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Lyra Therapeutics, Inc. (Nasdaq: LYRA) is a clinical-stage therapeutics company focused on advancing and commercializing innovative drug and delivery solutions specifically designed for ear, nose, and throat diseases. Founded in 2005 and headquartered in Watertown, Massachusetts, Lyra Therapeutics leverages its proprietary XTreo™ technology platform to deliver sustained medication directly to the targeted tissue via a single administration.
The company's primary product candidates, LYR-210 and LYR-220, are bioresorbable polymeric matrices targeting the treatment of chronic rhinosinusitis (CRS). These candidates are formulated to provide up to six months of continuous drug therapy through a non-invasive, in-office procedure. LYR-210 is intended for patients who have not undergone sinus surgery, while LYR-220 is designed for those who have had prior ethmoid sinus surgery.
Recent advancements include the BEACON Phase 2 clinical trial of LYR-220, which demonstrated significant improvement in CRS patients post-surgery, and the ongoing ENLIGHTEN Phase 3 clinical trials of LYR-210, targeting patients who have not had surgery. Lyra's financial condition remains robust, with cash and short-term investments totaling $102.6 million as of September 30, 2023, expected to support operations into the first quarter of 2025.
Lyra Therapeutics continues to innovate within the CRS treatment landscape, aiming to address the unmet medical needs of the estimated four million CRS patients in the United States who fail to respond to existing treatments annually. The company remains committed to advancing its product portfolio and achieving regulatory milestones to bring these therapies to market.
Lyra Therapeutics reported Q3 2024 financial results and provided updates on its ENLIGHTEN clinical program for LYR-210 in chronic rhinosinusitis (CRS) treatment. The company reported topline 52-week safety data from ENLIGHTEN 1 extension study showing no product-related serious adverse events. Cash position stands at $51.6M as of September 30, 2024. R&D expenses decreased to $5.9M from $12.4M year-over-year, while G&A expenses reduced to $3.9M from $5.0M. Net loss was $11.9M compared to $15.7M in Q3 2023. The company expects topline results from ENLIGHTEN 2 pivotal trial in Q2 2025.
Lyra Therapeutics (Nasdaq: LYRA) has announced full enrollment for its pivotal Phase 3 ENLIGHTEN 2 clinical trial of LYR-210, a treatment for chronic rhinosinusitis (CRS) in adult patients without prior ethmoid sinus surgery. LYR-210 is a bioresorbable nasal implant designed to deliver six months of continuous anti-inflammatory medication (mometasone furoate) to sinonasal passages.
The company expects to report topline results in Q2 2025. This trial is the second of two pivotal studies for LYR-210 in CRS patients. Dr. Maria Palasis, President and CEO of Lyra Therapeutics, expressed gratitude to the participants and investigators involved in the ENLIGHTEN studies, emphasizing the potential benefit of their technology for CRS patients.
Lyra Therapeutics (Nasdaq: LYRA) announced upcoming presentations of study results for its chronic rhinosinusitis (CRS) treatments at two major medical conferences. The company will present:
1. Results from the Phase 3 ENLIGHTEN 1 study for LYR-210 at the 70th Annual Meeting of the American Rhinologic Society (ARS) on September 27-28 in Miami.
2. Additional results from the Phase 2 BEACON study for LYR-220 at the Annual Meeting of the American Academy of Otolaryngology–Head and Neck Surgery (AAO-HNS) on September 28 - October 1 in Miami.
The LYR-210 presentation will be a poster session on September 27th, while the LYR-220 presentation will be an oral presentation on September 29th, focusing on improvements in smell and sleep for CRS patients.
Lyra Therapeutics (NASDAQ: LYRA) reported Q2 2024 financial results and provided a corporate update. Key points include:
1. Primary focus on ENLIGHTEN 1 Phase 3 extension study results expected in Q4 2024 and ENLIGHTEN 2 pivotal Phase 3 trial results in 1H 2025.
2. Further analysis of ENLIGHTEN 1 data showed LYR-210 improved symptomatic endpoints in CRS patients with nasal polyps.
3. Q2 2024 financial highlights: $67.5 million in cash and equivalents, $13.3 million in R&D expenses, and $5.1 million in G&A expenses.
4. Net loss for Q2 2024 was $48.1 million, compared to $15.6 million in Q2 2023.
5. Cost-cutting measures implemented, including a 75% workforce reduction and pausing LYR-220 development.
Lyra Therapeutics (Nasdaq: LYRA) announced significant cost-cutting measures, including laying off 75% of its workforce and pausing the manufacturing and commercialization efforts. The company will focus on its ENLIGHTEN Phase 3 trials evaluating LYR-210 for chronic rhinosinusitis. The ENLIGHTEN 1 trial did not meet its 24-week primary endpoint, but data from the 52-week extension phase is expected in Q4 2024. Lyra had $87.1 million in cash and equivalents as of March 31, 2024, and aims to extend its cash runway into 2026. The company is also pausing efforts on LYR-220 and seeks to sublease its facilities. Lyra plans to evaluate strategic options to maximize shareholder value but offers no assurance on any resulting transactions.
Lyra Therapeutics announced the topline results from its Phase 3 ENLIGHTEN 1 trial for the treatment of chronic rhinosinusitis (CRS) with LYR-210. Unfortunately, the trial did not meet its primary endpoint, showing no significant improvement compared to the sham control in the composite score of CRS symptoms. The company plans to evaluate the full dataset to determine the next steps.
Lyra Therapeutics, a biotechnology company, reported its financial results for Q1 2024 and provided an update on its clinical-stage product candidates LYR-210 and LYR-220 for treating chronic rhinosinusitis. LYR-210's Phase 3 results are expected in May, aiming to revolutionize CRS treatment. LYR-220's Phase 2 trial data will be presented in May 2024.
Financially, the company's cash balance decreased to $87.1 million. Research and development expenses increased to $18.2 million, while general and administrative expenses rose to $5.8 million. The net loss for Q1 2024 was $22.5 million.
Lyra Therapeutics, a clinical-stage biotech company, has granted non-qualified stock options to new non-executive employees as inducement awards. The options allow the purchase of 78,400 shares of Lyra Therapeutics common stock, with a ten-year term and an exercise price of $4.72 per share. Vests over a four-year period, subject to continued service.
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