The U.S. FDA accepted, with priority review, Takeda Pharmaceutical Co. Ltd.’s NDA submission for oveporexton (TAK-681), bringing the oral orexin receptor 2 agonist closer to clearance in narcolepsy type 1.
Newco Vesalic Ltd. has formed to take forward research indicating extracellular vesicles secreted by skeletal muscle cells carry toxic payloads that are key drivers of motor neuron diseases, including amyotrophic lateral sclerosis. The discovery of this process, which is largely external to the brain and the central nervous system, has opened up new targeting possibilities, and Vesalic is now working on in vivo studies to demonstrate preclinical proof of concept.
Angelini Pharma SpA and Quiver Bioscience Inc. have entered into a collaboration and licensing agreement to advance novel therapeutics for genetic epilepsies. Under the multiyear collaboration, Angelini Pharma will leverage Quiver’s technology platform to gain deeper understanding of a broad set of developmental and epileptic encephalopathies.
Neurosoft Bioelectronics SA has signed an agreement with Science Corp. to gain access to its full stack of clinical-grade neural recording tools as it looks to advance its brain-computer interface (BCI) system.
Vanda Pharmaceuticals Inc. gained U.S. FDA approval for Bysanti (milsaperidone), cleared for use in acute bipolar I disorder and schizophrenia and ensuring continuation of the firm’s atypical antipsychotic franchise, with Fanapt (iloperidone) set to start losing patent protection in 2027. It also offered a rare straightforward regulatory win for Vanda, which has tussled with the FDA in recent years.
Brise Pharmaceutical (Shanghai) Co. Ltd. has discovered carbocyclic or heterocyclic derivatives acting as transient receptor potential cation channel subfamily M member 3 (TRPM3) antagonists.
Work at Emcure Pharmaceuticals Ltd. and Peptris Technologies has led to the identification of new fused bicyclic heterocyclic derivatives acting as histone deacetylase (HDAC) inhibitors.
Japan is backing conditional approvals of Amchepry (raguneprocel, Sumitomo Pharma Co. Ltd./Racthera Co. Ltd.) and Reheart (Cuorips Inc.), positioning them to become the world’s first induced pluripotent stem cell-derived (iPSC) therapies to receive regulatory clearance.
Lario Therapeutics Ltd. has received a total of $2.4 million in grant funding from The Michael J. Fox Foundation for Parkinson’s Research (MJFF) and Wellcome to support the continued expansion of its neuronal calcium channel drug discovery platform. The funding provides validation of Lario’s work on selective small-molecule inhibitors of voltage-gated neuronal calcium channels.
Shanghai SIMR Biotech Co. Ltd. has prepared and tested new GABA-A receptor subunit α5 (GABRA5) inverse agonists. They are reported to be useful for the treatment of pain, stroke and Alzheimer’s disease.
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