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Lyra Stock Soars 356% in a Week on Strong Rhinosinusitis Study Success
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Key Takeaways
LYRA shares jumped 355.5% this week after LYR-210 met the goal in the phase III ENLIGHTEN 2 CRS study.
LYR-210 showed strong symptom relief and improved SNOT-22 scores at 24 weeks, starting as early as week 4.
Lyra plans to discuss ENLIGHTEN 2 data with the FDA and may seek approval for LYR-210 in CRS without polyps.
Shares of Lyra Therapeutics (LYRA - Free Report) have skyrocketed 355.5% in a week after the company announced encouraging results from the late-stage study on its lead candidate, LYR-210, which is being developed for adult patients with chronic rhinosinusitis (CRS). The candidate is a bioabsorbable nasal implant designed to deliver six months of continuous anti-inflammatory medication to the sinonasal passages.
LYRA’s Late-Stage Rhinosinusitis Study Data in Detail
Per the data readout, the pivotal phase III ENLIGHTEN 2 study met its primary endpoint, with LYR-210 showing a statistically significant improvement over the sham control in the composite of the three cardinal symptoms (nasal obstruction, nasal discharge, and facial pain/pressure) of CRS at week 24 in patients without nasal polyps.
Lyra Therapeutics’ ENLIGHTEN 2 study also achieved its key secondary endpoints, showing statistically significant improvement in the three cardinal symptoms score at week 24 in the overall population (including patients with and without nasal polyps), as well as in the clinically validated Sino-Nasal Outcome Test (SNOT-22) score, an important metric for rhinosinusitis-related health burden, at week 24. Symptom improvements were evident as early as week 4 and were sustained throughout the study.
LYR-210 was well-tolerated and demonstrated a safety profile comparable to sham control, consistent with prior studies. Most adverse events related to treatment were mild to moderate in severity.
Year to date, LYRA shares have rallied 121.1% compared with the industry’s 9.9% growth.
Image Source: Zacks Investment Research
Please note that Lyra Therapeutics’ ENLIGHTEN program comprises two phase III studies, ENLIGHTEN 1 and ENLIGHTEN 2, to evaluate the efficacy and safety of LYR-210 for the treatment of CRS.
Though the ENLIGHTEN 1 study failed to meet its primary endpoint in 2024, a pooled data analysis of a total of 64 CRS patients with small nasal polyps from the two phase III studies showed consistent trends favoring LYR-210 over sham control across multiple endpoints over 24 weeks.
Notable findings included improvements in the composite of three cardinal symptoms by week 24 and SNOT-22 scores among others. Symptom relief with LYR-210 was observed as early as week 4 across several measures.
Based on the totality of the data available, LYR-210 has significant potential to benefit a vast number of patients who do not respond to standard CRS medical management. Subject to approval, the candidate can significantly reduce the treatment burden faced by CRS patients as it offers six months of therapy in a single administration. This is expected to boost patient compliance as well.
LYRA’s Next Steps in the CRS Therapy Developmental Program
Following the phase III ENLIGHTEN 2 study's success, Lyra Therapeutics is gearing up to discuss the data with the FDA and potentially file a new drug application seeking the approval of LYR-210 to treat CRS in patients without nasal polyps.
Per LYRA, encouraging findings from the combined analysis of ENLIGHTEN 1 and ENLIGHTEN 2 data in CRS patients with nasal polyps support advancing the development of the candidate in this patient subgroup. This decision aligns with the FDA’s December 2024 guidance on key study parameters, including endpoints, patient population, inclusion criteria, background therapy and assessment methods.
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Lyra Stock Soars 356% in a Week on Strong Rhinosinusitis Study Success
Key Takeaways
Shares of Lyra Therapeutics (LYRA - Free Report) have skyrocketed 355.5% in a week after the company announced encouraging results from the late-stage study on its lead candidate, LYR-210, which is being developed for adult patients with chronic rhinosinusitis (CRS). The candidate is a bioabsorbable nasal implant designed to deliver six months of continuous anti-inflammatory medication to the sinonasal passages.
