Ocugen Will No Longer Pursue an EUA for Covaxin


Keep an eye on Ocugen (OCGN).

The stock is pulling back after saying it would no longer pursue emergency use authorization (EUA) for its CV-19 vaccine, Covaxin.  Instead, the company will file for full U.S. approval after a recommendation from the US FDA.

“Although we were close to finalizing our EUA application for submission, we received a recommendation from the FDA to pursue a BLA [Biologics License Applications] path. While this will extend our timelines, we are committed to bringing COVAXIN to the US. This differentiated vaccine is a critical tool to include in our national arsenal given its potential to address the SARS-CoV-2 variants, including the delta variant, and given the unknowns about what will be needed to protect US population in the long term,” said Dr. Shankar Musunuri, CEO and Co-founder of Ocugen, as quoted in a company press release.

At the moment, shares of OCGN are down about 30% in pre-market on the EUA news.  However, weakness could be an opportunity as it pursues a BLA path.


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