Bit Bio Ltd. (dba Bit.bio) has disclosed its cell therapy pipeline and a lead cell therapy candidate, bbHEP01, which is targeted to enter the clinic in 2025.
While executives of Durect Corp. plugged “compelling” reduction in mortality from a phase IIb study testing DNMT inhibitor larsucosterol in severe alcohol-associated hepatitis and looked ahead to a potential registrational trial, investors focused on the fact that the study, called Ahfirm, fell short of statistical significance on both primary and secondary endpoints, sending shares (NASDAQ:DRRX) down 79%.
It is well known that mutations in the cystic fibrosis transmembrane regulator (CFTR) gene are causative of cystic fibrosis, a lethal autosomal recessive Mendelian disorder. Several studies have also pointed to an association between CFTR mutations and inflammatory bowel disease (IBD).
F-box/WD repeat-containing protein 7 (FBXW7) is known to regulate the protein stability of key metabolic transcription factors, including the major transcriptional regulator of lipid biosynthesis, SREBP1, the overactivation of which has been previously linked to elevated lipogenesis.
Phathom Pharmaceuticals Inc. will begin marketing Voquezna (vonoprazan) in December, thanks to the Nov. 1 approval by U.S. regulators, who cleared the potassium-competitive acid blocker at 10-mg and 20-mg doses for all grades of erosive gastroesophageal reflux disease (GERD), maintenance of healing of all grades of the condition and relief of associated heartburn.
After a delay caused by the April complete response letter from the U.S. FDA for Eli Lilly and Co.’s Omvoh (mirikizumab-mrkz), regulators cleared the drug for moderately to severely active ulcerative colitis (UC) in adults. Given by infusion (300 mg/15 mL)/injection (100 mg/mL), Omvoh stands as the first and only interleukin (IL)-23p19 antagonist for the treatment of moderately to severely active UC in adults – as well as the pharma giant’s first drug approval in the space.
FL2022-001 Inc. has patented new 17-β-hydroxysteroid dehydrogenase 13 (HSD17B13; 17-β-HSD 13) inhibitors reported to be useful for the treatment of liver fibrosis and nonalcoholic steatohepatitis.
Biologics innovators typically take a lifecycle approach to developing new indications and formulations of their prescription drugs, especially when biosimilar competition is on the horizon.
For a whopping $7.1 billion up front, Roche AG is buying Telavant Holdings Inc., a firm that is owned by Roivant Sciences Ltd. and Pfizer Inc. The deal also includes $150 million on the back end, and Roche gains rights to develop, manufacture and commercialize a fully human monoclonal antibody targeting tumor necrosis factor-like ligand 1A, RVT-3101, for treating inflammatory bowel disease (IBD) and possibly other diseases in the U.S. and Japan. Pfizer retains the rights for the rest of the world.
Abivax SA’s debut on the U.S. market received a somewhat chilly reception Oct. 20, as the firm priced on the low end of its proposed range and ended the first day of trading in the red. But the company managed to pull in about $235.8 million in gross proceeds, the majority of which will support late-stage efforts for obefazimod, an oral candidate with a novel mechanism of action it hopes to advance in the lucrative inflammatory bowel disease space.
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