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 societ脿 biotecnologica specializzata in terapie geniche per malattie della cecit脿, ha annunciato la sua partecipazione alla BIO International Convention 2025 che si terr脿 a Boston dal 16 al 19 giugno 2025. Il CEO, Dr. Shankar Musunuri, interverr脿 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 猫 quasi completato, con l'intenzione di presentare la domanda di Licenza Biologica entro la met脿 del 2026.
Ocugen (NASDAQ: OCGN), una empresa biotecnol贸gica enfocada en terapias g茅nicas para enfermedades de la ceguera, anunci贸 su participaci贸n en la Convenci贸n Internacional BIO 2025 en Boston del 16 al 19 de junio de 2025. El CEO, Dr. Shankar Musunuri, presentar谩 en varias sesiones, incluyendo una presentaci贸n corporativa y paneles sobre la optimizaci贸n de programas cl铆nicos y el panorama regulatorio. La compa帽铆a recientemente asegur贸 los derechos exclusivos en Corea para OCU400 mediante un acuerdo de asociaci贸n y alcanz贸 hitos clave, como la alineaci贸n con la FDA para el ensayo pivotal de fase 2/3 y la Designaci贸n para Enfermedades Pedi谩tricas Raras para OCU410ST. Cabe destacar que el reclutamiento para el ensayo cl铆nico de fase 3 liMeliGhT de OCU400 est谩 casi completo, con planes para presentar una Solicitud de Licencia Biol贸gica a mediados de 2026.
Ocugen (NASDAQ : OCGN), une entreprise biotechnologique sp茅cialis茅e dans les th茅rapies g茅niques pour les maladies de la c茅cit茅, a annonc茅 sa participation 脿 la Convention Internationale BIO 2025 脿 Boston, du 16 au 19 juin 2025. Le PDG, Dr Shankar Musunuri, interviendra lors de plusieurs sessions, incluant une pr茅sentation de l'entreprise et des tables rondes sur l'optimisation des programmes cliniques et le paysage r茅glementaire. La soci茅t茅 a r茅cemment obtenu les droits exclusifs pour OCU400 en Cor茅e gr芒ce 脿 un accord de partenariat et a atteint des jalons cl茅s, tels que l'alignement avec la FDA pour l'essai pivot de phase 2/3 et la d茅signation de maladie p茅diatrique rare pour OCU410ST. Notamment, le recrutement pour l'essai clinique de phase 3 liMeliGhT d'OCU400 est presque termin茅, avec l'intention de d茅poser une demande d'autorisation de mise sur le march茅 biologique d'ici mi-2026.
Ocugen (NASDAQ: OCGN), ein Biotechnologieunternehmen, das sich auf Gentherapien f眉r 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 Unternehmenspr盲sentation und Podiumsdiskussionen zur Optimierung klinischer Programme und zum regulatorischen Umfeld. Das Unternehmen sicherte sich k眉rzlich exklusive koreanische Rechte f眉r OCU400 durch eine Partnerschaftsvereinbarung und erreichte wichtige Meilensteine, darunter die Abstimmung mit der FDA f眉r die Phase-2/3-Schl眉sselstudie sowie die Rare Pediatric Disease Designation f眉r OCU410ST. Bemerkenswert ist, dass die Rekrutierung f眉r die Phase-3-liMeliGhT-Studie von OCU400 nahezu abgeschlossen ist, mit Pl盲nen 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鈥檚 leadership team will host meetings with potential partners and pharmaceutical executives to explore opportunities for the Company鈥檚 novel modifier gene therapy platform targeting major blindness diseases with a one-time therapy for life.
鈥淲e 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,鈥� said Dr. Shankar Musunuri, Chairman, CEO, and Co-founder of Ocugen. 鈥淭his 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.鈥�
Ocugen鈥檚 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鈥檚 speaking opportunities at BIO are as follows:
Company Presentation Date: Monday, June 16, 2025 Time: 4 p.m. EDT Location: Room 153A
Panel Discussion鈥擮ptimizing 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听Conference taking place in conjunction with BIO.
Panel Discussion鈥擭avigating 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鈥檚 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鈥檚 modifier gene therapies address the entire disease鈥攃omplex 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鈥攍ate stage dry age-related macular degeneration. Discover more at听听and follow us on听听and听.
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 鈥減redicts,鈥� 鈥渂elieves,鈥� 鈥減otential,鈥� 鈥減roposed,鈥� 鈥渃ontinue,鈥� 鈥渆stimates,鈥� 鈥渁nticipates,鈥� 鈥渆xpects,鈥� 鈥減lans,鈥� 鈥渋ntends,鈥� 鈥渕ay,鈥� 鈥渃ould,鈥� 鈥渕ight,鈥� 鈥渨ill,鈥� 鈥渟hould,鈥� 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 鈥淩isk Factors鈥� 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
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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