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Shares of Lyra Therapeutics, Inc. (LYRA) rocketed 370% on Monday after the company announced positive results from its late-stage clinical trial of LYR-210 in adult patients with chronic rhinosinusitis.
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 to treat CRS.
LYR-210 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, the company said.
The trial enrolled approximately 180 CRS patients who had not had prior ethmoid sinus surgery. While some received the company’s lead product, others received a sham control.
The implant was well-tolerated, and most commonly reported adverse events included epistaxis, upper respiratory tract infection, chronic sinusitis, acute sinusitis, nasopharyngitis, COVID-19, and headache, the company added.
Lyra said that its therapy is expected to help the estimated four million CRS patients in the United States who fail medical management each year.
Lyra CEO Maria Palasis stated that the company now plans to align with the FDA on the path forward for submitting a new drug application.
The company had previously conducted a late-stage study for the implant, which did not meet its goals.
On Stocktwits, retail sentiment around Lyra jumped from ‘bearish’ to ‘extremely bullish’ over the past 24 hours while message volume rose from ‘normal’ to ‘extremely high’ levels.
LYRA stock is up by about 116% this year and by about 43% over the past 12 months.
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