Welcome to our dedicated page for Zynerba Pharmaceuticals news (Ticker: ZYNE), a resource for investors and traders seeking the latest updates and insights on Zynerba Pharmaceuticals stock.
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 55th Gatlinburg Conference, highlighting the long-term safety and efficacy of Zygel for treating children with Fragile X syndrome and 22q11.2 deletion syndrome. The interim results from the ongoing trials indicate Zygel shows sustained improvements over extended treatment periods. Specifically, children with complete methylation of their FMR1 gene experienced significant enhancements in social avoidance metrics. Additionally, Zygel demonstrated statistically significant improvements in anxiety and behavioral symptoms through 38 weeks of treatment in the INSPIRE trial. The company is actively enrolling participants for its Phase 3 RECONNECT trial, aimed at further demonstrating Zygel's efficacy.
Zynerba Pharmaceuticals (Nasdaq: ZYNE) announced its participation in the 55th Gatlinburg Conference, scheduled for April 10-13, 2023, in Kansas City, Mo. The company will present two posters: one on the long-term safety and sustained efficacy of ZYN002 in children with Fragile X Syndrome on April 12, and another on an open-label study of ZYN002 for children with 22q11.2 deletion syndrome on April 13. Zygel, Zynerba's transdermal cannabinoid gel, aims to treat behavioral symptoms associated with these conditions and has received Fast Track designation from the FDA.
Zynerba Pharmaceuticals, Inc. (Nasdaq: ZYNE) reported its 2022 financial results, highlighting a net loss of $35.0 million and cash reserves of $50.6 million as of December 31, 2022. The company is focused on enrolling patients in its Phase 3 RECONNECT trial for Zygel™, targeting Fragile X syndrome, with topline results expected in the first half of 2024. The European Commission granted orphan drug designation for cannabidiol in 22q11.2 deletion syndrome. Zynerba has issued shares under sales agreements, generating approximately $7.8 million in gross proceeds in 2022. The company projects sufficient cash runway into mid-2024 to support its operations.
Zynerba Pharmaceuticals (Nasdaq: ZYNE) announced that it has no cash deposits or securities at Silicon Valley Bank, ensuring its financial security amid concerns affecting other firms. The company specializes in innovative transdermal cannabinoid therapies for neuropsychiatric disorders, including Fragile X syndrome and 22q11.2 deletion syndrome. This communication is vital for investors, reaffirming that Zynerba is not impacted by any potential liquidity issues related to Silicon Valley Bank. The firm remains committed to advancing its clinical development programs and providing solutions for patients with chronic health conditions.
Zynerba Pharmaceuticals (Nasdaq: ZYNE), a leader in transdermal cannabinoid therapies for orphan neuropsychiatric disorders, announced that Armando Anido, Chairman and CEO, will present at the Oppenheimer 33rd Annual Healthcare Conference on March 13, 2023, at 4:40 p.m. ET. The company will also host investor meetings during this event. Investors can arrange virtual meetings through the conference coordinator. A webcast of the presentation will be accessible on Zynerba's website and available on-demand for 60 days post-event.
Zynerba is dedicated to enhancing the lives of patients with severe chronic conditions, including Fragile X syndrome and 22q11.2 deletion syndrome.
Zynerba Pharmaceuticals, a leader in transdermal cannabinoid therapies for neuropsychiatric disorders, announced that Armando Anido, its CEO, will present at Cowen's 43rd Annual Health Care Conference on March 8, 2023, at 2:50 PM ET. The event will take place at the Boston Marriott Copley Place in Massachusetts. Interested investors can arrange meetings with company management through the conference coordinator. An archived webcast of the presentation will be available for 60 days on the Zynerba website.
Zynerba focuses on improving lives for patients with chronic conditions like Fragile X syndrome.
Zynerba Pharmaceuticals (Nasdaq: ZYNE) announced the publication of a paper in the Journal of Neurodevelopmental Disorders, highlighting the endocannabinoid system's role in Fragile X syndrome (FXS) and the potential of cannabidiol (Zygel) as a treatment. The Phase 3 CONNECT-FX trial showed significant behavioral symptom reduction in patients with ≥90% methylation of the FMR1 gene. The findings support ongoing clinical trials, including the pivotal Phase 3 RECONNECT trial.
FAQ
What is the market cap of Zynerba Pharmaceuticals (ZYNE)?
What is the primary focus of Zynerba Pharmaceuticals?
What are Zynerba’s main products?
What recent significant achievement has Zynerba made?
What is Zygel and what conditions is it used for?
What makes Zygel unique compared to other cannabinoid products?
What designations has Zygel received from regulatory agencies?
What is the current status of Zygel’s clinical trials?
How will the acquisition by Harmony Biosciences benefit Zynerba?
What financial terms were involved in the acquisition by Harmony Biosciences?
What does the future hold for Zynerba Pharmaceuticals post-acquisition?
