Proactiveinvestors USA & Canada Zynerba Pharmaceuticals https://www.proactiveinvestors.com Proactiveinvestors USA & Canada Zynerba Pharmaceuticals RSS feed en Wed, 26 Jun 2019 05:04:39 -0400 http://blogs.law.harvard.edu/tech/rss Genera CMS action@proactiveinvestors.com (Proactiveinvestors) action@proactiveinvestors.com (Proactiveinvestors) <![CDATA[News - Zynerba wins new US patent for treatment of Autism Spectrum Disorder with CBD ]]> https://www.proactiveinvestors.com/companies/news/221882/zynerba-wins-new-us-patent-for-treatment-of-autism-spectrum-disorder-with-cbd-221882.html Zynerba Pharmaceuticals Inc (NASDAQ:ZYNE) revealed Tuesday that the US Patent and Trademark Office granted the company a new patent for treating Autism Spectrum Disorder, characterized by challenges with social skills and speech, with cannabidiol (CBD).

The company said it received US Patent No 10,314,792, titled “Treatment of Autism Spectrum Disorder with Cannabidiol,” which includes claims linked to methods of treating Autism Spectrum Disorder by administering a therapeutically effective amount of synthetic CBD.

The new patent, which expires in 2038, is part of an expanding intellectual property portfolio covering the Devon, Pennsylvania-based company’s Zygel, a CBD gel.

Zygel was earlier referred to as ZYN002, a synthetic cannabidiol formulated as a permeation-enhanced gel for skin delivery.

READ: Zynerba Pharmaceuticals scores Fast Track FDA designation for Zygel CBD gel

The new patent arrives as enrollment speeds up in Zynerba’s open label Phase 2 BRIGHT study evaluating the safety, tolerability and potency of Zygel for treating children and adolescents with Autism Spectrum Disorder. The company expects to report top line data in the first half of 2020.

Zynerba already has a patent (No 10,213,390) for claims linked to methods of treating Fragile X Syndrome by administering an effective dose of synthetic or purified CBD.

The US Food and Drug Administration earlier granted fast track designation to Zygel to expedite the development of the drug to treat Fragile X syndrome in children and young adults suffering from this common form of inherited learning disability and attention deficit disorder.

Enrollment is progressing in a pivotal CONNECT-FX Trial of Zygel in Fragile X syndrome, the company said in a statement with “data expected in the second half of 2019.”

Contact Uttara Choudhury at uttara@proactiveinvestors.com

Follow her on Twitter: @UttaraProactive 

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Tue, 11 Jun 2019 07:50:00 -0400 https://www.proactiveinvestors.com/companies/news/221882/zynerba-wins-new-us-patent-for-treatment-of-autism-spectrum-disorder-with-cbd-221882.html
<![CDATA[News - Zynerba tells FDA it should regulate CBD and cannabis-derived products like standard pharmaceuticals ]]> https://www.proactiveinvestors.com/companies/news/221313/zynerba-tells-fda-it-should-regulate-cbd-and-cannabis-derived-products-like-standard-pharmaceuticals-221313.html Zynerba Pharmaceuticals Inc. (NASDAQ:ZYNE) on Friday told the US Food and Drug Administration that it should regulate all cannabis-derived products and compounds just like standard pharmaceuticals.

The FDA is holding its first public hearing on how it should regulate cannabis and CBD, and the agency has asked Zynerba and other companies involved with the plant and its byproducts to offer up their opinions, information and data.

Ray Mannion, Zynerba’s vice president of manufacturing, will provide a slide show at the hearing in Maryland, entitled “Cannabinoid Manufacturing and Product Quality.”

READ:  Zynerba launches the Phase 2 trial of its Zygel CBD gel to treat 22q genetic condition

In a prepared statement released in a run-up to Friday’s heaing, CEO Armando Anido weighed in on the matter, saying the use of products and treatments made from cannabis needs to be strongly regulated to ensure public safety.

“The FDA has a well-established history of protecting public health and safety through a variety of essential strategies, including existing regulations and processes that govern the manufacture of pharmaceutical products and establish controls to ensure necessary quality and safety standards are met,” he said. “This existing robust framework should be leveraged in the regulation of all cannabinoid products, as less stringent manufacturing and quality standards would create an unnecessary public health risk.”

Zynerba, based in Devon, Pennsylvania, is currently developing Zygel, a CBD gel, in children aged three to 17 with Fragile X syndrome. Topline results are expected in the second half of 2019 from a clinical trial that evaluated the gel’s potency and safety. The company also has started a trial to assess how Zygel can treat the pediatric behavioral and emotional symptoms of 22q11.2 Deletion Syndrome.

FDA just gathering information and data

The FDA is not expected to issue any decisions during what is a information-gathering process, but the agency will place a strong focus on how CBD is marketed and how much CBD should be added to food and drinks. That agency also has expressed concern that allowing CBD in food could dampen incentives for drug makers to conduct research into CBD’s health benefits.

The regulator has been under pressure to create a regulatory framework for CBD -- which took a new urgency when Congress make hemp legal in December under the Farm Bill. CBD was not legalized, but was moved under the purview of the FDA. Some 17 states have legalized CBD.

READ: FDA to hold its first public hearing Friday on regulating CBD

The vast majority of CBD is extracted from hemp, which is a cannabis plant that has trace amounts of THC (0.3% or less when dried). THC, or tetrahydrocannabinol, is the psychoactive compound that gets people “high.”

Zynerba’s position calling for robust regulations of CBD and other related cannabis products matches what other players in the industry say are needed to create a thriving yet safe marketplace. 

Industry players want FDA guidance on critical matters such as establishing a credible verification process to guarantee product purity, quality manufacturing, and labeling transparency.

Contact the author: patrick@proactiveinvestors.com

Follow him on Twitter @PatrickMGraham

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Fri, 31 May 2019 09:09:00 -0400 https://www.proactiveinvestors.com/companies/news/221313/zynerba-tells-fda-it-should-regulate-cbd-and-cannabis-derived-products-like-standard-pharmaceuticals-221313.html
<![CDATA[News - Zynerba launches the Phase 2 trial of its Zygel CBD gel to treat 22q genetic condition ]]> https://www.proactiveinvestors.com/companies/news/221134/zynerba-launches-the-phase-2-trial-of-its-zygel-cbd-gel-to-treat-22q-genetic-condition-221134.html Zynerba Pharmaceuticals Inc (NASDAQ:ZYNE) announced Wednesday that it has initiated the Phase 2 INSPIRE trial to assess how the company’s lead development candidate Zygel can treat the pediatric behavioral and emotional symptoms of 22q11.2 Deletion Syndrome.

The symptoms of 22q11.2 Deletion Syndrome can range from mild behavioural issues to serious physical and psychological complications. It is a disorder caused by a small missing piece of the 22nd chromosome that can affect every system in the body.

Researchers say there can be up to 180 possible symptoms including congenital heart defects, a cleft palate and slow development linked to the condition. It is the second most common chromosomal disorder after Down syndrome.

Shares in Devon, Pennsylvania-based Zynerba shot up 7.6% to $13 in afternoon trade.

READ: Zynerba Pharmaceuticals’ quest for CBD gel to treat Fragile X syndrome ventures where big pharma fears to tread

Zygel was earlier referred to as ZYN002, a synthetic cannabidiol, which is a non-psychoactive cannabinoid, formulated as a permeation-enhanced gel for delivery through the skin.

Topline data in 2020

The INSPIRE trial will assess the safety, tolerability and potency of Zygel for the treatment of behavioral symptoms of 22q11.2 Deletion Syndrome. Topline data from this study is expected in the first half of 2020, said the company.  

