“People have some inability to focus on [Regeneron Pharmaceuticals Inc.’s] pipeline,” which stands as “the most prolific in the industry, I would dare to say,” CEO Leonard Schleifer remarked during the Morgan Stanley health care conference Sept. 8. Most recently, Regeneron bragged on two prospects. The ultra-rare disease fibrodysplasia ossificans progressiva (FOP) took center stage Sept. 17 with news that the phase III Optima trial testing fully human monoclonal antibody garetosmab met its primary endpoint. Separately, Regeneron provided updated analyses of the phase II Courage trial that tested new pairings of GLP-1 receptor agonist semaglutide plus the anti-GDF8/anti-myostatin compound trevogrumab, with or without garetosmab, in obesity.
Phase III results from Sanofi SA’s study of amlitelimab in treating atopic dermatitis met the primary and key secondary endpoints, but investors took a step back.
The U.S. FDA approved 17 drugs in July, down from 23 in June, bringing the year-to-date total to 125. Through July, 2025 remains the third-highest count in BioWorld’s records, trailing 135 approvals in 2024 and 126 in 2020.
Amid the increasingly competitive myasthenia gravis drug development space, siRNA candidate cemdisiran met phase III endpoints, with the monotherapy showing numerically higher results than a combination product. Regeneron Pharmaceuticals Inc., which has a worldwide license to cemdisiran from Alnylam Pharmaceuticals Inc., plans to file for U.S. approval in generalized myasthenia gravis, a rare and chronic autoimmune disease leading to life-threatening muscle weakness, in the first quarter of 2026.
The U.S. FDA approved 17 drugs in July, down from 23 in June, bringing the year-to-date total to 125. Through July, 2025 remains the third-highest count in BioWorld’s records, trailing 135 approvals in 2024 and 126 in 2020.
Regeneron Pharmaceuticals Inc. disclosed within a positive second-quarter earnings report that it had received a complete response letter (CRL) two days earlier from the U.S. FDA for its bispecific antibody, odronextamab, for relapsed/refractory follicular lymphoma following two or more lines of systemic therapy.
It may be a year later than originally planned, but Regeneron Pharmaceuticals Inc. is set to commercialize Lynozyfic (linvoseltamab) in the U.S. following FDA approval for use in adults with relapsed and refractory multiple myeloma. A bispecific antibody targeting B-cell maturation antigen (BCMA) and CD3, Lynozyfic was cleared under the accelerated approval pathway, with continued approval contingent upon a confirmatory trial.
The 23andme Holding Co.’s saga came full circle with founder Anne Wojcicki regaining control of the bankrupt genetic testing company in a bidding battle against Regeneron Pharmaceuticals Inc.
The BioWorld Biopharmaceutical Index extended its downward trend over April and May, closing the latter month down 6.47% after reaching a peak gain of 9.64% at the end of February. The Nasdaq Biotechnology Index followed a similar trajectory, finishing May with a 5.37% decline. Meanwhile, the Dow Jones Industrial Average dipped through April but rebounded slightly in May, ending the month down 0.64%.
Regeneron Pharmaceuticals Inc. is adding to its obesity pipeline by in-licensing Hansoh Biomedical Co. Ltd.’s phase III dual glucagon-like peptide 1 (GLP-1)/gastric inhibitory polypeptide (GIP) receptor agonist, HS-20094, for up to $2 billion.