Ocugen Announces That FDA Suspends COVAXIN (BBV152) Evaluation Application

Ocugen is a medical company that focuses on the treatment of blindness through gene therapy. The list of products includes OCU200, intended for the treatment of retinopathy and is under development and research; OCU410, for the treatment of wet AMD; OCU400, designed to restore the retina of the eyes. Moreover, it’s engaged in the marketing of COVAXIN with Bharat Biotech. The worth of OCGN is 8% less than the weekly highest price of $ 8.03 at $ 7.11. At the same time, the company costs $ 1.414B, and the trading volume is $ 8,668.905.

The FDA informed it has temporarily suspended its review of the company’s application that has been filed to evaluate a new drug BBV152 (COVAXIN™) in other countries. The FDA wants to find and resolve the shortcomings that led to the suspension, for which the company plans to work with the FDA. COVAXIN is a vaccine candidate, which feature is using a platform designed to generate Vero cells. It is in the research phase and was developed by Bharat Biotech and ICMR. So, it was approved in nearly 20 countries around the world for use in emergency situations. However, about 60 countries have not yet approved, but are awaiting consideration.