Regeneron Pharmaceuticals (REGN) Wins FDA Approval For Pasatru In Adult FOP

Regeneron (REGN) and Sanofi (SNYNF) completed a long-term safety extension trial for itepekimab in COPD patients. The double-blind study evaluated the drug's safety and tolerability over 72 weeks. The trial's completion and positive results could reduce perceived risks, support a COPD launch, and enhance the companies' revenue outlook in respiratory care.

Dupilumab reduced moderate/severe COPD exacerbations across all seasons, with the largest reductions in summer and spring. Data from phase 3 trials showed a 31% decrease in exacerbation rate vs. placebo. According to researchers, dupilumab's efficacy is consistent year-round, providing clinicians with further confidence in its use for eligible COPD patients.

Regeneron highlighted growth in Dupixent's respiratory and dermatology indications, with COPD and chronic spontaneous urticaria showing strong performance. The company discussed its immunology and inflammation pipeline, including long-acting antibodies and bispecific candidates. Regeneron also mentioned ongoing discussions with Sanofi about the future of their collaboration on Dupixent. The company expects an FDA decision on cemdisiran for myasthenia gravis in November and Phase III readouts for

Regeneron Pharmaceuticals (REGN) and certain officers face a securities class action lawsuit over alleged misleading statements about the Phase III Fianlimab-Libtayo study. Investors claim the trial's statistical assumptions were flawed and the study may not meet its primary endpoint. The lawsuit and a Libtayo recall could lead to higher legal costs, regulatory scrutiny, and potential impact on the company's pipeline and financial profile. REGN has a market value of about $80.6 billion.

Regeneron Pharmaceuticals (REGN) hit a 52-week high of $847.60, up 50.05% over the past year. The stock trades at $847.19, 32% below its InvestingPro Fair Value of $1,118. Q2 2026 earnings were $14.29 per share, with revenue of $4.29 billion, up 17% YoY. Analysts raised price targets, with BofA Securities at $891 and Bernstein SocGen at $756.

Regeneron Pharmaceuticals (REGN) received FDA approval for Pasatru (garetosmab-grts), a new rare disease therapy for fibrodysplasia ossificans progressiva. The drug can be infused at home and showed strong lesion-reduction results. Analysts discuss its impact on Regeneron's investment case, with projections of $19.4B revenue and $6.0B earnings by 2029. Pasatru adds to Regeneron's portfolio but EYLEA's performance remains a key focus.