Ocugen Inc Stock Price, News & Analysis

Ocugen announced positive findings from a third-party study of its COVID-19 vaccine candidate, COVAXIN™ (BBV152), published on medRxiv. The study revealed that immune responses from vaccinated individuals showed antibody levels comparable to those from natural infections. Additionally, T and B cell memory persisted for at least six months. The findings suggest that COVAXIN™ may be effective against current and future COVID-19 variants. Ongoing studies aim to evaluate its efficacy against the Omicron variant.

Ocugen (OCGN) has announced that the FDA accepted their IND application to initiate a first-in-human trial for OCU400, a gene therapy targeting retinitis pigmentosa due to NR2E3 and RHO gene mutations. The study aims to enroll patients starting Q1 2022. OCU400 has the potential to address numerous mutations with a single therapy, differing from traditional methods that target individual mutations. This gene therapy has received multiple orphan drug designations, indicating its potential to treat a variety of genetic retinal diseases.

Ocugen announced a clinical hold from the FDA on its Investigational New Drug application for the COVID-19 vaccine candidate COVAXIN™ (BBV152). The FDA will specify deficiencies leading to the hold, and Ocugen plans to address these promptly. COVAXIN™, developed by Bharat Biotech, has shown 77.8% overall efficacy in Phase 3 trials with 25,800 participants. Despite over 100 million doses administered globally, the FDA's hold may impact future emergency use authorization requests.

Ocugen (NASDAQ: OCGN) announced on November 18, 2021, that its Board's Compensation Committee granted stock options for 93,000 shares and restricted stock units (RSUs) for 15,600 shares to six employees. The stock options have a ten-year term and an exercise price of $8.13 per share, based on the stock's closing price on the grant date. Vesting occurs over three years, contingent on continued employment. This grant is in accordance with Nasdaq rules and is outside Ocugen's 2019 Equity Incentive Plan, reflecting the company's commitment to employee retention and motivation.

Ocugen filed an Emergency Use Authorization application for its COVID-19 vaccine candidate, COVAXIN™ (BBV152), targeting children aged 2-18. The company also submitted Investigational New Drug applications for both COVAXIN™ and its gene therapy candidate OCU400. The collaboration with CanSinoBIO has expanded to include OCU410 for manufacturing development. As of September 30, 2021, Ocugen reported cash reserves of $107.5 million and a net loss per share of $0.05, highlighting significant growth in research and development expenses.

Ocugen, Inc. (NASDAQ: OCGN) announced the submission of an Investigational New Drug (IND) application to the FDA for OCU400, a gene therapy targeting retinitis pigmentosa caused by NR2E3 and RHO mutations. This Phase 1/2 clinical trial aims to evaluate the safety and proof-of-concept of the therapy in 18 patients. OCU400’s innovative platform could treat multiple retinal diseases with one product, having received orphan drug designations from the FDA for various conditions. The company aims to initiate a Phase 3 study post-trial, pending data analysis.

Ocugen has submitted a request for Emergency Use Authorization (EUA) from the FDA for its COVID-19 vaccine candidate, COVAXIN™ (BBV152), for pediatric use (ages 2-18). This follows the World Health Organization's recent Emergency Use Listing for the vaccine. The submission is based on a Phase 2/3 clinical trial showing comparable neutralizing antibody responses in children to a previous adult trial. No serious adverse events were recorded in the pediatric study, suggesting a strong safety profile. COVAXIN™ has been administered in over 100 million doses globally, demonstrating promising efficacy and safety.

Ocugen, Inc. (NASDAQ: OCGN) announced a conference call on November 9, 2021, at 8:30 a.m. ET to discuss its Q3 2021 financial results and provide a business update. An earnings announcement will precede this call. Investors can join via dial-in numbers or webcast available on Ocugen's website. The company focuses on gene therapies for blindness and developing a COVID-19 vaccine. They are co-developing Bharat Biotech’s COVAXIN™ vaccine for the U.S. and Canadian markets.

Ocugen has submitted an Investigational New Drug (IND) application to the FDA to evaluate its COVID-19 vaccine candidate, COVAXIN™, based on the efficacy trial in India. This Phase 3 study is designed to assess the immune response in U.S. participants against the data collected in India. With over 25,000 participants in the Indian trial, COVAXIN™ showed 93.4% efficacy against severe COVID-19 and 77.8% against symptomatic disease. The study aims to enroll several hundred U.S. adults and to compare immunogenicity and safety data, targeting completion in H1 2022.