therapy.

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis. The incidence is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.4% (94/2799) of patients receiving KEYTRUDA, including fatal (0.1%), Grade 4 (0.3%), Grade 3 (0.9%), and Grade 2 (1.3%) reactions. Systemic corticosteroids were required in 67% (63/94) of patients. Pneumonitis led to permanent discontinuation of KEYTRUDA in 1.3% (36) and withholding in 0.9% (26) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Pneumonitis resolved in 59% of the 94 patients.

Pneumonitis occurred in 8% (31/389) of adult patients with cHL receiving KEYTRUDA as a single agent, including Grades 3-4 in 2.3% of patients. Patients received high-dose corticosteroids for a median duration of 10 days (range: 2 days to 53 months). Pneumonitis rates were similar in patients with and without prior thoracic radiation. Pneumonitis led to discontinuation of KEYTRUDA in 5.4% (21) of patients. Of the patients who developed pneumonitis, 42% interrupted KEYTRUDA, 68% discontinued KEYTRUDA, and 77% had resolution.

Pneumonitis occurred in 7% (41/580) of adult patients with resected NSCLC who received KEYTRUDA as a single agent for adjuvant treatment of NSCLC, including fatal (0.2%), Grade 4 (0.3%), and Grade 3 (1%) adverse reactions. Patients received high-dose corticosteroids for a median duration of 10 days (range: 1 day to 2.3 months). Pneumonitis led to discontinuation of KEYTRUDA in 26 (4.5%) of patients. Of the patients who developed pneumonitis, 54% interrupted KEYTRUDA, 63% discontinued KEYTRUDA, and 71% had resolution.

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis, which may present with diarrhea. Cytomegalovirus infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (1.1%), and Grade 2 (0.4%) reactions. Systemic corticosteroids were required in 69% (33/48); additional immunosuppressant therapy was required in 4.2% of patients. Colitis led to permanent discontinuation of KEYTRUDA in 0.5% (15) and withholding in 0.5% (13) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Colitis resolved in 85% of the 48 patients.

Hepatotoxicity and Immune-Mediated Hepatitis

KEYTRUDA as a Single Agent

KEYTRUDA can cause immune-mediated hepatitis. Immune-mediated hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.4%), and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 68% (13/19) of patients; additional immunosuppressant therapy was required in 11% of patients. Hepatitis led to permanent discontinuation of KEYTRUDA in 0.2% (6) and withholding in 0.3% (9) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, none had recurrence. Hepatitis resolved in 79% of the 19 patients.

KEYTRUDA With Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider monitoring more frequently as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased alanine aminotransferase (ALT) (20%) and increased aspartate aminotransferase (AST) (13%) were seen at a higher frequency compared to KEYTRUDA alone. Fifty-nine percent of the patients with increased ALT received systemic corticosteroids. In patients with ALT ≥3 times upper limit of normal (ULN) (Grades 2-4, n=116), ALT resolved to Grades 0-1 in 94%. Among the 92 patients who were rechallenged with either KEYTRUDA (n=3) or axitinib (n=34) administered as a single agent or with both (n=55), recurrence of ALT ≥3 times ULN was observed in 1 patient receiving KEYTRUDA, 16 patients receiving axitinib, and 24 patients receiving both. All patients with a recurrence of ALT ≥3 ULN subsequently recovered from the event.

Immune-Mediated Endocrinopathies

Adrenal Insufficiency

KEYTRUDA can cause primary or secondary adrenal insufficiency. For Grade 2 or higher, initiate symptomatic treatment, including hormone replacement as clinically indicated. Withhold KEYTRUDA depending on severity. Adrenal insufficiency occurred in 0.8% (22/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.3%), and Grade 2 (0.3%) reactions. Systemic corticosteroids were required in 77% (17/22) of patients; of these, the majority remained on systemic corticosteroids. Adrenal insufficiency led to permanent discontinuation of KEYTRUDA in <0.1% (1) and withholding in 0.3% (8) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

Hypophysitis

KEYTRUDA can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism. Initiate hormone replacement as indicated. Withhold or permanently discontinue KEYTRUDA depending on severity. Hypophysitis occurred in 0.6% (17/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.3%), and Grade 2 (0.2%) reactions. Systemic corticosteroids were required in 94% (16/17) of patients; of these, the majority remained on systemic corticosteroids. Hypophysitis led to permanent discontinuation of KEYTRUDA in 0.1% (4) and withholding in 0.3% (7) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

Thyroid Disorders

KEYTRUDA can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated. Withhold or permanently discontinue KEYTRUDA depending on severity. Thyroiditis occurred in 0.6% (16/2799) of patients receiving KEYTRUDA, including Grade 2 (0.3%). None discontinued, but KEYTRUDA was withheld in <0.1% (1) of patients.

