On 2025‑10‑07, Lyra Therapeutics, Inc. announced today its clinical plan for the lead product candidate LYR‑210 and the scheduled oral presentation of the positive Phase 3 ENLIGHTEN 2 trial results at the AAO‑HNS 2025 Annual Meeting in Indianapolis (Oct 11‑14). The company confirmed that the presentation will highlight the trial’s primary endpoint achievement—statistically significant improvement in the composite of three cardinal symptoms (3CS) at week 24 in non‑polyp patients (–1.13; p = 0.0078) and key secondary endpoints, including 3CS in the full population and SNOT‑22 score improvements.
Lyra’s announcement also detailed a new regulatory strategy: following a September 2025 meeting with the U.S. Food and Drug Administration, the company will proceed with an additional clinical trial that the FDA has identified as required for a New Drug Application (NDA) submission for LYR‑210 in patients without nasal polyps. The plan will refine the trial design based on lessons from ENLIGHTEN 1 and ENLIGHTEN 2 and incorporate FDA feedback, positioning LYR‑210 for a potential NDA filing in the near term.
The positive ENLIGHTEN 2 results, coupled with the upcoming presentation and the clarified NDA pathway, represent a significant step toward regulatory approval. If the additional trial meets expectations, LYR‑210 could become a six‑month, in‑office implantable therapy for the estimated four million U.S. CRS patients who fail standard medical management, potentially unlocking a large, underserved market and advancing Lyra’s commercial prospects.
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