April 22 Quick Takes: Accelerated approval for Immunomedics’ Trodelvy; plus BioNTech-Pfizer, AskBio, Astellas, Merck KGaA, oNKo-Gilead, Myovant, Afyx and Sangam

Immunomedics’ Trodelvy approved for TNBC
FDA granted accelerated approval to Trodelvy sacituzumab govitecan from Immunomedics Inc. (NASDAQ:IMMU) for adult metastatic triple-negative breast cancer patients in the third-line setting. Immunomedics said continued approval of the TROP2-targeting antibody-drug conjugate (ADC) is contingent on verification of clinical benefit in the Phase III ASCENT study. Top-line data for the trial, which was stopped this month due to “compelling efficacy,” are due midyear (see “Immunomedics Doubles in Value on Phase III Update”).

BioNTech, Pfizer COVID-19 vaccine enters clinic
Shares of BioNTech SE (NASDAQ:BNTX) rose $11.24 (27%) to $53.50 Wednesday after Germany’s Paul-Ehrlich-Institut approved a Phase I/II trial of the four COVID-19 vaccine candidates comprising the BNT162 program. BioNTech and Pfizer Inc. (NYSE:PFE) expect to gain FDA’s permission to run a clinical trial of the lipid nanoparticle mRNA vaccines soon...