Hyperthyroidism occurred in 3.4% (96/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (0.8%). It led to permanent discontinuation of KEYTRUDA in <0.1% (2) and withholding in 0.3% (7) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. Hypothyroidism occurred in 8% (237/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (6.2%). It led to permanent discontinuation of KEYTRUDA in <0.1% (1) and withholding in 0.5% (14) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. The majority of patients with hypothyroidism required long-term thyroid hormone replacement. The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC, occurring in 16% of patients receiving KEYTRUDA as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. The incidence of new or worsening hypothyroidism was higher in 389 adult patients with cHL (17%) receiving KEYTRUDA as a single agent, including Grade 1 (6.2%) and Grade 2 (10.8%) hypothyroidism. The incidence of new or worsening hyperthyroidism was higher in 580 patients with resected NSCLC, occurring in 11% of patients receiving KEYTRUDA as a single agent as adjuvant treatment, including Grade 3 (0.2%) hyperthyroidism. The incidence of new or worsening hypothyroidism was higher in 580 patients with resected NSCLC, occurring in 22% of patients receiving KEYTRUDA as a single agent as adjuvant treatment (KEYNOTE-091), including Grade 3 (0.3%) hypothyroidism.

Type 1 Diabetes Mellitus (DM), Which Can Present With Diabetic Ketoacidosis

Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. Withhold KEYTRUDA depending on severity. Type 1 DM occurred in 0.2% (6/2799) of patients receiving KEYTRUDA. It led to permanent discontinuation in <0.1% (1) and withholding of KEYTRUDA in <0.1% (1) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

Immune-Mediated Nephritis With Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Immune-mediated nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.1%), and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 89% (8/9) of patients. Nephritis led to permanent discontinuation of KEYTRUDA in 0.1% (3) and withholding in 0.1% (3) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, none had recurrence. Nephritis resolved in 56% of the 9 patients.

Immune-Mediated Dermatologic Adverse Reactions

KEYTRUDA can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms, and toxic epidermal necrolysis, has occurred with anti– PD-1/PD-L1 treatments. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate nonexfoliative rashes. Withhold or permanently discontinue KEYTRUDA depending on severity. Immune-mediated dermatologic adverse reactions occurred in 1.4% (38/2799) of patients receiving KEYTRUDA, including Grade 3 (1%) and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 40% (15/38) of patients. These reactions led to permanent discontinuation in 0.1% (2) and withholding of KEYTRUDA in 0.6% (16) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 6% had recurrence. The reactions resolved in 79% of the 38 patients.

Other Immune-Mediated Adverse Reactions

The following clinically significant immune-mediated adverse reactions occurred at an incidence of <1% (unless otherwise noted) in patients who received KEYTRUDA or were reported with the use of other anti–PD-1/PD-L1 treatments. Severe or fatal cases have been reported for some of these adverse reactions. Cardiac/Vascular: Myocarditis, pericarditis, vasculitis; Nervous System: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy; Ocular: Uveitis, iritis and other ocular inflammatory toxicities can occur. Some cases can be associated with retinal detachment. Various grades of visual impairment, including blindness, can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss; Gastrointestinal: Pancreatitis, to include increases in serum amylase and lipase levels, gastritis, duodenitis; Musculoskeletal and Connective Tissue: Myositis/polymyositis, rhabdomyolysis (and associated sequelae, including renal failure), arthritis (1.5%), polymyalgia rheumatica; Endocrine: Hypoparathyroidism; Hematologic/Immune: Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection, other transplant (including corneal graft) rejection.

Infusion-Related Reactions

KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% of 2799 patients receiving KEYTRUDA. Monitor for signs and symptoms of infusion-related reactions. Interrupt or slow the rate of infusion for Grade 1 or Grade 2 reactions. For Grade 3 or Grade 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after anti–PD-1/PD-L1 treatments. Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute and chronic GVHD, hepatic veno-occlusive disease after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between anti–PD-1/PD-L1 treatments and allogeneic HSCT. Follow patients closely for evidence of these complications and intervene promptly.

Contacts

Media Contacts:

Julie Cunningham

(617) 519-6264

Marian Cutler

(973) 517-0519

Investor Contacts:

Peter Dannenbaum

(732) 594-1579

Steven Graziano

(732) 594-1583

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Kallyope To Present at the 44th Annual J.P. Morgan Healthcare Conference




Kallyope To Present at the 44th Annual J.P. Morgan Healthcare Conference

NEW YORK–(BUSINESS WIRE)–Kallyope, a late-stage biotechnology company leveraging unique insights into neural signaling pathways to develop innovative therapies for health challenges faced by hundreds of millions of people globally, today announced that the Company will present at the 44^th Annual J.P. Morgan Healthcare Conference to be held January 12-15 in San Francisco, CA.

