A phase III study of Sage Therapeutics Inc.’s zuranolone in major depressive disorder hit not only its primary endpoint but also its key secondary endpoint. Despite that, the Cambridge, Mass.-based company’s share value (NASDAQ:SAGE) closed 17.4% lower Feb. 16, at $35.91 each.
LONDON – Curve Therapeutics Ltd. has gone straight from £4.5 million (US$6.1 million) in startup funding to signing a $1.7 billion drug discovery agreement with Merck & Co. Inc. The deal will see Curve apply its mammalian cell discovery technology to five oncology and neuroscience targets nominated by Merck.
Kallyope Inc., a company leveraging connections between the gut and brain to develop new medicines for diabetes, obesity and other diseases, has raised $236 million in series D financing to support its work. Readouts of early clinical data for its most advanced programs, phase I small molecules for metabolic disease and gut barrier conditions, will start to arrive later this year, company CEO and President Jay Galeota told BioWorld.
Collegium Pharmaceutical Inc. said it plans to acquire all outstanding shares of Biodelivery Sciences International Inc. for $5.60 each, putting the price tag at about $604 million. At the heart of the deal are Biodelivery Sciences' Belbuca (buprenorphine buccal film), a schedule III opioid, and Elyxyb (celecoxib), an oral migraine treatment that gives Collegium a foothold into the neurology market.
Arkuda Therapeutics Inc., a company targeting lysosomal dysfunction to address neurodegeneration, has completed a $64 million series B financing co-led by Cormorant Asset Management and Pivotal Bioventure Partners. The funds will help advance its lead program, a small-molecule progranulin enhancer for frontotemporal dementia in people with an autosomal dominant mutation in the GRN gene, which codes for the protein.
Bionomics Ltd.’s U.S. debut last December, when the firm raised about $23 million through the sale of American depositary shares, called new attention to the Australian firm and its prospects in social anxiety disorder (SAD) and post-traumatic stress disorder (PTSD).
In one of its familiar U-turns, the U.K. National Institute for Health and Care Excellence (NICE) has recommended NHS England should fund a rare disease gene therapy from Orchard Therapeutics plc, considered to be the world’s most expensive drug. The list price for Libmeldy (atidarsagene autotemcel) in England and Wales is £2,875,000 (US$3.9 million), making it the most expensive drug that NICE has ever evaluated.
Sio Gene Therapies Inc. is retrenching the business as it terminated the company’s AXO-Lenti-PD license agreement with Oxford Biomedica plc for treating Parkinson’s disease. Also, Sio’s CEO, Pavan Cheruvu, is leaving the company. Sio said it is deprioritizing its Parkinson’s disease program due to several factors, including resource requirements and development timelines “to reach meaningful value inflection for the program and an increasingly challenging market and regulatory environment” for the indication.
Anavex Life Sciences Corp. reported top-line data from the 33-subject phase III study with Anavex 2-73 (blarcamesine) in adult females with Rett syndrome, turning up a statistically significant improvement over placebo for the primary efficacy endpoint as well as for all the secondary efficacy endpoints. The sigma-1 receptor activator, given as a once-daily, oral liquid, proved well-tolerated, too, with good compliance by patients, Anavex said.
While comments continue to pour in, both in opposition and support, regarding the U.S. Centers for Medicare & Medicaid Services’ (CMS) proposed national coverage decision that would restrict Medicare coverage of monoclonal antibodies intended to treat Alzheimer’s to those used in CMS- or NIH-approved clinical trials, some groups also are appealing to Health and Human Services (HHS) Secretary Xavier Becerra to step into an HHS agency turf war.
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