BioCentury
ARTICLE | Clinical News

May 15 Clinical Quick Takes: Principia, Agios, Y-mAbs, Pfizer

May 15, 2019 10:42 PM UTC

Principia gets $30M from Sanofi for Phase IIb MS trial start
Principia Biopharma Inc. (NASDAQ:PRNB) said partner Sanofi (Euronext:SAN; NASDAQ:SNY) began a Phase IIb trial of SAR442168 to treat relapsing multiple sclerosis, triggering a $30 million milestone payment to Principia. Sanofi has exclusive, worldwide rights to the covalent Btk inhibitor from Principia under a 2017 deal.

Agios planning sNDA for Tibsovo in cholangiocarcinoma
Agios Pharmaceuticals Inc. (NASDAQ:AGIO) said late Wednesday that it plans to submit an sNDA to FDA by year end for Tibsovo ivosidenib to treat previously treated IDH1 mutant cholangiocarcinoma after the drug met the primary endpoint of improving progression-free survival (PFS) vs. placebo in the Phase III ClarIDHy trial. Tibsovo is approved to treat acute myelogenous leukemia (AML) with a susceptible IDH1 mutation. Agios gained $6.65 (14%) to $54 in after-hours trading Wednesday...