Shares in biopharma Immunomedics (IMMU) soared 29% in Wednesday’s after-market trading following an early FDA approval for Trodelvy (sacituzumab govitecan) in triple-negative breast cancer. The drug is approved for patients who have already received two other lines of therapy for metastatic disease.The decision had been expected on the PDUFA date of June 2nd, so the announcement took investors and analysts by surprise.Previously, in January 2019, IMMU received a CRL (complete response letter) from the FDA on its first filing attempt seeking accelerated approval for the drug.“The issues related to approvability in the CRL were exclusively focused on Chemistry, Manufacturing and …read more
Source:: Yahoo Finance
