Lyra Therapeutics Announces Positive Outcome of End-of-Phase 2 Meeting with the FDA for LYR-210 for the Treatment of Chronic Rhinosinusitis
Lyra Therapeutics, Inc. (LYRA)
Company Research
Source: Business Wire
Single primary endpoint defined as three cardinal symptoms at 24 weeksCompany to host conference call at 5:00 PM ET today WATERTOWN, Mass.--(BUSINESS WIRE)--Lyra Therapeutics, Inc. (Nasdaq: LYRA), a clinical-stage therapeutics company leveraging its proprietary XTreo™ platform to enable precise, sustained, and local delivery of medications to the ear, nose and throat (ENT) passages and other diseased tissues, today announced the successful outcome of an End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) for LYR-210, its lead candidate for the treatment of chronic rhinosinusitis (CRS).Lyra and the FDA established key elements of the Phase 3 program to support a 505(b)(2) new drug application for LYR-210 for the treatment of CRS. The single primary endpoint will evaluate improvement at week 24 using a composite score of three cardinal symptoms (3CS) of CRS: nasal blockage, nasal discharge, and facial pain. Based on the Agency’s suggestion, Lyra intends to
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LYRA
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- 8/8/23 - Beat
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Sec Filings
- 4/19/24 - Form PRE
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- 4/2/24 - Form EFFECT
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