Ocugen Eases on Tests

Ocugen (OCGN) announced its gene therapy OCU400 received provisional approval in the Bahamas, aiming to treat the first retinitis pigmentosa patient within 90 days. Shares rose 3%. The company expects Phase 3 trial results in Q1 2027 and a U.S. BLA submission in Q2. Ocugen has other late-stage eye-disease programs and expects cash runway through 2028.

Kowa Pharmaceuticals' NDA for K-911, an IOP-lowering eye drop, was accepted by the FDA, with a PDUFA target date of April 30, 2027. Ocugen dosed the first patient in a Phase 3 trial for OCU410, a gene therapy for dry AMD. Bausch + Lomb surveyed awareness of dry eye in menopause, finding low recognition. ASCRS announced events and policy statements. Research highlighted KLEx-CXL outcomes and enVista Aspire IOL performance.

Ocugen, Inc. (OCGN) shares fell slightly as the company announced the first patient was dosed in its global Phase 3 trial for OCU410, a gene therapy for dry age-related macular degeneration. The FDA granted RMAT designation to OCU410, potentially accelerating development. The trial follows a successful End-of-Phase 2 meeting with the FDA.

Ocugen, Inc. (OCGN) filed an SEC Form 8-K — Results of Operations and Financial Condition. Exhibit 99.1 Ocugen Provides Business Update with Second Quarter 2026 Financial Results Conference Call and Webcast Today at 8:30 a.m. ET · Received U.S. Food and Drug Administration (FDA) clearance to initiate OCU410 Phase 3 trial for geographic atrophy (GA), secondary to dry ag

Ocugen (NASDAQ: OCGN) said it signed a binding term sheet to negotiate an exclusive license for its OCU400 modifier gene therapy for retinitis pigmentosa in the Middle East and North Africa with Roots Pharmaceutical and Al-Dhow International Holding. Ocugen expects up to $4 million in upfront and near-term milestones, up to $255 million in sales milestones, and 22% royalties on net sales. Ocugen will manufacture OCU400, with a definitive deal expected within 90 days.

Johnson & Johnson (JNJ) reported that its Tremfya treatment showed significant improvement in spinal pain and stiffness in a Phase 4 study for axial psoriatic arthritis. The study met primary and secondary endpoints, including MRI-confirmed inflammation reduction. Tremfya is already approved for inflammatory conditions, and the study's safety profile aligned with its established profile. Detailed results are pending presentation at a scientific congress.