Shares of Athersys Inc. fell sharply May 20 after its partner and top investor Healios K.K. reported that Multistem (invimestrocel), the experimental cell therapy they've co-developed since 2016, missed the primary endpoint of a Japanese phase II/III ischemic stroke study called Treasure.
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. In addition, Orion could pay the Chinese company development, commercialization, and sales milestones that Orion suggested could be “significant,” as well as tiered royalties of 8% to 15% based on future sales.
Not long ago, people who touted the prospects of psychedelic drugs might have been accused of hallucinating, but in the U.S. and elsewhere the space has expanded in recent years, as mental health treatments remain “stuck where cancer was 50 years ago,” said Roth analyst Elemer Piros.
Pfizer Inc. is taking over Biohaven Pharmaceutical Holding Co. Ltd. for $11.6 billion to bring aboard Nurtec ODT (rimegepant), the calcitonin gene-related peptide (CGRP) receptor antagonist first approved in February 2020 for acute migraine in adults with or without aura.
Aspen Neuroscience Inc. has closed a series B financing of $147.5 million. The funds will help get its autologous neuron replacement candidate into a phase I/IIa study for Parkinson’s disease. Privately held Aspen has been talking about initiating the phase I/IIa clinical trial since at least 2019. But in April 2022, it came a lot closer to reality. That’s when the company launched its first patient screening studies at several sites in the U.S. Now, the trial-ready cohort study is designed to screen potential participants for the study.
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. Pepgen stock (NASDAQ:PEPG) closed at $12.89 per share May 6, up 7.4% on the day. Bausch & Lomb also had a solid IPO launch May 6 as shares (NYSE:BLCO) closed 11.1% upward at $20 each.
Little more than a month after selling a narcolepsy drug from its portfolio, Jazz Pharmaceuticals plc has replaced it with another. The company entered an exclusive development and commercialization rights agreement Sumitomo Pharma Co. Ltd.’s candidate for treating narcolepsy along with idiopathic hypersomnia and other sleep disorders. Sumitomo retains the rights for Japan, China and certain other Asia-Pacific countries and regions while Jazz gets the rights to everywhere else.
The flop that is Aduhelm (aducanumab) made itself felt in Biogen Inc.’s executive suite as CEO Michael Vounatsos is leaving the company. He had the job for five and a half years and for less than a year after the controversial Alzheimer’s treatment was approved. He will stick around until a successor is found.
The U.S. Centers for Medicare & Medicaid Services’ (CMS) decision last month restricting coverage of a class of Alzheimer’s drugs to clinical trials meeting the agency’s standards still isn’t sitting well with some lawmakers.
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.
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