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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 a forthcoming teleconference with the FDA in Q4 2020 to discuss the regulatory pathway for Zygel™ targeting Fragile X Syndrome (FXS). This meeting is significant for assessing pivotal CONNECT-FX data and the treatment's tolerability. The company also secured a new patent for FXS treatment. Additionally, the FDA advised focusing on individual syndromes in its developmental and epileptic encephalopathies (DEE) program, with Zynerba evaluating potential targets for late-stage clinical trials.
Zynerba Pharmaceuticals (NASDAQ: ZYNE) announced that CEO Armando Anido will present at two virtual investor conferences: the HC Wainwright Virtual 22nd Annual Healthcare Conference on September 14, 2020, at 3:30 PM EDT, and the Cantor Global Virtual Healthcare Conference on September 15, 2020, at 1:20 PM EDT. Both presentations will be accessible through the Investor Relations page on Zynerba's website. The company specializes in transdermal cannabinoid therapies targeting rare neuropsychiatric disorders such as Fragile X syndrome and autism spectrum disorder.
Zynerba Pharmaceuticals (NASDAQ:ZYNE) reported its second quarter 2020 financial results, showing a net loss of $20.3 million and a loss per share of $(0.78). The company noted significant progress in its clinical trials, particularly with Zygel for Fragile X Syndrome and autism spectrum disorder, where statistically significant improvements were observed. Financially, cash and cash equivalents rose to $77 million, providing sufficient funding to sustain operations into Q4 2021. However, guidance on the Phase 2 INSPIRE trial has been withdrawn due to COVID-19-related delays.
Zynerba Pharmaceuticals, a leader in transdermal cannabinoid therapies for rare neuropsychiatric disorders, announced a presentation by CEO Armando Anido at the 40th Annual Canaccord Genuity Growth Conference. The event will occur virtually on August 12, 2020, at 4:30 PM EDT, with a live webcast available on their Investor Relations page. Zynerba focuses on improving the lives of patients with severe conditions such as Fragile X syndrome and autism spectrum disorder. More details can be found at zynerba.com.
Zynerba Pharmaceuticals (NASDAQ: ZYNE) will present its Zygel™ (ZYN002) program focusing on Fragile X syndrome at the 17th NFXF International Fragile X Conference Research Roundup on July 22, 2020. The pivotal CONNECT-FX trial studied the efficacy of Zygel CBD gel in 212 patients, with results indicating a statistically significant improvement in social avoidance behaviors. In this presentation, caregiver-reported data will also be discussed, highlighting the positive impact on anxiety and other behavioral challenges among patients with Fragile X Syndrome.
Zynerba Pharmaceuticals announced results from its pivotal CONNECT-FX trial, assessing Zygel™ CBD gel for Fragile X syndrome. The study, involving 212 patients, did not achieve statistical significance in primary endpoints against placebo. However, a pre-planned analysis of patients with full methylation of the FMR1 gene (comprising 80% of participants) achieved significance (p=0.020) in the Social Avoidance subscale. Zynerba plans to discuss FDA regulatory pathways based on these findings. The safety profile of Zygel was consistent with prior studies, showing mild to moderate adverse events.
Zynerba Pharmaceuticals (NASDAQ: ZYNE) has shared promising results from the Phase 2 FAB-C trial of Zygel™ (CBD transdermal gel) for treating Fragile X syndrome, highlighting sustained improvements in behavioral symptoms over two years. Data presented showed statistically significant enhancements in various measures from baseline, maintained throughout the study. The company looks forward to pivotal trial CONNECT-FX results expected in late Q2 2020. Zygel demonstrated a strong tolerability profile, with mild adverse events and no serious treatment-related issues reported.
Zynerba Pharmaceuticals (NASDAQ: ZYNE) announced findings from the Phase 2 BELIEVE trial, which evaluates Zygel™, a transdermal gel for children with developmental and epileptic encephalopathies. Results indicate a median 43.5% reduction in seizure frequency over 26 weeks, with notable improvements in quality of life measures for 84% of caregivers. The treatment was well tolerated, with no major safety concerns. These data support further investigation into Zygel’s efficacy in this patient population, potentially enhancing care for medically fragile children.
Zynerba Pharmaceuticals (NASDAQ: ZYNE) announced a shift to a virtual format for its Annual Meeting on June 10, 2020, in light of COVID-19 public health guidance. The meeting will commence at 8:00 a.m. ET, with online check-in starting at 7:30 a.m. ET. Shareholders must register by June 7 to participate via audio webcast and vote electronically. The company emphasizes the importance of pre-voting to ensure all votes are counted. Zynerba focuses on transdermal cannabinoid therapies for rare neuropsychiatric disorders.
Zynerba Pharmaceuticals (NASDAQ:ZYNE) reported Q1 2020 financial results, highlighting a net loss of $12.3 million and cash reserves of $60.6 million. The company remains focused on developing Zygel for rare neuropsychiatric disorders, with key clinical trials on track despite COVID-19 disruptions. Topline results from the pivotal CONNECT-FX trial for Fragile X syndrome are expected by late Q2 2020, followed by a potential New Drug Application submission in H2 2020. New U.S. patent received for ASD treatment further strengthens its product pipeline.
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