Ocugen (NASDAQ:OCGN) has had a volatile past year, to say the least. For starters, OCGN stock has a 52-week high of $17.65 and a 52-week low of $2.37. That low represents a decrease of 86% from the nearly $18 high.
Now, shares of OCGN stock are down roughly 20% today after negative news from the U.S. Food and Drug Administration (FDA). Specifically, Ocugen announced this morning that the FDA has declined its pediatric Emergency Use Authorization (EUA) application for Covaxin, the company’s vaccine candidate for Covid-19.
Here’s what investors should know moving forward.
Why Is OCGN Stock Down Today?
Covaxin is Ocugen’s lead Covid-19 vaccine candidate which the company hoped to be approved for use in “individuals aged 2 to 18.” The vaccine has already received EUA from 20 other countries and has EUA applications in over 60 countries as well. Ocugen developed the vaccine in collaboration with India-based biotech company Bharat Biotech. Covaxin is one of the most popular novel coronavirus vaccines in India.
This past January, Ocugen announced promising results from its Covaxin study conducted at Emory University. The study demonstrated that 100% of test serum samples showed neutralization against the delta variant. Furthermore, 90% of test serum samples showed neutralization against the omicron variant of Covid-19.
Many see this vaccine as unique because both adults and children can receive the same dosage. That said, the FDA’s EUA rejection today is a major blow to OCGN stock shareholders, especially after the FDA had just lifted its clinical hold on Covaxin’s Investigational New Drug application (IND) application last month. The hold had been placed on Covaxin last November.
What’s Next for Ocugen?
Moving forward, this drug company says that it plans on working with U.S. federal regulators to “evaluate the regulatory pathway for the pediatric use of COVAXIN.”
In the meantime, Ocugen also plans on submitting a Biologics License Application (BLA) to the FDA for Covaxin as well. The BLA is a “request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce.”
Finally, Ocugen has submitted a response to Health Canada. The agency had given Covaxin a “Notice of Deficiency” for its New Drug Submission (NDS) last December. The response is currently under review by regulators.
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On the date of publication, Eddie Pan did not hold (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.