Ocugen, Inc. - OCGN STOCK NEWS

Ocugen, Inc. (NASDAQ: OCGN) announced the approval of stock options and restricted stock units (RSUs) totaling 787,268 shares and 217,681 shares, respectively, for three new hires. The grants were made on January 10 and January 17, 2022, as incentives for employment in compliance with Nasdaq Listing Rule 5635(c)(4). The stock options have a ten-year term with exercise prices of $4.32 and $4.25. They will vest in equal installments over three years, contingent upon continued service. Ocugen focuses on gene therapies for blindness diseases and the COVAXIN vaccine for COVID-19.

Ocugen, Inc. (NASDAQ: OCGN) and Bharat Biotech announced that the booster dose of their candidate vaccine, COVAXIN™ (BBV152), generated strong neutralizing antibody responses against the Omicron and Delta variants. The study showed that 100% of serum samples neutralized the Delta variant, while over 90% neutralized Omicron. These findings suggest COVAXIN™ is a viable option amid the evolving COVID-19 pandemic. The results will be published on medRXiv soon. COVAXIN™ is currently in review for emergency use authorization in the U.S. among children aged 2-18 years.

Ocugen (NASDAQ: OCGN) announced positive Phase 2 results for its COVID-19 vaccine candidate, COVAXIN™, showcasing significant increases in neutralizing titers after a booster dose. Participants aged 12-64 exhibited over a 10-fold boost in neutralizing antibodies against multiple variants six months post-second dose. Additionally, the analysis reported persistent immune responses and no serious adverse events. COVAXIN™ is currently authorized in 17 countries, with efficacy against the Omicron variant under study. These findings support the potential of COVAXIN™ as a durable vaccine option amid evolving COVID-19 variants.

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.