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OCUL 資訊
OCUL 事件
Ocular Therapeutix Stock Price Rises
Ocular Therapeutix is up…
Ocular Therapeutix Reports Q2 Revenue of $13.48M, Exceeding Expectations
Reports Q2 revenue $13.48M, consensus $13.2M. "We continue to execute with discipline, precision, and urgency to redefine the retina experience and make AXPAXLI available to patients as early as possible. Our June Investor Day marked a pivotal milestone with the announcement of a clear, FDA-aligned path to submit the AXPAXLI NDA for wet AMD in the fourth quarter of 2026," said Pravin U. Dugel, MD, Executive Chairman, President and CEO of Ocular Therapeutix. "This approach is designed to support the fastest risk-mitigated path to NDA submission and review. Consistent with the FDA Type C meeting minutes, the AXPAXLI NDA submission will be based on SOL-1 efficacy and safety data, interim safety data from SOL-R and supporting confirmatory evidence, including axitinib's established profile as a VEGFR inhibitor from more than a decade of clinical use since FDA approval for renal cell carcinoma. By pursuing the 505(b)(2) regulatory pathway, we believe the AXPAXLI NDA submission is strongly positioned to benefit from a review timeline up to 60 days shorter than the typical new molecular entity."
Ocular Therapeutix to Resume Trading at 9:15 AM ET
Ocular Therapeutix, which announced plans to showcase its FDA-aligned plans to submit its NDA for AXPAXLI, is set to resume trading at 9:15am ET, with quotation scheduled to resume at 9:10am ET, according to Nasdaq.
Ocular Therapeutix Q1 Revenue $10.79M, Below Consensus
Reports Q1 revenue $10.79M, consensus $12.7M. "2026 is off to a tremendous start for Ocular, driven by the superiority demonstrated with AXPAXLI in the landmark SOL-1 Phase 3 trial in wet AMD," said Pravin U. Dugel, Executive Chairman, President and CEO of Ocular Therapeutix. "AXPAXLI delivered highly statistically significant, consistent, and superior outcomes with substantially fewer rescues compared to a single dose of aflibercept in SOL-1. The trial not only met a high bar for clinical success, but it also defined a clear, differentiated, and compelling product profile, with data showing unmatched durability combined with a level of sustained disease control that is exceptional. The strength of these data has generated overwhelming enthusiasm across the retina community and reinforces our belief that AXPAXLI has the potential to fundamentally change how wet AMD is treated. We look forward to submitting our NDA based on SOL-1 Week 52 data, subject to our ongoing formal discussions with the U.S. FDA, and are rapidly advancing our commercial readiness efforts."
Ocular Therapeutix Enrolls First Patient in Axpali Long-Term Trial
Ocular Therapeutix announced that the first patient has been enrolled in the SOL-X long-term extension trial for Axpali for the treatment of wet age-related macular degeneration.
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