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. develops gene therapies for blindness diseases through a modifier gene therapy platform designed to address inherited and multifactorial retinal disorders. Company news commonly covers programs such as OCU400 for retinitis pigmentosa, OCU410 for geographic atrophy secondary to dry age-related macular degeneration, and OCU410ST for Stargardt disease.
Recurring updates include clinical trial data and dosing milestones, clinical and regulatory disclosures, operating and financial results, investor presentations, convertible-note financing, shareholder voting matters, capital-structure actions, and governance matters tied to the company's Nasdaq-listed common stock.
Ocugen announced that Dr. Shankar Musunuri, the company's Chairman and CEO, will participate in a fireside chat at the H.C. Wainwright Global Investment Conference on May 24, 2022, at 1:30 PM ET in Miami Beach, Florida. The event focuses on the company's innovative gene therapies and vaccines aimed at improving health outcomes. Interested parties can register to watch the chat virtually. A replay will be available on the Investor’s section of the Ocugen website starting on May 24 for 90 days.
Ocugen, Inc. announces the lifting of the clinical hold by the U.S. FDA on its Phase 2/3 trial for COVAXIN™ (BBV152), a COVID-19 vaccine candidate. Dosing will resume immediately, affirming Ocugen's commitment to providing differentiated vaccine options. The vaccine has been administered over 350 million times globally, approved in India, and authorized in 25 countries. Further emergency use applications are pending in 60 others. Ocugen aims to advance this critical vaccine's development in the U.S., Canada, and Mexico amidst ongoing global demand.
Ocugen, Inc. (NASDAQ: OCGN) reported its first quarter 2022 results, indicating a cash position of $129.9 million, up from $95.1 million in Q4 2021. Significant milestones include the Phase 1/2 trial for OCU400, with the first patient dosed in March and a second in May. The company expanded its COVAXIN™ marketing rights to cover all of North America, including Mexico. R&D expenses rose to $7.9 million from $2.9 million year-over-year. The net loss was $0.09 per share, compared to $0.04 last year. A conference call is scheduled for further discussion.
Ocugen, Inc. (NASDAQ: OCGN) announced a conference call scheduled for May 6, 2022, at 8:30 a.m. ET, to discuss its first quarter 2022 financial results. The company will issue a pre-market earnings announcement on the same day. Investors can join the call via a toll-free dial-in number or through a webcast available on Ocugen's website for approximately 45 days post-call. Ocugen focuses on developing innovative gene therapies and vaccines aimed at addressing unmet medical needs.
Ocugen, Inc. (NASDAQ: OCGN) announced two significant presentations at the ARVO 2022 Annual Meeting related to its innovative treatments for age-related macular degeneration (AMD) and diabetic macular edema (DME). The company is showcasing its RORA modifier gene therapy, OCU410, aimed at treating dry AMD, and a biologic product candidate, OCU200, for wet AMD and DME. Both presentations highlight promising approaches to combat these vision-threatening conditions, which currently have limited treatment options and affect millions.
Ocugen announced that the independent Data and Safety Monitoring Board (DSMB) has recommended the continuation of its Phase 1/2 clinical trial for OCU400, a modifier gene therapy candidate aimed at treating Retinitis Pigmentosa linked to NR2E3 and RHO mutations. The study recently dosed its first patient, and there were no serious adverse events reported. This therapy has the potential to address multiple retinal diseases with a single product, showcasing Ocugen's innovative approach in gene therapy.
Ocugen (NASDAQ: OCGN) announced that Dr. Shankar Musunuri, Chairman and CEO, will present at NobleCon18, Noble Capital Markets’ Eighteenth Annual Investor Conference on April 21, 2022, at 10:30 AM ET. The event will take place at the Hard Rock Hotel & Casino in Hollywood, Florida. A high-definition video webcast of the presentation will be available the next day on Ocugen’s website and Noble’s conference website. This event highlights Ocugen’s focus on advancing biotechnology and their innovative therapies.
Ocugen has expanded its agreement with Bharat Biotech to include the commercialization of COVAXIN™ in Mexico, granting it rights across North America. The vaccine is already authorized for emergency use in adults in Mexico and is under review for children aged 2-18. Dr. Shankar Musunuri, Ocugen's CEO, expressed optimism about the vaccine's role in combatting COVID-19 in Mexico. COVAXIN™ is noted for its robust immune response and logistical advantages. The agreement retains the same profit-sharing structure as in the U.S.
Ocugen announced that the FDA placed its Phase 2/3 immuno-bridging study for COVAXIN™ on clinical hold due to a voluntary pause in dosing participants. This decision follows the World Health Organization’s inspection of Bharat Biotech's manufacturing facility. The company aims to address the FDA's questions while evaluating these findings. Ocugen remains focused on advancing its innovative therapies and will collaborate with the FDA to resolve the clinical hold for OCU-002.
Ocugen, a biotechnology company, has commenced the Phase 1/2 clinical trial of OCU400 for treating retinitis pigmentosa (RP), marking its first clinical trial in humans for its modifier gene therapy platform. The first patient has been dosed in this observer-blind trial, which aims to evaluate safety and efficacy. RP, affecting approximately two million people globally, currently has no approved therapies. The trial focuses on genetic mutations in the NR2E3 and RHO genes, with potential future expansions to target more mutations.