Shares of Lyra Therapeutics, Inc. (LYRA) rose 19% on Monday after the company stated that it intends to proceed with an additional clinical trial for its lead product candidate for chronic rhinosinusitis.
The company stated that the U.S. Food and Drug Administration confirmed at a meeting in September that an additional trial was required for the submission of a new drug application for LYR-210 in the treatment of chronic rhinosinusitis without nasal polyps. The design of the new trial will be based on the learnings from previous trials, as well as feedback from the FDA, the company said.
"We look forward to continuing the development of LYR-210 as a six-month treatment option for millions of patients who do not respond to standard CRS medical management,” CEO Maria Palasis said.
On Stocktwits, retail sentiment around LYRA stock stayed within the ‘bullish’ territory over the past 24 hours, while message volume stayed at ‘high’ levels.
In June, Lyra announced positive results from a late-stage trial of LYR-210 in adult patients with CRS. It demonstrated statistically significant improvement compared to sham control in key symptoms of chronic rhinosinusitis, such as nasal obstruction, nasal discharge, and facial pain/pressure at week 24 in patients with or without nasal polyps in the trial.
LYR-210 is an investigational bioabsorbable nasal implant for the treatment of chronic rhinosinusitis (CRS) in patients who have failed current therapies and require further intervention. It is designed to be inserted in a simple, in-office procedure and intended to deliver six months of continuous anti-inflammatory therapy, mometasone furoate, to the sinonasal passages for the treatment of CRS.
LYRA stock is down 19% this year and approximately 25% over the past 12 months.
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