Ocugen, Inc. - OCGN STOCK NEWS

Ocugen, Inc. announced the FDA's approval of its Phase 3 study design for NeoCart®, a regenerative cell therapy aimed at repairing knee cartilage lesions in adults. This crucial step follows their pipeline expansion initiative from May 2022. The randomized trial seeks to demonstrate NeoCart's superiority over existing treatments. Additionally, Ocugen is establishing a Good Manufacturing Practice facility and aims to file an Investigational New Drug amendment by late 2023 or early 2024. The FDA previously designated NeoCart® as a regenerative medicine advanced therapy.

Ocugen announced the FDA has granted orphan drug designation to OCU400 for treating retinitis pigmentosa (RP) and Leber congenital amaurosis (LCA). This designation highlights the potential of OCU400, a nuclear hormone-based gene therapy, in addressing rare inherited retinal diseases that currently lack treatment options. Approximately 110,000 people in the U.S. are affected by RP, and 10,000 by LCA. The company aims to advance OCU400 through clinical development, providing hope for affected patients.

Ocugen, Inc. (NASDAQ: OCGN) will ring the Nasdaq Closing Bell on December 19, 2022, to celebrate its 2022 achievements and discuss future clinical and regulatory goals. CEO Dr. Shankar Musunuri emphasized the company’s innovative approach, particularly its modifier gene therapy for retinal diseases and COVID-19 vaccine technologies. Ocugen aims for Biologics License Application filings or product launches annually for the next five years, showcasing its commitment to 'Courageous Innovation.'

Ocugen announced continued positive safety data for OCU400 in its clinical trials, establishing high dose as the maximum tolerable dose (MTD). The Data Safety and Monitoring Board endorsed advancing dosing for patients with NR2E3 and RHO mutations associated with Retinitis Pigmentosa and CEP290 mutations linked to Leber Congenital Amaurosis. No serious adverse events have been reported. Ocugen plans to complete enrollment by Q1 2023 and file a Biologics License Application for OCU400 in 2025, targeting a critical unmet need affecting millions globally.

Ocugen, a biotechnology company, announced that its Chief Scientific Officer, Arun Upadhyay, will participate in the 3rd Annual Dry AMD Therapeutics Summit in Boston from November 30 to December 2, 2022. Dr. Upadhyay will present the company’s innovative Modifier Gene Therapy platform aimed at treating dry AMD with its candidate OCU410, which targets the RORA gene. The company plans to file an IND application to begin Phase 1/2 clinical trials in Q2 2023. This therapy aims to address significant unmet medical needs in retinal disease treatment.

Ocugen reported its Q3 2022 financial results, highlighting the completion of enrollment for the Phase 2/3 COVAXIN™ trial and initiation of dosing in the OCU400 gene therapy clinical trial's third cohort. The company expanded its product pipeline with OCU500, a mucosal COVID-19 vaccine, and OCU410ST for Stargardt disease. As of September 30, 2022, Ocugen had $101.6 million in cash, expecting to fund operations through Q4 2023. Research and development expenses rose to $15.6 million. The net loss per share was $0.10, up from $0.05 in Q3 2021.

Ocugen, a biotechnology company, announced plans for a conference call on November 8, 2022, at 8:30 a.m. ET to discuss its Q3 2022 financial results and business updates. A pre-market earnings announcement will precede this call. Investors can join via specified dial-in numbers or through a webcast accessible on Ocugen's investor site. The company focuses on gene and cell therapies and vaccines, aiming to address multiple diseases, including retinal and infectious diseases.

Ocugen, a biotechnology company, announces its in-person Research & Development (R&D) Day on November 1, 2022, at the Nasdaq Market Site in New York City. The event aims to showcase Ocugen's innovative gene therapy and vaccine technologies, with panel discussions featuring leading experts such as Neena B. Haider, Mark Pennesi, and David Fajgenbaum. Attendees will gain insights into Ocugen's pipeline and business strategies. Registration is required, and a webcast replay will be available within 48 hours post-event.

Ocugen, Inc. (NASDAQ: OCGN) announced that the Independent Data and Safety Monitoring Board completed a review of the safety data for its OCU400 Phase 1/2 clinical trial and recommends proceeding to enroll subjects in Cohort 3. No safety concerns were noted in the ongoing trial, which focuses on treating inherited retinal degeneration. The company expects to complete Cohort 3 enrollment by Q4 2022. OCU400 aims to address unmet needs in patients with retinitis pigmentosa associated with NR2E3 and RHO mutations.