Nov. 2 Quick Takes: EMA reviewing filgotinib and DBV’s peanut allergy therapy; plus Royalty Pharma-CF Foundation, CARSgen, Karyopharm, Aurinia, Regeneron and Astellas
EMA reviewing filgotinib for ulcerative colitis
Gilead Sciences Inc. (NASDAQ:GILD) and Galapagos N.V. (Euronext:GLPG; NASDAQ:GLPG) said EMA is reviewing its MAA for Jyseleca filgotinib to treat ulcerative colitis. The partners are seeking the JAK inhibitor’s approval based on the Phase IIb/III SELECTION study, in which the therapy significantly improved remission rates vs. placebo.
EMA reviewing DBV’s peanut allergy patch
Shares of DBV Technologies S.A. (Euronext:DBV; NASDAQ:DBVT) rose 23% to $1.76 on NASDAQ Monday after the company said EMA is reviewing its MAA for Viaskin Peanut (DBV-712), an epicutaneous patch to treat peanut allergies in children ages 4-11. In August, the company received a complete response letter from FDA requesting patch modifications, a new human factor study and additional CMC data...