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.
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.
A team of inventors predominantly based in the state of New York are seeking patent protection for an earbud system that integrates real-time electroencephalography (EEG) monitoring with audio playback. Using specialized silicone electrodes, it captures and interprets EEG data, serving as a passive and continuous tool for screening neurological conditions.
Mainline Biosciences (Shanghai) Co. Ltd. has described peptides acting as tachykinin NK1 receptor antagonists reported to be useful for the treatment of pain and opioid dependence.
Bolden Therapeutics Inc. has closed a $1.5 million pre-seed convertible note financing. This financing, together with National Institutes of Health (NIH) small business grants, will support preclinical development of Bolden's antisense oligonucleotides to promote neurogenesis.
Inhibiting the aggregation process of Aβ42 is one of the main objectives in the development of therapies for Alzheimer’s disease, but the heterogeneous nature of the neurotoxic oligomers poses a significant challenge. Researchers from the Universita degli Studi di Firenze presented the preclinical evaluation of DesAb-O, a single-domain antibody targeting Aβ42 oligomers.
Quibim SL recently launched its artificial intelligence (AI)-based software QP-Brain, which is designed to detect early-stage neurodegenerative diseases, after it received U.S. FDA 510(k) clearance, as well as CE and UKCA marks from the EU and U.K. regulators, respectively. QP-Brain quantifies and presents data from patients’ brain images to help clinicians with early diagnosis and treatment strategies for diseases such as Alzheimer’s, multiple sclerosis and dementia.
Solid Biosciences Inc.’s SGT-003 has been granted orphan drug designation by the FDA. The company’s next-generation Duchenne muscular dystrophy gene therapy candidate was also granted fast track designation last month.
RSS
