Investors are keeping a close watch on shares of Ocugen (NASDAQ:OCGN) this morning as the firm gets closer to submitting its emergency-use authorization application for its Covid-19 vaccine Covaxin. OCGN stock looks set to reverse this week’s declines, gaining 3.5% in pre-market trading.
The biopharmaceutical company said on Thursday morning that it will hand in its EUA request next month to the U.S. Food and Drug Administration. The application follows months of discussions between the company and the regulator over whether the agency’s recently revised guidance regarding EUAs raised any concerns about Ocugen’s ability to submit Covaxin as planned.
“We believe that the FDA’s new guidance confirms that Ocugen continues to meet all criteria for submission of an EUA. Once the EUA application has been submitted, Ocugen intends to commence pre-biologics license application (BLA) discussions with the FDA,” said chairman and CEO Dr. Shankar Musunuri.
To be sure, Ocugen’s announcement today provided no concrete developments on the FDA front, where the firm’s master files were submitted on March 26 and still await feedback. If things go as planned, Ocugen will get 45% of the U.S. commercialization profits.
OCGN Stock’s Wild Ride On Pandemic News
The Malvern, Pennsylvania-based company’s share price has largely been propped up in recent months on vaccine excitement. In February, Ocugen shared details of its definitive agreement with India-based vaccine developer Bharat Biotech to bring Covaxin to the U.S. marketplace.
Depending on the headlines, both here and in India, OCGN stock has swung from a February low of $1.72 a share to as high as $18.77 on the deal news. Days later, it fell back to just under $9 as investors tried to divine if the pharmaceutical company that primarily develops treatments for eye disease was too late to the Covid-19 vaccination race.
InvestorPlace contributor Tezcan Gecgil earlier this week took a deep dive on OCGN stock and came to the conclusion that “it remains a risky investment as most of the potentially good news is already priced into the shares.”
“Investors in biopharma stocks should understand that getting approval from the FDA would only be the first step in the two companies’ ambitious efforts stateside. Potential investors should also factor in production, logistics, pricing and distribution as rather risky steps,” she wrote, advising long-term investors to proceed with caution.
On the date of publication, Robert Lakin did not have (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.
InvestorPlace contributor Robert Lakin is a veteran financial writer and editor, including previous stints with Bloomberg News and as a buyside equity research editor.