Thursday, September 29, 2022
Ocugen, Inc. is a biotechnology company focused on developing and commercializing novel gene therapies, biologicals, and vaccines. The lead product, Covaxin, is a killed-virus vaccine for COVID-19 in-licensed from Bharat Biotech (India). The lead product in its gene therapy program, OCU400, is in Phase 1/2 clinical trials for retinitis pigmentosa.
Robert LeBoyer, Vice President, Research Analyst, Life Sciences , Noble Capital Markets, Inc.
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New Vaccine For Protection and Prevention of Transmission. Ocugen has licensed a nasally administered COVID-19 vaccine from Washington University. Preclinical models show the vaccine produces a strong immune response in the tissues of the nasal passages and respiratory tract where the SARS-CoV-2 virus enters the body and first colonizes. This strong local immunity could potentially stop both infection and transmission. Ocugen plans to develop the vaccine as a “universal booster” for protection against current and future strains.
The Vaccine Has Been Licensed For Other Territories. Ocugen’s partner for Covaxin, Bharat Biotech (India), has also licensed the vaccine from Washington University and received Emergency Use authorization for India. We see this as positive sign for regulatory approval in the US and other territories. Ocugen plans to begin discussions with the FDA to determine the clinical requirements for approval.
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