reports
Lynozyfic™ (linvoseltamab) Approved in the European Union for the Trea...
Lynozyfic™ (linvoseltamab) Approved in the European Union for the Treatment of Relapsed/Refractory Multiple Myeloma Approval of Lynozyfic is based on data showing deep and durable responses in relapsed/refractory multiple myeloma Lynozyfic will provide a new option with convenient dosing and administration to patients who face cycles of relapse and remission TARRYTOWN, N.Y., April 28, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the European Commission (EC) has granted conditional marketing approval of Lynozyfic™ (linvoseltamab) to treat ...
EYLEA HD® (aflibercept) Injection 8 mg Presentations at ARVO Reinforce...
EYLEA HD® (aflibercept) Injection 8 mg Presentations at ARVO Reinforce Continued Safety and Efficacy and Highlight Early Real-World Outcomes for Patients with Serious Retinal Disease Initial real-world data from nearly 40,000 EYLEA HD patients will provide early insights on effectiveness of EYLEA HD in everyday clinical practice New indirect comparisons will evaluate EYLEA HD and faricimab on measures of efficacy, dosing frequency and potential economic benefits in patients with wet age-related macular degeneration and diabetic macular edema TARRYTOWN, N.Y., April 28, 2025 (GLOBE NEWSW...
Regeneron Announces New Investment in Manufacturing of its Industry-Le...
Regeneron Announces New Investment in Manufacturing of its Industry-Leading Biologic Medicines New manufacturing and supply agreement with FUJIFILM Diosynth Biotechnologies in North Carolina will enable additional production of Regeneron’s biologic medicines and support high-paying jobs in the region Regeneron’s ongoing and planned investments in New York and North Carolina infrastructure and manufacturing expected to total more than $7 billion TARRYTOWN, N.Y., April 22, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced a significant exp...
Regeneron Announces Investor Conference Presentations
Regeneron Announces Investor Conference Presentations TARRYTOWN, N.Y., April 21, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) will webcast management participation as follows: BofA Securities 2025 Health Care Conference at 10:00 a.m. PT (1:00 p.m. ET) on Tuesday, May 13, 20252025 RBC Capital Markets Global Healthcare Conference at 11:00 a.m. ET on Tuesday, May 20, 2025Bernstein 41st Annual Strategic Decisions Conference at 11:00 a.m. ET on Wednesday, May 28, 2025Goldman Sachs 46th Annual Global Healthcare Conference at 10:40 a.m. ET on Monday, June 9, 2025 The...
Regeneron Provides Update on EYLEA HD® (aflibercept) Injection 8 mg Su...
Regeneron Provides Update on EYLEA HD® (aflibercept) Injection 8 mg Supplemental Biologics License Application TARRYTOWN, N.Y., April 18, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the supplemental Biologics License Application (sBLA) for the addition of extended dosing intervals (up to every 24 weeks) for EYLEA HD® (aflibercept) Injection 8 mg across all approved indications. The CRL did not identify any issues with the safety or efficacy of...
Dupixent® (dupilumab) Approved in the U.S. as the First New Targeted T...
Dupixent® (dupilumab) Approved in the U.S. as the First New Targeted Therapy in Over a Decade for Chronic Spontaneous Urticaria (CSU) Approval based on Phase 3 trials demonstrating Dupixent significantly reduced itch and hives compared to placebo In the U.S., there are more than 300,000 adults and adolescents aged 12 years and older living with CSU who remain symptomatic despite antihistamine treatment CSU is the seventh disease with underlying type 2 inflammation in which Dupixent is approved TARRYTOWN, N.Y. and PARIS, April 18, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals...
EYLEA HD® (aflibercept) Injection 8 mg sBLA Accepted for FDA Priority ...
EYLEA HD® (aflibercept) Injection 8 mg sBLA Accepted for FDA Priority Review for Both the Treatment of Macular Edema Following Retinal Vein Occlusion (RVO) and for Monthly Dosing in Approved Indications If approved, EYLEA HD would be the first and only treatment for RVO indicated for up to every 8-week dosing after an initial monthly dosing period – halving the number of injections that are indicated for all other anti-VEGF therapies Potential for as frequent as monthly dosing for all approved indications would provide greater dosing flexibility for physicians and patients TARRYTOWN, N.Y....
