Oragenics: FDA 'agrees' with company's COVID-19 vaccine development approach

Oragenics

06/10/2020 13:11

** Drug developer's shares  OGEN.A  rise 22% to $0.72
premarket
    ** Company says timelines for filing an investigational new
drug (IND) application and commencement of an early-stage study
for its SARS-CoV-2 vaccine, Terra CoV-2, will proceed as
scheduled  urn:newsml:reuters.com:*:nBw6nKy9Wa
    ** Decision follows meeting with U.S. FDA, where the health
agency "broadly agreed" with company's clinical development
approach
    ** OGEN expects to file IND by Q1 end, 2021 and commence
patient enrollment in Q2, 2021
    ** Stock up 13% this year, as of last close

 (Reporting By Mrinalika Roy in Bengaluru)
 ((mrinalika.roy@thomsonreuters.com; within U.S. +1 646 223
8780, outside U.S. +91 806749 8325))