“Children born with 22q often require surgeries to rectify acute physical concerns, like anomalies of the heart and palate; once corrected, there are a myriad of behavioral symptoms that need to be addressed,” said Zynerba Pharmaceuticals CEO Armando Anido.

Anido went on to explain that parents of children with 22q report significantly higher rates of “withdrawn behavior, affective disorders, pervasive developmental problems and anxiety” in their children compared to non-affected children.

READ: Zynerba boosts cash position in 1Q, gears up for top-line data from four key trials with Zygel CBD gel

“There is also an increased risk of developing psychoses such as schizophrenia later in life, compared to the general population,” said Anido. “We are very excited to initiate the INSPIRE trial to assess the potential impact of Zygel in these children and adolescents, and look forward to presenting topline data in the first half of 2020.”

The 14-week INSPIRE trial is an open-label multi-dose Phase 2 clinical trial designed to evaluate the potency and safety of Zygel in 20 children and adolescents (ages six through 17) with genetically confirmed 22q.

Enrolled patients will receive weight-based doses of 250 mg daily or 500 mg daily of Zygel. The efficacy assessments include the Aberrant Behavior Checklist-Community, the Anxiety, Depression and Mood Scale, the Columbia Suicide Severity Rating scale, the Qualitative Caregiver Reported Behavioral Problem Survey, and Clinical Global Impression – Severity and Improvement standards.

Contact Uttara Choudhury at uttara@proactiveinvestors.com

Follow her on Twitter: @UttaraProactive 

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Wed, 29 May 2019 12:35:00 -0400 https://www.proactiveinvestors.com/companies/news/221134/zynerba-launches-the-phase-2-trial-of-its-zygel-cbd-gel-to-treat-22q-genetic-condition-221134.html
<![CDATA[News - Zynerba boosts cash position in 1Q, gears up for top-line data from four key trials with Zygel CBD gel ]]> https://www.proactiveinvestors.com/companies/news/219890/zynerba-boosts-cash-position-in-1q-gears-up-for-top-line-data-from-four-key-trials-with-zygel-cbd-gel-219890.html Zynerba Pharmaceuticals Inc (NASDAQ:ZYNE) posted first-quarter earnings Wednesday that showed it had raised its cash reserves as it heads into key trials and expects top-line data from four neuropsychiatric disorder trials with the company’s lead development candidate, Zygel.

Significantly, the company revealed that as of March 31, it has cash and cash equivalents of $68.3 million, compared to $59.8 million on December 31, 2018. Included in this cash pile is $18.1 million in net proceeds from the sale of about 3.4 miilion shares at $5.44 per during the first quarter to boost R&D spend.

READ: Zynerba Pharmaceuticals scores Fast Track FDA designation for Zygel CBD gel

Management said the company's $68.3 million war chest is “sufficient to fund operations and capital requirements beyond the expected New Drug Application submission and potential approval in Fragile X syndrome and into the first quarter of 2021.”

“We are entering a transformational period for Zynerba during which we expect top-line data from four neuropsychiatric disorder trials with Zygel, our patent protected CBD gel,” said Zynerba Pharmaceuticals CEO Armando Anido.

For the first quarter, the company reported a net loss of $9.1 million, or $0.47 per share. The results beat Wall Street expectations, with analysts surveyed by Zacks Investment Research calling for a loss of $0.48 per share.

Fast track designation 

The US Food and Drug Administration granted Fast Track designation to the company’s lead development candidate, Zygel. The Devon, Pennsylvania, company is on track to report top-line results from tests of its Zygel, a CBD gel treatment for children and adolescents with Fragile X syndrome, the most common form of inherited learning disability and autism spectrum disorder.

“We’ve made great progress with Zygel, which was recently designated as a Fast Track development program by the FDA for treating behavioral symptoms of Fragile X Syndrome,” said Anido. “Over the next 14 months, we expect to announce data from the CONNECT-FX pivotal trial in Fragile X, our Phase 2 BELIEVE 1 trial in developmental and epileptic encephalopathies, our Phase 2 BRIGHT trial in Autism Spectrum Disorder, and the Phase 2 trial in 22q11.2 Deletion Syndrome that we intend to initiate this quarter.”

The CEO expects the company’s “cash position will take us through all of these data readouts, through our anticipated NDA submission and potential approval for Zygel in FXS, and into the first quarter of 2021.”

Zygel was previously referred to as ZYN002, a synthetic cannabidiol, which is a non-psychoactive cannabinoid, formulated as a patent-protected permeation-enhanced gel for transdermal delivery through the skin and into the circulatory system. The company recently selected Zygel as the new brand name for ZYN002.

Enrollment is progressing in a pivotal CONNECT-FX Trial of Zygel in Fragile X syndrome, said the company in a statement with “data expected in the second half of 2019.”

Fragile X is also the most commonly known single gene cause of autism spectrum disorder.

Zynerba Pharmaceutical’s principal line of business are cannabinoid treatments delivered via the skin to treat neurological and psychiatric disorders.

Contact Uttara Choudhury at uttara@proactiveinvestors.com

Follow her on Twitter: @UttaraProactive 

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Wed, 08 May 2019 08:43:00 -0400 https://www.proactiveinvestors.com/companies/news/219890/zynerba-boosts-cash-position-in-1q-gears-up-for-top-line-data-from-four-key-trials-with-zygel-cbd-gel-219890.html
<![CDATA[News - Zynerba Pharmaceuticals scores Fast Track FDA designation for Zygel CBD gel ]]> https://www.proactiveinvestors.com/companies/news/219715/zynerba-pharmaceuticals-scores-fast-track-fda-designation-for-zygel-cbd-gel-219715.html Zynerba Pharmaceuticals Inc (NASDAQ:ZYNE) shares jumped Monday after the US Food and Drug Administration granted Fast Track designation to the company’s lead development candidate, Zygel.

Devon, Pennsylvania-based Zynerba is on track to report top-line results from tests of its Zygel, a CBD gel treatment for children and adolescents with Fragile X syndrome, the most common form of inherited learning disability and attention deficit disorder.

In response, investors sent Zynerba shares 9.5% higher to $12.54 in midday trade.

READ: Zynerba’s 4Q shows momentum as it heads into key clinical trial

Zygel was previously referred to as ZYN002, a synthetic cannabidiol, which is a non-psychoactive cannabinoid, formulated as a patent-protected permeation-enhanced gel for transdermal delivery through the skin and into the circulatory system. The company recently selected Zygel as the new brand name for ZYN002.

Enrollment is progressing in a pivotal CONNECT-FX Trial of Zygel in Fragile X syndrome, said the company in a statement with “data expected in the second half of 2019.”

The FDA fast-tracking program looks to quicken the review process for drugs which treat serious conditions and fill an unmet medical need. It leads to expedited reviews by the FDA in order to get key drugs to patients earlier.

“The FDA’s decision to grant fast track designation for Zygel underscores the significance and severity of the unmet medical need that exists for patients living with Fragile X Syndrome and their caregivers,” said Zynerba Pharmaceuticals CEO Armando Anido. “We believe that Zygel has the potential to be the first treatment indicated to directly address the core behavioral symptoms of this syndrome.

Anido said the company looked forward to “working closely with the FDA” to obtain approval to market Zygel “as soon as possible.”

CONNECT-FX clinical trial

The company said enrollment is speeding up in the CONNECT-FX clinical trial, which is a pivotal, multinational, placebo-controlled study evaluating the potential and safety of Zygel in Fragile X syndrome.

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 phase.

Top-line results are expected in the second half of 2019 from its CONNECT-FX clinical trial, which will evaluate the potency and safety of Zygel in children aged three to 17 with Fragile X syndrome.

Fragile X is also the most commonly known single gene cause of autism spectrum disorder.

