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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 that Stephen O’Quinn, Pharm.D., Vice President of Medical Affairs, will speak at the 2022 Cantor Neurology & Psychiatry Conference on October 7, 2022, in San Francisco. The panel is titled Who to Target: Leveraging Biomarkers for Patient Selection in Neuro/Psych Clinical Trials and will take place from 7:50 a.m. to 8:50 a.m. PST. Zynerba management is also available for investor meetings during the conference. The company focuses on transdermal cannabinoid therapies for orphan neuropsychiatric disorders.
Zynerba Pharmaceuticals (Nasdaq: ZYNE) announced that CEO Armando Anido will present at the Ladenburg Thalmann 2022 Healthcare Conference on September 29, 2022, at 3:00 p.m. ET. The conference takes place in New York City, and investor meetings will be hosted as well. An archived webcast of the presentation will be available for 60 days post-event on Zynerba's website. Zynerba is a leader in transdermal cannabinoid therapies targeting orphan neuropsychiatric disorders, aiming to improve the lives of patients with conditions like Fragile X syndrome and autism spectrum disorder.
Zynerba Pharmaceuticals (Nasdaq: ZYNE) presented positive results from the Phase 2 INSPIRE trial at the SSBP Symposium in Oslo, which evaluated Zygel for children with 22q11.2 deletion syndrome.
The trial showed statistically significant and clinically meaningful improvements in anxiety and behavioral symptoms, particularly on the Pediatric Anxiety Rating Scale (PARS-R) and other assessments. Zygel demonstrated a favorable tolerability profile with mild adverse events noted in a few patients. CEO Armando Anido expressed optimism about Zygel's potential and the FDA regulatory path.
Zynerba Pharmaceuticals (Nasdaq: ZYNE) announced that CEO Armando Anido will present at the H.C. Wainwright 24th Annual Global Investment Conference on September 13, 2022, at 2:00 p.m. ET in New York City. Anido will also hold investor meetings during the event. Investors can access an archived webcast of the presentation on Zynerba's website for 60 days post-conference. Zynerba specializes in transdermal cannabinoid therapies for orphan neuropsychiatric disorders, aiming to improve the lives of patients with conditions like Fragile X syndrome and autism.
Zynerba Pharmaceuticals (Nasdaq: ZYNE) announced the acceptance of their oral presentation at the SSBP 24th International Research Symposium in Oslo, Norway, set for September 8-10, 2022. The presentation will focus on the INSPIRE trial showcasing the efficacy of ZYN002 (Cannabidiol) in children and adolescents with 22q11.2 Deletion Syndrome. The slides will be available on the company's corporate website post-presentation. Zynerba emphasizes its commitment to improving lives through cannabinoid therapies for orphan neuropsychiatric disorders.
Zynerba Pharmaceuticals (Nasdaq: ZYNE) continues enrollment in the RECONNECT Phase 3 trial for Zygel in Fragile X syndrome, with topline results expected in H2 2023. The company recently reported positive Phase 2 results for Zygel in 22q11.2 deletion syndrome, showing meaningful improvements. Financially, Zynerba reported $62.5 million in cash as of June 30, 2022, indicating a runway through early 2024. Despite a net loss of $9.9 million in Q2 2022, the company is focusing on FXS and 22q while deferring ASD program development due to market conditions.
Zynerba Pharmaceuticals (Nasdaq: ZYNE) announced that Armando Anido, CEO and Chairman, will present updates at the Canaccord Genuity 42nd Annual Growth Conference on August 10, 2022, at 9:00 a.m. ET in Boston, Massachusetts. The company focuses on transdermal cannabinoid therapies for orphan neuropsychiatric disorders such as Fragile X syndrome and autism spectrum disorder. Investors interested in meetings should contact the conference coordinator. An archived webcast will be available for 60 days after the presentation on Zynerba's website.
Zynerba Pharmaceuticals (Nasdaq: ZYNE) has entered into a $20 million equity purchase agreement with Lincoln Park Capital Fund, LLC. Zynerba can sell shares at its discretion over 36 months, providing flexibility for future financial needs. The company plans to use proceeds for general corporate purposes, including R&D. As of March 31, 2022, Zynerba reported $69.7 million in cash, expected to fund operations into early 2024. This agreement is aimed at supporting the clinical development of Zygel for Fragile X syndrome and 22q11.2 deletion syndrome.
Zynerba Pharmaceuticals (Nasdaq: ZYNE) announced two poster presentations at the 18th NFXF International Fragile X Conference, scheduled for July 14-17, 2022, in San Diego, California. The presentations focus on the long-term safety and efficacy of ZYN002, a cannabidiol transdermal gel, for treating behavioral symptoms in Fragile X syndrome. Management will also present a company overview during a keynote session on July 15, highlighting their commitment to developing therapies for rare neuropsychiatric disorders.
Zynerba Pharmaceuticals (Nasdaq: ZYNE) announced positive results from its Phase 2 INSPIRE trial evaluating Zygel for treating behavioral symptoms in children with 22q11.2 deletion syndrome. The trial showed statistically significant improvements in anxiety, mood, and behavior after 14 weeks of treatment. Zygel demonstrated a favorable safety profile with mild adverse effects. The company plans to focus on developing treatments for Fragile X syndrome and 22q, and its cash runway has been extended through early 2024, allowing for continued operations and development activities.
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