What happened
Shares of Ocugen (OCGN +1.56%) trended upward on Friday, growing by more than 13.1% as of 4:09 p.m. on news that regulators in India from the National Technical Advisory Group on Immunization's (NTAGI) Standing Technical Sub-Committee (STSC) had opted to recommend the coronavirus vaccine called Covaxin produced by its collaborator, Bharat Biotech, for use in children between the ages of 5 and 12. As Ocugen is licensing Covaxin from Bharat Biotech with the hopes of selling it in North America, the recommendation by Indian regulators is a positive sign for the jab's chances of approval with the Food and Drug Administration (FDA).
NASDAQ: OCGN
Key Data Points
So what
Ocugen has no revenue to speak of, and all of its pipeline programs are in the early stages of clinical trials or in preclinical development. Commercializing Covaxin in North America would be a massive boon, because it'd mean that the company would realize huge revenue growth without needing to invest significant resources into developing a vaccine from scratch.
Now what
Ocugen still needs to get U.S. and Canadian regulators to assent to selling Covaxin, and to help accomplish that goal it recently published the favorable results from a phase 2/3 clinical trial in India.
As of early May, the company was in discussions with the FDA to determine what additional studies it would need to conduct to satisfy regulators' concerns and support its Biologics License Application (BLA). If it announces that regulators are satisfied with the data that it already has on hand, it could proceed to file its approval paperwork promptly, which would doubtlessly catalzye further growth in its stock price.
