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Regeneron (REGN) Outperforms Industry YTD: What Lies Ahead?
ZACKS· 2024-06-18 18:25
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 ...
Updated Linvoseltamab Data Showcase Continued Deepening of Responses in Patients with Heavily Pre-Treated Multiple Myeloma
Newsfilter· 2024-06-16 10:10
At 14-months median follow-up in the pivotal trial, 50% of patients achieved a complete response or better and a 71% overall response rate, as presented in an EHA oral presentation and simultaneously published in the Journal of Clinical Oncology Also presented at EHA, a retrospective study of patient outcomes that compared investigational linvoseltamab to real-world standard-of-care treatment in clinical practice TARRYTOWN, N.Y., June 16, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN ...
Regeneron's Dupixent COPD Sales To Reach $20B By 2026, Analyst Sees Larger Addressable Market
Benzinga· 2024-06-13 13:39
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) Goldman Sachs 45th Annual Global Healthcare Conference (Transcript)
2024-06-11 14:07
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]
Kevzara® (sarilumab) Approved by FDA for the Treatment of Active Polyarticular Juvenile Idiopathic Arthritis (pJIA)
Newsfilter· 2024-06-11 11:00
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 ...
Kevzara® (sarilumab) Approved by FDA for the Treatment of Active Polyarticular Juvenile Idiopathic Arthritis (pJIA)
GlobeNewswire News Room· 2024-06-11 11:00
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. (REGN) Management presents at Jefferies 2024 Global Healthcare Conference (Transcript)
2024-06-05 16:43
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 ...
Health Care Stocks Show Relative Strength as S&P 500 Stalls
ZACKS· 2024-06-04 19:45
The U.S. economy has begun to show signs of weakness as we head into the summer months. This morning, the Bureau of Labor Statistics reported that job openings fell in April to their lowest level in more than three years. The new data revealed that there were 8.06 million jobs open at the end of the month, a decrease from the 8.35 million openings in March.Coming off the heels of a weak April jobs report, it’s yet another sign that the hiring boom following the pandemic is cooling off. We’ll get more in the ...
Dupixent® (dupilumab) Recommended for EU Approval by the CHMP to Treat Patients with COPD
GlobeNewswire News Room· 2024-05-31 05:05
Recommendation for adults with uncontrolled COPD with raised blood eosinophils based on data from two landmark Phase 3 trials demonstrating Dupixent significantly reduced exacerbations and improved lung function If approved, Dupixent would be the first-ever targeted therapy for COPD in the EU and the first new treatment approach for this disease in more than a decade TARRYTOWN, N.Y. and PARIS, May 31, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that th ...
Dupixent® (dupilumab) Recommended for EU Approval by the CHMP to Treat Patients with COPD
Newsfilter· 2024-05-31 05:05
Recommendation for adults with uncontrolled COPD with raised blood eosinophils based on data from two landmark Phase 3 trials demonstrating Dupixent significantly reduced exacerbations and improved lung function If approved, Dupixent would be the first-ever targeted therapy for COPD in the EU and the first new treatment approach for this disease in more than a decade TARRYTOWN, N.Y. and PARIS, May 31, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) and Sanofi today announced that the ...