Ocugen (OCGN) Stock News

Carisma Therapeutics and OrthoCellix have entered into a definitive merger agreement to create a Nasdaq-listed company focused on regenerative cell therapies for orthopedic diseases. The combined entity will prioritize the development of OrthoCellix's Phase 3-ready NeoCart®, an autologous cartilage implant technology for knee cartilage defects. Under the agreement, OrthoCellix will merge with Carisma's subsidiary, with OrthoCellix stockholders and financing participants owning approximately 90% of the combined company, while existing Carisma stockholders will retain 10%. The merger includes a concurrent $25.0 million financing to fund NeoCart's Phase 3 trial. The combined company will be renamed OrthoCellix, Inc. and trade under the ticker 'OCLX'. The transaction is expected to close in second half of 2025, subject to stockholder approvals and regulatory requirements.

Ocugen (NASDAQ: OCGN) has received FDA clearance for its IND amendment to begin a Phase 2/3 pivotal confirmatory trial of OCU410ST, a modifier gene therapy for Stargardt disease. The therapy, which previously received Rare Pediatric Disease and Orphan Drug Designations, showed promising Phase 1 results with 48% slower lesion growth and significant visual improvement at 12 months. The Phase 2/3 trial will enroll 51 participants, with 34 receiving OCU410ST and 17 serving as controls. The study aims to evaluate reduction in atrophic lesion size and improvements in visual acuity. The therapy addresses a significant unmet need, targeting a condition affecting approximately 100,000 patients in the U.S. and Europe combined. Ocugen plans to submit a Biologics License Application (BLA) in 2027.

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) has signed a binding term sheet for licensing OCU400, its modifier gene therapy for retinitis pigmentosa (RP), to a leading Korean pharmaceutical company. The agreement includes upfront fees and near-term development milestone payments of up to $11 million, plus sales milestones of $1 million for every $15 million in net sales. Ocugen will receive a 25% royalty on net sales and will manufacture the commercial supply. The deal targets approximately 15,000 RP patients in Korea. OCU400 is currently in Phase 3 clinical development with a planned Biologics License Application filing by mid-2026. This regional licensing strategy aligns with Ocugen's business development approach to partner with established companies while preserving rights in larger markets.

Ocugen (NASDAQ: OCGN) has received Rare Pediatric Disease Designation (RPDD) from the FDA for OCU410ST, its gene therapy treatment for ABCA4-associated retinopathies, including Stargardt disease. This designation applies to serious diseases affecting children under 18 and fewer than 200,000 people in the U.S. The treatment already holds Orphan Drug designations from both FDA and European Medicines Agency. Approximately 100,000 people in the U.S. and Europe combined are affected by Stargardt disease. If the Priority Review Voucher (PRV) program is reauthorized, Ocugen could receive a voucher worth approximately $100 million. The company plans to begin Phase 2/3 pivotal confirmatory trials soon, targeting a Biologics License Application (BLA) filing in 2027.

Ocugen (NASDAQ: OCGN) reported Q1 2025 financial results and provided updates on its gene therapy pipeline. The company's OCU400 Phase 3 trial for retinitis pigmentosa is progressing well, with potential BLA/MAA filings by mid-2026. Earlier Phase 1/2 data showed significant improvement in visual function. The company plans to initiate OCU410ST Phase 2/3 trial for Stargardt disease by mid-2025. In Q1, Ocugen completed dosing in OCU410 Phase 2 trial for geographic atrophy, showing promising 12-month data. Financially, Ocugen reported cash and restricted cash of $38.1M as of March 31, 2025, with runway into Q1 2026. The company posted a net loss of $0.05 per share, with total operating expenses of $16.0M. All three modifier gene therapies received Advanced Therapy Medicinal Product classification from EMA, potentially accelerating regulatory review.

Ocugen (NASDAQ: OCGN), a biotechnology company specializing in gene therapies for blindness diseases, has scheduled a conference call and live webcast for Friday, May 9, 2025, at 8:30 a.m. ET. The event will cover the company's first quarter 2025 financial results and provide business updates.

The company will release its earnings announcement before the market opens on May 9. Investors can join via phone using U.S. dial-in (800) 715-9871 or international dial-in (646) 307-1963 with Conference ID 1773288. A webcast will be available on Ocugen's investor site, with a replay accessible for approximately 45 days after the event.

Ocugen announced upcoming presentations of its modifier gene therapy platform at two major ophthalmology events: The ARVO 2025 Annual Meeting in Salt Lake City (May 4-8) and Retina World Congress in Ft. Lauderdale (May 8-11). The company will showcase three key therapies:

• OCU400 for retinitis pigmentosa (Phase 3 LiMeliGhT trial)
• OCU410ST for Stargardt disease (Phase 2/3 pivotal trial)
• OCU410 for geographic atrophy (Phase 2 ArMaDa trial)

CEO Dr. Shankar Musunuri confirmed plans to file three Biologics License Applications/Marketing Authorization Applications within three years. The presentations include clinical trial updates, safety data, and efficacy results across multiple sessions. Dr. Huma Qamar, Chief Medical Officer, will lead the company showcase at Eyecelerator and participate in panel discussions at both events.

Ocugen (NASDAQ: OCGN), a biotechnology company focused on gene therapies for blindness diseases, announced its participation in the 2025 Cell & Gene Meeting on the Mediterranean in Rome, Italy from April 15-17, 2025.

Dr. Shankar Musunuri, Chairman, CEO, and Co-founder, will present on the panel 'Commercializing ATMPs: Moving from Innovation to Market Success' on April 15 at 10:45 a.m. CEST. The presentation will highlight Ocugen's modifier gene therapy platform and its potential to offer one-time treatments for major blindness diseases.

The company's gene therapy portfolio includes:

• OCU400 for retinitis pigmentosa
• OCU410ST for Stargardt disease
• OCU410 for geographic atrophy

All three therapies have received Advanced Therapy Medicinal Products (ATMP) classification from the European Medicines Agency's Committee for Advanced Therapies.