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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 is under investigation for potential claims against its officers related to a securities class action. This follows allegations that the company misled investors about its Zygel drug trial, where a significant percentage of patients experienced adverse events. Following the negative trial results announced on September 18, 2019, Zynerba's stock plummeted nearly 22%. Currently, the share price hovers below $4.50, a drastic drop from $8.84. The case is set to advance to trial after the court denied a motion to dismiss.
Zynerba Pharmaceuticals (NASDAQ: ZYNE) recently presented promising results from the Phase 2 BELIEVE trial at the 2020 American Epilepsy Society meeting. The data showed a median 73% reduction in monthly seizure frequency after 12 months of Zygel treatment in children with developmental and epileptic encephalopathies (DEE). The trial also highlighted Zygel's positive impact on sleep disturbances, with significant improvements reported across various sleep issues. The results underscore Zygel's potential as a well-tolerated treatment in a challenging patient population, warranting further investigation.
Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE) announced the acceptance and presentation of two posters at the 2020 virtual annual meeting of the American Epilepsy Society, taking place from December 4-8, 2020. The posters will detail findings from the BELIEVE clinical trial of ZYN002, a transdermal cannabinoid gel, focused on children and adolescents with developmental and epileptic encephalopathies. The presentations are scheduled for December 4, 2020, and will be accessible on Zynerba's website post-presentation.
Zynerba Pharmaceuticals (NASDAQ:ZYNE) reported third-quarter results for 2020, highlighting significant clinical progress, especially in its Zygel treatments for Fragile X Syndrome (FXS) and Autism Spectrum Disorder (ASD). Key findings from the CONNECT-FX trial indicated that over 58% of patients showed clinically meaningful improvement in socially avoidant behavior. The company also received a new U.S. patent for cannabidiol treatment of FXS. Financially, Zynerba ended the quarter with $64.3 million in cash, reporting a net loss of $9 million. Management anticipates sufficient funding until late Q4 2021.
Zynerba Pharmaceuticals (NASDAQ:ZYNE) presented data from the CONNECT-FX trial at the virtual Joint 16th International Child Neurology Congress and the AACAP 2020 Annual Meeting. The study investigated the role of FMR1 methylation status in children with Fragile X syndrome (FXS) as it relates to disease severity and treatment response to Zygel (ZYN002). The results indicate that patients with fully methylated FMR1 achieved significant improvements in behavioral symptoms compared to placebo, including statistically significant changes in social avoidance and irritability. FDA discussions are planned for Q4 2020.
Zynerba Pharmaceuticals (NASDAQ:ZYNE) presented new data from the Phase 2 BRIGHT trial indicating that Zygel (ZYN002) may improve core behavioral symptoms in children and adolescents with Autism Spectrum Disorder (ASD) when added to standard care. The trial enrolled patients aged 3 to <18 years and showed statistically significant caregiver-reported improvements across all Autism Impact Measure subscales, with notable results in Communication (p<0.001) and Social Reciprocity (p=0.0053). The findings were shared at the virtual Joint 16th International Child Neurology Congress and the upcoming AACAP 2020 Annual Meeting.
Zynerba Pharmaceuticals (NASDAQ:ZYNE) recently presented data from the Phase 2 BRIGHT trial for Zygel™, a transdermal gel for treating children and adolescents with Autism Spectrum Disorder (ASD). Initial findings suggest Zygel may improve core behavioral symptoms when combined with standard care. Key improvements in caregiver-reported outcomes across all Autism Impact Measure subscales were statistically significant. The trial evaluated safety, tolerability, and efficacy over 14 weeks, with results indicating a positive benefit-risk profile. Future controlled trials are anticipated to validate these findings.
Zynerba Pharmaceuticals (NASDAQ: ZYNE) announced the acceptance of two oral presentations at the virtual AACAP 2020 Annual Meeting occurring from October 12-24, 2020. The presentations will focus on clinical trial responses to Zygel in children and adolescents with Fragile X syndrome and autism spectrum disorder. Dr. Joseph Palumbo expressed gratitude for the opportunity to share significant findings with the scientific community. The oral presentations are scheduled for October 23, 2020, and will discuss the role of methylation status and the efficacy of ZYN002 Cannabidiol transdermal gel.
Zynerba Pharmaceuticals (NASDAQ:ZYNE) announced the acceptance of two posters for the virtual Joint 49th Annual Child Neurology Society & 16th International Child Neurology Society Congress (CNS-ICNA) from October 12-23, 2020. The posters focus on ZYN002, a transdermal cannabidiol gel, addressing its role in Fragile X Syndrome and its efficacy in Autism Spectrum Disorder. The data aims to explore disease severity and treatment tolerability in children and adolescents. Full posters will be available on the company's website during the event.
Zynerba Pharmaceuticals (NASDAQ: ZYNE) has received orphan drug designation from the FDA for its cannabidiol (CBD) gel, Zygel™, intended to treat 22q11.2 deletion syndrome (22q), a rare condition affecting 81,000 individuals in the U.S. The designation may provide tax incentives, fee waivers, and a seven-year exclusive marketing period. CEO Armando Anido emphasized the urgency in developing therapeutics for this patient group. 22q syndrome is associated with significant neuropsychiatric and behavioral challenges, including anxiety and social interaction difficulties.
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