LYRA’s Late-Stage Rhinosinusitis Study Data in Detail
Per the data readout, the pivotal phase III ENLIGHTEN 2 study met its primary endpoint, with LYR-210 showing a statistically significant improvement over the sham control in the composite of the three cardinal symptoms (nasal obstruction, nasal discharge, and facial pain/pressure) of CRS at week 24 in patients without nasal polyps.
Lyra Therapeutics’ ENLIGHTEN 2 study also achieved its key secondary endpoints, showing statistically significant improvement in the three cardinal symptoms score at week 24 in the overall population (including patients with and without nasal polyps), as well as in the clinically validated Sino-Nasal Outcome Test (SNOT-22) score, an important metric for rhinosinusitis-related health burden, at week 24. Symptom improvements were evident as early as week 4 and were sustained throughout the study.
LYR-210 was well-tolerated and demonstrated a safety profile comparable to sham control, consistent with prior studies. Most adverse events related to treatment were mild to moderate in severity.
Year to date, LYRA shares have rallied 121.1% compared with the industry’s 9.9% growth.
Image Source: Zacks Investment Research
Please note that Lyra Therapeutics’ ENLIGHTEN program comprises two phase III studies, ENLIGHTEN 1 and ENLIGHTEN 2, to evaluate the efficacy and safety of LYR-210 for the treatment of CRS.
Though the ENLIGHTEN 1 study failed to meet its primary endpoint in 2024, a pooled data analysis of a total of 64 CRS patients with small nasal polyps from the two phase III studies showed consistent trends favoring LYR-210 over sham control across multiple endpoints over 24 weeks.
Notable findings included improvements in the composite of three cardinal symptoms by week 24 and SNOT-22 scores among others. Symptom relief with LYR-210 was observed as early as week 4 across several measures.
Based on the totality of the data available, LYR-210 has significant potential to benefit a vast number of patients who do not respond to standard CRS medical management. Subject to approval, the candidate can significantly reduce the treatment burden faced by CRS patients as it offers six months of therapy in a single administration. This is expected to boost patient compliance as well.
LYRA’s Next Steps in the CRS Therapy Developmental Program
Following the phase III ENLIGHTEN 2 study's success, Lyra Therapeutics is gearing up to discuss the data with the FDA and potentially file a new drug application seeking the approval of LYR-210 to treat CRS in patients without nasal polyps.
Per LYRA, encouraging findings from the combined analysis of ENLIGHTEN 1 and ENLIGHTEN 2 data in CRS patients with nasal polyps support advancing the development of the candidate in this patient subgroup. This decision aligns with the FDA’s December 2024 guidance on key study parameters, including endpoints, patient population, inclusion criteria, background therapy and assessment methods.
Lyra Therapeutics, Inc. Price and Consensus
Lyra Therapeutics, Inc. price-consensus-chart | Lyra Therapeutics, Inc. Quote
LYRA’s Zacks Rank and Stocks to Consider
Lyra Therapeutics currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Bayer (BAYRY - Free Report) , Lexicon Pharmaceuticals (LXRX - Free Report) and Amarin (AMRN - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, estimates for Bayer’s earnings per share have increased from $1.19 to $1.25 for 2025. During the same time, earnings per share have increased from $1.28 to $1.31 for 2026. Year to date, shares of Bayer have gained 47.7%.
BAYRY’s earnings beat estimates in one of the trailing four quarters, matched twice and missed on the remaining occasion, the average negative surprise being 13.91%.
In the past 60 days, estimates for Lexicon’s loss per share have narrowed from 37 cents to 32 cents for 2025. During the same time, loss per share estimates for 2026 have narrowed from 35 cents to 31 cents. Year to date, shares of LXRX have lost 10.5%.
LXRX’s earnings beat estimates in three of the trailing four quarters and missed the same on the remaining occasion, delivering an average surprise of 11.97%.
In the past 60 days, estimates for Amarin’s loss per share for 2025 have narrowed from $5.00 to $2.78. During the same time, loss per share estimates for 2026 have narrowed from $3.87 to $2.04. Year to date, shares of AMRN have gained 22.1%.
AMRN’s earnings beat estimates in two of the trailing four quarters, matched once and missed the same on the remaining occasion, delivering an average surprise of 29.11%.