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Zynerba Pharmaceuticals, Inc. (NASDAQ: ZYNE) is at the forefront of developing next-generation synthetic cannabinoid therapeutics designed for transdermal delivery. This innovative approach is aimed at patients with significant unmet medical needs, including refractory epilepsy, osteoarthritis, Fragile X syndrome (FXS), fibromyalgia, and peripheral neuropathic pain. The company’s mission is to enhance the lives of individuals suffering from these severe health conditions through advanced therapeutics.
Zynerba's development pipeline features patent-protected transdermal cannabinoid products, notably the CBD gel ZYN002 and the THC pro-drug patch ZYN001. ZYN002, marketed as Zygel™, is the first and only pharmaceutically manufactured, synthetic cannabidiol, designed as a permeation-enhanced gel for transdermal delivery. Unlike many cannabinoid products, Zygel contains no THC, eliminating the euphoric effects associated with cannabis. Zygel is currently under evaluation in a pivotal Phase 3 clinical trial for FXS (the RECONNECT Trial) and has shown promising results in a Phase 2 trial for 22q11.2 deletion syndrome (the INSPIRE Trial).
Recent developments highlight Zynerba’s potential impact. On August 14, 2023, Harmony Biosciences Holdings, Inc. (NASDAQ: HRMY) announced a definitive agreement to acquire Zynerba, emphasizing the strategic fit between the two companies. Harmony’s acquisition aims to advance the development and delivery of transformative treatments for rare neuropsychiatric disorders. The transaction terms include an upfront cash payment of $1.1059 per share, totaling $60 million, and the issuance of a contingent value right (CVR) per share, which could lead to additional payments up to $140 million.
Zynerba’s lead candidate, Zygel, has been granted orphan drug designation by the FDA and the European Medicines Agency (EMA) for treating FXS and 22q11.2 deletion syndrome. Additionally, Zygel has received FDA Fast Track designation for FXS behavioral symptoms treatment. These designations highlight Zynerba’s commitment to addressing conditions that currently lack FDA-approved therapies.
Zynerba Pharmaceuticals continues to push the boundaries of cannabinoid science, aiming to provide new, effective treatment options for patients not adequately served by current therapies. The company’s focus on rigorous clinical trials and regulatory compliance positions it as a leader in the field of synthetic transdermal cannabinoid therapeutics.
Zynerba Pharmaceuticals has announced a delay in the topline results from its Phase 3 RECONNECT trial of Zygel for treating Fragile X syndrome, now expected in the first half of 2024 due to environmental factors including high rates of RSV, influenza, and COVID-19 affecting screening visits and enrollment. The company has prioritized resources to complete the trial and confirmed its cash runway is extended to mid-2024.
Zynerba Pharmaceuticals (Nasdaq: ZYNE) presented encouraging 38-week data from the Phase 2 INSPIRE trial of Zygel, showing statistically significant improvements in anxiety-related and behavioral symptoms in children with 22q11.2 deletion syndrome. The results, shared at the 61st Annual Meeting of the American College of Neuropsychopharmacology, indicated that Zygel was well-tolerated, with only mild treatment-related adverse events reported. With 20 patients enrolled and promising outcomes, this trial reinforces Zygel's potential as a viable treatment option for managing symptoms associated with 22q syndrome.
Zynerba Pharmaceuticals (Nasdaq: ZYNE) announced a poster presentation at the 61st Annual Meeting of the American College of Neuropsychopharmacology from December 4-7, 2022, in Phoenix, Arizona. The study focuses on the tolerability and efficacy of ZYN002 (cannabidiol) as a transdermal gel for children with 22q11.2 deletion syndrome. The poster will be available online starting December 5, 2022. Zygel, the company’s investigational drug, targets neuropsychiatric conditions like Fragile X syndrome and autism spectrum disorder and has received orphan drug designation from the FDA.
