Lyra Therapeutics (NASDAQ: LYRA) ‘s shares surged 550% in pre-market trading on Monday following a breakthrough in its drug trials.
The stock, which closed at $4.93 on Friday, jumped to over $32 in early trading despite being down more than 50% year-to-date.
The rally comes after the biotech company announced that its drug candidate, LYR-210, delivered statistically significant results in treating chronic rhinosinusitis (CRS) in adults.
Specifically, the ENLIGHTEN 2 trial met its primary endpoint, demonstrating marked improvement in a composite of three core CRS symptoms, nasal obstruction, discharge, and facial pain, at 24 weeks. Encouragingly, these improvements were seen in patients both with and without nasal polyps.
The trial also hit key secondary endpoints. Notably, patients receiving LYR-210 showed a 22.4-point reduction in their SNOT-22 score, a clinical measure of symptom severity, more than twice the threshold for clinical significance.
LYR-210 was well-tolerated, with a safety profile comparable to the control group.
“Given these data we reported today, we plan to align with the FDA on a path forward for an NDA submission in patients without nasal polyps,” said Harlan Waksal, Executive Chairman, Lyra Therapeutics.
Lyra Therapeutics’ challenging fundamentals
However, despite the clinical success, Lyra continues to face financial challenges. For instance, in Q1 2025, Lyra posted revenue of just $0.18 million, missing consensus estimates by nearly 24%.
For comparison, the company generated $0.53 million in the same quarter last year. Lyra has beaten revenue expectations only once in the past four quarters.
Even with Monday’s dramatic stock surge, Wall Street remains cautious. According to TipRanks, all three covering analysts maintain a ‘Hold’ rating, with a 12-month price target of $2.00, suggesting a potential 59% downside from Friday’s close.
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