Shares of biopharmaceutical company, Ocugen, Inc. OCGN, gained 17.7% after it announced that its co-development partner, Bharat Biotech, released positive data on a late-stage study of COVAXIN, a vaccine for COVID-19.
Bharat Biotech shared positive results of the second interim analysis of its phase III study of COVAXIN, which demonstrated an efficacy of 78% in mild, moderate and severe COVID-19 disease and an efficacy of 100% against severe COVID-19 disease.
The trial enrolled 25,800 participants in India from the age group of 18-91, including 2,433 above the age of 60 and 4,500 with comorbidities.
The primary endpoint of the phase III study is based on the first occurrence of PCR-confirmed symptomatic (mild, moderate, or severe) COVID-19, with onset at least 14 days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline.
The second interim analysis is based on accruing more than 87 symptomatic cases of COVID-19. However, due to the recent surge in cases in India, 127 symptomatic cases were recorded. This, in turn, resulted in a point estimate of vaccine efficacy of 78% against mild, moderate and severe COVID-19 disease.
Based on a subgroup of approximately 8,000 participants who visited the clinical trial site each month for an RT-PCR test, the efficacy against asymptomatic COVID-19 infection was 70%.
The trial will continue to its pre-planned conclusion.
We note that in February 2021, Ocugen entered a co-development, supply and commercialization agreement with Bharat Biotech for the development and commercialization of COVAXIN in the U.S. market. Bharat Biotech will supply a specified minimum number of doses of COVAXIN, once it receives an Emergency Use Authorization (EUA), and then support the technology transfer for manufacturing for the U.S. market. Ocugen will share the profits from the sale of COVAXIN in the U.S. market with Bharat Biotech, with Ocugen retaining 45% of the profit.
Shares of Ocugen have surged 255.2% in the year so far compared with the industry’s growth of 2.1%.
The company is discovering, developing and commercializing gene therapies to cure blindness.
The FDA has already granted EUA to Pfizer PFE / BioNTech and Moderna’s MRNA vaccines for COVID-19. The agency also granted EUA to Johnson & Johnson’s JNJ single-dose COVID-19 vaccine in individuals 18 years of age and older.
Ocugen currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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