Ocugen, Inc. - OCGN STOCK NEWS

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.

Ocugen, Inc. (OCGN) announced that its R&D head, Arun Upadhyay, PhD, will present pre-clinical data on OCU410, a modifier gene therapy candidate for Dry Age-related Macular Degeneration (Dry AMD), at the 2nd Annual Dry AMD Therapeutic Development conference on October 20, 2021. OCU410 targets the RORA receptor, which plays a crucial role in several physiological functions affecting Dry AMD, a condition impacting approximately 196 million people worldwide. The therapy is expected to enter clinical trials in 2022, following a collaboration with CanSinoBIO for its development.

Ocugen (NASDAQ: OCGN) announced the approval of stock options for 48,800 shares and restricted stock units (RSUs) covering 8,200 shares to three new employees as of October 16, 2021. The stock options, with a ten-year term, have an exercise price of $8.66 per share, equal to the closing stock price on the grant date. The options and RSUs will vest annually over three years, contingent on continued employment. This grant is made under Nasdaq Listing Rule 5635(c)(4) as a material inducement to employment.

Ocugen, a biopharmaceutical company (NASDAQ: OCGN), announced that CEO Dr. Shankar Musunuri will present at the 2021 Cantor Virtual Global Healthcare Conference on September 28, 2021, at 8 a.m. ET. He will discuss the company’s investigational COVID-19 vaccine COVAXIN™, co-developed with Bharat Biotech, and its innovative modifier gene therapy platform aimed at treating retinal diseases. The presentation will be accessible live and later on Ocugen's Investor Relations page.

On September 16, 2021, Ocugen approved the grant of stock options for 137,250 shares and restricted stock units (RSUs) for 23,000 shares to seven employees as inducements for employment. The stock options have a ten-year term with an exercise price of $7.54, set at the common stock's closing price on the grant date. Both the stock options and RSUs vest over three years, contingent on the employees' continued service. These grants are in accordance with Nasdaq Listing Rule 5635(c)(4) and were issued outside of Ocugen's 2019 Equity Incentive Plan.