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. Auvelity builds on one of the market's most common second-generation antidepressants – the aminoketone and CYP450 2D6 inhibitor bupropion – by combining it with the N-methyl-D-aspartate receptor agonist dextromethorphan. It is expected to be commercially available in the U.S. in the fourth quarter of 2022. The New York-based company’s stock (NASDAQ:AXSM) took flight on the news, with shares reaching nearly $60 each, surpassing their previous 52-week high of $48.82.

Jemincare out-licenses prostate cancer drug to Genentech in $650M deal

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.

Menarini chases first-in-class approvals for oral SERD after Sanofi’s woes

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.

Everest lands $455M deal to hand Trodelvy rights in Asia back to Gilead’s Immunomedics

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.

Ryvu planning broad phase II advance for CDK8 inhibitor 

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 (MDS), in low-risk MDS, and in a number of solid-tumor indications.

Private-public tuberculosis collaboration advances two new NCEs to phase II

The Project to Accelerate New Treatments for Tuberculosis is progressing two investigational tuberculosis (TB) combination treatment regimens into phase II trials under a joint development agreement. The collaboration will evaluate whether the regimens, which combine registered products and new chemical entities (NCEs), can effectively treat all forms of active pulmonary TB using much shorter treatment durations than existing drug regimens, with the goal of identifying a regimen suitable for phase III development.

Also in the news

89bio, ABVC, Alnylam, Aim, Arcturus, Astellas, Athersys, Aum, Bavarian Nordic, Biocryst, Bridgebio, Cassava, CG, Clarus, CSL, Curevac, Curis, Eagle, Genentech, Genfleet, Grünenthal, GSK, Havn, ICT, Innovent, Jazz, Jemincare, Junshi, Kymera, Maplight, Nordic Nanovector, Novavax, Odyssey Health, Oncopeptides, PCI, Plus, Tela, Ultimovacs, Valneva, Valo, Vifor