What happened

Shares of Ocugen (OCGN -5.60%) were tanking by 12.7% as of 11:16 a.m. EDT on Friday after falling as much as 20.6% earlier in the day. The big decline came after the company provided its first-quarter update before the market opened today.

So what

Ocugen didn't generate any revenue in the first quarter. The drugmaker posted a net loss of nearly $7.1 million, or $0.04 per share. Only two analysts surveyed by Refinitiv cover the stock. One expected revenue of $156.2 million and earnings of $1.01 per share, while the other analyst projected no revenue and a loss of $0.02 per share. 

Gloved hand holding a vaccine vial with a syringe and needle

Image source: Getty Images.

However, it likely wasn't Ocugen's revenue and earnings misses that concerned investors. Instead, the bigger issue was probably that the company still hasn't made tangible progress toward securing U.S. Emergency Use Authorization (EUA) for COVID-19 vaccine Covaxin. 

Ocugen stated that it's "currently in discussions" with the Food and Drug Administration about Covaxin. But that's what the company has been saying for months.

There was one new development, though. Ocugen said that it has "submitted key information and data to date as a Master File for FDA review prior to a planned EUA application once additional data is received from Bharat Biotech from the ongoing Phase 3 clinical trial."

Now what

It's obvious that the big catalyst the biotech stock needs is for the FDA to indicate that it's open to an EUA filing for Covaxin based on Bharat's clinical studies in India. Expect Ocugen's shares to remain highly volatile until there's more clarity from the agency.