Sanofi SA has exercised its option to exclusively license Nurix Therapeutics Inc.’s STAT6 program, including the drug development candidate NX-3911, an oral, highly selective STAT6 degrader.
Sanofi SA is to acquire Blueprint Medicines Inc. in a $9.5 billion deal that will give the French pharma ownership of a marketed rare disease immunotherapy heading toward blockbuster status, a follow-on product in phase II/III, and a phase II clinical program relevant to a number of autoimmune diseases.
Facing erosion of its mighty Eylea (aflibercept) franchise and near-term loss of exclusivity with Dupixent (dupilumab), Regeneron Pharmaceuticals Inc. took a blow as one of two phase III trials with IL-33-blocking monoclonal antibody itepekimab failed in chronic obstructive pulmonary disease (COPD). The Tarrytown, N.Y.-based firm’s shares (NASDAQ:REGN) closed May 30 at $490.28, down $115.11, or 19%. Partner Sanofi SA, of Paris, saw its stock (NASDAQ:SNY) dip somewhat, too, and ended at $49.37, down $2.98. Cantor analyst Carter Gould opined that the latest news “all but [ruled] out a path forward short of a new study” with the compound.
Sanofi SA made good on its plan to bear down on M&A by agreeing to buy Vigil Neuroscience Inc. for $8 per share (NASDAQ:VIGL). Included in the transaction is a non-tradeable contingent value right entitling the holder to potentially collect $2 per share more in cash, payable following the first commercial sale of the phase II-ready VG-3927, a small-molecule triggering receptor expressed on myeloid cells 2 (TREM2) antagonist for Alzheimer’s disease, if achieved within a specific period. Watertown, Mass.-based Vigil’s stock closed May 22 at $7.88, up $5.57, or 241%.
Frets about how the new federal administration might affect prospects for vaccines were quelled at least somewhat by the U.S. FDA green light for Novavax Inc.’s COVID-19 vaccine Nuvaxovid, indicated for adults 65 and over and people 12-64 years old with at least one underlying condition that puts them at risk of severe outcomes from infection by the virus.
First quarter 2025 results presentations were the first chance analysts have had to quiz pharma companies in public about their exposure to the threat of U.S. import tariffs and what action they are taking to mitigate the risks.
First quarter 2025 results presentations were the first chance analysts have had to quiz pharma companies in public about their exposure to the threat of U.S. import tariffs and what action they are taking to mitigate the risks. BioWorld reporters have listened in to the analyst meetings and filleted out responses to the tariff question by CEOs and senior executives, to get an overview of how the sector as a whole is responding. One thing is very clear: While pharmaceuticals are for now exempt from tariffs, the industry has been bracing for their imposition whilst at the same time lobbying strongly against them, on the grounds that drug shortages could result.
If U.S. sectoral tariffs on biopharmaceuticals become a reality and most country-by-country tariffs on other medical products resume, manufacturers may have to rethink their use of U.S. free trade zones to turn foreign-sourced active pharmaceutical ingredients and other components into finished products for the U.S. market.
The U.S. FDA issued a complete response letter in October 2023 for Dupixent (dupilumab) in treating chronic hives but has now approved the monoclonal antibody for the indication. The approval makes Dupixent the first targeted biologic the agency has approved in the past 11 years for chronic spontaneous urticaria.
Earendil Labs will collaborate with Sanofi SA in a $1.8 billion license deal. Earendil, which specializes in artificial intelligence-based R&D for biologics, is getting $125 million up front and $50 million as a near-term payment. In return, Sanofi gets the exclusive global rights to the bispecific antibodies HXN-1002 and HXN-1003.