Orion Corp. has secured exclusive global rights, outside China, to a non-opioid pain drug candidate from Jiangxi Jemincare Group Co. Ltd. The deal, for oral sodium channel inhibitor JMKX-000623, brought Jemincare €15 million (US$15.6 million) up front.
IPOs continue to be sluggish but two companies, Pepgen Inc. and Bausch & Lomb Corp., that began trading May 6 managed to sidestep the turbulence despite having to lower their expectations before the market opened.
A quartet of companies on May 2 announced three complete response letters (CRLs) that left them scrambling to get back on the path to approval. Hutchmed Ltd.'s surufatinib met with word from the U.S. FDA that two positive phase III studies in China and a bridging study in the U.S. would not support approval of the drug for pancreatic and extra-pancreatic neuroendocrine tumors. A multi-regional clinical trial in the U.S. is needed, the regulator said, brushing aside China-only studies when seeking a U.S. approval.
Ashvattha Therapeutics Inc. secured $69 million in a series B financing that it said will strengthen its ability to develop hydroxyl dendrimer-based medicines and accelerate efforts to advance its candidates to the clinic.
After failing to meet primary safety and efficacy endpoints in a phase I/II trial for stroke, Teijin Ltd. and JCR Pharmaceuticals Co. Ltd. have terminated a co-development and Japan licensing agreement to develop JTR-161, an allogeneic regenerative candidate containing dental pulp stem cells.
SK Biopharmaceuticals Co. Ltd.'s three-pronged plan for tackling epilepsy is going strong, with lead drug cenobamate for drug-resistant focal-onset seizures nearing the finish line, and earlier-stage programs for a mRNA-based approach and a digital therapeutic in the works.
Regenerative medicine company Sanbio Co. Ltd. submitted its BLA for its lead mesenchymal stem cell-based treatment, SB-623, to Japan’s Ministry of Health, Labour and Welfare for chronic motor deficit due to traumatic brain injury. The application was submitted through Japan’s Sakigake designation system.
A new study from researchers at Aevisbio Inc. and the National Institutes of Health on the effect of 3,6’-dithiopomalidomide on neuroinflammation adds new detail to what might one day become a significant new therapeutic strategy to treat Alzheimer's disease and other neurological disorders.
Biorchestra Co. Ltd. has raised ₩54 billion ($45.1 million) in its latest series C fundraising, which will boost the development of the company’s lead RNA-based candidate for treating neurodegenerative diseases.