What happened
Shares of Ocugen (OCGN 0.83%) skyrocketed 339% in the first half of 2021. This huge gain came as investors' excitement increased over the prospects that the company would be able to win U.S. emergency use authorization (EUA) for Covaxin. Ocugen announced in December 2020 that it was partnering with Bharat Biotech to commercialize the COVID-19 vaccine in the U.S. market.
The biotech stock rose more than 760% year to date by early February. Although shares subsequently fell, Ocugen stock nearly regained its previous high in early May. However, much of those gains evaporated after the company announced on June 10 that it wouldn't pursue an EUA filing for Covaxin in the U.S. after receiving feedback from the Food and Drug Administration (FDA).
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So what
Ocugen's impressive stock performance during the first six months of the year might be surprising, considering that investors' hopes of a quick EUA in the U.S. went up in smoke. However, there are two key reasons why the stock still delivered strong gains.
First, Ocugen still has a path to get Covaxin on the U.S. market. The company plans to file for full FDA approval of the vaccine. However, it expects that data from another clinical trial will be required to support this submission.
Second, in June, Ocugen expanded its commercialization rights for Covaxin to include Canada. The company is working with Health Canada to potentially secure authorization for the vaccine.
Now what
The main thing to watch with Ocugen right now is its progress in winning authorization for Covaxin in Canada. It's possible that the emergence of worrisome coronavirus variants could help the company's efforts.
