Navitas stock soars as company advances 800V tech for NVIDIA AI platforms
WATERTOWN, Mass. - Lyra Therapeutics, Inc. (NASDAQ:LYRA), currently valued at $11.5 million with its shares trading at $7, announced Monday its clinical development plan for LYR-210 following a meeting with the FDA in September. According to InvestingPro analysis, the company has seen a notable 7.7% return over the past week despite facing cash burn challenges. The agency confirmed that an additional clinical trial will be required before the company can submit a New Drug Application for its chronic rhinosinusitis (CRS) treatment.
The biotechnology company plans to proceed with a third clinical trial for patients without nasal polyps, building on findings from its ENLIGHTEN 1 and ENLIGHTEN 2 studies. With its next earnings report due on November 7, investors following InvestingPro data note that analysts anticipate a sales decline in the current year.
"Now that we have clarity on the path forward for LYR-210, we are focused on advancing a third clinical trial in patients without nasal polyps," said Maria Palasis, President and CEO of Lyra Therapeutics.
The company also announced that positive results from its ENLIGHTEN 2 Phase 3 trial will be presented at the Annual Meeting of the American Academy of Otolaryngology-Head and Neck Surgery on October 13 in Indianapolis.
In June, Lyra reported that ENLIGHTEN 2 met its primary endpoint, demonstrating statistically significant improvement compared to sham control in a composite of the three cardinal symptoms of CRS at week 24 in patients without nasal polyps. The trial also met key secondary endpoints, with symptom improvement observed as early as week 4.
LYR-210 is a bioabsorbable sinonasal implant designed to deliver six months of continuous anti-inflammatory medication to treat CRS. The implant is administered through an in-office procedure and contains mometasone furoate.
The company is developing treatments for the estimated four million CRS patients in the United States who fail medical management each year.
According to the press release, LYR-210 was generally well-tolerated in clinical trials, with a safety profile similar to sham control.
In other recent news, Lyra Therapeutics announced it received a notice from The Nasdaq Stock Market regarding non-compliance with an equity requirement. As of June 30, 2025, the company reported stockholders’ equity of approximately $1.6 million, falling short of the $2.5 million minimum mandated by Nasdaq Listing Rule 5550(b)(1). This notification does not immediately impact the listing or trading of Lyra Therapeutics’ common stock, which will continue to trade under its current symbol. These developments are significant as they relate to the company’s compliance with Nasdaq’s financial standards. Investors will be watching closely to see how Lyra Therapeutics addresses this issue to maintain its listing status.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.