Hopes raised by the phase IIb Harmony study with FGF21 analogue efruxifermin (EFX) in pre-cirrhotic nonalcoholic steatohepatitis (NASH), which appeared in a scientific journal last week, were less than fulfilled as Akero Therapeutics Inc. rolled out disappointing 36-week results from another, same-stage trial called Symmetry in NASH patients with cirrhosis. The company is forging ahead with U.S. FDA talks to figure out how a phase III effort might be designed.
Teva Pharmaceutical Industries Ltd. is partnering with Sanofi SA in a 50-50 collaboration to develop and commercialize its anti-TL1A candidate, TEV ‘574, initially for inflammatory bowel disease (IBD), in a deal that comes with an up-front payment of €469 million (US$500 million) and up to €940 million in development and launch milestones.
Three months after Intercept Pharmaceuticals Inc. received its second complete response letter for obeticholic acid to treat fibrosis due to nonalcoholic steatohepatitis, causing a mass layoff and the decision to drop development for the indication, Bologna, Italy-based Alfasigma SpA agreed to acquire the company for $19 per share in cash, or about $793.8 million.
Inventiva SA is getting $10 million up front and the possibility of $231 in clinical, regulatory and commercial milestones by exclusively licensing its nonalcoholic steatohepatitis (NASH) candidate, lanifibranor, to Hepalys Pharma Inc. to sell in Japan and South Korea, two massive markets for the indication.
Positive phase III data from Cymabay Therapeutics Inc. with seladelpar, the peroxisome proliferator-activated receptor for primary biliary cholangitis (PBC), could mean trouble for Intercept Pharmaceuticals Inc.’s second-line therapy, the farnesoid X receptor agonist Ocaliva (obeticholic acid), which Cymabay aims to replace with its compound as the preferred choice.
Phathom Pharmaceuticals Inc. made recent headway with its new mechanism of action in gastroesophageal reflux disease (GERD) even as further, disturbing discoveries in the space are seeing daylight. Florham Park, N.J.-based Phathom turned over to the U.S. FDA the requested six-month stability data related to reformulated vonoprazan tablets, and the numbers remained consistent with three-month data, reflecting N-nitroso-vonoprazan nitrosamine control and levels comfortably more than tenfold below the acceptable daily intake limit.
Terns Pharmaceuticals Inc.’s unveiled positive top-line data from the phase IIa Duet study testing TERN-501, an oral thyroid hormone receptor-beta (THR-B) agonist, given as a monotherapy or in combination with TERN-101, a liver-distributed farnesoid X receptor agonist, for the treatment of nonalcoholic steatohepatitis (NASH).
With a phase II failure, Palisade Bio Inc. has decided to halt development into one of two indications for its only asset, LB-1148. The oral formulation of a broad-spectrum serine protease inhibitor missed the primary endpoint in the Profile study of reducing intra-abdominal adhesions after bowel resection. Palisade said the safety data and efficacy results no longer support further development of LB-1148 in the indication.
Celloram Inc., the U.S. subsidiary of the Seoul, South Korea-based Medpacto Inc., signed a €160 million (US$175.88 million) licensing deal with Genfit SA to develop Celloram’s inflammasome inhibitor, CLM-022, for liver disease.
Dealmaking proved alive and well, with Sangamo Biosciences Inc. disclosing a tie-up worth as much as $1.19 billion with a subsidiary of Eli Lilly and Co., while Mirum Pharmaceuticals Inc. pledged to acquire for $445 million the bile-acid product portfolio owned by Travere Therapeutics Inc.
RSS
