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Zynerba's FDA Meeting Lands It One Step Closer To FDA Approval


  • Zynerba Pharmaceuticals achieves positive meeting with the FDA, expected to initiate pivotal late-stage study to treat patients with fragile x syndrome.
  • Pivotal phase 3 study is expected to begin by mid-2018, which should act as a potential catalyst.
  • The prior phase 2 study met on the endpoint of Aberrant Behavior Checklist in Fragile X Syndrome, which is exactly what the phase 3 endpoint is set as.
  • Zynerba has enough cash to carry it well into 2019, which means there is no near-term risk of dilution.
  • Zynerba is using its cannabinoid technology to target a multitude of diseases with unmet medical needs.

On Monday, Zynerba Pharmaceuticals (NASDAQ:ZYNE) announced that it had held a positive meeting with the FDA in regards to a pivotal clinical trial design for its drug ZYN002 treating fragile x syndrome. Fragile X syndrome is a genetic disease characterized by intellectual disability, and autism spectrum disorder. Shares of Zynerba closed lower on this news, but it is my opinion that it provides a great entry point at $9.66 per share. What makes this a great opportunity is the unmet medical need that exists in fragile x syndrome. There are currently no FDA approved drugs available to treat this disease. In addition, there are no drugs that adequately treat the symptoms associated with the disease either.

Phase 3 Study Planned

The pivotal phase 3 trial that is going to help Zynerba potentially file for approval of ZYN002 for fragile syndrome is expected to start in mid-2018. That is a catalyst that could potentially push the stock higher. The trial is expected to recruit up to 200 pediatric and adolescent patients. The primary endpoint and the secondary endpoint were agreed upon with the FDA. They are to include the observational behavior in patients as reported by the caregiver using a checklist known as Aberrant Behavior Checklist in Fragile X syndrome (ABC-FXS). Considering the positive data from the phase 2 study I think that the primary and secondary endpoints have a high probability of success. However, that doesn't take away from the risk involved in terms of the variability of the data. That's because the observation will be made by a human, and then they will interpret what they are seeing according to their perception. Which then has to be translated to a checklist. The risk here is that observations can sometimes vary from person to person. Therefore, that is a risk to consider with respect to this trial design.

This article is published by Terry Chrisomalis, who runs the Biotech Analysis Central pharmaceutical investment research service on Seeking Alpha Marketplace. If you like what you read here and would like to subscribe to my Service, I'm currently offering a two-week free trial period for subscribers to take advantage of. My service offers deep dive analysis of many pharmaceutical companies throughout the biotech sector. Come see for yourself if my service is right for you.

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This article was written by

Terry Chrisomalis profile picture

I am the Founder of Biotech Analysis Central, A subscription service on Seeking Alpha's Marketplace. If you want to learn more about biotech investing or you want to check out my biotech analysis you can do so with a free 2-week trial to my service. Just hit the "Learn More" button on the bottom of the Marketplace Research Tab. I have a Bachelors of Applied Science Degree In Technology Management, Industrial and Business Services Management from St. Petersburg College Florida. I have been investing in biotech stocks for many years, and I prefer to invest as a long term investor. With that In mind I seek stocks that have long term value! I primarily Like to Invest In biotechnology stocks and I accept the risks. I Write for the Healthcare Sector and Stock market in general. I contribute to Seeking Alpha.

You can follow me on stocktwits.com under the name BiopharmaPro where I currently have (62.5K) followers. Join me in my quest to find the best biotechnology stocks that deliver results to help patients with new treatment options.

Analyst’s Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

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Comments (5)

Stephen Ayers profile picture
Terry, I'm doing research on ZYNE. I am very impressed with their prospects in Fragile X syndrome, but I also think they should stop wasting time and money on potential seizure indications.

I've read your prior articles on ZYNE. I can't help but chuckle that you've made a complete 180 degree turn within months. After stating, "the technology for the delivery method is weak", what has made you suddenly confident in their delivery method - out of pure curiosity?


neilsprovstromous profile picture
Yup...no trust in anything stock related..please..

I have ice to sell you in the winter.
In the past weeks, this stock received many buy ratings with target price way above current price. On top of that, it has a positive meeting with FDA. Still going lower. What is their problem. Hidden facts?
Why down so much yesterday?
Terry Chrisomalis profile picture
Sell on the news event. But it was a good buying opportunity.
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