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Zynerba Pharmaceuticals (Nasdaq: ZYNE) announced that the European Commission granted orphan drug designation for Zygel™ in treating Fragile X syndrome (FXS). The company is enrolling patients in the pivotal Phase 3 trial, RECONNECT, with topline results expected in the second half of 2023. Zynerba completed enrollment for a Phase 2 trial in 22q11.2 deletion syndrome, expecting results mid-2022. The company reported a cash position of $67.8 million as of December 31, 2021, ensuring operations through the second half of 2023.
Zynerba Pharmaceuticals has received orphan drug designation from the European Commission for its transdermal gel Zygel™, targeting Fragile X syndrome (FXS). This designation, which addresses a significant unmet medical need, provides 10-year market exclusivity in the EU upon regulatory approval, along with benefits like reduced EMA application fees. The company is currently enrolling patients in the pivotal Phase 3 trial RECONNECT, expecting topline results in H2 2023. They estimate about 105,000 patients with FXS in the EU, supporting future market potential for Zygel.
Zynerba Pharmaceuticals announced the completion of enrollment in its 14-week Phase 2 INSPIRE trial assessing Zygel for treating behavioral symptoms of 22q11.2 deletion syndrome in children. The trial, which includes 20 patients, expects to release topline data by mid-2022. Zygel has received orphan drug designation from the FDA for its potential application in 22q. The trial aims to evaluate the efficacy and safety of Zygel, a transdermal cannabinoid gel. CEO Armando Anido highlighted the trial's significance for patients facing behavioral challenges associated with 22q.
Zynerba Pharmaceuticals (Nasdaq: ZYNE) has appointed Albert P. Parker as the new Chief Legal Officer and Corporate Secretary, effective after the retirement of Suzanne Hanlon at the end of February 2022. Parker brings over 25 years of experience in the pharmaceutical and biotech industries, including prior roles at Oncocyte Corporation and Sunovion Pharmaceuticals. The leadership change aims to strengthen Zynerba's capacity in developing therapies for rare neuropsychiatric disorders, such as Fragile X syndrome and autism spectrum disorder.
Zynerba Pharmaceuticals (Nasdaq: ZYNE) announced that Armando Anido, its Chairman and CEO, will present a company overview at the 11th Annual SVB Leerink Global Healthcare Conference on February 18, 2022, at 8:40 a.m. ET. The presentation will focus on their innovative transdermal cannabinoid therapies aimed at treating rare neuropsychiatric disorders. Interested investors can arrange virtual meetings or view the presentation via a webcast on the Zynerba website. An archived replay will also be available for 60 days post-event.
Zynerba Pharmaceuticals (Nasdaq: ZYNE) announced that CEO Armando Anido will present at the H.C. Wainwright BioConnect Conference from January 10-13, 2022. The presentation will focus on the company's innovative transdermal cannabinoid therapies aimed at treating rare neuropsychiatric disorders such as Fragile X syndrome and autism spectrum disorder. An on-demand webcast will be available starting January 10, 2022, at 7:00 a.m. ET on the company's website, and an archived replay will be accessible for 60 days thereafter.
Zynerba Pharmaceuticals (Nasdaq: ZYNE) is focusing on the development of Zygel for the treatment of Fragile X syndrome (FXS), autism spectrum disorder (ASD), and 22q11.2 deletion syndrome (22q). The company plans to initiate a Phase 3 trial for ASD in the second half of 2022 and is awaiting topline results from its ongoing Phase 3 trial for FXS in the second half of 2023. Zynerba has sufficient cash reserves of $75.6 million to fund operations into late 2023, supporting its clinical programs. The completion of patient enrollment in the INSPIRE trial for 22q is ongoing, with results expected mid-2022.
Zynerba Pharmaceuticals (Nasdaq: ZYNE) announced its participation in the BRAIN Foundation Synchrony 2021 Symposium, happening virtually on December 11-12, 2021. The company will present on the efficacy and safety of ZYN002 Cannabidiol Transdermal Gel, focusing on its clinical research related to autism and Fragile X syndrome. The oral presentation is scheduled for 5:00 p.m. ET on December 11, and the slides will be available on Zynerba's website after the presentation.
Zynerba Pharmaceuticals (Nasdaq: ZYNE) announced the issuance of European Patent No. 3687513, titled “Treatment of Fragile X Syndrome and Autism with Cannabidiol.” This patent protects methods for treating behavioral symptoms associated with Fragile X syndrome and autism spectrum disorder using Zygel™, a transdermal CBD gel. Expiring in 2038, this patent enhances Zynerba's international intellectual property portfolio, which already includes five U.S. patents related to these conditions.
Zynerba Pharmaceuticals (ZYNE) has initiated the pivotal Phase 3 RECONNECT trial for Zygel in patients with Fragile X Syndrome (FXS), with topline results anticipated in the second half of 2023. The trial aims to validate positive results from earlier studies and involves around 200 participants across multiple sites. As of September 30, 2021, the company reported a cash position of $75.6 million, sufficient to fund operations into the first half of 2024. However, the third quarter net loss stood at $10.6 million, equating to a loss per share of $(0.26).
