The U.S. FDA issued a complete response letter to Shin Nippon Biomedical Laboratories Ltd.’s U.S. subsidiary, Satsuma Pharmaceuticals Inc., for its NDA for dihydroergotamine nasal powder (STS-101) for acute treatment of migraine, with or without aura, in adults. Shin Nippon acquired Satsuma for $220 million in April 2023 and gained rights to STS-101.
Dana-Farber Cancer Institute Inc. has identified proteolysis targeting chimera (PROTAC) compounds comprising a Von Hippel-Lindau disease tumor suppressor (VHL) ligase binding moiety covalently bonded to a histone deacetylase (HDAC) targeting moiety through a linker.
The Kv1.1 potassium channel regulates neuronal excitability both in the central and peripheral nervous systems and its dysfunction is associated with epilepsy, among others.
Vesper Bio ApS has been awarded a grant worth $873,000 by The Michael J. Fox Foundation for Parkinson’s Research (MJFF) to assess sortilin inhibition in Parkinson’s disease.
Axonis Therapeutics Inc. has disclosed dual specificity mitogen-activated protein kinase kinase (MAP2K7; MKK7) inhibitors reported to be useful for the treatment of amyotrophic lateral sclerosis, spinal cord injury, multiple sclerosis, neurodegeneration, lysosomal storage, Parkinson’s disease, Huntington’s disease and Alzheimer’s disease, among others.
Promis Neurosciences Inc. has selected a lead vaccine candidate, PMN-400, against synucleinopathies, including multiple system atrophy, Parkinson’s disease and Lewy body dementia.
Synendos Therapeutics AG has received approval from the European Medicines Agency (EMA) to initiate a first-in-human trial of its lead asset, SYT-510, a first-in-class inhibitor that modulates a newly identified drug target in the endocannabinoid system (ECS) to restore healthy brain physiology.
Stalicla SA announced the first close of a series B round at $17.4 million, which provides the means to complete preparations for both a phase III trial of the lead program, STP-7, in the treatment of cocaine misuse disorder, and of a phase II trial of STP-1 in autism spectrum disorder (ASD).
After the U.S. FDA granted clearance in March 2023, sales began promptly of Acadia Pharmaceuticals Inc.’s new Rett syndrome therapy, Daybue (trofinetide), and questions during the recent J.P. Morgan Healthcare Conference in San Francisco had to do with – among other matters – sales guidance from the firm, which is hardly alone in seeking treatments for the disease. Other players include Anavex Life Sciences Corp., Neurogene Inc. and Taysha Gene Therapies Inc.
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