Sanofi's riliprubart gets FDA orphan drug status for organ transplant rejection, unlocking key development perks.
Sanofi earns CHMP backing to expand Sarclisa's use for newly diagnosed multiple myeloma patients eligible for transplant.
SNY and REGN's Dupixent gets FDA approval for a rare and chronic skin disease, marking its eighth approved indication for the drug.
The Food and Drug Administration approved the drug for adult patients with bullous pemphigoid, which mainly affects the elderly and is characterized by itchiness, blisters and lesions.
Sanofi (NASDAQ:SNY ) Goldman Sachs 46th Annual Global Healthcare Conference Call June 10, 2025 4:00 PM ET Company Participants Brian Foard - Executive VP & Head of Specialty Care Conference Call Participants James Patrick Quigley - Goldman Sachs Group, Inc., Research Division James Patrick Quigley Excellent. So welcome, everybody.
The Food and Drug Administration approved Merck's shot designed to protect infants from respiratory syncytial virus during their first season of the virus. The decision will allow the company to launch the drug, which will be marketed as Enflonsia, ahead of the RSV season that typically kicks off around fall and winter.
SNY's $9.5 billion deal to acquire BPMC boosts its immunology pipeline and adds fast-growing Ayvakit to its portfolio.
Sanofi SA (ADR) (NYSE:SNY) is placing a major bet on rare immune disorders with its $9.1bn acquisition of US biotech firm Blueprint Medicines, part of a wider push to become a global leader in immunology. The deal gives Sanofi access to Blueprint's lead drug Ayvakit, the only approved treatment for systemic mastocytosis, a rare and often debilitating disease caused by the uncontrolled growth and activation of mast cells, a type of immune cell.
French pharma group Sanofi has agreed to buy US-based Blueprint Medicines Corporation , a biopharmaceutical company specializing in systemic mastocytosis, a rare immunological disease, the companies said on Monday.
The deal includes a drug approved in the U.S. and the EU for systemic mastocytosis, a rare immunology disease, as well as an early-stage immunology pipeline, the companies said.
Sanofi faces setbacks after itepekimab's Phase 3 COPD failure, removing a key growth prospect and highlighting reliance on Dupixent. Despite challenges, Sanofi is attractively valued, with my DCF analysis showing the stock is undervalued by about 12%. Sanofi's future growth hinges on Dupixent, but the looming patent cliff and biosimilar competition pose significant risks.
Itepekimab's inconsistent phase 3 results represent a setback for Regeneron Pharmaceuticals and Sanofi. The results do not support regulatory submissions and a 3-4 year approval delay, and lower peak sales potential looks like a best-case scenario for itepekimab. Regeneron faces a greater impact, as it is losing an important growth driver in the second half of the decade.