Zynerba Pharmaceuticals (ZYNE)

[dhbuzz]

Nice move in Germany Friday for ZYNE ON Munich market.


https://finance.yahoo.com/quote/6ZY.MU?p=6ZY.MU&.tsrc=fin-srch

[dhbuzz]

I continue to hold, positive news on FMFX from FDA is the key here now,then ASD going forward.If green lighted for FMFX, then the sp should finally make a substantial move up IMO.

[Jdanger 2]

Still here. Still a great price to load up

[dhbuzz]

.

[Taurus69]

$zyne $3.4 v -0.03 (-0.87%)
Volume: 313,484 @10/30/20 7:41:54 PM EDT

[Stockfun1]

I would think there should be word from FDA on FMX very soon. Correct???

[dhbuzz]

We wait,and we watch.

[dhbuzz]

https://www.tipranks.com/stocks/zyne/forecast

[dhbuzz]

https://finance.yahoo.com/news/canaccord-predicts-over-100-rally-150126313.html

[Stockfun1]

Short interest only 19.9%. Anyone understand what’s going on with this PPS?

[dhbuzz]

.

[whytestocks]

NEWS: $ZYNE Zynerba Pharmaceuticals Presents Data Supporting FMR1 Methylation Status as a Correlate to Fragile X Syndrome Severity at the Virtual Joint 16th International Child Neurology Congress (ICNC) & 49th Annual Child Neurology Society (CNS) Meeting

DEVON, Pa., Oct. 15, 2020 (GLOBE NEWSWIRE) -- Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for rare and near-rare neuropsychiatric disorders, is presenting a poster describing data from the CONNECT-FX ( C...

Got this from ZYNE - Zynerba Pharmaceuticals Presents Data Supporting FMR1 Methylation Status as a Correlate to Fragile X Syndrome Severity at the Virtual Joint 16th International Child Neurology Congress (ICNC) & 49th Annual Child Neurology Society (CNS) Meeting

[whytestocks]

JUST IN: $ZYNE New Data Describing Statistically Significant Results from the Phase 2 BRIGHT Trial in Patients with Autism Spectrum Disorder (ASD) Presented at the Virtual Joint 16th International Child Neurology Congress (ICNC) & 49th Annual Child Neurology Society (CN

DEVON, Pa., Oct. 15, 2020 (GLOBE NEWSWIRE) -- Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for rare and near-rare neuropsychiatric disorders, is presenting a poster describing data from the Phase 2 BRIGHT (...

In case you are interested ZYNE - New Data Describing Statistically Significant Results from the Phase 2 BRIGHT Trial in Patients with Autism Spectrum Disorder (ASD) Presented at the Virtual Joint 16th International Child Neurology Congress (ICNC) & 49th Annual Child Neurology Society (CN

[Jdanger 2]

Amazing results resented at the conference today. ZYNE currently halted at +10%!

[dhbuzz]

[Taurus69]

$zyne $3.41 ^ 0.04 (1.19%)
Volume: 651,327 @10/06/20 5:25:17 PM EDT

[dhbuzz]

“Zynerba is committed to developing Zygel™ CBD gel in certain rare and near-rare conditions, including 22q, for which there is an urgent need for new, innovative therapeutics,” said Armando Anido, Chairman and Chief Executive Officer of Zynerba. “We are pleased that the FDA shares our sense of urgency regarding the development of effective therapeutics in this important patient population. The receipt of this designation represents another important milestone for us, and we look forward to working closely with the FDA to develop Zygel in pediatric and adolescent patients with 22q as expeditiously as possible.”

About Orphan Drug Designation
Under the Orphan Drug Act (ODA), the FDA may grant orphan drug designation to drugs intended to treat rare diseases or conditions that affect fewer than 200,000 individuals in the U.S. The first NDA applicant to receive FDA approval for a particular active moiety to treat a particular disease with FDA orphan drug designation is entitled to various incentives of the ODA, including tax credits for qualified clinical testing, waiver of new drug application (NDA) / biologics license application (BLA) user fees, and eligibility for a seven-year exclusive marketing period for that drug and use upon marketing approval.

[dhbuzz]

https://byebyedoctor.com/digeorge-syndrome/

[dhbuzz]

ZANERBA is about to get some serious

market attention on two fronts...