Zynerba Pharmaceutical’s principal line of business are cannabinoid treatments delivered via the skin to treat neurological and psychiatric disorders.

—Updates with details about CONNECT-FX clinical trial; Updates share price—

Contact Uttara Choudhury at uttara@proactiveinvestors.com

Follow her on Twitter: @UttaraProactive 

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Mon, 06 May 2019 07:33:00 -0400 https://www.proactiveinvestors.com/companies/news/219715/zynerba-pharmaceuticals-scores-fast-track-fda-designation-for-zygel-cbd-gel-219715.html
<![CDATA[News - Zynerba rockets as investors await CEO's presentation at London conference ]]> https://www.proactiveinvestors.com/companies/news/217900/zynerba-rockets-as-investors-await-ceo-s-presentation-at-london-conference-217900.html Shares of Zynerba Pharmaceuticals Inc (NASDAQ:ZYNE) soared Wednesday on the back of news that its CEO Armando Anido will present a company overview at the 2019 HC Wainwright Global Life Sciences Conference in the UK this month.

The presentation will take place on April 9 at 12:10 pm at the Grosvenor House in London.

Devon, Pennsylvania-based Zynerba is on track to report top-line results in the second half of the year from Phase 2/3 trials of its Zygel (ZYN002), a CBD gel treatment for children and adolescents with Fragile X syndrome, the most common form of inherited learning disability and attention deficit disorder.

READ: Zynerba’s 4Q shows momentum as it heads into key clinical trial

Enthused by the publicity the London conference will bring, investors sent Zynerba shares up 19.9% to $7.77 in afternoon trade.

Zynerba Pharmaceuticals focuses on treating cannabinoid therapies for rare neuropsychiatric disorders.

The company’s cash and cash equivalent position as of December 31, 2018 was $59.8 million while its research and development expenses for the fourth quarter came in at $4.9 million. 

Management said last month it believes its cash position is “sufficient to fund operations” beyond the potential approval in Fragile X syndrome and “into the first quarter of 2021.”

Contact Ellen Kelleher at ellen@proactiveinvestors.com

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Wed, 03 Apr 2019 13:50:00 -0400 https://www.proactiveinvestors.com/companies/news/217900/zynerba-rockets-as-investors-await-ceo-s-presentation-at-london-conference-217900.html
<![CDATA[Media files - Zynerba Pharmaceuticals well-funded for its CBD clinical trials into 2021 ]]> https://www.proactiveinvestors.com/companies/stocktube/12575/zynerba-pharmaceuticals-well-funded-for-its-cbd-clinical-trials-into-2021-12575.html Tue, 12 Mar 2019 13:24:00 -0400 https://www.proactiveinvestors.com/companies/stocktube/12575/zynerba-pharmaceuticals-well-funded-for-its-cbd-clinical-trials-into-2021-12575.html <![CDATA[News - Zynerba’s 4Q shows momentum as it heads into key clinical trial ]]> https://www.proactiveinvestors.com/companies/news/216216/zynerbas-4q-shows-momentum-as-it-heads-into-key-clinical-trial-216216.html Zynerba Pharmaceuticals Inc (NASDAQ:ZYNE) said Monday that it saw “clinical momentum” in the fourth quarter as it posted financial results that showed it has $59.8 million to fund clinical trials for its cannabis-derived treatments.

Devon, Pennsylvania-based Zynerba is on track to report top-line results from tests of its Zygel, a CBD gel treatment for children and adolescents with Fragile X syndrome, the most common form of inherited learning disability and attention deficit disorder.

Zygel was previously referred to as ZYN002, a synthetic cannabidiol, which is a non-psychoactive cannabinoid, formulated as a patent-protected permeation-enhanced gel for transdermal delivery through the skin and into the circulatory system. The company has now selected Zygel as the new brand name for ZYN002.

READ: Zynerba Pharmaceuticals’ quest for CBD gel to treat Fragile X syndrome ventures where big pharma fears to tread

“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,” Zynerba Pharmaceuticals CEO Armando Anido said in a statement.

The company said enrollment is speeding up in the CONNECT-FX clinical trial, which is a pivotal, multinational, placebo-controlled study evaluating the potential and safety of Zygel in Fragile X syndrome.

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 phase.

Top-line results are expected in the second half of 2019 from its CONNECT-FX clinical trial, which will evaluate the potency and safety of ZYN002, a CBD gel, in children aged three to 17 with Fragile X syndrome.

Fragile X is also the most commonly known single gene cause of autism spectrum disorder.

“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,” said Anido.

In addition to Fragile X syndrome and ultra-rare epilepsies known as developmental and epileptic encephalopathies, Zygel is also in Phase 2 clinical development in patients with refractory epilepsy, Autism Spectrum Disorder and 22q11.2 Deletion Syndrome, a disorder caused by a small missing piece of the 22nd chromosome. This tiny missing portion of chromosome 22 can affect every system in the body.

Financial outlook

The company’s cash and cash equivalent position as of December 31, 2018 was $59.8 million. Research and development expenses for the fourth quarter were $4.9 million. The net loss for the pre-revenue company was $7.8 million, or $0.44 per share.

In addition to the $59.8 million cash position the company had at the end of the year, the company received $18.1 million in net proceeds from the shares sold in the first quarter of 2019.

“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,” said Anido.

Management said it believes the cash position including the $59.8 million and the $18.1 million in net proceeds from the shares sold in the first quarter of 2019, is “sufficient to fund operations” beyond the expected NDA submission and potential approval in Fragile X syndrome and “into the first quarter of 2021.”

Contact Uttara Choudhury at uttara@proactiveinvestors.com

Follow her on Twitter: @UttaraProactive 

 

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Mon, 11 Mar 2019 13:19:00 -0400 https://www.proactiveinvestors.com/companies/news/216216/zynerbas-4q-shows-momentum-as-it-heads-into-key-clinical-trial-216216.html
<![CDATA[News - Zynerba Pharmaceuticals launches Phase 2 trial of Zygel in autism spectrum disorder ]]> https://www.proactiveinvestors.com/companies/news/216010/zynerba-pharmaceuticals-launches-phase-2-trial-of-zygel-in-autism-spectrum-disorder-216010.html Zynerba Pharmaceuticals Inc (NASDAQ:ZYNE) announced Thursday that it has initiated the Phase 2 BRIGHT study to evaluate the potency and safety of Zygel, a CBD gel, in children and adolescents aged three to 17 with Autism Spectrum Disorder (ASD), a developmental disorder that impairs the ability to communicate and interact.

Zygel was previously referred to as ZYN002, a synthetic cannabidiol (CBD), which is a non-psychoactive cannabinoid, formulated as a patent-protected permeation-enhanced gel for transdermal delivery through the skin and into the circulatory system.The company has now selected Zygel as the new brand name for ZYN002.

Devon, Pennsylvania-based Zynerba which is doing trail-blazing work pushing clinical trials for cannabis-derived treatments, expects to present top-line data from this study in the first half of 2020.

DEEP DIVE: Zynerba Pharmaceuticals’ quest for CBD gel to treat Fragile X syndrome ventures where big pharma fears to tread

“Autism spectrum disorder can have a devastating impact on a child and their family,” Zynerba Pharmaceuticals CEO Armando Anido said in a statement. “The medical need is significant and unmet despite high awareness and advocacy efforts.”

Anido elaborated that though there has been an “accelerating rate of diagnosis,” there are only two FDA approved products indicated for the treatment of ASD symptoms.

“Both have significant side effect profiles, and neither have been approved to address the key symptoms of social impairment and anxiety,” said Anido.“We are excited to initiate the BRIGHT trial evaluating the role of Zygel in ASD and are hopeful that Zygel may improve some of the core social and behavioral symptoms of ASD. We look forward to presenting topline data in the first half of 2020.”

