Wall Street’s hoped-for phase III derisking event from Insmed Inc. materialized, and shares of the firm (NASDAQ:INSM) closed Sept. 5 at $26.37, up $3.73, or 16.5%, on positive top-line results from the study called Arise with inhaled Arikayce (amikacin) in patients with newly diagnosed or recurrent nontuberculous mycobacterial lung infection by Mycobacterium avium complex (MAC) who had not started antibiotics. “We crushed it” on culture conversion with Arikayce, CEO William Lewis said. “We could not be happier about the results of this study. It exceeded all of our expectations on every front.” Read More
Star Therapeutics Inc. brought on board six new investors in its oversubscribed $90 million series C round, raising the company’s total funding to more than $190 million since its founding in 2018 to advance in-house drug discovery efforts via formation of portfolio companies. Since emerging from stealth in early 2022, Star has launched two aptly named companies, Electra Therapeutics Inc. and Vega Therapeutics Inc., with plans to unveil additional ventures arising from its antibody discovery efforts. Read More
As a pioneer of harnessing artificial intelligence (AI) to drug discovery, Insilico Medicine Inc. recently made breakaway progress to bring a generative AI-designed drug to life, announcing the progression of its INS018-055 candidate to phase II trials for idiopathic pulmonary fibrosis. Read More
The queue of lawsuits challenging the constitutionality of the U.S. Inflation Reduction Act’s (IRA) prescription drug price negotiations continues to grow. Novartis AG is the latest drug company, but probably not the last, to join the line. It filed its challenge in federal court in New Jersey Sept. 1, a few days after the Centers for Medicare & Medicaid Services included the company’s heart failure drug, Entresto (sacubitril and valsartan), on its list of the 10 drugs subject to the first round of IRA negotiations. Read More
Otsuka Pharmaceutical Co. Ltd. announced plans to acquire Mindset Pharma Inc. for C$80 million (US$50.76 million) in an all-cash deal that will see Otsuka strengthen its neurology and psychiatric pipeline. Mindset, of Toronto, is developing next-generation psychedelic therapeutics to treat psychiatric and neurological disorders with high unmet needs. Read More
Biopharma grants are up nearly 150% compared to the same time period last year, largely due to a number of $100 million-plus grants from the Biomedical Advanced Research and Development Authority (BARDA). Meanwhile, nonprofit deal value has declined year-over-year, with the number of transactions down 42.21%. Read More
New hires and promotions in the biopharma industry, including: Alvotech, Engitix, Eterna, Glyscend, Grifols, Iomx, Ipsen, Pleco, Sernova, Xilio. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acticor, AI, Bavarian Nordic, Carisma, Nuvox, Roche, Tvardi. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Arecor, BMS, Boston Immune, Cadrenal, Centogene, Chr. Hansen, Fuji, Gilead, Goodlife, Invlos, Macrogenics, Merck, Mirum Nestlé, Novozyme, Portgage, Sinovac, Sallergenes Greer, TC, Tetris, Theragenix, Travere, Vistagen, Zenas. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: GSK. Read More
