Aug. 19 Company Quick Takes: PharmaMar gets bump on FDA timeline in SCLC; plus Shionogi, Vanda and Moderna

PharmaMar seeking accelerated approval of SCLC candidate

PharmaMar S.A. (Madrid:PHM) climbed €0.46 (29%) to €2.06 after the company said that based on the results of dialogue with FDA, it will submit an NDA next quarter seeking accelerated approval of Zepsyre lurbinectedin to treat small cell lung cancer. Data presented in June at the American Society of Clinical Oncology (ASCO) meeting showed that the DNA transcription inhibitor, which targets RNA polymerase II (Pol II) in its active state, led to an ORR of 35.2% in the SCLC cohort of a Phase II basket trial among patients who received one prior chemotherapy (see "ASCO Quick Takes")...