Medical,and
Cannabis

[dhbuzz]

Hey Lumpy

sure hope you are still in.

[Stockfun1]

https://seekingalpha.com/article/4375033-making-case-for-zynerba-pharmaceuticals

Strong article and makes a great case for why Zynerba will get approval for FMFX and go to $15. It’s a long article but for those who have the time this is a superb read.

[dhbuzz]

Today may get interesting.

[dhbuzz]

https://seekingalpha.com/article/4375033-making-case-for-zynerba-pharmaceuticals

[whytestocks]

NEWS: $ZYNE Zynerba Pharmaceuticals Receives Orphan Drug Designation for Cannabidiol for the Treatment of 22q11.2 Deletion Syndrome

DEVON, Pa., Sept. 17, 2020 (GLOBE NEWSWIRE) -- Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for rare and near-rare neuropsychiatric disorders, today announced that the U.S. Food and Drug Administration has ...

In case you are interested ZYNE - Zynerba Pharmaceuticals Receives Orphan Drug Designation for Cannabidiol for the Treatment of 22q11.2 Deletion Syndrome

[Stockfun1]

Love the market response. It’s really about time.

[dhbuzz]

Zynerba Pharmaceuticals Receives Orphan Drug Designation for Cannabidiol for the Treatment of 22q11.2 Deletion Syndrome
September 17 2020 - 01:55PM
GlobeNewswire Inc.
Alert
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Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for rare and near-rare neuropsychiatric disorders, today announced that the U.S. Food and Drug Administration has granted orphan drug designation for cannabidiol (CBD) for use in treating 22q11.2 deletion syndrome (22q). 22q is a rare midline condition featuring physical abnormalities and debilitating neuropsychiatric and behavioral symptoms including anxiety, withdrawn behavior, and social interaction problems.
“Zynerba is committed to developing Zygel™ CBD gel in certain rare and near-rare conditions, including 22q, for which there is an urgent need for new, innovative therapeutics,” said Armando Anido, Chairman and Chief Executive Officer of Zynerba. “We are pleased that the FDA shares our sense of urgency regarding the development of effective therapeutics in this important patient population. The receipt of this designation represents another important milestone for us, and we look forward to working closely with the FDA to develop Zygel in pediatric and adolescent patients with 22q as expeditiously as possible.”

About Orphan Drug Designation
Under the Orphan Drug Act (ODA), the FDA may grant orphan drug designation to drugs intended to treat rare diseases or conditions that affect fewer than 200,000 individuals in the U.S. The first NDA applicant to receive FDA approval for a particular active moiety to treat a particular disease with FDA orphan drug designation is entitled to various incentives of the ODA, including tax credits for qualified clinical testing, waiver of new drug application (NDA) / biologics license application (BLA) user fees, and eligibility for a seven-year exclusive marketing period for that drug and use upon marketing approval.

About 22q11.2 Deletion Syndrome (22q)
As the second most common chromosomal disorder after Down syndrome, 22q is caused by a small missing piece of the 22nd chromosome. The deletion occurs near the middle of the chromosome at a location designated q11.2. It is considered a mid-line condition, with physical symptoms including characteristic palate abnormalities, heart defects, immune dysfunction, and esophageal / GI issues, as well as debilitating neuropsychiatric and behavioral challenges. Anxiety is among the most common neuropsychiatric symptoms of 22q and researchers have found that for children with 22q, anxiety is linked to poorer adaptive behaviors such as self-care and communication skills that affect daily life. Children with 22q also experience withdrawn behavior, ADHD, cognitive impairment, and autism spectrum disorder that affect communication and social interaction. Later in life, they are at an increased risk of developing mental illnesses such as schizophrenia. It is estimated that 22q occurs in between one in 3,000 and one in 6,000 live births, suggesting that there are approximately 81,000 people living with 22q in the U.S.

About Zynerba Pharmaceuticals, Inc.
Zynerba Pharmaceuticals is the leader in pharmaceutically-produced transdermal cannabinoid therapies for rare and near-rare neuropsychiatric disorders. We ar

[dhbuzz]

Stockfun

Check out MTNB

[Stockfun1]

I think your right!!

[dhbuzz]

Just a reminder...The next FMFX response from FDA will be virtual,not written.


