Merck & Co. Inc. is buying Cidara Therapeutics Inc. for $9.2 billion to acquire a late-stage flu candidate and also to outrace blockbuster Keytruda’s looming patent expiration. CD-388, Cidara’s lead candidate, is in a phase III study of adolescents and adults for preventing influenza A and B in those who are at a high risk of developing complications.
Phase III data from Novartis AG for the malaria treatment Ganlum (KLU-156) show it met the primary endpoint of noninferiority to the current standard of care, Coartem, a combination of artemether and lumefantrine. The results are a step to curbing a problem that has seen rising numbers in recent years.
Alkermes plc’s placebo-controlled phase II study of alixorexton in treating narcolepsy type 2 (NT2) hit its dual primary endpoints, producing statistically significant and clinically meaningful improvement in wakefulness and excessive daytime sleepiness. Alkermes said alixorexton is the first oral orexin 2 receptor agonist that has shown efficacy in a large phase II clinical trial in those with NT2.
Bluejay Therapeutics Inc.’s lead compound, the fully human monoclonal antibody brelovitug (BJT-778), produced positive virologic response data in the company’s phase II study of chronic hepatitis D virus, a condition with no approved treatment in the U.S.
Cogent Biosciences Inc. is now lining up two NDA submissions for its tyrosine kinase inhibitor bezuclastinib in treating two forms of cancer. Cogent intends to submit an NDA for bezuclastinib, a tyrosine kinase inhibitor that targets and inhibits mutated KIT proteins, specifically KIT D816V, in the first half of 2026 to treat gastrointestinal stromal tumors. That will follow the company’s plans for an NDA submission for bezuclastinib in treating non-advanced systemic mastocytosis before the end of 2025.
The U.S. FDA’s complete response letter (CRL) for Biohaven Ltd.’s lead asset, troriluzole, to treat spinocerebellar ataxia has prompted a wave of downstream changes at the company. There will be a roughly 60% cutback in annual R&D spending, not including personnel, as Biohaven focuses on three other late-stage clinical programs.
The U.S. FDA has approved UCB SA’s Kygevvi (doxecitine and doxribtimine), the first treatment for the ultra-rare, genetic and life-threatening mitochondrial disease thymidine kinase 2 deficiency. The approval comes as the company reaps a reward of rebuilding and reorganizing that it began little more than a year ago.
Early stage data from Terns Pharmaceuticals Inc.’s lead candidate showed a large reduction in the number of leukemia cells in those with previously treated chronic myeloid leukemia. Results from the ongoing phase I Cardinal study of TERN-701, an oral, allosteric BCR-ABL tyrosine kinase inhibitor, were “unprecedented,” according to Terns.
With a modest $7 million up front but an ultimate payout potentially topping $1 billion on the line, Modex Therapeutics Inc. will collaborate with Regeneron Pharmaceuticals Inc. to find and develop multispecific antibodies for treating multiple indications.
With a modest $7 million up front but an ultimate payout potentially topping $1 billion on the line, Modex Therapeutics Inc. will collaborate with Regeneron Pharmaceuticals Inc. to find and develop multispecific antibodies for treating multiple indications.
