Ocugen (OCGN) Stock News, Jun-Sep 2025

Ocugen (NASDAQ: OCGN) received positive scientific advice from the European Medicines Agency (EMA) regarding the approval pathway for OCU410ST, its gene therapy treatment for Stargardt disease. The EMA's Committee for Medicinal Products for Human Use (CHMP) has accepted a single U.S.-based trial for Marketing Authorization Application (MAA) submission.

The Phase 2/3 GARDian3 clinical trial will enroll 51 participants, with 34 receiving OCU410ST treatment and 17 serving as controls. The therapy has shown promising Phase 1 results, including 48% slower lesion growth and a statistically significant 2-line/9-letter gain in visual acuity (p=0.031). The company plans to complete enrollment by Q1 2026 and submit a Biologics License Application (BLA) in H1 2027.

The treatment targets approximately 100,000 Stargardt patients in the U.S. and Europe combined, who currently have no approved treatment options.

Ocugen (NASDAQ: OCGN), a biotechnology company focused on gene therapies for blindness diseases, has completed its previously announced $20 million registered direct offering. The offering includes 20 million shares of common stock and warrants at $1.00 per share.

The warrants allow purchase of up to 20 million additional shares at $1.50 per share, are immediately exercisable, and expire in two years. The company can call the warrants when the stock's VWAP exceeds $2.50 for at least 5 days in a 30-day period. If fully exercised, the warrants could provide additional proceeds of $30 million.

The offering proceeds are expected to extend Ocugen's cash runway into Q2 2026, or Q1 2027 if warrants are fully exercised.

Ocugen (NASDAQ: OCGN), a biotechnology company focused on gene therapies for blindness diseases, has announced a $20 million registered direct offering of common stock and warrants. The company will sell 20 million shares at $1.00 per share to Janus Henderson Investors.

The offering includes warrants to purchase an additional 20 million shares at an exercise price of $1.50 per share, exercisable immediately and expiring in two years. If fully exercised, these warrants could provide up to $30 million in additional proceeds. The warrants are callable when the stock's VWAP exceeds $2.50 for at least 5 days in a 30-day period.

Ocugen (NASDAQ: OCGN) reported significant progress in Q2 2025 across its gene therapy pipeline. The company initiated dosing in the OCU410ST Phase 2/3 GARDian3 pivotal trial for Stargardt disease and continues actively dosing patients in the OCU400 Phase 3 liMeliGhT trial for retinitis pigmentosa, targeting 2026 BLA filing.

Key developments include a binding term sheet for Korean rights to OCU400 worth up to $11 million in upfront and milestone payments, plus 25% royalties. The company also announced a strategic reverse merger of OrthoCellix with Carisma Therapeutics to unlock value from its NeoCart technology. Financial results show $27.3 million in cash as of June 30, 2025, providing runway into Q1 2026, with a quarterly net loss of $0.05 per share.

The company's OCU410 demonstrated promising Phase 1 results, showing 23% slower geographic atrophy lesion growth and a 2-line gain in visual acuity.

Ocugen (NASDAQ: OCGN), a biotechnology company focused on gene therapies for blindness diseases, has announced significant additions to its leadership structure. The company has expanded its Retina Scientific Advisory Board (SAB) with three renowned retinal surgeons: Dr. Jeffrey S. Heier, Dr. Peter K Kaiser, and Dr. Arshad M. Khanani, joining existing members under the leadership of SAB chair Dr. Lejla Vajzovic.

Additionally, Ocugen has strengthened its executive team with two key appointments: Dr. Vijay Tammara as Chief Development Officer, bringing over 32 years of global regulatory leadership and experience with nine Marketing Authorization approvals, and Abhi Gupta as Executive Vice President of Commercial and Business Development, with extensive experience in gene therapy commercialization and a track record at companies like Pfizer and Johnson & Johnson.

These appointments align with Ocugen's strategic goal of pursuing three Biologics License Applications (BLAs) in the next three years.

Ocugen (NASDAQ: OCGN) has announced the dosing of its first patient in the Phase 2/3 GARDian3 pivotal confirmatory trial for OCU410ST, a modifier gene therapy candidate for Stargardt disease. The trial follows encouraging Phase 1 results that showed 48% slower lesion growth and a statistically significant 2-line gain in visual acuity at 12-month follow-up.

The Phase 2/3 study will enroll 51 participants, with 34 receiving a one-time subretinal injection of OCU410ST and 17 serving as untreated controls. The therapy targets ABCA4-associated retinopathies, affecting approximately 100,000 patients in the U.S. and Europe. Ocugen plans to submit a Biologics License Application (BLA) in 2027, based on one-year follow-up data.

Ocugen (NASDAQ: OCGN), a biotechnology company focused on gene therapies for blindness diseases, has scheduled its Q2 2025 earnings conference call for August 1, 2025, at 8:30 a.m. ET. The company will release its financial results before the market opens on the same day.

Investors can access the call via U.S. dial-in (800-715-9871) or international dial-in (646-307-1963) using conference ID 9627149. A webcast will be available on Ocugen's investor relations website, with a replay accessible for approximately 45 days after the event.

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.