Renalys Pharma Inc. completed a ¥6 billion (US$38.199 million) series A round that will enable it to complete a phase III trial for sparsentan for immunoglobulin A nephropathy (IgAN) in Japan. Tokyo-based Renalys in-licensed rights to sparsentan in January 2024 from Travere Therapeutics Inc. to develop the compound in Japan and 13 Asian countries to treat IgAN, a rare kidney disease.
Tiumbio Co. Ltd., of Seongnam-si, Gyeonggi-do, reported positive phase IIa top-line data on May 8 for Merigolix, its lead asset to reduce pain in female patients with moderate to severe endometriosis.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of Pfizer Inc.’s Emblaveo (aztreonam-avibactam), an antibiotic combination that would offer a new option to patients with serious bacterial infections caused by multidrug-resistant gram-negative bacteria.
Asieris Pharmaceuticals Co. Ltd plans to submit a China NDA in the second quarter following positive phase III data for its cold light photodynamic drug-device combination product, Cevira, which is used as nonsurgical therapy for treating high-grade cervical dysplasia.
Dimerix Ltd. announced a AU$20 million ($US13.22 million) capital raise following the news that its lead candidate, DMX-200, was successful in a prespecified interim analysis of the efficacy endpoint in its pivotal phase III trial in focal segmental glomerulosclerosis, a rare kidney disease.
Otsuka Pharmaceutical Co. Ltd.’s sibeprenlimab (VIS-649) met the primary efficacy endpoint in a phase II trial for treating immunoglobulin A nephropathy (IgAN), demonstrating that 12 months of treatment resulted in significant reductions in proteinuria compared to placebo.
Dimerix Ltd. has out-licensed lead candidate DMX-200 to Advanz Pharma Corp. for focal segmental glomerulosclerosis (FSGS) in a carve-out deal that grants commercialization rights to Advanz in the European Union, the U.K., Switzerland, Canada, Australia and New Zealand.
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.
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