What happened

Shares of Ocugen (OCGN) gained 64.9% in October, according to data from S&P Global Market Intelligence. The biotech stock had already been enjoying strong momentum thanks to an increasingly favorable outlook for the Covaxin COVID-19 vaccine it developed in conjunction with Bharat Biotech, and shares posted more big gains following a new regulatory approval and other catalysts. 

OCGN Chart

OCGN data by YCharts.

After receiving Emergency Use Authorization (EUA) for adults in January, Ocugen and Bharat Biotech's Covaxin vaccine was recommended for EUA for people between the ages of 2 and 18 on Oct. 12 by India's Subject Expert Committee.

The stock then gained more ground following news that Covaxin had been submitted to the Food and Drug Administration for phase 3 trials and in conjunction with a panel held by the World Health Organization's (WHO) technical advisory group to determine the vaccine's Emergency Use Listing (EUL) status.  

A dollar sign launching like a rocket.

Image source: Getty Images.

So what

Following the latest emergency use approval from India's Subject Expert Committee, investor attention mostly turned to whether the WHO would grant EUL status to the vaccine. The WHO had requested some additional data on Covaxin on Oct. 26, but it has subsequently given EUL approval for the vaccine, and its decision could create more bullish momentum for Ocugen. 

Now what

Ocugen stock has continued to make big gains early in November's trading. The share price is up roughly 26% in the month so far. 

OCGN Chart

OCGN data by YCharts.

News came in on Wednesday morning that the WHO had granted the EUL for Covaxin. The approval paves the way for people who have received Covaxin to face lighter travel and quarantining restrictions in many countries and is a significant point of distinction in the market appeal of COVID vaccines. The announcement is certainly a positive development for the partners, but more risk-conscious investors should also keep Ocugen's valuation in mind.

Ocugen now has as market capitalization of roughly $3.1 billion. The stock has already posted stellar gains on the Covaxin outlook, the COVID vaccine market is already quite competitive, and the WHO has granted EUL status to six other vaccines. 

Investors probably won't have to wait long to get a closer look at Ocugen and what unfolding approvals for Covaxin could mean for the business. The company is scheduled to release its third-quarter earnings results and hold a conference call before the market opens on Nov. 9.