The 14-week BRIGHT trial is an open-label multi-dose Phase 2 clinical trial designed to evaluate the potency and safety of Zygel in approximately 36 children and adolescents aged between four through 17 with ASD.

Enrolled patients will receive weight-based initial doses of 250 mg daily or 500 mg daily of Zygel. The efficacy assessments include the Aberrant Behavior Checklist, parent-rated anxiety scale for children with autism, autism impact measure, and clinical global impression severity and improvement scale.

Zynerba Pharmaceutical’s principal line of business is cannabinoid treatments delivered via the skin to treat neurological and psychiatric disorders.

— (Adds Zygel brand name details) —

Contact Uttara Choudhury at uttara@proactiveinvestors.com

Follow her on Twitter: @UttaraProactive 

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Thu, 07 Mar 2019 07:40:00 -0500 https://www.proactiveinvestors.com/companies/news/216010/zynerba-pharmaceuticals-launches-phase-2-trial-of-zygel-in-autism-spectrum-disorder-216010.html
<![CDATA[News - Zynerba Pharmaceuticals receives new US patent for treatment of Fragile X syndrome with CBD ]]> https://www.proactiveinvestors.com/companies/news/215326/zynerba-pharmaceuticals-receives-new-us-patent-for-treatment-of-fragile-x-syndrome-with-cbd-215326.html Zynerba Pharmaceuticals Inc (NASDAQ:ZYNE) announced Tuesday that the US Patent and Trademark Office has issued a new patent to the company for its transdermal cannabinoid treatment for patients suffering Fragile X syndrome, the most common form of inherited learning disability and attention deficit disorder.

Interestingly, the company’s flagship product ZYN002 is a synthetic cannabidiol (CBD), which is a non-psychoactive cannabinoid, formulated as a patent-protected permeation-enhanced gel for transdermal delivery through the skin and into the circulatory system.

The newly granted US patent No 10,213,390, titled “Treatment of Fragile X Syndrome with Cannabidiol,” includes claims directed at methods of treating Fragile X syndrome by administering “a therapeutically effective amount of synthetic or purified cannabidiol.”

Shares jumped nearly 17% to $5.88 in pre-market trading on heavy volume.

READ: Zynerba Pharmaceuticals’ quest for CBD gel to treat Fragile X syndrome ventures where big pharma fears to tread

The new patent which expires in 2038, is part of an expanding intellectual property portfolio covering the company's ZYN002 CBD gel.

The new patent comes at an auspicious time as enrollment speeds up in the CONNECT-FX clinical trial, which is a pivotal, multinational, randomized, double blind, placebo-controlled study evaluating the potential and safety of ZYN002.

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 phase.

The Devon, Pennsylvania-based Zynerba is on track to reporting topline results from the tests of its cannabidiol gel treatment for children and adolescents, aged three to 17, with Fragile X syndrome the second half of 2019.

Fragile X is also the most commonly known single gene cause of autism spectrum disorder.  

The company could be filing a New Drug Application for ZYN002 in the first half of 2020 for Fragile X Syndrome.

Zynerba is working on designing cannabis-derived treatments that can help patients suffering from rare epilepsies and neurological disorders.

--ADDS share price--

Contact Uttara Choudhury at uttara@proactiveinvestors.com

Follow her on Twitter: @UttaraProactive 

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Tue, 26 Feb 2019 07:49:00 -0500 https://www.proactiveinvestors.com/companies/news/215326/zynerba-pharmaceuticals-receives-new-us-patent-for-treatment-of-fragile-x-syndrome-with-cbd-215326.html
<![CDATA[News - Zynerba Pharmaceuticals’ quest for CBD gel to treat Fragile X syndrome ventures where big pharma fears to tread ]]> https://www.proactiveinvestors.com/companies/news/215151/zynerba-pharmaceuticals-quest-for-cbd-gel-to-treat-fragile-x-syndrome-ventures-where-big-pharma-fears-to-tread-215151.html Zynerba Pharmaceuticals Inc (NASDAQ:ZYNE) and GW Pharmaceuticals PLC (NASDAQ:GWPH) are both doing trailblazing work pushing clinical trials for cannabis-derived treatments that some pharma giants are too scared to undertake.  

With pluck, these two companies are working on dazzling discoveries, designing cannabis-derived treatments that can help patients suffering rare epilepsies and neurological disorders. 

“GW Pharmaceuticals has done a great service to the space,” Zynerba CEO Armando Anido told Proactive Investors. “It was meticulous in carrying out studies and clinical trials. It left no stone unturned in getting regulatory approval. It set good standards.”    

READ: Zynerba Pharmaceuticals stock soars amid slew of positive drivers

The first in a new category of anti-epileptic drugs, the Food and Drug Administration granted a license in June last year to GW Pharma’s cannabis-derived Epidiolex treatment for seizures associated with Lennox-Gastaut Syndrome in patients two years of age or older.  

Approval was based on three studies and an open-label extension study, showing Epidiolex when added to other drugs significantly reduced the frequency of seizures in patients. GW Pharma is now developing Epidiolex in tuberous sclerosis, and if approved in the third indication, sales could break through the billion-dollar annual sales barrier. 

Taking a page out of GW Pharma’s playbook 

What GW Pharmaceuticals has achieved underlines the latent potential of Zynerba, which is developing novel cannabinoid treatments delivered via the skin to treat neurological and psychiatric disorders. 

In fact, Devon, Pennsylvania-based Zynerba is on track to reporting top-line results from tests of its cannabidiol gel treatment for children and adolescents with Fragile X syndrome, the most common form of inherited learning disability and attention deficit disorder. 

Topline results are expected in the second half of 2019 from its CONNECT-FX clinical trial, which will evaluate the potency and safety of ZYN002, a CBD gel, in children aged three to 17 with Fragile X syndrome. 

Fragile X is also the most commonly known single gene cause of autism spectrum disorder.  

Top-line data  

“We started enrolling the trial in the second half of last year. We should be in a position to report our top line data in the second half of 2019, so all is a go at this point,” said Anido. 

The company could be filing a New Drug Application for ZYN002 in the first half of 2020 for Fragile X Syndrome, Anido added. 

The CEO pointed out that if successful, ZYN002 has the potential to become “the first product” for the treatment of behavioral symptoms of Fragile X syndrome.  

“Children with Fragile X syndrome are dramatically impacted by this genetic condition and its debilitating behavioral and emotional challenges, including anxiety, social withdrawal, irritability, inattention and aggression,” said Elizabeth M Berry-Kravis, professor of pediatrics, neurological sciences and biochemistry at Rush University Medical Center. 

Interestingly, ZYN002 is a synthetic cannabidiol (CBD), which is a non-psychoactive cannabinoid, formulated as a patent-protected permeation-enhanced gel for transdermal delivery through the skin and into the circulatory system. 

Analysts weigh in positively  

Pharma investing is always a high-risk, high-reward proposition as the sector’s ever-volatile stocks show. However, analysts have weighed in positively on Zynerba’s ZYN002 candidate in multiple indications. 

In addition to Fragile X syndrome, ZYN002 is also in Phase 2 clinical development in patients with refractory epilepsy, Autism Spectrum Disorder and 22q11.2 Deletion Syndrome, a disorder caused by a small missing piece of the 22nd chromosome. This tiny missing portion of chromosome 22 can affect every system in the body. 

ZYN002 is also being tested for a heterogeneous group of rare and ultra-rare epilepsies known as developmental and epileptic encephalopathies (DEE). 

“ZYN002 visibility enhanced, expanded with pipeline updates,” wrote Cantor Fitzgerald analysts Charles C Duncan and Pete Stavropoulos in a note to clients. 