Zynerba has been notified that the U.S. Food and Drug Administration (FDA) will meet with the Company via teleconference in the fourth quarter of 2020 to discuss the pivotal CONNECT-FX data and the regulatory path forward in patients with FXS and a fully methylated FMR1 gene (FMet). The Company also expects to disclose the outcome of the meeting in the fourth quarter of this year.

[dhbuzz]

As I said ... (one step ahead)


The Company is in the process of finalizing its evaluation of which epileptic syndromes it may pursue with Zygel.


KEY WORD..."FINALIZING"

[dhbuzz]

The meeting with the FDA will be an important milestone for patients and their families who live with the debilitating behavioral impact of Fragile X,” said Armando Anido, Chairman and Chief Executive Officer of Zynerba. “Our ongoing evaluation of the pivotal CONNECT-FX data continues to clarify the impact that Zygel achieved in the most severely impacted children and adolescents with FXS, as well as the excellent tolerability profile. We look forward to discussing the pivotal data and the regulatory path for potential approval in FMet patients with the FDA in the fourth quarter of this year.”

[dhbuzz]

Stockfun,maybe we get a little feed back on DEES at this afternoons presentation .

My guess would be Zanerba team is all ready a step ahead with this.

[Stockfun1]

Agreed dhbuzz. Very much agreed.

[dhbuzz]

Concerning yesterdays updates.

This link will help in understanding what the FDA is asking with the DEES path forward.

.https://www.epilepsy.com/learn/types-epilepsy-syndromes

*************************

With that thinking in mind,I think Zanerba has done just that with FX phase lll trial in as they had positive results with a specific group,FMFX
This gives me more reason to feel NDA from FDA on Zygel for FMFX will happen.



*************************

Congrats on the latest patent.

[dhbuzz]

Maybe something like this in Zanerbas future one day?

https://ih.advfn.com/stock-market/NASDAQ/immunomedics-IMMU/stock-news/83250738/immunomedics-shares-more-than-double-after-gilead

[dhbuzz]

Here's to a great week ahead!

[dhbuzz]

I'm sure it will be recorded Stockfun.





LOL,a Zanerba tease...

[Stockfun1]

Lol!! Enticing me to buy now aren’t you??? I wish I could be in the virtual call. Hoping I can still listen to it later in the day via Zynerba website. Will it be recorded and still be available on the site?

[dhbuzz]

Wouldn't it be a nice Mon. if FDA gave their blessing tomarrow on FMFX.Now that would sure give our CEO something to add to the presentation.

[dhbuzz]

NSS

[Taurus69]

$zyne $3.55 ^ 0.04 (1.14%)
Volume: 257,991 @09/11/20 5:00:31 PM EDT

[dhbuzz]

I think its better than 50\50 simply because of how Zanerba went about the trial.A very smart move on their part IMO,giving them some pie instead of none perhaps with the FMFX group.

Looking forward to the days ahead,and news on several fronts.

GL my friend.

[Stockfun1]

Agree with you on the ASD. Also in the PPS if FDA does not give okay on FMFX. Curious what your thoughts are on the odd of an okay by FDA for FMFX. 50/50? Or better than??

[dhbuzz]

Trial results info on this are also in our near future.


https://en.wikipedia.org/wiki/DiGeorge_syndrome

[dhbuzz]

If FDA does not give NDA ok with FMFX I can see it dropping more.

RED ZONE ...This is a VERY big call by the (reffs)FDA.It creates a starting mark ,and opens some doors not only in the U.S. but also over seas IMO.for Zanerba and the FMFX population.

Going forward IMO FDA will ask for a phase lll on ASD with a larger number of people in the trial.


I dont expect any big news on anything with the 2 presentations this week other than all is still on track.

[Stockfun1]

We are certainly in buying territory now. I may be averaging down this week. Trying to beat any announcements. I don’t think Zynerba can have any further appreciable drop below $3.50.

[dhbuzz]

****RED ZONE****

[dhbuzz]

https://www.americanbankingnews.com/2020/09/07/head-to-head-survey-zynerba-pharmaceuticals-nasdaqzyne-aptevo-therapeutics-nasdaqapvo.html

[dhbuzz]

HMMMM,Large trade at the bell.

[dhbuzz]

It is always good to learn new things.

https://www.fraxa.org/a-tribute-to-doris-buffett-philanthropist/