Ocugen forced to pursue a BLA path in the US for COVID-19 candidate

USA-based biotech firm Ocugen (Nasdaq: OCGN) suffered a setback yesterday when it revealed that, on the recommendation of the US Food and Drug Administration (FDA), it will pursue submission of a biologics license application (BLA) for its COVID-19 vaccine candidate, COVAXIN.

The company will no longer pursue an Emergency Use Authorization (EUA) for COVAXIN, which would have been a much faster route to potential approval, as has been the case with all the COVID-19 vaccines that have been cleared for use. As a result, the company’s shares fell as much as 40% yesterday, closing down 28% at $6.69.

Ocugen acquired rights to develop the vaccine in the USA and Canada from India’s Bharat Biotech.