Harmony Biosciences to Acquire Zynerba Pharmaceuticals for Pipeline Including Non-Euphoric CBD Gel

Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) will acquire Zynerba Pharmaceuticals (ZYNE), a leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for orphan neuropsychiatric disorders.

Zynerba’s lead candidate, Zygel, a synthetic cannabidiol (CBD), is currently being evaluated in a pivotal Phase 3 clinical trial for patients living with Fragile X Syndrome (FXS).

Jeffrey M. Dayno, M.D., President and Chief Executive Officer at Harmony Biosciences, said, “We are excited to continue to diversify our portfolio beyond…by adding Zynerba’s clinical development programs to our pipeline. The team at Zynerba has been dedicated to these programs and we are confident that our combined efforts could have a profound impact on individuals living with rare neuropsychiatric disorders and their families.”

The transaction is expected to close by the fourth quarter of 2023.


Under the terms of the definitive agreement, Harmony will commence a tender offer to acquire all outstanding shares of Zynerba for a purchase price of $1.1059 per share in cash, or $60 million in the aggregate, plus one non-tradeable contingent value right (CVR) per share, representing the right to receive potential additional payments of up to $140 million in the aggregate, subject to the achievement of certain clinical, regulatory and sales milestones.

Zynerba’s lead asset, Zygel, is the first and only pharmaceutically manufactured, synthetic cannabidiol, a non-euphoric cannabinoid, formulated as a patent-protected permeation-enhanced gel for transdermal delivery through the skin and into the circulatory system.

Zygel is manufactured through a synthetic process in a cGMP facility and is not extracted from the cannabis plant. Therefore, it is devoid of THC, which is what causes the euphoric effect of cannabis, and has the potential to be a nonscheduled product if approved.

CBD has been granted Orphan Drug and Fast Track designations by the FDA and the European Medicines Agency for the treatment of FXS and for the treatment of 22q11.2 deletion syndrome (22q).

FXS is a rare genetic disorder that affects approximately 80,000 people in the U.S., causing intellectual disabilities and behavioral challenges and there are currently no FDA approved therapies to treat FXS.

There are approximately 80,000 people living with 22q in the U.S.

About Harmony Biosciences

At Harmony Biosciences, we specialize in developing and delivering treatments for rare neurological diseases that others often overlook. We believe that where empathy and innovation meet, a better life can begin for people living with neurological diseases. Established by Paragon Biosciences, LLC, in 2017 and headquartered in Plymouth Meeting, PA, our team of experts from a wide variety of disciplines and experiences is driven by our shared conviction that innovative science translates into therapeutic possibilities for our patients, who are at the heart of everything we do. For more information, please visit www.harmonybiosciences.com.

About Zynerba Pharmaceuticals

Zynerba Pharmaceuticals is the leader in innovative pharmaceutically produced, synthetic transdermal cannabidiol therapies for orphan neuropsychiatric disorders. We are committed to improving the lives of patients and their families living with severe, chronic health conditions including Fragile X syndrome and 22q11.2 deletion syndrome. Learn more at www.zynerba.com.

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Harmony Biosciences to Acquire Zynerba Pharmaceuticals for Pipeline Including Non-Euphoric CBD Gel

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