What a difference 60 weeks can make. That’s the lesson Akero Therapeutics Inc. shared with the rollout of what executives called “unprecedented” data from the phase IIb Symmetry trial testing efruxifermin (EFX), its FGF21 receptor agonist, in patients with compensated cirrhosis due to metabolic dysfunction-associated steatohepatitis (MASH). While earlier findings had shown only a trend in improvement at 36 weeks, full 96-week results showed more than doubling of earlier effect size, hitting the primary endpoint and sending shares of Akero (NASDAQ:AKRO) up 97% to close Jan. 27 at $51.71. Read More
Positive data for Veru Inc.’s enobosarm lend more weight to the potential progress of the company’s body-mass preservation program in patients taking Wegovy (semaglutide). The side effect of lean mass loss has dogged those taking GLP-1s. The study results didn’t support the company’s stock on the day of the data release as it had the previous four weeks. Read More
Inflammatory diseases specialist AB2 Bio Ltd. has signed a potential $686 million U.S. commercialization deal for its interleukin-18 neutralizing drug tadekinig. The agreement with Japanese pharma company Nippon Shinyaku Co. Ltd. includes an initial payment of $6 million, with a further $30 million due later this year. Read More
In another cautionary tale of kicking all the tires before an acquisition, Pfizer Inc. agreed to a nearly $60 million settlement to resolve a whistleblower’s claims that Biohaven Pharmaceutical Holding Co. Ltd. was paying kickbacks to induce prescriptions of its migraine drug ahead of Pfizer’s $11.6 billion acquisition of the company in October 2022. Read More
The liver and pancreas are the main actors in glucose metabolism, but not the only ones. Muscles, adipose tissue and the brain play different roles. However, the prize for the best new actor in glucagon production goes to the innate lymphoid cells (ILCs), which, according to a study published in Science, respond to intestine neuron signals traveling to the pancreas to control glucose. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: CG Pharmaceuticals, Eisai, Exuma, Merck, Neuvivo, Novo Nordisk, Page, Rakuten, Vedanta. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abyssinia, Astrazeneca, Cordance, Moderna, Purdue. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Clarity, X4. Read More