“The positive open-label data from the Fragile X syndrome trial on social and behavioral scales is suggestive of efficacy in the new indications, in our view, especially given the mechanistic rationale that we believe is supported externally,” they added. 

Cantor Fitzgerald sees Zynerba as “great value for money” and has an Overweight rating and a $21 price target on the shares, which currently trade in the $5 range. 

Bullish investment case

Similarly, H.C. Wainwright analyst Oren Livnat describes Zynerba as a “severely discounted” stock less than “a year from potential transformational” data. The analyst said Zynerba has reiterated “all expected pipeline timelines,” and exhibited “financial discipline.” 

“With the prospects of very dramatic upside on potential positive FXS pivotal data less than a year away, and a multi-billion dollar comparable for CBD in DEE indications from GW Pharma, and the company is relatively well capitalized through all 2019 data, we see exceptional potential risk-reward at this extremely discounted $34 million enterprise value,” wrote Livnat. 

H.C Wainwright has a Buy rating and $23 price target on Zynerba stock. 

Zynerba has $59.8 million in cash to fund operations and reach clinical milestones in the first half of 2020. 

Since pharma companies are embarked on voyages into the unknown, it can be tough for investors to weigh the risks. However, if a company is sufficiently far along with clinical trials, it’s a good indication it won’t flame out. 

“A lot of the heavy lifting for this program has already been done. ZYN002 has already been in over 600 patients, in some for as long as two years, so we already know a lot about its safety and activity,” said Anido.  

“Thanks to that data, we are now in the midst of a period of time where we have a number of near-term catalysts, including two new Phase 2 clinical trial initiations, Phase 2 DEE data, pivotal Fragile X data, and soon thereafter, ASD and 22q data,” he added. 

Zynerba is also looking at a big addressable market. If GW Pharma’s Epidiolex is aimed at 35,000 to 40,000 patients suffering rare epilepsies, ZYN002 is looking at double the market for just Fragile X syndrome.  

“For Fragile X it is 71,000 patients, for a heterogeneous group of rare and ultra-rare epilepsies known as developmental and epileptic encephalopathies it is 45,000, and almost a million patients are diagnosed with autism,” said Anido.  

Contact Uttara Choudhury at uttara@proactiveinvestors.com

Follow her on Twitter: @UttaraProactive

 

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Fri, 22 Feb 2019 10:19:00 -0500 https://www.proactiveinvestors.com/companies/news/215151/zynerba-pharmaceuticals-quest-for-cbd-gel-to-treat-fragile-x-syndrome-ventures-where-big-pharma-fears-to-tread-215151.html
<![CDATA[News - Zynerba Pharmaceuticals adds pharma exec to its board ]]> https://www.proactiveinvestors.com/companies/news/214974/zynerba-pharmaceuticals-adds-pharma-exec-to-its-board-214974.html Zynerba Pharmaceuticals Inc (NASDAQ:ZYNE) said Wednesday that it has appointed Pamela Stephenson to its board of directors.

Stephenson is currently vice president of Global Market Access and Value at Vertex Pharmaceuticals Inc (NASDAQ:VRTX), where she has served since 2008. Prior to that, she spent 10 years at Pfizer Inc (NYSE:PFE) in various capacities.

“Zynerba is in an important phase of its journey as it begins its preparations for a potential launch of the first product ever indicated for use in children and adolescents with Fragile X Syndrome,” said Stephenson in a statement. “I am excited to join Zynerba’s board of directors at this time, and look forward to contributing to the company’s future successes.”

The Devon, Pennsylvania, company develops transdermal cannabinoid therapies for rare and near-rare neuropsychiatric disorders, including Fragile X Syndrome – a genetic cause of intellectual disability -- and Autism Spectrum Disorder.

“Pamela brings with her a wealth of expertise in commercial planning, market development, product launch and market access,” said Zynerba CEO Armando Anido. “This experience will be essential as we develop the market for ZYN002 in Fragile X Syndrome and await data from our ongoing pivotal CONNECT-FX study.”

Zynerba shares closed at $5.03 Tuesday.

Contact Paul Curcio at paul.curcio@proactiveinvestors.com

Follow him on Twitter @GoCurcioGo

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Wed, 20 Feb 2019 08:56:00 -0500 https://www.proactiveinvestors.com/companies/news/214974/zynerba-pharmaceuticals-adds-pharma-exec-to-its-board-214974.html
<![CDATA[Media files - Zynerba updates on its two clinical CBD studies ]]> https://www.proactiveinvestors.com/companies/stocktube/12172/zynerba-updates-on-its-two-clinical-cbd-studies-12172.html Mon, 11 Feb 2019 17:05:00 -0500 https://www.proactiveinvestors.com/companies/stocktube/12172/zynerba-updates-on-its-two-clinical-cbd-studies-12172.html <![CDATA[News - Proactive Investors cannabis conference in New York showcases industry potential for investors ]]> https://www.proactiveinvestors.com/companies/news/213750/proactive-investors-cannabis-conference-in-new-york-showcases-industry-potential-for-investors-213750.html Oil and water can mix to the benefit of the cannabis industry, executives of Pressure BioSciences Inc (OTCMKTS:PBIO) told qualified investors at the Proactive Investors’ Invest In Cannabis conference.

More than 100 received updates from Pressure BioSciences and four other companies at the event in New York City on Wednesday.

Richard Schumacher, president and CEO of South Easton, Massachusetts-based Pressure BioSciences, told the conference that the company’s nano-scale emulsion system has significant potential for suppliers of cannabidiol (CBD) oils.

READ: Pressure BioSciences and NutraFuels strike deal to collaborate on nutraceuticals

The company’s Ultra Shear technology applies pressure to oils to break them down into nano-droplets, making it easier for the oils to mix with water.

“Oil and water do mix if you have the right technology,” Bradford Young, senior vice president and chief commercial officer, told the conference.

Earlier this week, the company announced that it’s working with NutraFuels Inc (OTCQB:NTFU) to advance the development of nutraceuticals products based on its technology.

Making a difference

Alchemist Inc (NSE:AMS) CEO Paul Mann told the conference of proprietary software making it easier for cannabis companies to attain regulatory clearance, adding that the company began generating revenue in January.

“Getting before the planning board of the cities and working with the states – that’s the difference,” Mann told the conference. He started in his role last year as the Vancouver-based company that shifted from mining.

Jim Fickenscher, chief financial officer of Zynerba Pharmaceuticals Inc (NASDAQ:ZYNE), cited progress in its clinical trials of a cannabidiol (CBD) gel for treatment of anxiety in young patients with autism or autism-related disorders.

“The hope is that data from the clinical trial is strong enough for a doctor to prescribe the drug," Fickenscher said.

In November, the Devon, Pennsylvania, company reported cash and cash equivalent position as of September 30 of $66.2 million, which it said was sufficient to fund operations and capital requirements into the first half of 2020.

The company now has almost $60 million in cash, Fickenscher told the Proactive Investors conference.

Eyeing cannabis industry

Cameron Chell, chairman of ICOX Innovations Inc (CVE: ICOX) (OTCMKTS:ICOX), said the blockchain and digital payment company is well-positioned to enter the cannabis industry as US marijuana laws evolve at the federal level.

This week the Los Angeles-based company announced FreedomCoin, a regulatory-compliant currency that will allow users of GunBroker.com, an online marketplace with more than 4.7 million customers, to pay for purchases using a digital wallet.

Pharmalogyx CEO Colte Koen and Chief Operating Officer Jeffrey McPhee told the conference of the privately held company’s progress in adapting its expertise in hops farming for cannabis production.

The company is looking to raise $18 million in capital to ramp up production at its 700-acre CBD hemp farm in Nevada.

“We are taking 174 years of evolved technologies from the hops industry and bringing them to the hemp space,” Koen said.