Dupixent® (dupilumab) Approved as the First-ever Biologic Medicine in ...
Dupixent® (dupilumab) Approved as the First-ever Biologic Medicine in Japan for Patients with Chronic Obstructive Pulmonary Disease (COPD) Following recent approvals in the EU, China and the U.S., this approval was based on pivotal Phase 3 results in adults with elevated eosinophils Approval marks the first new treatment approach for COPD in more than a decade in Japan and the sixth approved indication for chronic diseases with underlying type 2 inflammation TARRYTOWN, N.Y. and PARIS, March 28, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today ann...
Regeneron to Report First Quarter 2025 Financial and Operating Results...
Regeneron to Report First Quarter 2025 Financial and Operating Results and Host Conference Call and Webcast on April 29, 2025 TARRYTOWN, N.Y., March 25, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that it will report its first quarter 2025 financial and operating results on Tuesday, April 29, 2025, before the U.S. financial markets open. The Company will host a conference call and simultaneous webcast at 8:30 AM Eastern Time that day. Conference Call Information Participants may access the conference call live via webcast on the ’Investors a...
Regeneron Science Talent Search 2025 Awards More Than $1.8 Million to ...
Regeneron Science Talent Search 2025 Awards More Than $1.8 Million to High School Seniors for Innovative Scientific Research on Classifying Objects in Space, Treating a Rare Muscle Disease and Solving a Long-Standing Math Problem $250,000 top award goes to Matteo Paz in America’s longest running and most distinguished science and math competition TARRYTOWN, N.Y. and WASHINGTON, March 11, 2025 (GLOBE NEWSWIRE) -- (NASDAQ: REGN) and (the Society) announced that Matteo Paz,18, of Pasadena, CA, won the top award of $250,000 in the 2025 , the U.S.’s oldest and most prestigious science and...
Dupixent® (dupilumab) Late-Breaking Positive Pivotal Data in Bullous P...
Dupixent® (dupilumab) Late-Breaking Positive Pivotal Data in Bullous Pemphigoid Presented at AAD Five times more adults on Dupixent achieved sustained disease remission at 36 weeks compared to placebo; significant reductions were also seen in disease severity and itch Dupixent also significantly reduced oral corticosteroid and rescue medicine use compared to placebo Data support the potential of Dupixent to be the first and only targeted medicine to treat bullous pemphigoid, a skin disease with underlying type 2 inflammation; regulatory submissions are under review in the U.S. and the Eur...
Linvoseltamab Recommended for EU Approval by the CHMP to Treat Relapse...
Linvoseltamab Recommended for EU Approval by the CHMP to Treat Relapsed/Refractory Multiple Myeloma TARRYTOWN, N.Y., Feb. 28, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending conditional marketing authorization of linvoseltamab to treat adults with relapsed and refractory (R/R) multiple myeloma (MM). The recommendation is specific to those who have received at least three prior therapies, including a proteasome ...
Odronextamab BLA Accepted for FDA Review for the Treatment of Relapsed...
Odronextamab BLA Accepted for FDA Review for the Treatment of Relapsed/Refractory Follicular Lymphoma FDA decision expected by July 30, 2025 TARRYTOWN, N.Y., Feb. 26, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the Biologics License Application (BLA) for odronextamab in relapsed/refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. The target action date for the FDA decision is July 30, 2025. Acceptance of the BL...
Latest DB-OTO Results Demonstrate Clinically Meaningful Hearing Improv...
Latest DB-OTO Results Demonstrate Clinically Meaningful Hearing Improvements in Nearly All Children with Profound Genetic Hearing Loss in CHORD Trial As presented at ARO, 10 of 11 children with at least one post-treatment assessment showed notable improvements in hearing Speech and development progress followed dramatic improvements in hearing in first child treated in the trial TARRYTOWN, N.Y., Feb. 24, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced updated data for the investigational gene therapy DB-OTO from the Phase 1/2 CHORD trial in 12 ch...
