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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 its participation in the Virtual ISPOR 2021 conference from May 17-20, 2021. The company presented an oral session titled “Caregiver-Perceived Behavioral Challenges in Fragile X Syndrome (FXS)” and a poster on thresholds for the Aberrant Behavior Checklist-Community in children with FXS. These presentations highlight the effectiveness of Zynerba's clinical trial endpoints and their relevance to patients and caregivers. According to Chief Medical Officer Joseph M. Palumbo, the data support the use of these measures in ongoing clinical trials.
Zynerba Pharmaceuticals reported its Q1 2021 financial results, highlighting a net loss of $8.0 million and a cash position of $93.1 million as of March 31, 2021. The company plans to initiate the pivotal RECONNECT trial of Zygel for Fragile X Syndrome in Q3 2021, aiming to confirm previous positive results. In addition, Zynerba resumed patient screening for the Phase 2 INSPIRE trial in 22q11.2 Deletion Syndrome. The company believes it has sufficient cash to fund operations into the first half of 2024.
Zynerba Pharmaceuticals (Nasdaq: ZYNE) announced the initiation of a pivotal confirmatory Phase 3 trial named RECONNECT for its transdermal gel Zygel, targeting Fragile X syndrome (FXS). Scheduled for the third quarter of 2021, the trial follows positive results from the CONNECT-FX trial, focusing on children and adolescents. The primary endpoint measures changes in the Aberrant Behavior Checklist-Community FXS Specific Social Avoidance subscale. If successful, Zygel could become the first FDA-approved treatment for FXS, addressing a significant unmet medical need.
Zynerba Pharmaceuticals (Nasdaq: ZYNE) is showcasing two posters at the Society of Biological Psychiatry 2021 Virtual Meeting, focusing on their transdermal cannabinoid therapies for Fragile X Syndrome (FXS). The first poster discusses the responder thresholds for meaningful behavioral changes in FXS patients, demonstrating improvements with Zygel (ZYN2). The second poster, to be presented on April 30, highlights findings from the CONNECT-FX study. Zynerba aims to enhance the lives of patients with rare neuropsychiatric disorders through their innovative therapies.
Zynerba Pharmaceuticals (Nasdaq: ZYNE) announced the acceptance of two posters for presentation at the Society of Biological Psychiatry 2021 Virtual Meeting, taking place from April 29 to May 1, 2021. The posters focus on the potential benefits of Cannabidiol in treating Fragile X Syndrome. The first poster discusses the proposed mechanism of action, while the second highlights a pivotal study on ZYN002, a Cannabidiol transdermal gel for children and adolescents with Fragile X Syndrome. Both will be available on the corporate website during their presentation dates.
Zynerba Pharmaceuticals (Nasdaq: ZYNE) has announced that CEO Armando Anido will present a company overview at the 20th Annual Needham Virtual Healthcare Conference on April 12, 2021, at 1:30 p.m. ET. The presentation will focus on Zynerba's innovative transdermal cannabinoid therapies for rare neuropsychiatric disorders.
Investors can arrange virtual meetings with the management team via Needham's conference coordinator. A webcast will be available on Zynerba's website, with an archived replay accessible for 60 days post-event.
Zynerba Pharmaceuticals reported Q4 and full year 2020 financial results, reflecting a net loss of $9.6 million or $(0.33) per share for Q4, and a total net loss of $51.3 million or $(1.90) per share for the year. Research and development expenses totaled $35.7 million in 2020. As of December 31, 2020, the company held $59.2 million in cash. Notably, Zynerba plans to initiate a pivotal trial for Zygel in Fragile X syndrome and has resumed patient screening in the INSPIRE trial for 22q11.2 deletion syndrome. Positive data from Zygel trials show promising seizure reduction in developmental and epileptic encephalopathies.
Zynerba Pharmaceuticals (Nasdaq: ZYNE) will participate in the 33rd Annual ROTH Conference from March 15-17, 2021. The virtual event aims to connect the Company’s management with investors. Interested investors can arrange meetings on March 17 by contacting the ROTH conference coordinator or via the provided email address.
Zynerba focuses on transdermal cannabinoid therapies for rare neuropsychiatric disorders, including Fragile X syndrome and autism spectrum disorder. The Company is committed to improving the lives of patients with severe health conditions.
Zynerba Pharmaceuticals (Nasdaq: ZYNE) announced that CEO Armando Anido will speak at two virtual investor conferences. He will participate in a fireside chat at the H.C. Wainwright BioConnect Conference, available on demand from January 11-14, 2021. Anido will also present a company overview at the ICR Conference 2021 on January 14, 2021, at 10:00 a.m. ET. Investors can request virtual meetings during the ICR Conference through the conference coordinator or via email. Webcasts of both events will be accessible on Zynerba's website.
Zynerba Pharmaceuticals (NASDAQ: ZYNE) announced a pivotal double-blind, placebo-controlled trial for Zygel in patients with Fragile X syndrome (FXS) following positive results from the CONNECT-FX trial. The FDA meeting will help finalize trial design in early 2021, with expectations to initiate the trial by late 2021. Positive outcomes from this trial could support a New Drug Application (NDA) submission. The company's cash runway is projected to extend into early 2023, aiding development plans for Zygel across various neuropsychiatric disorders.
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