TARRYTOWN, N.Y., June 28, 2024 (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 odronextamab to treat adults with relapsed/refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy. The European Commission is expected to ann ...

TARRYTOWN, N.Y., June 27, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that it will report its second quarter 2024 financial and operating results on Thursday, August 1, 2024, 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 and Media’ page of Regeneron’s website at http ...

TARRYTOWN, N.Y., June 27, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that it will report its second quarter 2024 financial and operating results on Thursday, August 1, 2024, 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 and Media’ page of Regeneron’s website at https ...

Majority of patients in this age group with eosinophilic esophagitis (EoE) receiving Dupixent achieved histologic remission, with improvements sustained up to one year Dupixent is the first and only treatment indicated for EoE in the U.S. for this age group TARRYTOWN, N.Y. and PARIS, June 26, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced the New England Journal of Medicine (NEJM) has published results from a positive Phase 3 trial for Dupixent® (dupilumab ...

Dupixent positive phase 3 data in children one to 11 years of age with eosinophilic esophagitis published in NEJM Majority of patients in this age group with eosinophilic esophagitis receiving Dupixent achieved histologic remission, with improvements sustained up to one yearDupixent is the first-and-only medicine indicated for eosinophilic esophagitis in the US for this age group Paris and Tarrytown, NY, June 26, 2024. The New England Journal of Medicine has published results from a positive phase 3 study o ...

Dupixent positive phase 3 data in children one to 11 years of age with eosinophilic esophagitis published in NEJM Majority of patients in this age group with eosinophilic esophagitis receiving Dupixent achieved histologic remission, with improvements sustained up to one yearDupixent is the first-and-only medicine indicated for eosinophilic esophagitis in the US for this age group Paris and Tarrytown, NY, June 26, 2024. The New England Journal of Medicine has published results from a positive phase 3 study o ...

Majority of patients in this age group with eosinophilic esophagitis (EoE) receiving Dupixent achieved histologic remission, with improvements sustained up to one year Dupixent is the first and only treatment indicated for EoE in the U.S. for this age group TARRYTOWN, N.Y. and PARIS, June 26, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) and Sanofi today announced the New England Journal of Medicine (NEJM) has published results from a positive Phase 3 trial for Dupixent® (dupilumab) ...

Loading...Loading...Regeneron Pharmaceuticals Inc REGN released multiple ascending dose (MAD) data from a Phase 1 study evaluating garetosmab (anti-activin A) and trevogrumab (anti-myostatin) on body composition in healthy volunteers (n=34) at the American Diabetes Association meeting.The data demonstrated that combination therapy led to greater-than-additive increases in lean mass while decreasing fat mass in healthy participants.Thigh muscle volume (TMV) increased from baseline 7.7% with trevogrumab 6 mg/ ...

Biotech giant Regeneron Pharmaceuticals (REGN) is one of the few top biotech companies that has outperformed the industry year to date.Shares of the company have risen 19% year to date against the industry’s decline of 6.4%. Image Source: Zacks Investment ResearchRegeneron’s efforts to diversify its portfolio have impressed its investors, even as lead drug Eylea faces challenges. Regeneron’s top line is being boosted by its share of profits/losses in connection with the global sales of Dupixent. Partner San ...

Core Insights - Regeneron Pharmaceuticals announced promising results from the 14-month median follow-up of the Phase 1/2 LINKER-MM1 trial for linvoseltamab in relapsed/refractory multiple myeloma, showing a 71% overall response rate and 50% of patients achieving a complete response or better [1][2][4] Clinical Trial Results - The LINKER-MM1 trial demonstrated a 71% objective response rate (ORR) with 50% of patients achieving a complete response (CR) or better, and 63% achieving a very good partial response (VGPR) or better [2][4] - Median duration of response (DoR) was 29 months for all responders, with an 81% and 95% estimated probability of maintaining a response at 12 months for all patients and those achieving a CR or better, respectively [2][3] - Median progression-free survival (PFS) was not reached, with a 70% estimated probability of being progression-free at 12 months among all patients [2][4] - Median overall survival (OS) was 31 months for all patients, with a 75% and 100% estimated probability of survival at 12 months among all patients and those achieving a CR or better, respectively [2][4] Safety Profile - Safety data indicated that cytokine release syndrome (CRS) was the most common treatment-emergent adverse event (TEAE), occurring in 46% of patients, with 35% being Grade 1 and 10% Grade 2 [3] - Infections were reported in 74% of patients, with 36% classified as Grade 3 or 4, but decreased in frequency and severity after 6 months [3] Comparative Study - A retrospective study comparing linvoseltamab to real-world standard-of-care treatment showed an ORR of 70% for linvoseltamab versus 32% for standard treatment, with median PFS of 20 months versus 3 months [4] - The study also indicated that the median OS for linvoseltamab was not reached compared to 12 months for standard treatment [4] Regulatory Status - Linvoseltamab has received Fast Track Designation and is under Priority Review by the U.S. FDA for the treatment of relapsed/refractory multiple myeloma, with a target action date of August 22, 2024 [4][5] Ongoing Development - The Phase 3 confirmatory trial (LINKER-MM3) for linvoseltamab in patients with relapsed/refractory multiple myeloma is currently ongoing [5] - The broader clinical development program includes additional trials in earlier lines of therapy and stages of disease [9]