Shares of Ocugen (OCGN 4.58%) were skyrocketing 64.2% higher as of 11:35 a.m. EST on Monday. The huge gain came after the company's partner, Bharat Biotech, received emergency use authorization (EUA) in India for COVID-19 vaccine Covaxin.
Investors appear to expect that Bharat's big win for Covaxin in India could translate to success for Ocugen in the U.S. On Dec. 22, Ocugen and Bharat announced a binding letter of intent to jointly develop Covaxin for the U.S. market.
However, an EUA in India doesn't mean that Covaxin is a slam dunk to win EUA in the U.S., as well. Importantly, neither Bharat nor Indian regulators revealed the efficacy of the vaccine. COVID-19 vaccines from Pfizer and Moderna are already on the market in the U.S. with efficacy levels of 94% or greater.
Covaxin doesn't have an advantage in terms of dosing compared to these leading vaccines. Like Pfizer's BNT162b2 and Moderna's mRNA-1273, it requires two doses.
In December, Ocugen stated that it had put together an advisory board of "leading academic and industry experts to evaluate the clinical and regulatory path to approval in the U.S. market." The next key catalyst for the biotech stock could be the announcement of the details of the plan to win EUA for Covaxin in the U.S. market. For now, though, what happens in India stays in India.