BioCentury
ARTICLE | Company News

Jan. 28 Company Quick Takes: Kite, Alkermes, Regeneron- Sanofi, Incyte, NantHealth-NantOmics, Sorrento, MicroCures, Paion-Mundipharma

January 29, 2020 12:47 AM UTC

Kite’s KTE-X19 under review in Europe
EMA has accepted an MAA for KTE-X19 from Kite, positioning the CAR T cell therapy from the Gilead Sciences Inc. (NASDAQ:GILD) unit to become the first CAR T cell therapy approved for mantle cell lymphoma in Europe. It is already under review by FDA.
Alkermes’ ALKS 3831 under FDA review
FDA accepted for review an NDA for ALKS 3831 from Alkermes plc (NASDAQ:ALKS) to treat schizophrenia and bipolar I disorder, giving it a Nov. 15 PDUFA date. The oral combination of the antipsychotic olanzapine and the MOR antagonist samidorphan is designed to avoid olanzapine-associated weight gain.

Priority Review for Dupixent in new setting
FDA has accepted an sBLA and granted Priority Review to Dupixent dupilumab from Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and Sanofi (Euronext:SAN; NASDAQ:SNY) for moderate-to-severe atopic dermatitis in children aged 6 to 11 years for whom topical therapies do not adequately control disease. The mAb against IL-4R has breakthrough designation for children with severe atopic dermatitis. The PDUFA date is May 26. ...