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Ocugen To Present at BIO International Convention 2025

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Ocugen (NASDAQ: OCGN), a biotechnology company focused on gene therapies for blindness diseases, announced its participation in the 2025 BIO International Convention in Boston from June 16-19, 2025. CEO Dr. Shankar Musunuri will present at multiple sessions, including a company presentation and panel discussions on clinical program optimization and regulatory landscape. The company recently secured exclusive Korean rights for OCU400 through a partnership agreement and achieved key milestones, including FDA alignment for Phase 2/3 pivotal trial and Rare Pediatric Disease Designation for OCU410ST. Notably, enrollment is nearly complete for the OCU400 Phase 3 liMeliGhT clinical trial, with plans to file a Biologics License Application by mid-2026.
Ocugen (NASDAQ: OCGN), una società biotecnologica specializzata in terapie geniche per malattie della cecità, ha annunciato la sua partecipazione alla BIO International Convention 2025 che si terrà a Boston dal 16 al 19 giugno 2025. Il CEO, Dr. Shankar Musunuri, interverrà in diverse sessioni, tra cui una presentazione aziendale e discussioni di panel sull'ottimizzazione dei programmi clinici e il panorama regolatorio. Recentemente, l'azienda ha ottenuto i diritti esclusivi per OCU400 in Corea tramite un accordo di partnership e ha raggiunto traguardi importanti, come l'allineamento con la FDA per la fase 2/3 dello studio cardine e la Designazione per Malattie Pediatriche Rare per OCU410ST. Inoltre, l'arruolamento per lo studio clinico di fase 3 liMeliGhT su OCU400 è quasi completato, con l'intenzione di presentare la domanda di Licenza Biologica entro la metà del 2026.
Ocugen (NASDAQ: OCGN), una empresa biotecnológica enfocada en terapias génicas para enfermedades de la ceguera, anunció su participación en la Convención Internacional BIO 2025 en Boston del 16 al 19 de junio de 2025. El CEO, Dr. Shankar Musunuri, presentará en varias sesiones, incluyendo una presentación corporativa y paneles sobre la optimización de programas clínicos y el panorama regulatorio. La compañía recientemente aseguró los derechos exclusivos en Corea para OCU400 mediante un acuerdo de asociación y alcanzó hitos clave, como la alineación con la FDA para el ensayo pivotal de fase 2/3 y la Designación para Enfermedades Pediátricas Raras para OCU410ST. Cabe destacar que el reclutamiento para el ensayo clínico de fase 3 liMeliGhT de OCU400 está casi completo, con planes para presentar una Solicitud de Licencia Biológica a mediados de 2026.
Ocugen(NASDAQ: OCGN)는 실명 질환을 위한 유전자 치료제에 주력하는 바이오테크 회사로, 2025년 6월 16일부터 19일까지 보스턴에서 열리는 2025 BIO 국제 컨벤션에 참가한다고 발표했습니다. CEO인 Dr. Shankar Musunuri는 회사 발표와 임상 프로그램 최적화 및 규제 환경에 관한 패널 토론 등 여러 세션에서 발표할 예정입니다. 최근 회사는 파트너십 계약을 통해 OCU400의 한국 독점 권리를 확보했으며, FDA와의 2/3상 중추 임상시험 조율 및 OCU410ST에 대한 희귀 소아 질환 지정 등 주요 성과를 달성했습니다. 특히 OCU400 3상 liMeliGhT 임상시험의 등록이 거의 완료되었으며, 2026년 중반까지 생물학적 제제 허가 신청서를 제출할 계획입니다.
Ocugen (NASDAQ : OCGN), une entreprise biotechnologique spécialisée dans les thérapies géniques pour les maladies de la cécité, a annoncé sa participation à la Convention Internationale BIO 2025 à Boston, du 16 au 19 juin 2025. Le PDG, Dr Shankar Musunuri, interviendra lors de plusieurs sessions, incluant une présentation de l'entreprise et des tables rondes sur l'optimisation des programmes cliniques et le paysage réglementaire. La société a récemment obtenu les droits exclusifs pour OCU400 en Corée grâce à un accord de partenariat et a atteint des jalons clés, tels que l'alignement avec la FDA pour l'essai pivot de phase 2/3 et la désignation de maladie pédiatrique rare pour OCU410ST. Notamment, le recrutement pour l'essai clinique de phase 3 liMeliGhT d'OCU400 est presque terminé, avec l'intention de déposer une demande d'autorisation de mise sur le marché biologique d'ici mi-2026.
Ocugen (NASDAQ: OCGN), ein Biotechnologieunternehmen, das sich auf Gentherapien für Erblindungserkrankungen spezialisiert hat, gab seine Teilnahme an der BIO International Convention 2025 in Boston vom 16. bis 19. Juni 2025 bekannt. CEO Dr. Shankar Musunuri wird in mehreren Sitzungen auftreten, darunter eine Unternehmenspräsentation und Podiumsdiskussionen zur Optimierung klinischer Programme und zum regulatorischen Umfeld. Das Unternehmen sicherte sich kürzlich exklusive koreanische Rechte für OCU400 durch eine Partnerschaftsvereinbarung und erreichte wichtige Meilensteine, darunter die Abstimmung mit der FDA für die Phase-2/3-Schlüsselstudie sowie die Rare Pediatric Disease Designation für OCU410ST. Bemerkenswert ist, dass die Rekrutierung für die Phase-3-liMeliGhT-Studie von OCU400 nahezu abgeschlossen ist, mit Plänen zur Einreichung eines Biologics License Application Mitte 2026.
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MALVERN, Pa., June 11, 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 at the 2025 BIO International Convention at the Boston Convention & Exhibition Center from June 16-19, 2025.

