H.C. Wainwright lifts Lyra Therapeutics stock target to $16

On Tuesday, H.C. Wainwright analyst Matthew Caufield increased the price target on Lyra Therapeutics (NASDAQ:LYRA) shares to $16.00 from the previous $2.00 while maintaining a Neutral rating on the stock. The stock, currently trading at $18.41, has shown significant volatility with a 74% surge over the past six months, according to InvestingPro data. The adjustment follows the announcement of positive results from the company’s Phase 3 ENLIGHTEN-2 trial for LYR-210, a treatment for chronic rhinosinusitis (CRS).

The ENLIGHTEN-2 trial met its statistically significant primary and key secondary endpoints, which has led to a reevaluation of the stock’s potential value. While the company’s financial health shows some concerns, with InvestingPro data indicating rapid cash burn and negative EBITDA of -$44.7M, the analyst noted that the positive outcome of this trial contrasts with the previously announced failure of the Phase 3 ENLIGHTEN-1 trial and raises questions regarding the impact of saline irrigation on sham benefits in earlier studies.

Looking ahead, Lyra Therapeutics is expected to engage with the FDA in the second half of 2025 to discuss the next steps for development, particularly focusing on CRS patients without nasal polyps, who represent approximately 70% of CRS cases. The potential requirement of an additional Phase 3 trial, dubbed ENLIGHTEN-3, for non-polyp patients could shape the company’s strategy for future development, including treatments for patients with polyps.

The analyst expressed optimism about the therapeutic benefits demonstrated by LYR-210 in the ENLIGHTEN-2 trial. The upcoming FDA feedback is anticipated to provide strategic clarity for the company’s development pathway. In light of these developments, the price target has been raised significantly, albeit with a continued Neutral rating until further FDA guidance is received.

In other recent news, Lyra Therapeutics announced successful results from its ENLIGHTEN 2 Phase 3 clinical trial for LYR-210, a treatment for chronic rhinosinusitis (CRS). The trial met its primary endpoint, showing statistically significant improvements in CRS symptoms at 24 weeks, particularly for patients without nasal polyps. These positive outcomes were accompanied by key secondary endpoint achievements, including improvements in the Sino-Nasal Outcome Test (SNOT-22) scores. The treatment was well-tolerated, with a safety profile similar to the sham control. Despite the success of ENLIGHTEN 2, the earlier ENLIGHTEN 1 trial did not meet its primary endpoint, prompting further analysis. Lyra Therapeutics plans to engage with the FDA for a New Drug Application (NDA) submission and is considering development plans for patients with nasal polyps. BTIG analysts maintained a Neutral rating on Lyra Therapeutics, citing ongoing uncertainty regarding the approval pathway. The company remains focused on advancing its treatment options for CRS and will present the trial results at an upcoming medical conference.

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