What happened
Shares of Ocugen (OCGN 2.35%) were jumping 8.2% as of 12:04 p.m. ET on Monday. The gain reflected continued momentum for the stock after the company announced its fourth-quarter and 2021 full-year results on Friday.
NASDAQ: OCGN
Key Data Points
So what
Ocugen didn't report any revenue for the fourth quarter. It posted a net loss of nearly $14.6 million compared to a loss of $3.79 million in the prior-year period. However, investors cheered the progress the company is making on a couple of fronts.
In particular, the outlook for Covaxin appears more encouraging. On Feb. 18, the U.S. Food and Drug Administration (FDA) lifted the clinical hold on Ocugen's Investigational New Drug (IND) application for a phase 2/3 clinical study of the COVID-19 vaccine. The company also provided more data to the FDA that could help advance its Emergency Use Authorization (EUA) request for Covaxin in children.
Ocugen seems to be moving the ball forward in Canada as well. The company said it has "submitted comprehensive responses to a Notice of Deficiency received in December 2021 from Health Canada" related to its regulatory filing for Covaxin.
Image source: Getty Images.
Granted, these developments don't necessarily mean that Ocugen will win approvals or authorizations for Covaxin anytime soon. However, with the biotech stock down more than 70% from its peak last year, investors welcomed the good news.
Now what
Perhaps the next key advance for Ocugen will be to initiate the phase 2/3 study of Covaxin in the U.S. The company said it expects to kick off this clinical trial "as soon as possible" but didn't provide a specific target date.
