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On Monday, the U.S. Food and Drug Administration (FDA) extended the review date for Sanofi SA’s (NASDAQ:SNY) new drug application (NDA) of tolebrutinib for non-relapsing, secondary progressive multiple sclerosis (nrSPMS) and to slow disability accumulation independent of relapse activity in adult patients.
Based on the submission of additional analyses during the review, the FDA has determined that the additional information constituted a major amendment to the NDA and extended the target action date accordingly. The revised target action date for the FDA decision is December 28, 2025.
The FDA review of tolebrutinib is based on data from the global, double-blinded randomized HERCULES and GEMINI 1 and 2 phase 3 studies evaluating the efficacy and safety of tolebrutinib in patients with nrSPMS and relapsing MS (RMS), respectively.
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In addition to the completed HERCULES and GEMINI 1 and 2 studies, the PERSEUS phase 3 study in primary progressive MS is ongoing, with study results anticipated in the second half of 2025.
Separately on Monday, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended approving Regeneron Pharmaceutical Inc. (NASDAQ:REGN) partnered Dupixent (dupilumab) for chronic spontaneous urticaria (CSU) in adults and adolescents.
This recommendation covers those aged 12 years and above with moderate to severe disease, with inadequate response to histamine-1 antihistamines (H1AH), and who are naive to anti-immunoglobulin E (IgE) therapy.
A final decision is expected in the coming months.
The positive CHMP opinion is supported by data from two studies in the LIBERTY-CUPID phase 3 program, both of which demonstrated that Dupixent significantly reduced itch and hives at 24 weeks compared to placebo.
A third study from the LIBERTY-CUPID program, Study B, was conducted in a different CSU patient population and provided additional safety data.
Price Action: SNY stock was trading lower by 1.08% to $47.13, and REGN stock was trading higher by 0.79% to $596.66 at last check Monday.
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