Zynerba Pharmaceuticals (ZYNE) announces encouraging findings from the CONNECT-FX study, where Zygel improved behavioral symptoms in children with Fragile X syndrome (FXS). The Phase 3 trial involved 212 participants and revealed significant efficacy in patients with ≥90% FMR1 gene methylation, who showed a notable reduction in social avoidance and irritability. Though the primary endpoint for the full cohort was not met, results for the targeted population may support future drug applications. Topline results from the follow-on RECONNECT trial are expected in late 2023.
Zynerba Pharmaceuticals (Nasdaq: ZYNE) announced that the European Commission has granted orphan drug designation to cannabidiol, the active ingredient in its transdermal gel, Zygel™, for treating 22q11.2 deletion syndrome (22q). This designation is crucial for advancing Zygel as a potential treatment option. There are approximately 112,000 patients with 22q in the EU, highlighting a significant unmet medical need. Zynerba has previously received similar designations for Zygel in treating Fragile X syndrome, showcasing its commitment to neuropsychiatric disorders.
Zynerba Pharmaceuticals reported its financial results for Q3 2022, highlighting a net loss of $8.7 million and cash reserves of $55.9 million as of September 30, 2022. The company's pivotal Phase 3 RECONNECT trial for Zygel in Fragile X syndrome continues to enroll patients, with topline results expected in the latter half of 2023. Zynerba aims for Zygel to become the first FDA-approved treatment for FXS. Additionally, recent patents for treating FXS and 22q11.2 Deletion Syndrome using cannabidiol have been granted, enhancing its intellectual property portfolio.
Zynerba Pharmaceuticals (Nasdaq: ZYNE) announced the issuance of U.S. Patent No. 11,458,109 for treating 22q11.2 Deletion Syndrome using cannabidiol. This patent, expiring in 2040, expands Zynerba's intellectual property portfolio, which now includes seven U.S. patents and one EU patent related to various neuropsychiatric conditions. Zygel, the company's transdermal cannabidiol product, aims to treat behavioral symptoms associated with Fragile X syndrome, 22q, and autism spectrum disorder. The orphan drug designation and Fast Track status further strengthen ZYNE's position in the market.
Zynerba Pharmaceuticals (Nasdaq: ZYNE) showcased a poster titled “An Open-Label Tolerability and Efficacy Study of ZYN002” at the NORD Rare Diseases Summit. The study, involving 20 patients with 22q11.2 deletion syndrome, demonstrated significant improvements in anxiety and behavioral symptoms during a 14-week period. Key outcomes included notable enhancements in the Pediatric Anxiety Rating Scale and other assessment measures. Zygel, the transdermal gel used in the trial, was well tolerated, with mild adverse events reported. Zynerba aims to discuss regulatory pathways with the FDA based on the promising Phase 2 data.
Zynerba Pharmaceuticals (Nasdaq: ZYNE) announced a poster presentation at the 2022 National Organization for Rare Disorders (NORD) Rare Diseases and Orphan Products Breakthrough Summit on October 17-18, 2022. The poster, titled An Open-Label Tolerability and Efficacy Study of ZYN002 (Cannabidiol) Administered as a Transdermal Gel to Children and Adolescents with 22q11.2 Deletion Syndrome (INSPIRE), will highlight the company’s innovative transdermal cannabinoid therapies aimed at improving conditions like Fragile X syndrome, 22q11.2 deletion syndrome, and autism spectrum disorder.
Zynerba Pharmaceuticals (Nasdaq: ZYNE) announced the issuance of U.S. Patent No. 11,458,110 titled “Treatment of Fragile X Syndrome With Cannabidiol.” This patent expands its intellectual property for Zygel, a transdermal cannabidiol product candidate, which aims to treat behavioral symptoms of Fragile X syndrome and other neuropsychiatric disorders. Zygel is designated as a Fast Track development program and has received orphan drug status from the FDA and the European Commission. The patent is valid until 2038, enhancing the company's market position in the therapeutic landscape.
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