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Exelixis Faces FDA Delay & Karyopharm Faces October Deadline
Description
FDA extended its review of Exelixis's zanzalintinib-Tecentriq combination for metastatic colorectal cancer to March 3, 2027, after classifying updated data as a major amendment. Karyopharm missed a $15.8 million loan payment and secured a creditor standstill through October 15 tied partly to its selinexor-ruxolitinib myelofibrosis filing. Roche's Enspryng gained Priority Review in MOGAD; COSCIENS bought oral-film manufacturer Nualtis, and Frazier raised more than $1.1 billion for its Public Fund. Plus, Telix's Pixclara FDA decision remained unverified at our reporting cutoff.
Alex Mercer and Maya Patel host the Daily Roundup for September 11. Get the daily rundown in your inbox — subscribe at https://thepharmacloseout.com.