Dupixent® (dupilumab) sBLA Accepted for FDA Priority Review for the Ta...
Dupixent® (dupilumab) sBLA Accepted for FDA Priority Review for the Targeted Treatment of Bullous Pemphigoid (BP) If approved, Dupixent would be the first and only targeted medicine to treat BP in the U.S.; FDA decision expected by June 20, 2025 Priority Review granted based on positive pivotal results demonstrating significant improvements in sustained disease remission with Dupixent compared to placebo BP is a chronic, debilitating and relapsing skin disease with underlying type 2 inflammation characterized by intense itch and blisters, reddening of the skin and painful lesions TARRYTO...
Regeneron Announces Investor Conference Presentations
Regeneron Announces Investor Conference Presentations TARRYTOWN, N.Y., Feb. 11, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) will webcast management participation as follows: TD Cowen 45th Annual Health Care Conference at 11:50 a.m. ET on Tuesday, March 4, 2025Leerink Partners 2025 Global Healthcare Conference at 8:00 a.m. ET on Tuesday, March 11, 2025 The sessions may be accessed from the "Investors & Media" page of Regeneron's website at . Replays and transcripts of the webcasts will be archived on the Company's website for at least 30 days. About Regeneron...
Linvoseltamab BLA Accepted for FDA Review for the Treatment of Relapse...
Linvoseltamab BLA Accepted for FDA Review for the Treatment of Relapsed/Refractory Multiple Myeloma Acceptance follows resolution of third-party fill/finish manufacturing issues FDA decision expected by July 10, 2025 TARRYTOWN, N.Y., Feb. 11, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the Biologics License Application (BLA) for linvoseltamab for the treatment of adult patients with relapsed/refractory (R/R) multiple myeloma (MM) who have received at...
EYLEA HD® (aflibercept) Injection 8 mg Positive Phase 3 Results in Pat...
EYLEA HD® (aflibercept) Injection 8 mg Positive Phase 3 Results in Patients with Macular Edema following Retinal Vein Occlusion Presented at Angiogenesis Meeting EYLEA HD led to improved vision with extended dosing intervals, achieving non-inferior vision gains with an every 8-week dosing regimen compared to EYLEA® (aflibercept) Injection 2 mg dosed every 4 weeks TARRYTOWN, N.Y., Feb. 08, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the first presentation of positive results from the Phase 3 QUASAR trial investigating EYLEA HD® (aflibercept) In...
Three-Year Results for EYLEA HD® (aflibercept) Injection 8 mg in Patie...
Three-Year Results for EYLEA HD® (aflibercept) Injection 8 mg in Patients with Wet Age-related Macular Degeneration Demonstrate Continued Durable Vision Gains and Anatomic Improvements with Extended Dosing Intervals At three years of EYLEA HD treatment, the vast majority of patients maintained visual and anatomic improvements while achieving extended dosing regimens, including those of just twice a year: 77%, 58%, 40% and 24% achieved last assigned dosing intervals of ≥3, ≥4, ≥5 and 6 months, respectively At three years, the vast majority of patients who switched to EYLEA HD from a fixed 2...
Regeneron Reports Fourth Quarter and Full Year 2024 Financial and Oper...
Regeneron Reports Fourth Quarter and Full Year 2024 Financial and Operating Results; Initiates Quarterly Dividend and Increases Total Share Repurchase Capacity to ~$4.5 Billion Fourth quarter 2024 revenues increased 10% to $3.79 billion versus fourth quarter 2023Full year 2024 revenues increased 8% to $14.20 billion versus 2023; excluding RonapreveTM(a)(b), revenues increased 10%Fourth quarter 2024 Dupixent® global net sales (recorded by Sanofi) increased 15% to $3.70 billion versus fourth quarter 2023; full year 2024 Dupixent global net sales increased 22% to $14.15 billion versus 2023Four...
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