Sept. 27 Quick Takes: Padcev approved in Japan

Padcev enfortumab vedotin from Astellas Pharma Inc. (Tokyo:4503) Astellas and Seagen Inc. (NASDAQ:SGEN) could be the new standard of care for the treatment of radically unresectable urothelial carcinoma in Japan after the country’s Ministry of Health, Labour and Welfare approved it to treat patients who had progressed after chemotherapy. FDA approved Padcev for the same patient population under the accelerated pathway in 2019. Padcev is an antibody-drug conjugate directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer. Astellas and Seagen are co-developing Padcev under a 50:50 worldwide development and commercialization collaboration, although Astellas is responsible for commercialization activities and regulatory filing in Japan. Astellas was recently in the news after a fourth patient died in the company’s ASPIRO gene therapy study earlier this month. 

Shares of Acceleron Pharma Inc. (NASDAQ:XLRN) touched another new all-time high Monday following a Bloomberg report that said an undisclosed suitor is in discussions for a takeout worth $180 per share, or more than $11 billion. One potential buyer, Bristol Myers Squibb Co. (NYSE:BMY), markets Acceleron’s Reblozyl luspatercept-aamt to treat β thalassemia and myelodysplastic syndrome under a deal originally reached with Celgene Corp.; the pharma already owns an 11.5% stake Acceleron via its buyout of Celgene. The biotech’s sotatercept is in Phase III testing to treat pulmonary arterial hypertension. Acceleron mostly traded in the $130s for most of the month before rising abruptly after Sept. 21; it peaked at $182.44 Monday before closing at $177.03. Bloomberg's report was published late Friday...