44^th Annual J.P. Morgan Healthcare Conference Presentation Details

Presentation Date: Tuesday, January 13, 2025

Presentation Time: 11:00 AM PST

Presenter: Jay Galeota, Chief Executive Officer and President

Location: San Francisco, CA

During the presentation, Mr. Galeota will provide an overview of the Company’s lead programs, including elismetrep (K-304), an oral Transient Receptor Potential Melastatin 8 (TRPM8) antagonist for the acute treatment of migraine, expected to begin pivotal studies in mid-2026, and K-554, which targets a non-incretin peptide receptor for weight loss and glucose control and will enter Phase 1 clinical studies in mid-2026.

About Kallyope

Kallyope is a late-stage biotechnology company using unique insights into neural signaling pathways to develop innovative therapies for health challenges faced by hundreds of millions of people globally. Kallyope’s lead programs are in development for the treatment of people who struggle with migraine and obesity by targeting previously unknown drivers of disease in neural signaling pathways. For migraine, elismetrep (K-304) is poised to begin pivotal development for the acute treatment of migraine. The metabolism pipeline includes candidates against a novel target identified and validated by the Company’s Klarity™ platform, as well as oral small molecule approaches to the highly validated amylin pathway for the treatment of obesity. Kallyope was founded by world-leading neuroscientists and continues to explore the role of neural circuits in driving disease.

For more information, visit www.kallyope.com.

Contacts

Media Contact:
Ten Bridge Communications

Michael Galfetti

TBCKallyope@tenbridgecommunications.com

Investor Contact:
Kallyope

ir@kallyope.com

Future Forward Labs Appoints Dr. Delia DeBuc as Applied Science Mentor to Advance Applied Physics and Biomedical Innovation




Future Forward Labs Appoints Dr. Delia DeBuc as Applied Science Mentor to Advance Applied Physics and Biomedical Innovation

SEATTLE–(BUSINESS WIRE)–#highschool–Future Forward Labs today announced the appointment of Dr. Delia DeBuc as STEM Mentor – Applied Physics and Biomedical Science. Dr. DeBuc brings more than 20 years of multidisciplinary research, scientific leadership, and STEM education experience to the organization.

A Fulbright U.S. Scholar and nominee for the 2023 Presidential Awards for Excellence in Science, Mathematics & Engineering Mentoring (PAESM), Dr. DeBuc is internationally recognized for her work at the intersection of applied physics, neuroscience, vision science, and AI/ML-enabled health technologies. Her research has contributed to the development of imaging biomarkers, multimodal data-fusion methods, and neuro-ophthalmic tools that improve understanding of the eye–brain connection and support earlier detection of neurodegenerative disease.

Dr. DeBuc earned her Ph.D. in Applied Physics from the University of Michigan, Ann Arbor, and has been named among the Top 2% of Scientists worldwide in Clinical Medicine and Ophthalmology/Optometry by Stanford–Elsevier. She serves on the editorial board of Scientific Reports and collaborates with research institutions across the United States and Europe.

“We are honored to welcome Dr. DeBuc to Future Forward Labs,” said Vineet Taneja, Co-founder and President. “Her scientific expertise and dedication to mentorship align strongly with our mission to empower high school students to lead innovation in applied physics, biomedical science, and AI-driven research.”

In addition to her research accomplishments, Dr. DeBuc is a STEM educator who has mentored students from high school through graduate levels, providing research training, data analysis guidance, and support in scientific inquiry. Her mentorship has inspired students to pursue interdisciplinary careers in science and engineering.

“I’m excited to join Future Forward Labs and collaborate on initiatives that bridge science, technology, and real-world impact,” said Dr. DeBuc. “The organization’s commitment to interdisciplinary research and student-driven innovation creates an environment for developing future scientific leaders.”

About Future Forward Labs

Future Forward Labs is building a future where motivated students across the United States can access world-class STEM opportunities. As the need for scientific literacy accelerates, Future Forward Labs is expanding its programs to help students excel in science fairs like ISEF, Thermo Fisher JIC, Genius Olympiad, and research endeavors. Through personalized mentorship from scientists and educators, students prepare not only to compete, but to lead.

Contacts

Pallavi Kumari

+1 (425) 503-6820

pallavi@futureforward.app