Ocugen Will No Longer Pursue an EUA for Covaxin

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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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