Core Insights - Ocugen, Inc. has received Rare Pediatric Disease Designation (RPDD) from the U.S. FDA for OCU410ST, aimed at treating ABCA4-associated retinopathies, including Stargardt disease [1][2] - The designation highlights the urgent need for therapeutic options for Stargardt patients, as there are currently no FDA-approved treatments available [2] - Approximately 100,000 individuals in the U.S. and Europe are affected by Stargardt disease, which primarily impacts children [2] Regulatory and Developmental Aspects - If the Priority Review Voucher (PRV) program is reauthorized, Ocugen may receive a PRV, which can be sold for about $100 million or used for expedited review of another product [3] - The company plans to initiate a Phase 2/3 pivotal confirmatory trial for OCU410ST in the coming weeks, with a target for Biologics License Application (BLA) filing in 2027 [4] Product and Technology Overview - OCU410ST employs an AAV delivery platform to deliver the RORA gene, representing a modifier gene therapy approach that addresses multiple pathophysiological pathways linked to Stargardt disease [5] - Stargardt disease is characterized by retinal degeneration and vision loss, primarily affecting the macula, leading to decreased central vision while some peripheral vision may be preserved [6][7] Company Background - Ocugen, Inc. is a biotechnology leader focused on gene therapies for blindness diseases, with a gene-agnostic approach that targets complex diseases caused by imbalances in multiple gene networks [8]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K ___________________________________________________________ CURRENT REPORT Pursuant to Section 13 OR 15 (d) of The Securities Exchange Act of 1934 Date of Report (Date of Earliest Event Reported): May 9, 2025 OCUGEN, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 001-36751 04-3522315 (State or Other Jurisdiction of Incorporation) (Commission File Number) (Address, including zip code, and telephone number, ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ___________________________________________________________ FORM 10-Q ___________________________________________________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 001-36751 _________________ ...

Ocugen (OCGN) Q1 2025 Earnings Call May 09, 2025 08:30 AM ET Company Participants Tiffany Hamilton - AVP & Head of Corporate CommunicationsShankar Musunuri - Co-Founder, CEO & ChairmanRamesh Ramachandran - Chief Accounting OfficerHuma Qamar - Chief Medical OfficerArun Upadhyay - Chief Scientific Officer and Head of Research & Development Conference Call Participants Michael Okunewitch - Senior Biotechnology AnalystRobert Leboyer - Senior Biotechnology AnalystSwayampakula Ramakanth - Managing Director & Seni ...

Ocugen (OCGN) Q1 2025 Earnings Call May 09, 2025 08:30 AM ET Speaker0 Good morning, and welcome to Ocugen's First Quarter twenty twenty five Financial Results and Business Update. Please note that this call is being recorded at this time. All participant lines are in listen only mode. Following the speakers' commentary, there will be a question and answer session. I will now turn the call over to Tiffany Hamilton, Ocugen's Head of Corporate Communications. You may begin. Speaker1 Thank you, operator, and go ...

Conference Call and Webcast Today at 8:30 a.m. ET OCU400 Phase 3 clinical trial for retinitis pigmentosa (RP) is progressing well and on target for potential BLA/MAA filings by mid-2026Anticipate initiating OCU410ST Phase 2/3 pivotal confirmatory clinical trial for Stargardt disease mid- 2025 MALVERN, Pa., May 09, 2025 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today reported first quarter 2025 financia ...

MALVERN, Pa., May 02, 2025 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that it will host a conference call and live webcast to discuss the Company’s first quarter 2025 financial results and provide a business update at 8:30 a.m. ET on Friday, May 9, 2025. Ocugen will issue a pre-market earnings announcement on the same day. Attendees are invited to participate on the call using the follow ...

MALVERN, Pa., April 29, 2025 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that the Company will present on its innovative modifier gene therapy platform, including OCU400 for the treatment of retinitis pigmentosa (Phase 3 LiMeliGhT clinical trial), OCU410ST for the treatment of Stargardt disease (Phase 2/3 pivotal confirmatory clinical trial), and OCU410 for the treatment of geographic atr ...

MALVERN, Pa., April 08, 2025 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ:OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-founder of Ocugen will present at the 2025 Cell & Gene Meeting on the Mediterranean being held April 15-17, 2025 at the Rome Cavalieri in Rome, Italy. "I look forward to sharing more on how Ocugen's modifier gene therapy platform can potentially chan ...

MALVERN, Pa., April 08, 2025 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-founder of Ocugen will present at the 2025 Cell & Gene Meeting on the Mediterranean being held April 15-17, 2025 at the Rome Cavalieri in Rome, Italy. “I look forward to sharing more on how Ocugen’s modifier gene therapy platform can potentially cha ...