Ocugen Inc. (NASDAQ:OCGN) saw its stocks in the red on Black Friday, as the result of a clinical hold placed by the Food and Drug Administation has issued a clinical hold on its hold.
The hold affects Ocugen’s Investigational New Drug application (IND) to evaluate the COVID-19 vaccine candidate, BBV152 (known as Covaxin outside the U.S.). The FDA plans to identify the specific deficiencies that are the basis for clinical hold and information on addressing those deficiencies.
The Company expects to receive formal written communication with the additional information from the FDA and plans to work with the agency to resolve its questions as promptly as possible.
Covaxin is a highly purified and inactivated vaccine that is manufactured using a vero cell manufacturing platform.
With more than 100 million doses having been administered to adults outside the U.S., COVAXIN™ is currently authorized under emergency use in 17 countries, and applications for emergency use authorization are pending in more than 60 other countries.
The World Health Organization (WHO) recently added COVAXIN™ to its list of vaccines authorized for emergency use. And, as many as 110 countries have agreed to mutual recognition of COVID-19 vaccination certificates with India that includes vaccination using COVAXIN™. The trade name COVAXIN has not been evaluated by the FDA.
OCGN shares are down four cents to $7.06 soon after the bell to open an abbreviated session Friday.
