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Ocugen, Inc. (OCGN), a clinical stage biopharmaceutical company, focuses on the discovery, development, and commercialization of transformative therapies to cure blindness diseases.
The company's pipeline product includes OCU200, a novel fusion protein that is in preclinical development stage for the treatment of wet AMD, diabetic retinopathy, and diabetic macular edema; OCU400 to treat retinitis pigmentosa, a group of rare genetic disorders; and OCU410, which is in preclinical development stage for the treatment of dry AMD.
Ocugen, Inc. has a strategic partnership with CanSino Biologics Inc. for gene therapy co-development and manufacturing; and Bharat Biotech for the commercialization of COVAXIN in the United States market.
Ocugen, Inc. reported a 3rd Quarter September 2020 loss of $0.07 per share on revenue of $0.0 million. The consensus estimate was a loss of $0.02 per share.
Ocugen, Bharat Biotech announce Phase 3 interim results of COVAXIN - Ocugen announced that its co-development partner, Bharat Biotech, announced the results of the first interim analysis of its Phase 3 study of COVAXIN, a whole virion inactivated COVID-19 vaccine candidate. COVAXIN demonstrated a vaccine efficacy of 81%. Bharat Biotech's Phase 3 clinical trial enrolled 25,800 participants between 18-91 years of age, including 2,433 over the age of 60 and 4,500 with comorbidities.
The primary endpoint of the Phase 3 clinical trial is based on the first occurrence of PCR-confirmed symptomatic COVID-19 with onset at least 14 days after the second study vaccination in serologically negative adult participants at baseline.
The first interim analysis is based on 43 cases, of which 36 cases of COVID-19 were observed in the placebo group versus 7 cases observed in the COVAXIN group, resulting in a point estimate of vaccine efficacy of 80.6%. The interim analysis included a preliminary review of the safety database, which showed that severe, serious, and medically attended adverse events occurred at low levels and were balanced between vaccine and placebo groups.
The trial's conduct and monitoring are as per Good Clinical Practice guidelines and have been outsourced to IQVIA. Analysis from the National Institute of Virology indicates that vaccine-induced antibodies can neutralize the UK variant strains and other heterologous strains, which has been published in bioRxiv. Bharat Biotech expects to share further details of the trial results as additional data become available.
An additional interim analysis is planned for 87 cases, and the final analysis is planned for 130 cases. All data from the second interim and final analyses will be shared via pre-publication servers as well as submitted to a peer-reviewed journal for publication.
Following successful clinical trials towards a new COVID-19 vaccine, this stock should see an increase in share prices.
Entry Point: $10.25
Trading Range: $0.17 - $18.77
Stop Loss: $9.75
Target Price: $11.25
