Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agios, Celltrion, Eli Lilly, Johnson, Praxis.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Cara, Clarity, Catalent, Eli Lilly, Grit, Holoclara, Inceptor, Novo Nordisk, Photys, Structure, Tvardi, Ultimovacs, Zelluna.
AI-powered drug R&D platform firm Oncocross Co. Ltd. is leading the procession of year-end Korea biotech IPOs this week, pricing an offering of about 11.85 million shares on the Korea Exchange at ₩7,300 each for gross proceeds of ₩85.56 billion (US$59.5 million).
Its lead program might have hit a safety snag, but Bioage Labs Inc.’s longevity data platform caught the attention of Novartis AG, which agreed to pay $20 million up front in a collaboration to identify drug targets for aging-related diseases. Taking into account potential long-term research, development and commercial milestones, the agreement could bring in up to an additional $530 million.
Investors will get more details during the International Lewy Body Dementia Conference in Amsterdam late next month, but Wall Street is already buzzing about Cognition Therapeutics Inc.’s data from the phase II study with CT-1812 in dementia with Lewy bodies.
Merck & Co. Inc. has turned to Asia for a second time to get into the GLP-1 market, this time to Shanghai-based Hansoh Pharmaceutical Group Co. Ltd. for its investigational preclinical oral small-molecule GLP-1 receptor agonist. Hansoh is getting $112 million up front and could bring in another $1.9 billion in milestone payments. Merck said the addition to its GLP-1 arsenal is “to provide additional cardiometabolic benefits beyond weight reduction.”
With no time to spare, the U.S. Congress is coming together on a continuing resolution (CR) to keep the federal government running beyond Dec. 20. Intended to fund the government at current levels through March 14, the CR itself is temporary. But of the 1,500-plus pages in the package House leadership released late Dec. 17, only about 100 pages pertain to the actual CR. More than a third of the package is devoted to the health-care sector.