Jyong Biotech Ltd. filed for an IPO that could raise as much as $40 million to advance a pipeline that includes several prospects for urinary system disorders, including one that has reached the NDA stage in the U.S.
Shenzhen Salubris Pharmaceuticals Co. Ltd. received marketing approval from China’s NMPA for enarodustat as a treatment for anemic patients with chronic kidney disease that are not on dialysis.
Telix Pharmaceuticals Ltd. will acquire Lightpoint Medical Ltd. in a $35 million deal that will expand its urology pipeline and bring in house a new surgery-focused unit. Under the terms of the deal, Telix of Melbourne, Australia, will pay Lightpoint $20 million up front and a further $15 million on achievement of certain development milestones. The up-front payment will be paid in equity, and the additional milestones will be payable in cash or equity, at Telix’s election.
Rona Therapeutics Co. Ltd. and Keymed Biosciences Co. Ltd. formed a collaboration to jointly discover and develop first-in-class siRNA therapeutics for glomerulonephritis, also known as severe kidney diseases.
The U.S. FDA has approved a non-hormonal treatment from Astellas Pharma Inc. to reduce the number and severity of hot flashes. Veozah (fezolinetant), an oral, once-daily compound that targets the neurokinin-3 (NK3) receptor, is approved for treating moderate to severe vasomotor symptoms due to menopause. It’s the first NK3 receptor antagonist the FDA has greenlighted for the indication. The approval came on May 12, well before its May 22 PDUFA date. The PDUFA date was originally set for Feb. 22 but the FDA extended it, saying it needed more time to complete the NDA’s priority review. Veozah’s wholesale acquisition cost is $550 for a month’s supply and should be available by early June.
Alebund Pharmaceuticals Ltd. raised ¥200 million (US$29 million) in a pre-C financing round to support the clinical trials of its candidates for kidney disease. It also secured $800 million through a syndicated bank loan to build a manufacturing facility for small-molecule drugs in the Chinese city of Yangzhou, Jiangsu province, as it lays the groundwork for future commercialization.
Astellas Pharma Inc.’s fezolinetant met all four co-primary endpoints in the pivotal phase III SKYLIGHT 1 study for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. An oral, nonhormonal compound, fezolinetant targets the neurokinin 3 receptor to reduce the frequency and severity of moderate to severe VMS, or hot flashes, due to menopause.
New research presented by the University of Michigan revealed groundbreaking results for Certa Therapeutics Pty Ltd.’s lead candidate, FT-011, for serious inflammatory and fibrotic diseases.
Sumitovant Biopharma Ltd., a subsidiary of Sumitomo Pharma Co. Ltd., agreed to acquire Myovant Sciences Ltd. for $27 per share, up from its earlier offer of $22.75 per share. The deal is worth $1.7 billion on a fully diluted basis, with an equity value of about $2.59 billion.
Melbourne-based Occurx Pty Ltd. announced a AU$16 million (US$11 million) series B round that will progress lead candidate OCX-063 to phase II trials in chronic kidney disease. The capital raise was jointly led by Brandon Biocatalyst and Uniseed and includes a AU$1.5 million grant from Australian biomedical incubator Cureator.
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