The U.S. FDA’s accelerated approval of Vanrafia (atrasentan) from Novartis AG for primary immunoglobulin A nephropathy (IgAN) is the company’s second approval for the indication in the past year and a half. The nod also came without a required safety program through a black box warning.
Ushering in a new class of antibiotics, the U.S. FDA approved GSK plc’s gepotidacin for use in uncomplicated urinary tract infections. Branded Blujepa, the oral triazaacenaphthylene bacterial topoisomerase inhibitor is indicated for treating female adults and adolescents, 12 and older.
Retinoic acid receptor alpha (RARα) is a nuclear receptor with a central role in spermatogenesis. Genetic knockout studies in mice have shown that the lack of RARα leads to a complete absence of sperm production without affecting overall health, suggesting that targeted inhibition of RARα may constitute a feasible strategy for male contraception.
With Gilead Sciences Inc. stepping away from its exclusive option rights to casdatifan in treating cancer, Arcus Biosciences Inc. has decided to move on by pricing a $150 million common stock offering. Arcus said Gilead’s rights to the HIF-2a inhibitor, which just produced positive early phase data, had expired.
A week after the first IPO of the year was priced, obesity treatment developer Metsera Inc. and renal specialist Maze Therapeutics Inc. have begun trading on Nasdaq. Metsera (NASDAQ:MTSR) surged 47% on Jan. 31 to close at $26.50 per share while Maze (NASDAQ:MAZE) barely budged, closing three-tenths of a percentage point lower on the day.
Newco Linkgevity Ltd. has won backing from the KQ Labs accelerator program at the Francis Crick Institute in London, enabling it to take forward the lead program, an anti-necrotic drug for treating acute kidney injury, and to further develop its AI-driven system for identifying aging-related therapeutic targets. Alongside access to the Crick’s expertise in translational research and in shaping academic science to make it investible, companies joining KQ Labs receive an equity investment.
Newco Linkgevity Ltd. has won backing from the KQ Labs accelerator program at the Francis Crick Institute in London, enabling it to take forward the lead program, an anti-necrotic drug for treating acute kidney injury, and to further develop its AI-driven system for identifying aging-related therapeutic targets.
A paracrine hormone of skeletal muscle acts as an endocrine signal for the synthesis of a sex hormone. Scientists at McGill University have observed in mice how myostatin, which inhibits the development of muscle mass to control its growth, also stimulated the production of the pituitary follicle-stimulating hormone (FSH), modulating ovarian function. The hypothalamus-pituitary-gonadal axis could include an additional element through a yet unknown role in muscles.
Wall Street wasn’t jumping up and down about Repare Therapeutics Inc.’s early data in gynecological cancers, though the findings look positive and the company has big plans for the combo therapy.
Among the drug developers with clinical results featured at the annual meeting of the Society for Urologic Oncology (SUO) in Dallas were Protara Therapeutics Inc. with phase II numbers and CG Oncology Inc. with a phase III update. Protara’s shares (NASDAQ:TARA) closed Dec. 5 at $6.02, up $2.48, or 70%, having traded as high as $10.48 during the day. Less reactive was stock in CG (NASDAQ:CGON), which ended at $33.56, down $2.35.
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