(BNTX) Stock- Here’s What Is Going On With Ocugen (OCGN) Stock
Shares of Ocugen Inc. (NASDAQ:OCGN), India-based Bharat Biotech’s U.S. partner for COVID-19 vaccine Covaxin, fell 3.7% in Wednesday’s regular trading session.
What Happened: Ocugen said late Wednesday it plans to submit an Emergency Use Authorization (EUA) application for Covaxin to the U.S. Food & Drug Administration (FDA) in June.
Ocugen added it is in active talks regarding Covaxin with the FDA since late last year. The FDA’s recent decision that it may not review and process new COVID-19 vaccine EUA requests does not raise any concerns about Ocugen’s ability to submit the EUA for Covaxin as planned, the company noted.
According to Ocugen, the FDA’s guidance refers specifically to vaccines based on the spike protein, while Covxain uses an inactivated version of the whole virus with a novel adjuvant that provides a broadly protective immune response beyond the spike protein.
Ocugen said on Tuesday that it has submitted a “Master File” to the FDA before seeking a EUA for Covaxin in the U.S.
Why It Matters: Currently, vaccines from Pfizer Inc. (NYSE:PFE)-BioNTech SE ((NASDAQ:(BNTX))), Moderna Inc. (NASDAQ:MRNA), and Johnson & Johnson (NYSE:JNJ) are authorized for emergency use in the U.S.
The FDA’s decision will push later COVID-19 vaccine entrants to take the long route and submit a full marketing application with more manufacturing and safety data rather than use the shortened EUA process.
price Action: Ocugen closed 3.7% lower in Wednesday’s regular trading session at $7.66.
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