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Zynerba Pharmaceuticals, Inc. (ZYNE)

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3.2500-0.2500 (-7.14%)
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  • S
    Senior Analyst
    Hi folks!

    A few observations:

    1- I believe the FDA will allow the company to go ahead with submitting a NDA. I will just sum up many reasons already mentioned.

    a- the success in the subgroup was overwhelming.

    b. the subgroup of 168 patients is a huge study to say it was by chance.

    c- what is the accomplishment of redoing the study after having a study of 168 patients.

    d- the FDA would be risking that the company may not redo the study thereby destroying forever a treatment for a group that has no other alternative. I don't remember off hand but to date many many drugs trying to treat fragile x failed and not even one passed phase 2. So the chances that these children will see an alternative treatment in the near future is zilch. Furthermore, even if a second study is done this will deprive 45,000 patients from getting treatment for 3 years.

    d- There is a zero safety issue so what is the risk going forward and doing a phase 4 while approved.

    e- why would the FDA schedule a virtual meeting and not proceed with the written responses as until now if their intentions are to request another study.

    f- Another study is impossible since if cannot be accurate due to the fact that in dealing with disorders that are controlled by the mind of the patients as well as the CAREGIVERS and if the expectations are predisposed due the current positive phase 3 study, the placebo group can see an improvement of 30-40% which would be totally a wrong study. This can also have a untrue positive and even negative effects on the patients receiving zygel.

    So my guess is that the FDA will approve going forward with zygel for fragil x for the subgroup and "may" require a phase 4 study

    2- We saw huge buying last week after the 2 presentations. FOUR MILLION shares were accumulated. I still wonder who the sellers were for 13% of the company at these prices.

    3- I believe the at the market (atm's) program of the company is already halted or will be halted very soon so the belief that you will get these shares cheaper will be gone.

    4- Now i want discuss one more point. What is the potential of zygel in fragile x as it relates to revenue and the time frame.

    If the FDA gives the green light the company expects Zygel to be commercialized late 2021 (the company has enough cash until at least the end of 2021).

    The population for the subgroup is roughly 45000. It is reasonable to assume that in the first year Zygel will penetrate 10% of the market or 4500 since there are many societies that are affiliated with these patients and you don't need that many reps to get in contact with these 45000 patients to tell them there is a "safe" treatment available. Every competent doctor treating fragile x will know of the breakthrough of discovering this biomarker and its treatment

    In cases of an orphan drug for a rare disorder it is fairly safe to assume that the treatment can be priced at $50k per year. This amounts to revenues of $225 million. Even if this achieved by 2023 this is a goldmine. Let's figure. 30 million shares with $225 revenue or $7.5 per share probably netting $3-$4 a shares. At a 10 multiple this is $30-40

    But I believe that in 2-3 years on the market they will penetrate much more than 10% since a biomarker was discovered with its treatment so it will be an automatic procedure for a doctor handling fragile x to subscribe zygel. Just like penicillin for strep.

    This just for fragile x and what about the value for the 3 other indications with similar or even greater potentials?
  • A
    Zynerba's Pivotal Phase 3 CONNECT-FX study is the first placebo-controlled study to show statistical significance in children with Fragile X Syndrome (FXS) to date - a significant accomplishment.
    Zynerba's Pivotal Phase 3 CONNECT-FX study is the first placebo-controlled study to show statistical significance in children with Fragile X Syndrome (FXS) to date - a significant accomplishment.
  • R
    Rat Town King Rat
    The FDA has granted Orphan drug status for Zynerba's (ZYNE +6.2%) cannabidiol as a treatment of 22q.11.2 deletion syndrome, according to a post to the agency's website.

    Also known as DiGeorge syndrome, the syndrome is caused when a small part of chromosome 22 is missing, resulting in the poor development of several body systems, and most commonly heart abnormalities.
  • G
    Waaaaaaaay better presentation today, Armando. Thank you for the clarity.
  • B
    How soon before the stock price reaches Sub $2. We will not hear from the FDA until December. When has this company done anything early.
  • n
    Isn't this a nice change of pace!!!
  • H
    Have u ever
  • S
    So conditioned to the continuous let downs, then this. I'll take it. Time for a reversal to the upside for a change. Rock on!
  • M
    Matthew Avery
    This message board dried up just about as much as the average daily volume...
  • A
    Great news today glad I’ve been adding the last several weeks
  • j
    So, it seems that $10 may not be too far away!!
  • B
    Maybe we get some good news from Armando. With the shorts down over 2 million in the past month it would be a good time to squeeze the remainder on their way out.
  • v
    Can anybody enlighten me on these questions:
    - How many 'individual syndromes' can be identified among DEE patients (FDA suggest to pursue each of them separately).
    - Will Zynerba try only some (most promising) syndromes? Can they even guess which one is most promising based on Phase II results? (Since so far they suggested to go after the whole group.)
    - How much can one such study cost? (I guess there will be some input variables: like size of target group etc..but is there any ballpark figure say for 20-40k patient group?)
  • V
    FDA granted special-status to its drug
  • R
    Somebody knows something.
  • i
    anyone know whts up? volume and sp jumping
  • R
    Thank you Andy.
  • B
    Large international company buying them out. The announced closing will be 30 to 60 days from now. Price already starting to move up and very soon could spike big on announcement.
    Reverse Merger Underway With Protect Pharmaceutical Corp And Novgorod Would Increase PRTT Sales, Assets, And Growth Dramatically - BioResearch Alert
  • A
    When you see the word “however” after a positive statement its usually not good.

    “However, due to the heterogeneity of patients who fall under the DEE umbrella, the FDA suggests that Zynerba pursue individual syndromes rather than considering DEE patients as a single disorder or condition. The Company is in the process of finalizing its evaluation of which epileptic syndromes it may pursue with Zygel.”

    So what now? Do they have to burn more cash now evaluating these specific epileptic syndromes?