Contact Dennis Fitzgerald at dennis@proactiveinvestors.com

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Thu, 31 Jan 2019 10:40:00 -0500 https://www.proactiveinvestors.com/companies/news/213750/proactive-investors-cannabis-conference-in-new-york-showcases-industry-potential-for-investors-213750.html
<![CDATA[News - Zynerba Pharmaceuticals stock soars amid slew of positive drivers ]]> https://www.proactiveinvestors.com/companies/news/213552/zynerba-pharmaceuticals-stock-soars-amid-slew-of-positive-drivers-213552.html Zynerba Pharmaceuticals Inc (NASDAQ:ZYNE) stock rocketed Tuesday amid a slew of positive drivers showing institutional investors were buying shares of the neuropsychiatric pharmaceutical company.

The stock also popped after CNBC's Jim Cramer shared his outlook for the year ahead in the budding cannabis industry saying he expected "marijuana-adjacent" biotechnology companies to start getting more credit from investors for their cannabis-influenced businesses.

Zynerba’s stock climbed 25.2% to close at $4.81 Tuesday and continued the ascent Wednesday, adding another 4.8% to $5.04 in pre-market action.

READ: Zynerba on track to report cannabidiol gel treatment results for Fragile X childhood disorder

"These are not pot companies. They are drug companies focused on developing artificial cannabinoids that mimic what cannabis does to your body," Cramer explained.

"As we get more and more data showing the efficacy of medicinal marijuana, I think more investors will embrace actual medicines that do the same thing as marijuana, but they do it more reliably," added Cramer.

Like GW Pharmaceuticals PLC (NASDAQ:GWPH), which develops cannabis-plant-derived treatments for diseases including epilepsy, Zynerba Pharmaceutical’s principal line of business are cannabinoid treatments delivered via the skin to treat neurological and psychiatric disorders.

Positive data expected

Zynerba is on track to report top-line results from tests of its cannabidiol gel treatment for children and adolescents with Fragile X Syndrome.

The Devon, Pennsylvania-based company said in a release earlier this week that it expects the results in the second half of 2019. Fragile X is a genetic condition that leads to learning disabilities and attention deficit disorder.

“This is an incredibly exciting year for Zynerba and our stakeholders, with important clinical milestones across our pipeline,” William C Roberts, vice president of investor relations at Zynerba Pharmaceuticals told Proactive Investors. “We expect to deliver data from our pivotal trial of ZYN002 in children and teens with Fragile X in the second half of this year, and data from our Phase 2 study in developmental and epileptic encephalopathies in the third quarter.”

The company will also initiate new Phase 2 studies in Autism Spectrum Disorder and 22q11.2 Deletion Syndrome with ZYN002 in the first half of 2019.

“We have a deep clinical pipeline offering a potential multi-billion dollar market opportunity, our balance sheet is clean, and our cash runway should take us beyond our key clinical milestones and into the second half of 2020,” said Roberts.

Investors buying into stock

Meanwhile, a Securities and Exchange Commission filing showed that Genesis Capital Advisors LLC had ownership of a block of 797,477 shares of Zynerba Pharmaceuticals.

Four out of five analysts covering Zynerba have a Buy rating, reports Benzinga. “The stock has the most potential upside of all, with the average target price of $18.40 representing 385% upside,” it added

Contact Uttara Choudhury at uttara@proactiveinvestors.com

Follow her on Twitter: @UttaraProactive 

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Tue, 29 Jan 2019 15:22:00 -0500 https://www.proactiveinvestors.com/companies/news/213552/zynerba-pharmaceuticals-stock-soars-amid-slew-of-positive-drivers-213552.html
<![CDATA[News - SCYNEXIS names Zynerba CEO Armando Anido to its board ]]> https://www.proactiveinvestors.com/companies/news/213086/scynexis-names-zynerba-ceo-armando-anido-to-its-board-213086.html SCYNEXIS Inc (NASDAQ:SCYX) announced Tuesday that it has tapped Armando Anido to its board of directors.

Anido is currently the chairman and CEO of Zynerba Pharmaceuticals Inc (NASDAQ:ZYNE), a job he has held since October of 2014.

“On behalf of my fellow board members, I would like to welcome Armando and look forward to his contributions as we carry out the important work of bringing novel antifungal treatments to patients,” said Guy Macdonald, chairman of the board of the New Jersey-based biotech, in a statement.

READ: Zynerba Pharmaceuticals CEO welcomes FDA approval of cannabinoid products

Anido boasts more than 30 years of experience in the biopharmaceutical sector. Prior to his tenure at Zynerba, Anido served as CEO of NuPathe Inc, which was acquired by Teva Pharmaceuticals in February of 2014. He also previously was at the helm as CEO at Auxilium  Pharmaceuticals, which was acquired by Endo Pharmaceuticals in January of 2015.

SCYNEXIS’s lead drug candidate is ibrexafungerp (formerly known as SCY-078), an antifungal agent in clinical development for the treatment of serious and life-threatening fungal infections caused by candida and aspergillus species.

SCYNEXIS shares popped by 3.7% to $0.77 in Tuesday’s morning trading session.

Contact Ellen Kelleher at ellen@proactiveinvestors.com

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Tue, 22 Jan 2019 09:52:00 -0500 https://www.proactiveinvestors.com/companies/news/213086/scynexis-names-zynerba-ceo-armando-anido-to-its-board-213086.html
<![CDATA[News - Zynerba on track to report cannabidiol gel treatment results for Fragile X childhood disorder ]]> https://www.proactiveinvestors.com/companies/news/211523/zynerba-on-track-to-report-cannabidiol-gel-treatment-results-for-fragile-x-childhood-disorder-211523.html Zynerba Pharmaceuticals Inc (NASDAQ:ZYNE) is on track to report top-line results from tests of its cannabidiol gel treatment for children and adolescents with Fragile X Syndrome.

The Devon, Pennsylvania-based company said in a release earlier this week that it expects the results in the second half of 2019. Fragile X is a genetic condition that leads to learning disabilities and attention deficit disorder.

Shares of Zynerba were trading in a narrow range and recently changed hands at US$3.67 in Wednesday’s Nasdaq trading.

READ: MedMen cuts deal to expand into Arizona’s fast-growing medical marijuana market

Zynerba has completed enrollment for its Phase 2 clinical trial of the ZYN002 transdermal gel’s use on children and adolescents with developmental and epileptic encephalopathy. Top-line results of that study are due to be reported in the third quarter of 2019.

“Our aspirations and expectations are clear: to work closely with the US Food and Drug Administration to expand the opportunity for pharmaceutically developed cannabidiol  treatments that meet its rigorous medical and manufacturing standards, and in doing so, continue toward our goal of addressing significant unmet medical needs in neuropsychiatric disorders,” CEO Armando Anido said in a statement.

Expanded pipeline

Zynerba added that it has expanded its pipeline with the addition of two new childhood neuropsychiatric clinical targets for the cannabidiol gel: autism spectrum disorder and 22q deletion syndrome, a rare genetic syndrome leading to neuropsychiatric disorders.

The company expects to initiate Phase 2 studies in the first half of 2019 and report top-line results in the first half of 2020.

Zynerba said it has postponed the start of its clinical trial for adult epilepsy and added that it expects to have sufficient cash through the second half of 2020.


Contact Dennis Fitzgerald at dennis@proactiveinvestors.com

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Wed, 19 Dec 2018 13:57:00 -0500 https://www.proactiveinvestors.com/companies/news/211523/zynerba-on-track-to-report-cannabidiol-gel-treatment-results-for-fragile-x-childhood-disorder-211523.html
<![CDATA[News - Zynerba Pharmaceuticals CEO welcomes FDA approval of cannabinoid products ]]> https://www.proactiveinvestors.com/companies/news/208544/zynerba-pharmaceuticals-ceo-welcomes-fda-approval-of-cannabinoid-products-208544.html Last week, GW Pharmaceuticals PLC (NASDAQ:GWP) announced that Epidiolex, a cannabidiol oral medication for the treatment of seizures, is now available through a prescription in the US.

