RGNX 最新10-Q变化

相对上期新增的文字 · 来源:10-Q · 2026-08-06

• ATMOSPHERE® and ASCENT® are multi-center, randomized, active-controlled trials evaluating sura-vec versus ranibizumab and aflibercept, respectively. The primary endpoint is non-inferiority based on change from baseline in best-corrected visual acuity (BCVA) at 54 weeks and one year, respectively. Se…

• Enrollment in the ATMOSPHERE and ASCENT pivotal trials for the treatment of patients with wet AMD using subretinal delivery was completed in October 2025. These trials, which together enrolled over 1,200 participants across more than 200 sites, are expected to support global regulatory submissions i…

• In July 2026, we presented long-term follow-up data from the Phase I/IIa trial that demonstrated a durable safety and efficacy profile through five years, with participants in Cohorts 3 and 4, who received subretinal sura-vec at doses similar to those being studied in the ATMOSPHERE and ASCENT pivot…

• In August 2025, we and AbbVie announced an amendment to our collaboration agreement and plans to initiate a pivotal program consisting of a Phase IIb/III trial (NAAVIGATE) as well as a second Phase III trial. NAAVIGATE is a two-part, multicenter, randomized, masked, sham-controlled Phase IIb/III stu…

• Concurrent with the August 2025 announcement, we announced positive two-year data from the Phase II ALTITUDE® trial. The ALTITUDE trial is a multi-center, open label, randomized, controlled, dose-escalation Phase II trial to evaluate the efficacy, safety and tolerability of sura-vec using suprachoro…

相对上期删除的文字 · 来源:10-Q · 2026-05-14

• Enrollment in the ATMOSPHERE® and ASCENT® pivotal trials for the treatment of patients with wet AMD using subretinal delivery was completed in October 2025. These trials are expected to support global regulatory submissions with the U.S. Food and Drug Administration (FDA) and the European Medicines …

• The ALTITUDE® trial is a multi-center, open label, randomized, controlled, dose-escalation Phase II trial to evaluate the efficacy, safety and tolerability of sura-vec using suprachoroidal delivery for the treatment of DR. In November 2023, we announced data showing sura-vec was well tolerated at do…

• Concurrent with the two-year data announcement in August 2025, we and AbbVie announced an amendment to our collaboration agreement and plans to initiate a pivotal program consisting of a Phase IIb/III trial (NAAVIGATE) as well as a second Phase III trial. NAAVIGATE is a two-part, multicenter, random…

• In October 2025, we announced that enrollment had completed in the pivotal portion of AFFINITY DUCHENNE, which was designed to enroll approximately 30 patients in the U.S. and Canada, and that we continue to enroll participants in the ongoing confirmatory trial.

• As reported in the May 2026 topline data update, we have enrolled over 20 patients in the confirmatory trial (n=30) evaluating RGX-202 in ambulatory patients aged one year and older, and we expect to complete dosing in all 60 patients across the pivotal and confirmatory trials by mid-2026.

相对上期新增的文字 · 来源:10-Q · 2026-08-06

• Other than as set forth as follows, during the three months ended June 30, 2026, none of our directors or Section 16 reporting officers adopted or terminated a contract, instruction or written plan for the purchase or sale of our securities that is intended to satisfy the affirmative defense conditi…

相对上期删除的文字 · 来源:10-Q · 2026-05-14

• During the three months ended March 31, 2026, none of our directors or Section 16 reporting officers adopted or terminated any Rule 10b5-1 trading arrangement or non-Rule 10b5-1 trading arrangement (as such terms are defined in Item 408 of the SEC's Regulation S-K).