There have been no signs of liver damage with Novartis AG’s oral Bruton’s tyrosine kinase (BTK) inhibitor remibrutinib for treating chronic spontaneous urticaria, top-line results from two phase III trials show, suggesting that faith in the faltering BTK space could be restored. Read More
Six years of collaboration is ending in a buyout, as Decibel Therapeutics Inc. agreed to be acquired by Regeneron Pharmaceuticals Inc. in a deal valued at up to $213 million, including $109 million in equity, with additional payments via contingent value rights linked to clinical and regulatory milestones for DB-OTO, the lead gene therapy program targeting hearing loss. Read More
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. Read More
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). Read More
Alltrna Inc. raised $109 million in a series B round to back its work with transfer RNA, with the first targeted indication of stop codon disease: a condition that takes in thousands of rare and common afflictions stemming from nonsense mutations where the amino acid code has been mutated into a “stop” codon, also known as a premature termination codon. Read More
Novavax Inc. has signed off 6.5 million shares to SK Bioscience Co. Ltd. for an $85 million equity investment from the South Korean pharmaceutical firm, which also wrote off some of Novavax’s manufacturing liabilities, as part of their continuing vaccine alliance. Seongnam-si, South Korea-based SK Bioscience purchased Novavax shares at $13 each, reflecting a 59% premium over the 90-day trading value, to gain a 6.45% stake in the Gaithersburg, Md.-based mRNA vaccine company, an SK Bioscience spokesperson confirmed to BioWorld. Read More
Emerging from stealth mode, new immuno-oncology company Dotbio Pte. Ltd. closed an oversubscribed $5.6 million pre-series A round to accelerate development of its multifunctional and intracellular antibody therapies. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aim, Algernon, Bioxytran, Bright Minds, Cocrystal, Halia, Lexicon, Maia, Meissa, Monopar, Nasus, Nervgen, Novo Nordisk, Oculis, Palatin, Praxis, Telix, Urogen, Viracta. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Baxter, Celmatix, Dice, Eli Lilly, Gilead, Precigen, Resolutionrx, Respirerx, Salarius, Stealth, Takeda. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aleta, Aspen, Biophytis, Lisata, Novartis, NS, Puma. Read More
