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Windtree Therapeutics Inc. is out-licensing China rights for phase III-ready heart failure candidate istaroxime to Lee’s Pharmaceutical Ltd. for $138 million, plus royalties. Lee’s, of Hong Kong, plans to begin a phase III study for istaroxime in acute heart failure in greater China, while Windtree, of Warrington, Pa., will conduct a global trial in cardiogenic shock, a form of sudden heart failure. Windtree reported positive phase II data in April 2022 that tested istaroxime in cardiogenic ...

Acurx Pharmaceuticals Inc. continues to post positive data for its lead candidate ibezapolstat but that didn’t stop the stock from tumbling. The antibiotic outperformed vancomycin in a phase IIb study treating Clostridioides difficile infection (CDI). Vancomycin is a standard of care in the indication. Ibezapolstat eradicated fecal CDI at day 3 in 15 of 16 patients compared to vancomycin, which eradicated fecal CDI in 10 of 14 patients.

Allakos Inc. terminated all development of its lead drug, anti-Siglec-8 antibody lirentelimab (AK-002), and is cutting its workforce in half, following phase II failures for atopic dermatitis and chronic spontaneous urticaria. The San Carlos, Calif.-based company will now focus on phase I trials for anti-Siglec-6 antibody AK-006 as part of a restructuring that stretches the runway into mid-2026. Shares (NASDAQ:ALLK) sank by 60.2%, down $1.80, to close at $1.19 on Jan. 16.

Korean confectionary company Orion Holdings Inc. is growing its biotech presence by purchasing a majority stake of 25% in one of the hottest Korean antibody-drug conjugate developers, Legochem Biosciences Inc., although stocks dropped on the news. Under the contract announced Jan. 15, Seoul-headquartered Orion agreed to acquire a 25.73% stake in Daejeon-based Legochem by securing about 9.36 million shares for a total of ₩548.7 billion (US$412.11 million) by the deadline of March 29, 2024.

Six weeks after the U.S. FDA issued an alert, the EMA is following suit and starting a review of the safety of six approved CAR T-cell cancer therapies, following 23 reports of patients developing secondary cancers. The EMA said such malignancies were considered “an important potential risk” at the time of approval and are included in the risk management plan. Close monitoring is in place, with companies required to conduct long-term safety and efficacy follow-up studies and to file safety u...

The US Securities and Exchange Commission (SEC) indicated this summer that it plans to introduce proposals to regulate conflicts of interest associated with artificial intelligence...