Ocugen Shares Fall After Its Pivotal COVID-19 Vaccine Trial Put On FDA Hold

The FDA has issued a clinical hold on Ocugen Inc'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.
• BBV152 is an investigational vaccine candidate product in the U.S. It was developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology.
• Covaxin is a highly purified and inactivated vaccine that is manufactured using a vero cell manufacturing platform.
• Price Action: OCGN shares are down 16% at $5.94 during the premarket session on the last check Friday.