Welcome to our dedicated page for Lyra Therapeutics news (Ticker: LYRA), a resource for investors and traders seeking the latest updates and insights on Lyra Therapeutics stock.
Lyra Therapeutics, Inc. (Nasdaq: LYRA) is a clinical-stage biotechnology company whose news flow centers on the development and corporate status of its investigational sinonasal implant LYR-210 for chronic rhinosinusitis (CRS). Company press releases describe LYR-210 as a bioabsorbable implant designed for a simple, in-office procedure and intended to deliver six months of continuous anti-inflammatory therapy, mometasone furoate, to the sinonasal passages for CRS patients who have failed medical management.
News updates from Lyra highlight key milestones in the ENLIGHTEN Phase 3 clinical program, including topline results from the ENLIGHTEN 2 trial. The company has reported that ENLIGHTEN 2 met its primary endpoint in adult CRS patients without nasal polyps, with statistically significant improvements in a composite of the three cardinal symptoms of CRS at week 24, as well as statistically significant gains in key secondary endpoints such as SNOT-22 scores. Additional releases discuss pooled analyses in patients with small nasal polyps and 52-week extension data from ENLIGHTEN 1, which the company describes as supporting a favorable safety profile and durable symptom control.
Investors and observers can also find news about Lyra’s regulatory interactions with the U.S. Food and Drug Administration (FDA), including written feedback and meetings that clarify potential paths toward a New Drug Application for specific CRS populations. Corporate and financial news items cover quarterly and annual results, restructuring charges, workforce reductions, and financing transactions such as a registered direct offering and concurrent private placement of warrants.
More recent corporate updates include announcements that the Board of Directors has decided to suspend further development of LYR-210, cease product development operations, and implement workforce reductions while the company evaluates strategic alternatives. For those tracking LYRA, the news stream provides context on clinical data, regulatory discussions, capital markets activity, and changes in Lyra’s operating plans over time.
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Lyra Therapeutics, Inc. (Nasdaq: LYRA) has resumed screening and enrollment in its ENLIGHTEN II clinical trial for LYR-210, a bioresorbable nasal implant aimed at treating chronic rhinosinusitis (CRS). The trial targets patients who have not responded to medical management. Resumption of enrollment follows a temporary pause for in-house manufacturing adjustments, which Lyra anticipates will strengthen regulatory compliance. The company is also on track with the first ENLIGHTEN trial, with pivotal results expected in the first half of 2024. Each trial will enroll 180 patients, supporting a New Drug Application to the FDA for LYR-210. The product is designed to provide up to six months of sustained anti-inflammatory treatment, showing promising Phase 2 results with no serious adverse events reported.
Lyra Therapeutics, Inc. (Nasdaq: LYRA) reported its financial results for Q4 and full year 2022, highlighting significant advancements in its clinical trials and production capabilities. The company initiated two Phase 3 trials for LYR-210 aimed at chronic rhinosinusitis (CRS), with completion of enrollment expected by mid-2023. Additionally, data from the Phase 2 BEACON trial for LYR-220 is expected in Q4 2023. The transition to in-house manufacturing is set to enhance product quality and supply. Financially, Lyra recorded a net loss of $55.3 million for 2022, with cash reserves projected to sustain operations through mid-2024.
Lyra Therapeutics (Nasdaq: LYRA) has appointed John Bishop, Ph.D., as the new Chief Technology Officer, effective February 27, 2023. Dr. Bishop will spearhead the scaling-up of manufacturing operations for the company's late-stage product candidates, LYR-210 and LYR-220, designed for chronic rhinosinusitis (CRS). His extensive background in chemistry, manufacturing, and controls in biopharmaceuticals positions him to enhance Lyra's in-house systems. The company has approved an equity grant of 220,000 stock options to Dr. Bishop as part of his employment compensation.
Lyra Therapeutics, Inc. (Nasdaq: LYRA) has completed enrollment in the Phase 2 BEACON trial for LYR-220, targeting chronic rhinosinusitis (CRS) patients post-surgery. This investigational product aims to deliver six months of anti-inflammatory medication through a bioresorbable matrix. Initial results from Part 1 showed a significant 37% improvement in SNOT-22 scores, with no serious adverse events recorded. Topline results from Part 2 are expected in Q4 2023, building on the ongoing development of Lyra's previous candidate, LYR-210, for surgically-naïve CRS patients. These advancements position Lyra favorably in the CRS treatment landscape.
Lyra Therapeutics (NASDAQ: LYRA), a clinical-stage biotechnology company, has announced the issuance of an equity-based award to Gloria Cosgrove, its new Senior Vice President of Quality. This inducement grant includes a non-qualified stock option for 100,000 shares, approved by independent directors, as part of her employment compensation. Lyra is focused on developing therapies for chronic rhinosinusitis (CRS), with two investigational product candidates, LYR-210 and LYR-220, in advanced stages of development. These therapies aim to provide non-surgical treatment options for CRS patients, addressing a significant market need in the U.S.
Lyra Therapeutics (Nasdaq: LYRA) announced that CEO Maria Palasis, Ph.D., will speak at two investor conferences in November 2022. The first event is the Stifel 2022 Healthcare Conference, scheduled for November 15 at 4:10 p.m. ET. The second is the Jefferies London Healthcare Conference, set for November 17 at 4:25 p.m. GMT (11:25 a.m. ET). Webcasts of both presentations will be available on the company's Investor Relations section for 90 days.
Lyra Therapeutics (NASDAQ: LYRA) reported third-quarter 2022 financial results, showing a net loss of $14.8 million, up from $11.1 million a year prior. Cash reserves stand at $109.6 million, projected to fund operations through mid-2024. The company prioritizes the ENLIGHTEN I Phase 3 trial for LYR-210 in chronic rhinosinusitis, with enrollment expected to complete by mid-2023. Enrollment in the ENLIGHTEN II trial will temporarily pause to align with in-house manufacturing timelines, expected to resume in Q3 2023. Positive initial data from the BEACON Phase 2 trial of LYR-220 were also highlighted.