Ocugen sinks after FDA asks for more data on Covid vaccine
Shares of Ocugen are sinking are the company announced that upon recommendation from the Food and Drug Administration, it will no longer pursue an Emergency Use Authorization for Covaxin, its Covid-19 vaccine candidate. The company will pursue submission of a biologics license application for Covaxin.
The FDA provided feedback to Ocugen regarding the master file the company had previously submitted and recommended that Ocugen pursue a BLA submission instead of an EUA application and requested additional information and data. Ocugen said it is in discussions with the FDA to understand the additional information required to support a BLA submission. The company anticipates that data from an additional clinical trial will be required to support the submission. "While this will extend our timelines, we are committed to bringing COVAXIN to the US," said Dr. Shankar Musunuri, CEO of Ocugen.
Shares of Ocugen are down 29%, or $2.74, to $6.57 in premarket trading.