What happened
Shares of Ocugen (OCGN) had skyrocketed by 19.1% as of 11:15 a.m. ET on Tuesday. The huge gain came after the company announced that the Food and Drug Administration (FDA) had lifted the clinical hold on its investigational new drug (IND) application for COVID-19 vaccine Covaxin.
So what
Ocugen's announcement came after the market closed on Friday. Since the stock market was closed on Monday for Presidents' Day, investors had to wait for the biotech stock to soar.
The FDA initially placed a clinical hold on Ocugen's IND in November. As a result, Ocugen wasn't able to begin its planned phase 3 study of Covaxin in the U.S.
Ocugen needs the phase 3 study because the FDA shut down its path for securing an Emergency Use Authorization (EUA) for Covaxin to be administered to adults in the U.S. based on clinical studies conducted outside of the U.S. The company also filed for an EUA for the vaccine to be administered to children in November. However, the FDA still hasn't handed down a decision on that request.
Investors were justified in cheering the lifting of the clinical hold, as it removes a major obstacle standing between Ocugen and its goal of eventually marketing Covaxin in the U.S. Other obstacles remain, though, including actually conducting the phase 3 study, reporting positive results, securing FDA approval, and successfully launching the vaccine here.
Image source: Getty Images.
Now what
Ocugen could have more details to share related to its Covaxin efforts later on Friday, when it's scheduled to host a conference call to discuss its fourth-quarter and full-year results, and provide a business update.
