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]

Loading...Loading...RBC Capital Markets analyst Brian Abrahams reiterated an Outperform rating on Regeneron Pharmaceuticals, Inc. REGN, raising the price forecast to $1,299 from $1,200.Abrahams surveyed 31 pulmonologist physicians who see high volumes of COPD patients.The analyst writes that the surveyed pulmonologists were excited about the ph.III data, the proportion of patients they view as having type 2 inflammation, and the expected rapidity of adoption post-approval all suggest dupixent’s COPD sales p ...

Regeneron Pharmaceuticals, Inc. (REGN) and partner Sanofi (SNY) announced that the FDA has approved a label expansion of the arthritis drug Kevzara (sarilumab).The drug is now approved in the United States for the treatment of patients weighing 63 kilograms or more with active polyarticular juvenile idiopathic arthritis (pJIA).The FDA approval is supported by evidence from adequate and well-controlled studies and pharmacokinetic data from adults with rheumatoid arthritis as well as a pharmacokinetic, pharma ...

Regeneron Pharmaceuticals, Inc. Conference Call Summary Company Overview - **Company**: Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) - **Event**: Goldman Sachs 45th Annual Global Healthcare Conference - **Date**: June 11, 2024 Key Points Capital Allocation Strategy - Regeneron's capital allocation strategy is based on three pillars: 1. Investment in internal R&D capabilities, which is considered the best long-term value for shareholders [6] 2. Investment in manufacturing capabilities, including a recent investment in a fill package and labeling facility in Rensselaer, New York [6] 3. Returning capital to shareholders through share buybacks, with over $12 billion spent since the program began and an additional $3 billion authorized for buybacks [8] Development Balance with Sanofi - As of the first quarter, the development balance with Sanofi was $2.2 billion, expected to be fully reimbursed by the end of 2026, potentially adding $600 million to $800 million in profitability for Regeneron [10][11] EYLEA HD Product Update - EYLEA HD received a permanent J-code from CMS, streamlining reimbursement and increasing physician confidence in prescribing [14] - The product is seeing a steady increase in prescribing, with a significant portion of patients switching from EYLEA and other treatments [17][18] - Over 80% of lives are covered for EYLEA HD, indicating strong market penetration [19] Legal Matters - Regeneron is involved in litigation to protect its aflibercept formulation patent, with a recent favorable ruling in December 2023 [21] - The company is seeking injunctions against biosimilar applicants to prevent market entry until patent expiration in June 2027 [22] Dupixent Update - The FDA extended the PDUFA date for Dupixent in COPD due to additional analyses requested, but Regeneron remains confident in its approvability [24][25] - The patent portfolio for Dupixent is robust, with ongoing preclinical activities to extend treatment duration and explore biobetters [27] Pipeline Developments - Upcoming data releases include: - PDUFA date for linvoseltamab in August 2024 - Libtayo adjuvant CSCC data by the end of 2024 - Phase 3 melanoma data expected in 2025 [29][30] - Regeneron is also exploring obesity treatments with promising early data from Phase 1 studies [33][35] Allergy and Oncology Programs - Initial data from a combination study of linvoseltamab and Dupixent in severe food allergies is expected by the end of 2024 [42] - The oncology portfolio is highlighted by the fianlimab program, with lung data anticipated by the end of 2024 [46] M&A and Dividend Considerations - Regeneron has $17.5 billion in cash, providing flexibility for potential M&A opportunities, though no immediate plans are in place [57] - The company is evaluating the possibility of issuing dividends but has not committed to any at this time [58] Additional Insights - Regeneron is focused on innovative R&D across various therapeutic areas, including oncology, genetic medicines, and inflammation [54] - The company is optimistic about its pipeline and the potential for new treatments to address unmet medical needs [55]

Approval in patients with pJIA weighing 63kg or greater adds to Kevzara's position in treating adult chronic inflammatory conditions of moderately to severely active rheumatoid arthritis and polymyalgia rheumatica TARRYTOWN, N.Y. and CAMBRIDGE, MA, June 11, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) and Sanofi today announced that the U.S. Food and Drug Administration has approved Kevzara® (sarilumab) for the treatment of patients weighing 63 kg or greater with active polyarticul ...

Approval in patients with pJIA weighing 63kg or greater adds to Kevzara’s position in treating adult chronic inflammatory conditions of moderately to severely active rheumatoid arthritis and polymyalgia rheumatica TARRYTOWN, N.Y. and CAMBRIDGE, MA, June 11, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration has approved Kevzara® (sarilumab) for the treatment of patients weighing 63 kg or greater with active polyarticu ...

Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) Jefferies 2024 Global Healthcare Conference June 5, 2024 8:30 AM ET Company Participants Mark Hudson - Investor Relations Israel Lowy - SVP of Translational & Clinical Sciences, Oncology Andres Sirulnik - SVP of Translational & Clinical Sciences, Hematology Conference Call Participants Akash Tewari - Jefferies Akash Tewari All righty. Good morning, everyone. Day 1 of public companies for Jefferies Healthcare Conference here in beautiful Times Square. I'm not goi ...