Zynerba Pharmaceuticals (ZYNE)

[Fress]

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Just a reminder-FAB-C Data Accepted for Presentation at the Annual Meeting of the American Psychiatric Association (APA), May18-20-2019 in San Francisco,CA
Plus there’s another Presentation coming that will describe data from the FAB-C ( Treatment of Fragile x Syndrome Anxiety and Behavioral Challenges with CBD ) Trial that highlight the short - and long-term positive impact of ZYN002 on children and adolescents with FXS. The Poster entitled “Transdermal Cannabidiol (CBD) Gel for the treatment of Fragile x syndrome” (poster#P5-092) will be presented on Monday May 20, 2019 From 10:00AM to 12:00PM PDT during Poster session 5.
https://zynerba.com/zynerba-pharmaceuticals-reports-fourth-quarter-and-year-end-2018-financial-results-and-operational-highlights/




Company also announced that its current cash and cash equivalent position is expected to fund operations and capital requirements into the first quarter of 2021.

“The fourth quarter of 2018 was a period of strong clinical and corporate momentum, as we achieved our remaining 2018 milestones and positioned ourselves well for a watershed year in 2019,” said Armando Anido, Chairman and Chief Executive Officer of Zynerba. “We continued enrollment into CONNECT-FX, our pivotal trial of Zygel™ in Fragile X Syndrome, and completed enrollment in BELIEVE 1, our Phase 2 trial in Developmental and Epileptic Encephalopathies. We also initiated the BRIGHT trial, which will evaluate Zygel in Autism Spectrum Disorder and are on track to initiate a Phase 2 trial in 22q11.2 Deletion Syndrome in the second quarter of 2019. Finally, we have a cash position that we expect to take us through our expected NDA submission and potential approval for Zygel in Fragile X Syndrome.”

Fourth Quarter 2018 and Recent Highlights

Zygel in Fragile X Syndrome (FXS)

Fragile X Syndrome Pivotal Data Expected in the Second Half of 2019

Enrollment is progressing in CONNECT-FX, a pivotal, multi-national, randomized, double blind, placebo-controlled trial evaluating the efficacy and safety of Zygel (formerly referred to as ZYN002) in three through 17-year old patients with FXS. The primary endpoint is the change from baseline to the end of the treatment period in the Aberrant Behavior Checklist-Community FXS Specific (ABC-CFXS) Social Avoidance subscale. Clinical investigative sites are enrolling patients in the United States, Australia, and New Zealand. Patients who have completed the double-blind phase are now enrolling into the 12-month open label extension phase. The Company expects to report top line data in the second half of 2019. If the data are positive, the Company expects to submit its New Drug Application (NDA) for Zygel in FXS to the U.S. Food and Drug Administration in the first half of 2020, with potential approval by year-end 2020. There are currently no approved products indicated for FXS.

Presented New Data at the 57th Annual Meeting of the American College of Neuropsychopharmacology (ACNP) from the Ongoing Open Label FAB-C Phase 2 Trial of Zygel

Zynerba presented new data demonstrating that treatment with Zygel improved core emotional and behavioral symptoms of FXS with statistical significance versus baseline across multiple measures of efficacy at month three, and that these improvements were sustained through 12 months of treatment. For example, significant improvements vs. baseline in social avoidance as measured by the ABC-CFXS were demonstrated at three months (58% improvement; p=0.0040) and 12 months (77% improvement; p=0.0013) of treatment with Zygel.

Announced Receipt of New U.S. Patent for Treatment of Fragile X Syndrome with Cannabidiol (CBD)

The U.S. Patent and Trademark Office issued U.S. Patent No. 10,213,390 titled “Treatment of Fragile X Syndrome with Cannabidiol” which includes claims directed to methods of treating Fragile X Syndrome by administering a therapeutically effective amount of synthetic or purified CBD. This new patent expires in 2038 and is part of an expanding intellectual property portfolio covering Zygel.

FAB-C Data Accepted for Presentation at the Annual Meeting of the American Psychiatric Association (APA), May 18–22, 2019 in San Francisco, CA

The presentation will describe data from the FAB-C (Treatment of Fragile X Syndrome Anxiety and Behavioral Challenges with CBD) trial that highlight the short- and long-term positive impact of ZYN002 on children and adolescents with FXS. The poster entitled “Transdermal Cannabidiol (CBD) Gel for the Treatment of Fragile X Syndrome” (poster #P5-092) will be presented on Monday, May 20, 2019 from 10:00AM to 12:00PM PDT during Poster Session 5.


Charts says $36.49 Break in 2019 for a blue sky break out.

ZYNE is 3.0 Version of GWPH Biosynthetic Platform no reliance on the plant.
GWPH 5.4 Billion Market Cap
ZYNE 325 Million Market Cap



$ZYNE