The priority BLA from Otsuka Pharmaceutical Co. Ltd., of Tokyo, and its U.S. subsidiary, Otsuka Pharmaceutical Development & Commercialization Inc., for sibeprenlimab to treat immunoglobulin A nephropathy (IgAN) has received accelerated approved by the U.S. FDA.
Laekna Inc. outlicensed select rights to LAE-002 (afuresertib), an oral pan-AKT kinase inhibitor licensed from Novartis AG in 2018, to Qilu Pharmaceutical Co. Ltd. under a potential ¥2.045 billion (US$287.23 million) deal.
The recombinant fusion protein drug telitacicept from Remegen Co. Ltd. and Vor Bio Inc. has notched a phase III win in treating adults with IgA nephropathy. The clinical trial of the fusion protein hit the primary endpoint, reducing proteinuria, too much protein in patients’ urine, in stage A of the study in China.
Suzhou, China-based Kintor Pharmaceutical Ltd.’s KX-826 met the primary endpoint in a phase II trial for treating male adult androgenetic alopecia (AGA). Kintor is developing KX-826 (pyrilutamide), an androgen receptor inhibitor, for topical treatment of AGA as well as acne vulgaris.
Jyong Biotech Ltd. raised $20 million from its Nasdaq debut June 17 to advance a pipeline of botanical drugs targeting male urinary disorders. The New Taipei City, Taiwan-headquartered company’s shares began trading under the ticker MENS, and closed at $10.11 apiece at the bell, up 34.80% from its listing price of $7.50 per share. Shares had kicked up to $15 at opening, reaching double its offering price.
Hope Medicine Inc. reported positive interim results for monoclonal antibody HMI-115 in a phase II endometriosis trial that saw the mean non-menstrual pelvic pain score reduced by 50%. “HMI-115 is a prolactin receptor blocker, and we're using it to treat endometriosis and some other diseases. It is a first-in-class new mechanism to treat endometriosis,” Hope Medicine CEO Nathan Chen told BioWorld.
According to World Health Organization data, endometriosis affects about 10% of reproductive-age females globally. That already makes endometriosis a wildly underresearched and underfunded disease in relation to its prevalence. Plus, Rama Kommagani thinks even 10% is an underestimation.
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.
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