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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 (Nasdaq: ZYNE) presented findings at the ASCP 2022 Annual Meeting, showcasing enhancements in the RECONNECT trial design and the long-term safety of Zygel in treating Fragile X syndrome (FXS) in children and adolescents. Interim results indicated notable efficacy, particularly among patients with complete methylation of the FMR1 gene. The RECONNECT trial includes key modifications based on previous trials, aiming to establish Zygel's effectiveness while easing participation burdens for families. Zygel is a novel cannabidiol gel targeting neuropsychiatric conditions.
Zynerba Pharmaceuticals (Nasdaq: ZYNE) announced participation in the ASCP 2022 Annual Meeting from May 31 to June 3, 2022, in Scottsdale, Arizona. The company will present an oral podium session titled “Long-Term Safety and Sustained Efficacy of ZYN002 Cannabidiol Transdermal Gel in Children and Adolescents with Fragile X Syndrome” on May 31, 2022. Additionally, a poster presentation on the Phase 3 Trial of ZYN002 will occur on June 1, 2022. Presentations will be available on Zynerba's website after the event.
Zynerba Pharmaceuticals (Nasdaq: ZYNE) announced that CEO Armando Anido will present at the H.C. Wainwright Global Investment Conference from May 23-26, 2022. A webcast of the presentation will be accessible on-demand from May 24-26, 2022, on the Zynerba website. The company specializes in innovative transdermal cannabinoid therapies aimed at rare neuropsychiatric disorders, including Fragile X syndrome and autism spectrum disorder. Investors interested in virtual meetings during the conference can contact the conference coordinator.
Zynerba Pharmaceuticals (Nasdaq: ZYNE) reported its Q1 2022 financial results, with a cash position of $69.7 million expected to sustain operations into second-half 2023. The company is actively enrolling patients in the Phase 3 trial of Zygel for Fragile X syndrome, with topline results anticipated in late 2023. Zygel has received orphan drug designation for both FXS and 22q deletion syndrome. A Phase 2 trial for 22q is ongoing, and a Phase 3 trial for Autism Spectrum Disorder is expected to start in late 2022.
Zynerba Pharmaceuticals (NASDAQ: ZYNE) presented data at INSAR 2022 demonstrating the long-term safety and efficacy of Zygel in children and adolescents with Fragile X Syndrome (FXS). The analysis covered 240 patients over 15 months, showing significant improvements in social avoidance and irritability, especially in those with complete methylation of the FMR1 gene. Zygel was well tolerated, with mild adverse effects reported in 12.9% of participants. These findings bolster confidence in Zygel's potential as a treatment for FXS and highlight its unique transdermal delivery method.
Zynerba Pharmaceuticals (Nasdaq: ZYNE) has announced an oral podium presentation at the INSAR 2022 conference, scheduled for May 12, 2022, in Austin, Texas. The presentation will focus on the long-term safety and sustained efficacy of ZYN002, a cannabidiol transdermal gel aimed at treating children and adolescents with Fragile X syndrome. This event demonstrates Zynerba's commitment to advancing treatment options for rare neuropsychiatric disorders, and the presentation will be accessible on their corporate website following the event.
Zynerba Pharmaceuticals (Nasdaq: ZYNE) presented a poster at the 2022 Society of Biological Psychiatry Annual Meeting, highlighting the long-term safety and efficacy of Zygel in children with Fragile X Syndrome (FXS). The study showed Zygel was well-tolerated over 38 months, demonstrating meaningful improvements in social avoidance after 15 months of treatment, particularly in patients with complete methylation of the FMR1 gene. Zynerba emphasizes its commitment to advancing this therapy for affected children and adolescents.
Zynerba Pharmaceuticals (Nasdaq: ZYNE) announced it will present a poster titled Long-Term Safety and Sustained Efficacy of ZYN002 Cannabidiol Transdermal Gel in Children and Adolescents with Fragile X Syndrome at the upcoming Society of Biological Psychiatry (SOBP) Annual Meeting in New Orleans, scheduled for April 29, 2022. This presentation highlights the company's commitment to innovative therapies targeting rare neuropsychiatric disorders. The poster will be available on Zynerba's corporate website after the event.
Zynerba Pharmaceuticals (Nasdaq: ZYNE) announced that CEO Armando Anido will present a company overview at the 21st Annual Needham Virtual Healthcare Conference on April 11, 2022, at 12:45 p.m. ET. Investors interested in virtual meetings with management are encouraged to reach out to the conference coordinator. A webcast of the presentation will be available on Zynerba's website, with an archived replay accessible for 60 days post-event. Zynerba specializes in transdermal cannabinoid therapies aimed at treating rare neuropsychiatric disorders, including Fragile X syndrome, autism spectrum disorder, and 22q11.2 deletion syndrome.
Zynerba Pharmaceuticals (Nasdaq: ZYNE) announced that Stephen O’Quinn, Vice President of Medical Affairs, will participate in the 2022 Cantor Rare Orphan Disease Summit. The panel discussion, titled Rare Neurodevelopmental Disorders, is scheduled for March 30, 2022, from 11:00 a.m. to 12:15 p.m. ET. Zynerba specializes in transdermal cannabinoid therapies for rare neuropsychiatric disorders, aiming to improve the lives of patients with conditions like Fragile X syndrome and autism spectrum disorder.
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