Ocugen Inc Stock Price, News & Analysis

Ocugen, Inc. (OCGN) announced the initiation of a rolling submission to Health Canada for COVAXIN™, its COVID-19 vaccine candidate developed in collaboration with Bharat Biotech. This decision follows positive Phase 3 clinical trial results showcasing efficacy and safety among nearly 25,800 participants. The rolling submission allows for ongoing review of data as it becomes available, potentially speeding up the approval process. COVAXIN™ has demonstrated a strong safety profile and is currently administered under emergency authorizations in 13 countries.

Ocugen reported positive Phase 3 results for COVAXIN™, a COVID-19 vaccine candidate co-developed with Bharat Biotech. The vaccine demonstrated 77.8% efficacy against symptomatic COVID-19 and 93.4% against severe cases. Additionally, efficacy against the Delta variant stands at 65.2%. Adverse events were comparable to placebo, with 12.4% of subjects reporting mild side effects and less than 0.5% serious events. Ocugen plans to submit a Biologics License Application in the U.S. and is in discussions for approval in Canada.

Ocugen, Inc. (NASDAQ: OCGN) has appointed Ken Inchausti as the new Head of Investor Relations & Communications. With over 25 years of experience in healthcare communications, Inchausti previously worked at Novo Nordisk, where he led corporate media relations and reputation strategy. This appointment comes as Ocugen advances its plans for COVAXIN vaccine commercialization in the U.S. and Canada, alongside the initiation of its Phase 1/2a clinical trial for OCU400. His expertise is expected to enhance Ocugen's stakeholder engagement and public health initiatives.

Ocugen announced the grant of stock options and restricted stock units (RSUs) to four new employees as part of their compensation package. The stock options total 157,450 shares with an exercise price of $6.26, reflecting the stock's closing price on the grant date, June 15, 2021. The RSUs cover 26,300 shares, and both will vest over three years. These grants were made as inducements for employment per Nasdaq rules. Ocugen focuses on gene therapies for blindness and COVID-19 vaccine development, co-developing Bharat Biotech’s COVAXIN in the U.S.

Ocugen, Inc. (NASDAQ: OCGN) announced its inclusion in the Russell 3000® Index effective June 28, 2021. This recognition places Ocugen among the largest US companies, representing 98% of the investable US equity market. The Russell indexes are vital for investment managers and institutional investors, with approximately $10.6 trillion in assets benchmarked against them. Ocugen develops gene therapies for retinal diseases and COVAXIN™ for COVID-19, showcasing its commitment to innovative biopharmaceutical solutions.

Ocugen has announced a partnership with Jubilant HollisterStier for the manufacturing of COVAXIN™ in the US and Canada. This collaboration aims to prepare for potential commercial manufacturing of the COVID-19 vaccine, enhancing its availability in North America. Senior Vice President, J.P. Gabriel, emphasized the importance of securing US-based manufacturing capability as they approach regulatory submissions to the FDA and Health Canada. COVAXIN™ boasts a vaccine efficacy of 78% overall, with 100% against severe disease in clinical trials.

Ocugen, Inc. (NASDAQ: OCGN) has appointed Michael Shine as Senior Vice President, Commercial, enhancing its leadership ahead of potential COVAXIN commercialization in the US and Canada. Shine brings nearly 35 years of experience, including successful roles at Pfizer Vaccines, where he led the $6 billion Prevnar franchise. His expertise in marketing and sales is expected to drive Ocugen's vaccine and ophthalmic product launches, contingent on regulatory approvals. The company's focus remains on gene therapies for blindness and COVID-19 vaccine development.

Ocugen (NASDAQ: OCGN) plans to pursue a Biologics License Application (BLA) for its COVID-19 vaccine candidate, COVAXIN™, upon FDA recommendation, abandoning its earlier Emergency Use Authorization (EUA) strategy. The company aims to submit additional data from ongoing clinical trials to support this application. Additionally, Ocugen has secured exclusive commercialization rights for COVAXIN™ in Canada and is seeking expedited authorization under an interim order. The vaccine has shown a 78% efficacy rate and is well-tolerated in over 6.7 million doses administered in India.

Ocugen (NASDAQ: OCGN) has secured exclusive co-development, manufacturing, and commercialization rights for COVAXIN™ in Canada, enhancing its existing rights in the U.S. This expansion underscores the company’s strategic partnership with Bharat Biotech, as they aim to submit applications for emergency use authorization in both countries. Ocugen will share profits from COVAXIN™ sales in Canada, retaining 45%. COVAXIN™ has shown a 78% overall efficacy rate and demonstrated effectiveness against multiple SARS-CoV-2 variants, with an excellent safety record.