It is the first pharmaceutical formulation of a highly purified, plant-derived cannabidiol (CBD), a cannabinoid that lacks the high associated with marijuana, and is the first in a new category of anti-epileptic drugs. Epidiolex is an oral solution for seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients two years of age or older. The drug was approved by the Food and Drug Administration on June 25, 2018,

The approval by the FDA of a cannabinoid product is a vital inflection point for companies in the pharmaceutical CBD space, the chief executive of Zynerba Pharmaceuticals (NASDAQ:ZYNE), Armando Anido, said.

"This approval is great achievement for GW Pharma and an important milestone for all companies in the pharmaceutical CBD space, as the FDA is very clearly in support of cannabinoid (CBD) products when developed according to their standards," Anido told Proactive Investors.

READ: Zynerba Pharmaceuticals anticipates data in late 2019 for its phase 3 cannabinoid drug

Anido said Zynerba is developing its own CBD product, ZYN002.

He said that while GW Pharmaceuticals is working on Dravet and Lennox-Gastaut syndromes, two rare pediatric epilepsy syndromes, Zynerba is conducting work in Fragile X Syndrome, a known genetic cause "of both inherited intellectual disability and autism spectrum disorder."

"The importance of their approval is that it speaks directly to the validity of CBD as a therapeutic compound supported by FDA," Anido explained.

He added the company is in the middle of a critical study for patients with Fragile X Syndrome. Data from tests are expected in the second half of 2019 and if the drug goes to market, it would "impact our bottom line very favorably." 

The Zynerba CEO said the company's estimate of the market for Fragile X patients is approximately 71,000 patients in the US.

READ: GW Pharmaceuticals says first FDA approved cannabinoid medicine now available by prescription in US

While GW's CBD is extracted from cannabis, ZYN002 is manufactured pharmaceutically under the cGMP (current Good Manufacturing Practice) regulations enforced by the FDA.

Anido said manufacturing CBD through this method ensures consistent potency and efficient manufacturing without the cost, risks and logistical requirements of growing and harvesting cannabis themselves.

GW Pharma’s CBD is administered orally and enters the system through the stomach while ZYN002 is applied directly to the skin and enters the bloodstream through the skin. Doing it this way results in lower incidence of gastrointestinal side effects such as nausea, diarrhea and vomiting.

Zynerba Pharmaceutical is a company seeking to develop next-generation cannabinoid therapeutics for rare and near-rare neuropsychiatric conditions in patients with high unmet medical needs.

The company is based in Devon, Pennsylvania.

Reporting by Rene Pastor, contactable on rene.pastor@proactiveinvestors.com

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Mon, 05 Nov 2018 10:44:00 -0500 https://www.proactiveinvestors.com/companies/news/208544/zynerba-pharmaceuticals-ceo-welcomes-fda-approval-of-cannabinoid-products-208544.html
<![CDATA[Media files - Zynerba Pharmaceuticals anticipates data in late 2019 for its phase 3 cannabinoid drug ]]> https://www.proactiveinvestors.com/companies/stocktube/10912/zynerba-pharmaceuticals-anticipates-data-in-late-2019-for-its-phase-3-cannabinoid-drug-10912.html Thu, 18 Oct 2018 11:30:00 -0400 https://www.proactiveinvestors.com/companies/stocktube/10912/zynerba-pharmaceuticals-anticipates-data-in-late-2019-for-its-phase-3-cannabinoid-drug-10912.html <![CDATA[News - Daily CryptoCann Report: Buy a classic car with crypto; WeedMD inks distribution deal in Alberta ]]> https://www.proactiveinvestors.com/companies/news/200237/daily-cryptocann-report-buy-a-classic-car-with-crypto-weedmd-inks-distribution-deal-in-alberta-200237.html While US investors were enjoying the Fourth of July festivities, Bitcoin was slowly inching its way closer to the US$7,000 mark.

Bitcoin reached US$6,785 on Wednesday but couldn’t quite hit the target.

Wall Street strategist Tom Lee cut his year-end Bitcoin price target but still believes it could hit US$20,000 per unit by the end of the year.

The co-founder of Fundstrat Global Advisors gave a previous estimate of US$25,000.

"Bitcoin has historically traded at 2.5 times its mining costs. It's not out of the question that it could be over $20,000 by the end of the year at fair value," said Lee in an interview on CNCB’s Squawk Box.

Bitcoin was trading at US$6,622.22 in Thursday afternoon trading.

READ: Daily CryptoCann: India's top court upholds crypto ban; Los Angeles to begin licensing cannabis cultivators

Investors with a love for crypto and classic cars can now combine their interests.

Custom car builder Classic Recreations will now accept a variety of digital coins as payment, including Bitcoin, Bitcoin Cash, Litecoin and Ethereum, according to a Bitcoin News report.

“The true beauty of accepting cryptocurrency is the universal aspect of it which allows Classic Recreations to connect with consumers from anywhere in the world,” said owner Jason Engel in a press statement.

The Oklahoma-based company is licensed by Ford Motor Company (NYSE:F) and Shelby American to fabricate licensed Ford Mustang restorations and continuation cars.

The Cann Report

Cannabis can be delivered in a variety of ways from traditional smoking to pills to edibles.

Zynerba Pharmaceuticals Inc (NASDAQ:ZYNE), which develops cannabis-based therapies for rare neuropsychiatric disorders, attempted to deliver the THC component of marijuana through a transdermal skin patch.

Its placebo-controlled Phase 1 study studied 60 volunteers wearing differently formulated patches for varying amounts of time. Unfortunately, the skin patch failed to meet its goal target of THC levels in the blood.

The company will shift its focus to ZYN002 Fragile X syndrome, a treatment for epilepsy. Shares were down more than 5% to US$9.10.

READ: WeedMD makes major stride with strategy with Alberta Gaming, Liquor & Cannabis Commission deal

WeedMD Inc (CVE:WMD) inked a deal with the Alberta Gaming, Liquor and Cannabis Commission, furthering its distribution platform in Canada.

The cannabis company will join the network of suppliers reaching into the country’s legal adult-use market.

WeedMD recently signed a supply deal with Shoppers Drug Mart, one of Canada’s largest pharmacy chains.

The Ontario-based company shares were up nearly 4% to C$2.05.

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Thu, 05 Jul 2018 12:00:00 -0400 https://www.proactiveinvestors.com/companies/news/200237/daily-cryptocann-report-buy-a-classic-car-with-crypto-weedmd-inks-distribution-deal-in-alberta-200237.html
<![CDATA[News - Zynerba Pharmaceuticals shares sink after unsuccessful trial of cannabis-based skin patch ]]> https://www.proactiveinvestors.com/companies/news/200216/zynerba-pharmaceuticals-shares-sink-after-unsuccessful-trial-of-cannabis-based-skin-patch-200216.html Zynerba Pharmaceuticals Inc (NASADAQ:ZYNE) shares sank following an unsuccessful early-stage trial of ZYN001, its cannabinoid skin patch.

ZYN001 is designed to deliver THC through a transdermal patch.

In the placebo-controlled Phase 1 study, a total of 60 volunteers participated in the study with differently formulated patches and varying wear times.

While there were no serious adverse effects detected, the skin patch did not achieve its goal of target THC levels in the blood.

The company, which develops cannabis-based therapies for rare neuropsychiatric disorders, will shift its focus to ZYN002 Fragile X syndrome, a treatment for epilepsy.