During the conference, Ocugen’s leadership team will host meetings with potential partners and pharmaceutical executives to explore opportunities for the Company’s novel modifier gene therapy platform targeting major blindness diseases with a one-time therapy for life.

“We are excited to return to BIO this year on the heels of our recent execution of a binding term sheet with a well-established leader in the pharmaceutical and healthcare sector in Korea, for exclusive Korean rights to OCU400,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-founder of Ocugen. “This regional partnership is just the beginning, and we look forward to continuing conversations with industry leaders to propel the development of our first-in-class gene therapies while also enhancing shareholder value.”

Ocugen’s modifier gene therapy platform recently achieved several critical milestones, including FDA alignment for the Phase 2/3 pivotal confirmatory trial and Rare Pediatric Disease Designation for OCU410ST. Additionally, enrollment is nearing completion for the OCU400 Phase 3 liMeliGhT clinical trial, and the program remains on track to file a Biologics License Application (BLA) mid-2026.

Details of Dr. Musunuri’s speaking opportunities at BIO are as follows:

Company Presentation
Date: Monday, June 16, 2025
Time: 4 p.m. EDT
Location: Room 153A

Panel Discussion—Optimizing Your Clinical Program Outcomes: Creating an Evidence-based Value Proposition for Commercial Success
Date: Wednesday, June 18, 2025
Time: 9-10 a.m. EDT
Location: Room 258A

Dr. Musunuri will also participate in the Longwood Healthcare Leaders MIT CEO Conference taking place in conjunction with BIO.

Panel Discussion—Navigating the Regulatory Landscape
Date: Tuesday, June 17, 2025
Time: 3-3:30 p.m. EDT
Location: Koch Institute, Massachusetts Institute of Technology

Please visit Ocugen at Booth #1875 to learn more about the Company’s clinical programs and near-term catalysts.

About Ocugen, Inc.
Ocugen, Inc. is a pioneering biotechnology leader in gene therapies for blindness diseases. Our breakthrough modifier gene therapy platform has the potential to address significant unmet medical need for large patient populations through our gene-agnostic approach. Unlike traditional gene therapies and gene editing, Ocugen’s modifier gene therapies address the entire disease—complex diseases that are potentially caused by imbalances in multiple gene networks. Currently we have programs in development for inherited retinal diseases and blindness diseases affecting millions across the globe, including retinitis pigmentosa, Stargardt disease, and geographic atrophy—late stage dry age-related macular degeneration. Discover more at www.ocugen.com and follow us on X and LinkedIn.

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:
Tiffany Hamilton
AVP, Head of Communications
Tiffany.Hamilton@ocugen.com


FAQ

What are the key presentations scheduled for Ocugen at BIO International Convention 2025?

Ocugen's CEO Dr. Shankar Musunuri will give a company presentation on June 16 at 4 p.m. EDT and participate in panel discussions on clinical program optimization on June 18 and regulatory landscape on June 17 at MIT.

What recent milestones has Ocugen (OCGN) achieved for its gene therapy platform?

Ocugen has secured FDA alignment for Phase 2/3 pivotal trial, received Rare Pediatric Disease Designation for OCU410ST, and is nearing completion of OCU400 Phase 3 liMeliGhT trial enrollment.

When does Ocugen (OCGN) plan to file its Biologics License Application for OCU400?

Ocugen plans to file the Biologics License Application (BLA) for OCU400 by mid-2026.

What recent partnership has Ocugen (OCGN) secured for OCU400?

Ocugen has executed a binding term sheet with a pharmaceutical leader in Korea for exclusive Korean rights to OCU400.
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