Press release
Ocugen Provides Business Update and First Quarter 2022 Financial Results
Conference Call and Webcast Today at 8:30 a.m. ET OCU400 Phase 1/2 clinical trial for groundbreaking modifier gene therapy for the treatment of NR2E3 and
About this update from Ocugen, Inc.
[{"type":"text","content":"Conference Call and Webcast Today at 8:30 a.m. ET OCU400 Phase 1/2 clinical trial for groundbreaking modifier gene therapy for the treatment of NR2E3 and RHO-related retinitis pigmentosa is advancing after DSMB reviewOcugen’s exclusive territory for COVAXIN™ (BBV152) marketing expanded to include all of North America MALVERN, Pa., May 06, 2022 (GLOBE NEWSWIRE) -- Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene therapies, biologicals, and vaccines, today reported first quarter 2022 financial results along with a general business update. “We’ve made significant progress this quarter across multiple areas and we remain confident in the long-term opportunities and growth that we believe our pipeline will unlock,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-Founder of Ocugen. “I am very proud of our dedicated team for moving our breakthrough gene therapy into the clinic and for their commitment to advancing COVAXIN™ to fight against COVID-19.” Business Updates OCU400 Clinical Trial — The Company achieved a key milestone in its Phase 1/2 clinical trial for OCU400 of “first patient, first dose” in late March 2022. The Data and Safety Monitoring Board for the clinical trial reviewed safety data based on dosing to date and recommended that the study proceed with enrolling the remaining study subjects in the current cohort at the target dose level. A second patient was dosed in May 2022.COVAXIN™ Rights Expanded to include Mexico — In April 2022, the Company expanded its rights to develop, manufacture, and commercialize COVAXIN™ to include Mexico, where the vaccine is already authorized for emergency use in adults and is currently under review by local regulators for emergency pediatric use. The company is now working on commercializing the vaccine in Mexico. The Company’s exclusive territory for COVAXIN™ now encompasses the entire North American region.COVAXIN™ in the United States — The Company is actively engaged in discussions with the U.S. Food and Drug Administration (the “FDA”) to address its questions and resume the Company’s Phase 2/3 immuno-bridging and broadening clinical trial for COVAXIN™, OCU-002. In addition, the Company intends to continue working with the FDA to finalize the additional studies requir...