BioCentury
ARTICLE | Company News

June 27 Company Quick Takes: Zogenix soars; plus Gardasil, Darzalex, Soliris and more

June 28, 2019 1:12 AM UTC

Zogenix shares surge after agreement to resubmit Fintepla NDA
Zogenix Inc. (NASDAQ:ZGNX) closed up $8.24 (21%) to $47.65 on Thursday after the company announced it had reached an agreement with FDA to resubmit its NDA for Fintepla fenfluramine for seizures associated with Dravet syndrome next quarter. The agency issued Zogenix a refusal-to-file letter in April for the application. Separately, the FDA rescinded Breakthrough Therapy Designation for Fintepla because there are two approved therapies for the indication.

CDC committee backs broader Gardasil 9 use
Merck & Co. Inc. (NYSE:MRK) said the CDC Advisory Committee on Immunization Practices voted to expand recommendation of HPV vaccine Gardasil 9 to include individuals ages 13-26 who have not previously been vaccinated and to allow individuals ages 27-45 and their healthcare providers to decide on vaccination...