Ocugen Inc Stock Price, News & Analysis

Ocugen, a biopharmaceutical company (NASDAQ: OCGN), announced its participation in the H.C. Wainwright Bioconnect Conference from January 10-13, 2022. Dr. Shankar Musunuri, CEO and Co-Founder, will present on January 10, 2022, focusing on COVAXIN™, an investigational COVID-19 vaccine under FDA review, and the innovative OCU400 therapy, which begins clinical trials in Q1 2022. The presentation will be available on-demand starting at 7:00 AM ET.

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Ocugen, Inc. (Nasdaq: OCGN) announced successful results from a Phase 2/3 trial of COVAXIN™ in children aged 2-18, showing robust antibody responses similar to adults and a favorable safety profile. The study demonstrated a strong neutralizing antibody response with no serious adverse events reported. Following these results, Ocugen submitted a pediatric Emergency Use Authorization (EUA) application in the U.S. on November 5, 2021. The findings come amid rising COVID-19 cases globally, highlighting COVAXIN's potential to enhance pediatric vaccination efforts.

Ocugen, Inc. (NASDAQ: OCGN) announced on December 20, 2021, that its Compensation Committee has approved stock options and restricted stock units (RSUs) for a new employee. The stock options total 6,750 shares with an exercise price of $5.02, reflecting the closing price on the grant date of December 16, 2021. The RSUs cover 1,150 shares and both grants vest over three years. This move aligns with Nasdaq Listing Rule 5635(c)(4) as an inducement for employment, supporting Ocugen's focus on gene therapies and COVID-19 vaccine development.

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.