Lyra Therapeutics' Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by Lyra Therapeutics (LYRA).
Over the past two years, Lyra Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
LYR-210. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
LYR-210 FDA Regulatory Timeline and Events
LYR-210 is a drug developed by Lyra Therapeutics for the following indication: Chronic Rhinosinusitis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- LYR-210
- Announced Date:
- October 6, 2025
- Indication:
- Chronic Rhinosinusitis
Announcement
Lyra Therapeutics, Inc. announced the Company's clinical plan and upcoming oral presentation of results from the positive Phase 3 ENLIGHTEN 2 trial for LYR-210, the company's lead product candidate for CRS.
AI Summary
Lyra Therapeutics announced its clinical plan for LYR-210, its lead product candidate for chronic rhinosinusitis (CRS). After positive Phase 3 ENLIGHTEN 2 results, the company will launch a third clinical trial in patients without nasal polyps. The design of this new study will build on insights from ENLIGHTEN 1 and ENLIGHTEN 2 to support a future NDA submission.
Lyra also revealed an upcoming late-breaking oral presentation of ENLIGHTEN 2 findings at the 2025 Annual Meeting of the American Academy of Otolaryngology–Head and Neck Surgery, scheduled for October 11–14 in Indianapolis.
In ENLIGHTEN 2, LYR-210 met its primary endpoint by significantly improving nasal obstruction, discharge, and facial pain/pressure at 24 weeks in patients without polyps. Key secondary endpoints were also achieved in the full study population, with benefits seen as early as week 4. LYR-210 was generally well tolerated, matching the safety profile of sham control. The investigational implant is designed to deliver six months of continuous mometasone furoate therapy via a bioresorbable sinonasal device.
Read Announcement- Drug:
- LYR-210
- Announced Date:
- June 2, 2025
- Indication:
- Chronic Rhinosinusitis
Announcement
Lyra Therapeutics, Inc. announced positive results from the ENLIGHTEN 2 Phase 3 clinical trial of LYR-210 in adult patients with CRS.
AI Summary
Lyra Therapeutics, Inc. announced positive results from its ENLIGHTEN 2 Phase 3 trial for LYR-210, a bioresorbable nasal implant designed to treat chronic rhinosinusitis (CRS) in adults. The study met its primary endpoint by showing a statistically significant improvement in the composite of three key symptoms—nasal obstruction, discharge, and facial pain—at 24 weeks in patients without nasal polyps. Key secondary endpoints, including the SNOT-22 score, also demonstrated significant improvement starting as early as week 4. LYR-210 was well tolerated and had a safety profile similar to the sham control, suggesting it may offer six months of continuous anti-inflammatory relief through a simple in-office procedure.
These promising findings could pave the way for new treatment options for many CRS sufferers. Lyra plans to review the complete dataset to help guide the next steps in the development of LYR-210, potentially benefiting patients who have not responded to standard therapies.
Read Announcement- Drug:
- LYR-210
- Announced Date:
- May 7, 2025
- Indication:
- Chronic Rhinosinusitis
Announcement
Lyra Therapeutics, announced that the Company plans to present results from the 52-week Extension Stage of the ENLIGHTEN 1 Phase 3 study for LYR-210, the Company's lead product candidate for CRS, at the annual Combined Otolaryngology Spring Meetings (COSM 2025) being held May 14-18 in New Orleans.
AI Summary
Lyra Therapeutics announced plans to present key findings from the 52-week Extension Stage of its ENLIGHTEN 1 Phase 3 study at the annual Combined Otolaryngology Spring Meetings (COSM 2025). The study focuses on LYR-210, the company’s lead product candidate for chronic rhinosinusitis (CRS). The upcoming poster presentation, scheduled during the COSM 2025 meeting in New Orleans from May 14-18, will detail how LYR-210 was generally well tolerated over 52 weeks, with no treatment-related serious adverse events reported. It will also highlight the durable symptom control observed even after the cessation of treatment and improvements in symptoms among various patient groups, including those with nasal polyps. This event is an important opportunity for the company to share updated data and further demonstrate the safety profile observed in the Extension Stage, reinforcing LYR-210's potential as a meaningful treatment option for CRS patients.
Read Announcement
Lyra Therapeutics FDA Events - Frequently Asked Questions
As of now, Lyra Therapeutics (LYRA) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Lyra Therapeutics (LYRA) has reported FDA regulatory activity for LYR-210.
The most recent FDA-related event for Lyra Therapeutics occurred on October 6, 2025, involving LYR-210. The update was categorized as "Upcoming presentations," with the company reporting: "Lyra Therapeutics, Inc. announced the Company's clinical plan and upcoming oral presentation of results from the positive Phase 3 ENLIGHTEN 2 trial for LYR-210, the company's lead product candidate for CRS."
Currently, Lyra Therapeutics has one therapy (LYR-210) targeting the following condition: Chronic Rhinosinusitis.
More FDA Event Resources from MarketBeat
Companies With Recent FDA Events
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
FDA progress for OTCMKTS:LYRA last updated on 10/6/2025 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
Free LYRA Stock Alerts