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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) announced participation in a fireside chat at the Canaccord Genuity 41st Annual Growth Conference on August 11, 2021, at 1:30 p.m. ET. The event will be held virtually, and investors can arrange meetings with management through the conference coordinator. The fireside chat will be available via live webcast on www.zynerba.com and can be accessed later in an archived format for 60 days. Zynerba focuses on innovative transdermal cannabinoid therapies for rare neuropsychiatric disorders.
Zynerba Pharmaceuticals, the leader in innovative cannabinoid therapies, announced that Armando Anido, its CEO, will present a company overview at the Ladenburg Thalmann Virtual Healthcare Conference on July 14, 2021, at 12:00 p.m. ET. The presentation will be accessible via a webcast on Zynerba's website, with an archived replay available for 60 days post-event. Zynerba focuses on treating rare neuropsychiatric disorders, including Fragile X syndrome and autism spectrum disorder. Investors can arrange virtual meetings through the conference coordinator.
Zynerba Pharmaceuticals (Nasdaq: ZYNE) has adjourned its 2021 Annual Meeting of Stockholders due to a lack of quorum, with only 49% of shares voted. The meeting will reconvene on August 3, 2021, at 9:00 AM EDT, and will be held virtually. The record date for the annual meeting remains April 14, 2021. Stockholders are encouraged to vote via the internet, telephone, mail, or during the virtual meeting. Proxies already submitted will remain valid unless revoked.
Zynerba Pharmaceuticals (Nasdaq: ZYNE) presented promising Phase 2 trial data at SLEEP 2021, showcasing the impact of ZYN002 cannabidiol transdermal gel on sleep disorders in children with developmental and epileptic encephalopathies (DEE) and autism spectrum disorder (ASD). The trial indicated significant improvements in sleep-related metrics, particularly in patients with both DEE and ASD. Results were exploratory and warrant further research. Zygel was well tolerated, with most side effects being mild or moderate. The findings suggest better seizure control and behavior improvements due to enhanced sleep.
Zynerba Pharmaceuticals (Nasdaq: ZYNE) announced the adjournment of its 2021 Annual Meeting of Stockholders due to a lack of quorum, with only 46.4% of shares voted, just shy of the 50% required. The meeting is set to reconvene June 29, 2021, as a virtual event at 9:00 AM EDT. Stockholders are encouraged to submit their votes via Internet, telephone, mail, or during the virtual meeting. Proxies will be carried over unless revoked. The record date remains April 14, 2021.
Zynerba Pharmaceuticals (Nasdaq: ZYNE) announced the acceptance of a poster presentation at the SLEEP 2021 conference, taking place virtually from June 10-13, 2021. The poster, titled "Impact of ZYN002 Cannabidiol Transdermal Gel on Sleep in Children and Adolescents with Developmental and Epileptic Encephalopathies and Comorbid Autism Spectrum Disorder," will be presented on June 11 at 12:15 p.m. ET. The company focuses on developing innovative transdermal cannabinoid therapies for rare neuropsychiatric disorders. Details will be made available on their corporate website during the presentation.
Zynerba Pharmaceuticals (Nasdaq: ZYNE) presented a poster at the 2021 ASCP Annual Meeting, highlighting the potential of Zygel™ in treating Autism Spectrum Disorder (ASD) and related conditions. The poster showcases data from two open-label Phase 2 trials and a double-blind placebo-controlled trial, indicating Zygel may improve behavior, reduce seizures, and enhance sleep in children and adolescents with ASD. Zynerba's Chief Medical Officer expressed optimism about Zygel's prospects pending further validation in future trials.
Zynerba Pharmaceuticals (Nasdaq: ZYNE) announced the acceptance of a poster presentation at the 2021 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting, scheduled for June 1-4, 2021.
Zynerba Pharmaceuticals, Inc. (Nasdaq: ZYNE) announced that CEO Armando Anido will present a company overview at the Jefferies Virtual Healthcare Conference on June 3, 2021, at 4:30 p.m. ET. This presentation will focus on Zynerba's innovative transdermal cannabinoid therapies for rare neuropsychiatric disorders.
Investors can arrange virtual meetings by contacting the Jefferies conference coordinator. A webcast of the presentation will be available on Zynerba's website, with a replay accessible for 60 days post-event.
On April 28, 2021, Zynerba Pharmaceuticals entered into a Stipulation for the settlement of a derivative litigation involving current and former directors. The settlement, pending court approval, aims to resolve allegations of fiduciary duty breaches related to clinical trials for ZYN002. It includes corporate governance reforms and a proposed fee of up to $387,500 for Plaintiffs’ Counsel. Shareholders must act by June 24 to object to the settlement, which will bar future claims if approved.
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