Opus Genetics: FDA ने Phentolamine 0.75% प्रेस्बायोपिया sNDA के लिए PDUFA तिथि 17 अक्टूबर 2026 तय की

FDA accepted the sNDA for Phentolamine Ophthalmic Solution 0.75% in presbyopia and assigned a PDUFA action date of October 17, 2026. The filing acceptance establishes a defined regulatory timeline for the small-molecule asset. No other regulatory milestones for the gene-therapy pipeline are altered by this document.

मुख्य तथ्य

फाइल किया गया: 10 मार्च 2026, 11:17 am
घटना: PDUFA तारीख़ तय
दिशा: तटस्थ
कंपनी: IRDOpus Genetics
संपत्ति: Phentolamine Ophthalmic Solution 0.75%
स्रोत: SEC 8-K
विश्वसनीयता: स्रोत सहित
कैलेंडर: FDA फ़ैसला (PDUFA) · 17 अक्टू॰ 2026

स्रोत का अंश

EX-99.1 2 ef20067388_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Opus Genetics Announces Financial Results for Full Year 2025 and Provides Corporate Update - Favorable early safety and initial efficacy data from BEST1 program highlighted at premier gathering of global retinal experts with additional data expected mid-year 2026 - - Reauthorization of FDA’s Rare Pediatric Disease Priority Review Voucher (PRV) program provides opportunity for Opus’ deep pipeline in rare inherited retinal diseases - - FDA Prescription Drug User Fee Act (PDUFA) date in October 2026 for Phentolamine Ophthalmic Solution 0.75% for the treatment of presbyopia - - Funding from prominent healthcare investors expected to extend cash runway into 2028 - RESEARCH TRIANGLE PARK, N.C. - March 10, 2026 - Opus Genetics, Inc

SEC 8-K