A series of disappointments that drove Sage Therapeutics Inc.’s stock down by 85% since August of 2023 has evolved into an unsolicited takeout offer by partner Biogen Inc., followed by a lawsuit filed by Sage a week later. The two parties, both of Cambridge, Mass., first partnered in a $1.52 billion deal in 2020, primarily to develop Zurzuvae (zuranolone) for depression. The deal included Biogen taking a 10.2% equity stake in Sage, paying $104.14 per share, or $650 million total.
Shionogi & Co. Ltd. won a $375 million project agreement from the Rapid Response Partnership Vehicle to develop its 3CL protease inhibitor, S-892216, as a long-acting injectable for COVID-19 pre-exposure prophylaxis.
China’s National Medical Products Administration has given the green light to Innovent Biologics, Inc.’s and Jiangsu Aosaikang Pharmaceutical Co. Ltd.’s NDA for third-generation EGFR tyrosine kinase inhibitor limertinib, for treating adults with locally advanced or metastatic EGFR T790M-mutated non-small cell lung cancer.
In the final days of the Biden administration, the U.S. Department of Health and Human Services’ Centers for Medicare and Medicaid Services (CMS) laid out the latest 15 drugs that are subject to negotiated prices, with Novo Nordisk A/S’ GLP-1 drug Ozempic for type 2 diabetes topping the list, bringing Rybelsus and Wegovy along for the ride because they share the same active ingredient, semaglutide.
Immunoforge Co. Ltd.’s approval of an IND by the Korea Ministry of Food and Drug Safety reminded Wall Street – not that anybody needed reminding – about the marketplace jostle among therapies for chronic myeloid leukemia (CML), where a number of drugs are cleared by the U.S. FDA but significant need remains in terms of efficacy as well as tolerability.
Pheno Therapeutics Ltd. has received clinical trial authorization (CTA) from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for its lead candidate, PTD-802. The program will progress to a first-in-human phase I trial.
Yuhan Corp., Oscotec Inc. and Genosco Inc. were three companies with Asian ties to reap benefit from Johnson & Johnson’s stellar top-line Mariposa study results, wherein J&J’s Rybrevant (amivantamab-vmjw) and Lazcluze (lazertinib) combo regimen beat out Astrazeneca plc’s standard of care in non-small-cell lung cancer (NSCLC).
CSPC Pharmaceutical Group Ltd. on Jan. 13 gained the National Medical Products Administration’s approval of Shanzeping (prusogliptin tablets; DBPR-108) as a novel oral dipeptidyl peptidase-IV (DPP-4) inhibitor to treat adult patients with type 2 diabetes.
Day two of the J.P Morgan Healthcare Conference rolled on with positive data from Sling Therapeutics Inc. that is leading the company to a phase III study in treating thyroid eye disease. The privately held company posted top-line efficacy and safety results from a phase IIb/III study of its lead candidate, linsitinib, which hits its primary endpoint with statistical significance at the twice-daily, 150-mg oral dose.
Insilico Medicine Inc. nabbed a potential $550 million-plus deal with Menarini Group’s Stemline Therapeutics Inc. for an unnamed preclinical small-molecule drug targeting solid tumors, adding to a $500 million deal inked by the duo in January 2024.
RSS
