Axsome Therapeutics Inc. won U.S. FDA approval for Auvelity (AXS-05) to treat Alzheimer’s disease agitation, a condition that affects up to three-quarters of patients, gaining access to a $1 billion-plus market and a clean label that counters the boxed warning of a competitor. The agency accepted the supplemental NDA under priority review on Dec. 31, 2025, and the breakthrough therapy approval, specifically for agitation associated with dementia due to Alzheimer’s disease, came on the April 30, 2026, PDUFA date.
Beone Medicines Ltd. gained an exclusive option to develop cancer immunotherapy HH-160 worldwide in a deal potentially worth more than $2 billion for Huahui Health Ltd., the developer of the trispecific antibody.
More than five years after pleading guilty to its role in the opioid epidemic, Purdue Pharma LP was sentenced in federal court and ordered to pay $5 billion in criminal penalties.
More than two years after signing a $1.7 billion deal with Takeda Pharmaceutical Co. Ltd., Protagonist Therapeutics Inc. has opted out of a 50-50 U.S. profit-and-loss sharing arrangement for its hepcidin mimetic peptide, rusfertide, a priority review drug developed to treat adults with polycythemia vera.
Eli Lilly and Co. is acquiring Ajax Therapeutics Inc. for up to $2.3 billion in cash, gaining access to next-generation JAK inhibitors for patients with myeloproliferative neoplasms.
A flurry of deals focused on the neurological disease space in 2026 suggest large biopharma companies are searching for the next best therapeutics for everything from epilepsy and narcolepsy to post-traumatic stress disorder and hyperphagia.
Four months after receiving a complete response letter from the U.S. FDA for tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis, Sanofi SA received a positive opinion recommending approval in the EU.
Children and adults with a type of congenital hearing loss now have a free treatment option, with the U.S. FDA’s accelerated approval of Regeneron Pharmaceuticals Inc.’s DB-OTO, an AAV-mediated gene therapy. Branded Otarmeni (lunsotogene parvec), it is cleared specifically for hearing loss caused by variants in the otoferlin gene.
Arriving a week ahead of April 28 PDUFA date, the U.S. FDA approval of Merck & Co. Inc.’s Idvynso (doravirine/islatravir) brings a new treatment option to adults with HIV-1 infection who are virologically suppressed. The approval is for those with no history of virologic treatment failure and no known substitutions associated with resistance to doravirine.
Nearly a year after the first U.S. commercial launch of the multicancer molecular residual disease (MRD) detection platform Pathlight, developer Saga Diagnostics entered a definitive merger agreement under which Roche Holding AG subsidiary Foundation Medicine Inc. will take over the firm in return for up to $595 million in payments.
