Welcome to our dedicated page for Ocugen news (Ticker: OCGN), a resource for investors and traders seeking the latest updates and insights on Ocugen stock.
Ocugen, Inc. (NASDAQ: OCGN) is a pioneering biotechnology company that focuses on discovering, developing, and commercializing novel gene and cell therapies, as well as vaccines aimed at improving health and offering hope to patients worldwide. The company's innovative efforts are concentrated on addressing rare and underserved ocular disorders.
Ocugen's core business revolves around a robust clinical pipeline which includes:
- OCU400: A groundbreaking gene-agnostic modifier gene therapy for retinitis pigmentosa (RP), currently in Phase 3 clinical trials. It leverages the nuclear hormone receptor gene NR2E3 to reset altered cellular gene networks and improve retinal health.
- OCU410: A potential one-time gene therapy for geographic atrophy (GA), an advanced stage of dry age-related macular degeneration (dAMD). This therapy targets multiple pathways involved in the disease, including lipid metabolism, inflammation, oxidative stress, and the complement system.
- OCU410ST: Another modifier gene therapy in Phase 1/2 clinical trials for Stargardt disease, the most common form of inherited macular degeneration. It utilizes the AAV delivery platform for the RORA gene to regulate pathways linked to the disease.
Recent milestones include positive feedback from the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) for the OCU400 Phase 3 liMeliGhT clinical trial, as well as the inclusion of Ocugen in the Russell 3000® Index, highlighting its market presence and growth potential.
Ocugen's commitment to innovative therapies is evident through its modifier gene therapy platforms designed to fulfill unmet medical needs related to inherited retinal diseases such as RP, Leber congenital amaurosis, and Stargardt disease. Additionally, the company is advancing research in infectious diseases to bolster public health and orthopedic diseases to meet unmet medical needs.
For the latest updates and detailed information about Ocugen, Inc., visit their official website at www.ocugen.com and follow them on X and LinkedIn.
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.
Ocugen (NASDAQ: OCGN) announced plans to submit an Emergency Use Authorization (EUA) application for its COVID-19 vaccine, COVAXIN, to the FDA in June. Active discussions with the FDA have been ongoing since late last year, and the company expressed confidence in meeting the updated EUA criteria. COVAXIN is a traditional inactivated vaccine that has shown a 78% efficacy rate overall and is 100% effective against severe COVID-19 in Phase 3 trials. It demonstrates potential effectiveness against multiple SARS-CoV-2 variants, with a strong safety profile.
Ocugen reported promising updates regarding its COVID-19 vaccine COVAXIN and its ophthalmology pipeline. COVAXIN showed 100% efficacy against severe COVID-19 and a 78% overall efficacy in trials. The company raised $100 million through a direct stock offering, strengthening its financial position. Key talent was recruited to enhance manufacturing capabilities for COVAXIN. As of March 31, 2021, Ocugen's cash totaled $44.9 million, while R&D expenses increased to $2.9 million. A conference call is scheduled for today to discuss these results.
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