A year from the U.S. FDA’s August 2021 citation of deficiencies in the labeling for Axsome Therapeutics Inc.’s major depressive disorder therapy, Auvelity (dextromethorphan + bupropion), the agency has approved the drug for use by adults. The New York-based company’s stock (NASDAQ:AXSM) took flight on the news, with shares rising 40% to close at $59.55 Aug. 19, surpassing their previous 52-week high of $48.82 and starkly contrasting with a same-period low of $19.38. Read More
A subsidiary of Jiangxi Jemincare Group Co. Ltd. has out-licensed global rights to its androgen receptor degrader JMKX-002992 to Roche Holding AG and its subsidiary Genentech Inc. in a deal worth up to $650 million. Shanghai Jemincare Pharmaceutical Co. Ltd. will receive $60 million up front and is eligible to collect up to $590 million for achieving development, regulatory and sales-based milestone targets. Read More
The race to develop an oral selective estrogen receptor degrader (SERD) is under fresh scrutiny in light of Sanofi SA’s decision to axe development of its late-stage compound amcenestrant on Aug. 17, citing lack of efficacy in breast cancer trials. While there are concerns about the new class after Sanofi’s decision, a clear signal about its future could be growing nearer. The driver? Menarini Group and its development partner, Radius Health Inc., are advancing elacestrant, an oral SERD into regulatory reviews on both sides of the Atlantic. Read More
Everest Medicines Ltd. has inked an agreement with Gilead Sciences Inc. to pass the latter’s subsidiary, Immunomedics Inc., exclusive rights to develop and commercialize Trodelvy (sacituzumab govitecan) in greater China, Singapore, Indonesia, Philippines, Vietnam, Thailand, Malaysia and Mongolia. Everest stands to receive up to $455 million in total consideration, including $280 million up front and up to $175 million in potential milestone payments. Read More
Ryvu Therapeutics SA aims to move its lead drug candidate RVU-120 into three phase III trials in the first half of next year, to evaluate its potential in acute myeloid leukemia and high-risk myelodysplastic syndrome, in low-risk MDS, and in a number of solid-tumor indications. Read More
The Project to Accelerate New Treatments for Tuberculosis is progressing two investigational tuberculosis combination treatment regimens into phase II trials under a joint development agreement. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 89bio, Aim, Arcturus, Bridgebio, CG, CSL Behring, Grunenthal, Innovative Cellular, Innovent, Jazz, Maplight, Odyssey, Ultimovacs, Valohealth. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ABVC, Astellas, Aum, Biocryst, Curis, Genfleet, Junshi, Novavax, Oncopeptides, Otsuka. Read More
