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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 presentations at two significant virtual events: the Society for Developmental & Behavioral Pediatrics Annual Meeting and the 68th American Academy of Child & Adolescent Psychiatry Annual Meeting. Highlights include an oral presentation on the pivotal study of ZYN002 Cannabidiol Transdermal Gel for Fragile X Syndrome on October 23, 2021, and further findings related to Autism Spectrum Disorder on October 25 and 27, 2021. Presentation materials will be available on the Zynerba corporate website after each event.
Zynerba Pharmaceuticals (Nasdaq: ZYNE) announced a poster presentation at the 2021 NORD Rare Diseases and Orphan Products Breakthrough Summit on October 18-19, 2021. The poster, titled “RECONNECT (ZYN2-CL-033): Design of a Phase 3 Trial of ZYN002 Cannabidiol Transdermal Gel in Children and Adolescents with Fragile X Syndrome Based Upon Learnings from CONNECT-FX (ZYN2-CL-016),” is available on their corporate website. Zynerba focuses on pharmaceutically-produced transdermal cannabinoid therapies for rare neuropsychiatric disorders, including Fragile X syndrome.
Zynerba Pharmaceuticals, Inc. (Nasdaq: ZYNE) presented a poster at the 2021 American Academy of Pediatrics National Conference, detailing the long-term tolerability and efficacy of ZYN002 Cannabidiol Transdermal Gel for children with Autism Spectrum Disorder (ASD). The open-label Phase 2 study, titled BRIGHT (ZYN2-CL-030), showcases its commitment to addressing neuropsychiatric disorders. The poster is now available on the company's website. This presentation underscores Zynerba's dedication to innovative cannabinoid therapies for rare disorders.
Zynerba Pharmaceuticals, Inc. (Nasdaq: ZYNE), a leader in transdermal cannabinoid therapies, will have its CEO Armando Anido join a fireside chat at the 2021 Cantor Virtual Global Healthcare Conference. This event is scheduled for September 27, 2021, at 11:20 a.m. ET. Investors wishing to meet with the management can connect through the Cantor conference coordinator. A webcast of the chat will be accessible on the Company’s website, with an archived replay available for 60 days post-event.
Zynerba Pharmaceuticals has initiated the RECONNECT Phase 3 trial to evaluate the efficacy and safety of Zygel in treating children and adolescents with Fragile X syndrome (FXS). This pivotal trial will enroll approximately 200 participants across multiple countries, including the U.S., Australia, the UK, and Ireland, and is expected to confirm the positive results from the earlier CONNECT-FX trial. The primary endpoint focuses on social avoidance behaviors in patients with complete methylation of the FMR1 gene. Topline results are anticipated in the second half of 2023.
Zynerba Pharmaceuticals (Nasdaq: ZYNE) presented data from its Phase 2 BRIGHT trial on September 9, 2021, at the SSBP Conference 2021. The study evaluated Zygel, a transdermal cannabidiol gel, in children and adolescents with autism spectrum disorder (ASD) over a 38-week treatment period. Results indicated sustained improvements in efficacy measures for ASD. The safety profile was consistent with previous trials, showing mild to moderate adverse events. This data highlights the potential of Zygel to address unmet needs in ASD treatment.
Zynerba Pharmaceuticals (Nasdaq: ZYNE) announced positive results from its Phase 2 BELIEVE study, published in the JAMA Network Open, assessing the safety and efficacy of Zygel™ (ZYN002) for children with developmental and epileptic encephalopathies (DEEs). The study involved 48 patients, showing a median 58% reduction in focal impaired awareness seizures (FIAS) and a 43.5% reduction over 6.5 months. Serious adverse events occurred in 21% of participants but were non-critical. The findings indicate Zygel is a safe and effective non-oral option for managing DEEs.
Zynerba Pharmaceuticals, Inc. (Nasdaq: ZYNE) announced that Armando Anido, Chairman and CEO, will participate in a fireside chat at the H.C. Wainwright 23rd Annual Global Investment Conference from September 13-15, 2021. The event will be held virtually, and interested investors can arrange meetings with the company's management through the conference coordinator. A replay of the fireside chat will be available on-demand from September 13, 2021, at 7:00 a.m. ET on Zynerba's website. The company specializes in innovative transdermal cannabinoid therapies for neuropsychiatric disorders.
Zynerba Pharmaceuticals (Nasdaq: ZYNE) announced the acceptance of two oral presentations at the Society for the Study of Behavioural Phenotypes (SSBP) Conference 2021, taking place virtually on September 9-10, 2021. The presentations will cover the efficacy and tolerability of ZYN002 Cannabidiol Transdermal Gel for children and adolescents with Autism Spectrum Disorder and the pivotal study for those with Fragile X Syndrome. Presentation slides will be available on Zynerba's corporate website following the event.
Zynerba Pharmaceuticals, Inc. (Nasdaq: ZYNE) announced financial results for Q2 2021, reporting a net loss of $10 million with a loss per share of $(0.25). Cash reserves stood at $85.8 million, sufficient for operations into H1 2024. The company plans to initiate a pivotal Phase 3 trial, RECONNECT, for Zygel in Fragile X Syndrome (FXS) during Q3 2021, aiming to confirm previous positive results. Positive FDA feedback regarding Autism Spectrum Disorder (ASD) development options was received, with guidance expected by year-end.
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