Autoimmune disease
While Bruton’s tyrosine kinase inhibitors are often hailed as the next big breakthrough in multiple sclerosis, Immunic Therapeutics and others are leveraging neuroprotective targets and remyelination to keep the disease at bay.
Ocaliva won accelerated approval for primary biliary cholangitis in 2016, which the FDA refused to upgrade to full approval last year after an advisory committee was unable to verify a favorable risk/benefit profile.
The autoimmune and inflammatory disease–focused company canceled plans to go public earlier this year as the IPO window slammed shut.
Health Secretary Robert F. Kennedy Jr. will appear before the Senate Finance Committee Thursday, ahead of a vaccine advisory committee meeting later in September. Meanwhile, deal-making appetite appears healthy, and the weight loss space continues generating clinical data and other news.
Vertex Pharmaceuticals commits $45 million upfront to leverage Enlaza Therapeutics’ War-Lock platform to create drug conjugates and T cell engagers for autoimmune diseases and gentler conditioning for sickle cell/beta thalassemia gene-editing therapy Casgevy.
BMS is spinning out a new company with five immunology assets, including oral drugs being developed for systemic lupus erythematosus and plaque psoriasis, and $300 million in funds from Bain Capital.
The company didn’t share specific data for the molecule, gefurulimab, but said it hit all endpoints in the Phase III PREVAIL trial and promised to share more at an upcoming scientific meeting.
After a season of regulatory upheaval, obesity and rare genetic diseases will likely remain major themes for biopharma in 2025, according to Jefferies.
The all-cash buyout, which gives AbbVie access to Capstan Therapeutics’ in vivo edited CAR T therapy for B cell–mediated autoimmune diseases, adds to a growing sense of momentum in M&A, according to BMO Capital Markets.
Genrix’s velinotamig complements Cullinan’s own pipeline, according to William Blair, which added that the deal will put Cullinan in a better position to target autoimmune diseases.
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