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Zynerba Pharmaceuticals

Zynerba Pharmaceuticals scores Fast Track FDA designation for Zygel CBD gel

US regulators have awarded the distinction to expedite the development of the drug to treat Fragile X syndrome

A Zynerba presentation
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

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 [email protected]

Follow her on Twitter@UttaraProactive 

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Price: 5.71 USD

Market: NASDAQ
Market Cap: $132.46 m
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