Welcome to our dedicated page for Zynerba Pharmace news (Ticker: ZYNE), a resource for investors and traders seeking the latest updates and insights on Zynerba Pharmace stock.
Zynerba Pharmaceuticals, Inc. (NASDAQ: ZYNE) pioneers transdermal synthetic cannabinoid therapies for severe neurological conditions. This dedicated news hub provides investors and healthcare professionals with essential updates on clinical developments, regulatory milestones, and strategic partnerships.
Access timely reports on Zygel™ clinical trials for Fragile X syndrome and 22q11.2 deletion syndrome, FDA designations, and analysis of the Harmony Biosciences acquisition. Our curated news collection eliminates speculation while delivering actionable insights about ZYNE's novel therapeutic pipeline.
Key coverage areas: Phase 3 RECONNECT trial progress, orphan drug designation updates, partnership developments with Harmony Biosciences, and financial disclosures. All content maintains strict compliance with financial reporting standards and therapeutic research guidelines.
Bookmark this page for consolidated access to Zynerba's verified announcements. Monitor critical updates on synthetic cannabinoid advancements directly impacting treatment options for rare neuropsychiatric disorders.
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.