China’s drug regulator approved Alpha Biopharma Ltd.’s EGFR tyrosine kinase inhibitor (TKI), Zorifer (zorifertinib hydrochloride tablets; AZD-3759), as a first-line treatment for EGFR-mutated non-small-cell lung cancer (NSCLC) with brain metastases.
Rapt Therapeutics Inc. has decided to shut down its zelnecirnon (RPT-193) program in asthma and atopic dermatitis, causing the company’s stock (NASDAQ:RAPT) to sharply decline Nov. 11.
Wall Street promptly began trying to weigh the compound’s marketplace odds after Merck & Co. Inc. detailed positive data from the phase IIb/III trial known as MK-1654-004 with clesrovimab, an investigational prophylactic monoclonal antibody designed to protect infants from respiratory syncytial virus (RSV) disease during their first RSV season. The results, plus interim findings from the ongoing phase III experiment dubbed MK-1654-007 were offered during IDWeek 2024 in Los Angeles.
Coming off September, which saw five biopharma IPOs raise more than $1 billion, two firms priced upsized offerings that could total more than $330 million.
SK Bioscience Co. Ltd., of Seongnam-si, South Korea, said Oct. 8 that it will acquire a $3 million stake in Fina Biosolutions LLC to become the first and sole strategic investor of the Rockville, Md.-based vaccine specialist. For SK Bioscience, the investment is slated to boost its vaccine R&D capabilities, the company said, which currently includes manufacturing of pneumococcal and typhoid conjugate vaccines.
Cereno Scientific AB’s positive top-line results from the phase IIa trial of histone deacetylase inhibitor CS1 in pulmonary arterial hypertension provide a “clear path forward” in the debilitating, fatal disease, the company said.
The U.S. FDA’s approval of yet another indication for Dupixent (dupilumab), partnered between Regeneron Pharmaceuticals Inc. and Sanofi SA, could mean another $6.4 billion-plus in sales by the end of the decade. Regulators cleared the drug as an add-on maintenance treatment for chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype who are prone to flare-ups. Dupixent, the first-ever biologic for COPD, entered the market in March 2017.
Novartis AG is enlisting the help of Generate:Biomedicines Inc. and its artificial intelligence platform to generate drugs for multiple undisclosed targets. The number of targets and therapeutic areas also weren’t disclosed. Novartis will pick the targets, although the targets Generate has been working on are off limits. Generate will be responsible for creating the lead candidate, at which point Novartis will take over development.
Jacobio Pharmaceuticals Group Co. Ltd. out-licensed rights for two lung cancer assets in China to Shanghai Allist Pharmaceuticals Co. Ltd. through a potential ¥900 million (US$126.4 million) deal. Beijing-headquartered Jacobio said Aug. 30 that it signed off development, regulatory and commercial milestone rights to both glecirasib, a KRAS G12C inhibitor first targeting non-small-cell lung cancer, and a SHP2 inhibitor called JAB-3312.
The U.S. FDA granted approval of Verona Pharma plc’s ensifentrine on its PDUFA date of June 26, giving the chronic obstructive pulmonary disease (COPD) community its first new mechanistic option in a decade. The drug, branded Ohtuvayre, is also the first inhaled nonsteroidal therapy to treat a respiratory disease that combines both a bronchodilator and anti-inflammatory mechanism into one molecule. It is indicated for the maintenance treatment of COPD, which Verona said allows for broad use.
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