Shares of the Pennsylvania-based company fell more than 20% to US$7.64 in Thursday pre-market trading.

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Thu, 05 Jul 2018 08:57:00 -0400 https://www.proactiveinvestors.com/companies/news/200216/zynerba-pharmaceuticals-shares-sink-after-unsuccessful-trial-of-cannabis-based-skin-patch-200216.html
<![CDATA[News - Zynerba Pharmaceuticals shares plunge after its net loss in 1Q widens ]]> https://www.proactiveinvestors.com/companies/news/196588/zynerba-pharmaceuticals-shares-plunge-after-its-net-loss-in-1q-widens-196588.html Shares in Zynerba Pharmaceuticals (NASDAQ:ZYNE) took a nose-dive in afternoon trade after the clinical stage neuropsychiatric pharmaceutical company reported a widening in its net loss in the first quarter.

Zynerba’s stock dropped by 13% to US$9.01 after its net loss ballooned to US$12.3mln in the first quarter or $0.09 per share, which was even bigger than its loss of US$7.3mln or US$0.06 in the same period a year ago.

Zynerba's principal line of business are cannabinoid treatments delivered via the skin to treat neurological and psychiatric disorders.

As part of its research, it plans to enroll about 200 pediatric and adolescent patients from the U.S., Australia and New Zealand in a study to assess the use of its transdermal cannabinoid gel ZYN002 to treat Fragile X syndrome.

It has also begun a six-month Phase 2 clinical trial to evaluate the effectiveness of this same drug ZYN002 in fifty children who suffer from an array of epilepsy syndromes.

Lastly, Zynerba will use ZYN001, a drug consisting of THC delivered via a patch, in patients with Tourette syndrome, in a phase 2 study expected in the second half of this year.

Christopher Liu, an Oppenheimer analyst, estimates that ZYN002 has a 40% probability of clinical and commercial success in Fragile X syndrome, but he isn’t able to attribute a value for either the use of ZYN002 to treat epilepsy and other diseases or for ZYN001. As a result, Liu is remaining on the sidelines as far as the stock is concerned due to a lack of a "near-term, meaningful catalyst".

Liu expects Zynerba will spend as much as US$42mln this year and thinks its current cash level gives the company “runway” through mid 2019. The company can also take advantage of an at-the-market stock offering to fund operations  and hit milestones later in 2019.

The company said its cash position of US$52.1mln can fund its operations and capital requirements well into 2019.

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Tue, 08 May 2018 15:36:00 -0400 https://www.proactiveinvestors.com/companies/news/196588/zynerba-pharmaceuticals-shares-plunge-after-its-net-loss-in-1q-widens-196588.html
<![CDATA[News - Zynerba Pharmaceuticals shares tank after disappointing epilepsy trial results ]]> https://www.proactiveinvestors.com/companies/news/182065/zynerba-pharmaceuticals-shares-tank-after-disappointing-epilepsy-trial-results-182065.html Zynerba Pharmaceuticals Inc  (NASDAQ: ZYNE) tanked 55% on Nasdaq on Monday to be top loser on the back of disappointing clinical trial news.

The group's mid-stage clinical trial for ZYN002 - a cannabidiol gel in adult epilepsy with partial seizures -  didn't meet its primary endpoint or secondary endpoints, it said.

Very disappointed...

"We are very disappointed that the STAR 1 trial did not meet its primary endpoint in this patient population,” said Armando Anido, chairman and chief executive told investors.

But he added that the group will continue to evaluate this study and the ongoing STAR 2 open label study to determine next steps with ZYN002 in adult epilepsy patients.

But favorable safety and tolerability profile..

“Importantly, today’s results demonstrated ZYN002 to have a very favorable safety and tolerability profile, which is an encouraging fact as we look to develop ZYN002 as a treatment for a wide range of indications.

"We are excited that we will present top-line data from our ZYN002 STOP trial in osteoarthritis soon, followed by top-line data from our FAB-C study in Fragile X syndrome by the end of September.”

Zynerba is bidding to develop treatments for severe, chronic health conditions including epilepsy, Fragile X syndrome, osteoarthritis, fibromyalgia and peripheral neuropathic pain.

Shares lost over 54% in New York to $6.85.

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Mon, 07 Aug 2017 08:54:00 -0400 https://www.proactiveinvestors.com/companies/news/182065/zynerba-pharmaceuticals-shares-tank-after-disappointing-epilepsy-trial-results-182065.html
<![CDATA[News - Zynerba Pharma to highlight data to American Epilepsy Society ]]> https://www.proactiveinvestors.com/companies/news/169614/zynerba-pharma-to-highlight-data-to-american-epilepsy-society-169614.html Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE) said on Monday two of its posters related to its patented synthetic cannabidiol (CBD) gel will be presented at the 70th annual meeting of the  American Epilepsy Society next month.

The clinical-stage specialty pharmaceutical company dedicated to the development of innovative transdermal synthetic cannabinoid treatments said posters feature the company’s ZYN002 gel and include safety, tolerability and effects on cognition and mood changes in healthy volunteers and adult epilepsy patients with focal seizures.

The meeting will be held December 2 – 6 in Houston, Texas.

“We are encouraged to see that data further supporting the safety profile of ZYN002 were chosen for presentation at this year’s Annual Meeting for the American Epilepsy Society,” said Armando Anido, Chairman and Chief Executive Officer of Zynerba.

“These data demonstrate that ZYN002 CDB gel is safe, well-tolerated and show no psychoactive effects across a wide range of doses. Enrollment in our STAR 1 phase 2 clinical trial for adult refractory epilepsy patients with focal seizures is continuing and we remain on track to report top line results of this trial in the first half of 2017.  Earlier this month, we announced the initiation of our STAR 2 open-label extension trial which will support long-term safety and tolerability of ZYN002 CBD gel in this patient population.”

Zynerba shares, which closed on the half-day of trading on Friday down 1.8% at $14.04 were up 1.1% at $14.20 pre-market on Monday.

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Mon, 28 Nov 2016 09:03:00 -0500 https://www.proactiveinvestors.com/companies/news/169614/zynerba-pharma-to-highlight-data-to-american-epilepsy-society-169614.html
<![CDATA[News - Zynerba doses first patient in epilepsy gel trial ]]> https://www.proactiveinvestors.com/companies/news/128853/zynerba-doses-first-patient-in-epilepsy-gel-trial-128853.html Zynerba Pharmaceuticals Inc. (NASDAQ:ZYNE) has dosed its first patient in a clinical, multi-dose trial for its ZYN002 cannabidiol (CBD) gel for adults who suffer refractory focal epileptic seizures.  

The gel is designed to be transmitted through patches on the skin and as well as epilepsy is being targeted at  osteoarthritis (OA) and Fragile X syndrome (FXS).

Some 180 refractory epilepsy sufferers will be treated in the trial. After an  8-week baseline period the patients will split into three with two receiving different doses of ZYN002 and one a placebo.

The study is being conducted at 14 sites in Australia and New Zealand. Top line results are expected to be reported in the first half of 2017.

Armando Anido, Zynerba’s chief executive, said: “We are pleased by the pace of the clinical program for ZYN002 and remain on track to initiate additional Phase 2 studies in OA and FXS in the second half of this year.

“We expect to report top line results from all three studies in the first half of 2017.”

Transdermal therapeutics are absorbed through the skin directly into the systemic circulation

Approximately 2.2mln patients in the US and more in Europe and Japan are afflicted with epilepsy with focal seizures representing 35% of all epilepsy incidents.

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Mon, 01 Aug 2016 09:27:00 -0400 https://www.proactiveinvestors.com/companies/news/128853/zynerba-doses-first-patient-in-epilepsy-gel-trial-128853.html