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Zynerba Pharmaceuticals, Inc. - ZYNE STOCK NEWS

Welcome to our dedicated page for Zynerba Pharmaceuticals news (Ticker: ZYNE), a resource for investors and traders seeking the latest updates and insights on Zynerba Pharmaceuticals stock.

Zynerba Pharmaceuticals, Inc. (NASDAQ: ZYNE) is at the forefront of developing next-generation synthetic cannabinoid therapeutics designed for transdermal delivery. This innovative approach is aimed at patients with significant unmet medical needs, including refractory epilepsy, osteoarthritis, Fragile X syndrome (FXS), fibromyalgia, and peripheral neuropathic pain. The company’s mission is to enhance the lives of individuals suffering from these severe health conditions through advanced therapeutics.

Zynerba's development pipeline features patent-protected transdermal cannabinoid products, notably the CBD gel ZYN002 and the THC pro-drug patch ZYN001. ZYN002, marketed as Zygel™, is the first and only pharmaceutically manufactured, synthetic cannabidiol, designed as a permeation-enhanced gel for transdermal delivery. Unlike many cannabinoid products, Zygel contains no THC, eliminating the euphoric effects associated with cannabis. Zygel is currently under evaluation in a pivotal Phase 3 clinical trial for FXS (the RECONNECT Trial) and has shown promising results in a Phase 2 trial for 22q11.2 deletion syndrome (the INSPIRE Trial).

Recent developments highlight Zynerba’s potential impact. On August 14, 2023, Harmony Biosciences Holdings, Inc. (NASDAQ: HRMY) announced a definitive agreement to acquire Zynerba, emphasizing the strategic fit between the two companies. Harmony’s acquisition aims to advance the development and delivery of transformative treatments for rare neuropsychiatric disorders. The transaction terms include an upfront cash payment of $1.1059 per share, totaling $60 million, and the issuance of a contingent value right (CVR) per share, which could lead to additional payments up to $140 million.

Zynerba’s lead candidate, Zygel, has been granted orphan drug designation by the FDA and the European Medicines Agency (EMA) for treating FXS and 22q11.2 deletion syndrome. Additionally, Zygel has received FDA Fast Track designation for FXS behavioral symptoms treatment. These designations highlight Zynerba’s commitment to addressing conditions that currently lack FDA-approved therapies.

Zynerba Pharmaceuticals continues to push the boundaries of cannabinoid science, aiming to provide new, effective treatment options for patients not adequately served by current therapies. The company’s focus on rigorous clinical trials and regulatory compliance positions it as a leader in the field of synthetic transdermal cannabinoid therapeutics.

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Harmony Biosciences completes acquisition of Zynerba Pharmaceuticals, expanding its portfolio with Zygel
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Zynerba Pharmaceuticals reminds stockholders to tender their shares into the offer by Harmony Biosciences Holdings to purchase all outstanding shares of Zynerba common stock. The tender deadline is October 10, 2023, and stockholders will receive an up-front purchase price of $1.1059 per share plus one non-tradeable contingent value right per share. If all milestones are achieved, the total consideration payable to stockholders is up to $3.6503 per share in cash.
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Zynerba Pharmaceuticals urges stockholders to tender their shares in response to the pending tender offer by Harmony Biosciences Holdings. Harmony is offering an up-front purchase price of $1.1059 per share plus one non-tradable contingent value right (CVR) per share. The maximum additional payment to shareholders is up to an additional approximately $2.5444 per share in cash. The Offer is conditioned upon more than 50% of the outstanding shares of Zynerba common stock being tendered. As of September 27, approximately 32.1% of Zynerba's outstanding shares of common stock were tendered. The Offer has been extended until October 10, 2023. The Zynerba Board unanimously recommends that Zynerba stockholders tender their shares pursuant to the Offer.
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Harmony Biosciences Holdings, Inc. extends tender offer for Zynerba Pharmaceuticals, Inc.
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Zygel (ZYN002) achieved statistically significant and clinically meaningful improvements in multiple efficacy assessments in a Phase 2 trial for children and adolescents with 22q11.2 deletion syndrome. The treatment showed positive results in anxiety-related and other behavioral symptoms, with statistically significant improvements in various scales. Caregivers reported improvement in self-identified problems. Zygel was generally well-tolerated with mild adverse events. Further study is warranted.
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Harmony Biosciences announces agreement to acquire Zynerba Pharmaceuticals for $60 million in cash, with potential additional payments of up to $140 million based on milestones. Acquisition aims to develop treatment for Fragile X syndrome and other rare neuropsychiatric disorders. Zygel, Zynerba's lead asset, is currently being evaluated in a pivotal Phase 3 clinical trial for FXS. Transaction expected to close by Q4 2023.
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FAQ

What is the market cap of Zynerba Pharmaceuticals (ZYNE)?

The market cap of Zynerba Pharmaceuticals (ZYNE) is approximately 70.1M.

What is the primary focus of Zynerba Pharmaceuticals?

Zynerba Pharmaceuticals focuses on developing next-generation synthetic cannabinoid therapeutics for transdermal delivery to treat severe health conditions such as refractory epilepsy, osteoarthritis, Fragile X syndrome, fibromyalgia, and peripheral neuropathic pain.

What are Zynerba’s main products?

Zynerba's main products include the CBD gel ZYN002 (marketed as Zygel™) and the THC pro-drug patch ZYN001. Zygel is a patent-protected, pharmaceutically manufactured, synthetic cannabidiol formulated for transdermal delivery.

What recent significant achievement has Zynerba made?

Zynerba recently entered into a definitive agreement to be acquired by Harmony Biosciences. The acquisition aims to advance the development and delivery of transformative treatments for rare neuropsychiatric disorders.

What is Zygel and what conditions is it used for?

Zygel is a synthetic cannabidiol formulated as a permeation-enhanced gel for transdermal delivery. It is currently being evaluated for treating Fragile X syndrome (FXS) and 22q11.2 deletion syndrome.

What makes Zygel unique compared to other cannabinoid products?

Zygel is unique because it is the first and only pharmaceutically manufactured synthetic cannabidiol that is devoid of THC, the compound in cannabis responsible for euphoric effects.

What designations has Zygel received from regulatory agencies?

Zygel has been granted orphan drug designation by the FDA and the European Medicines Agency for the treatment of Fragile X syndrome (FXS) and 22q11.2 deletion syndrome. It has also received FDA Fast Track designation for the treatment of behavioral symptoms in patients with FXS.

What is the current status of Zygel’s clinical trials?

Zygel is currently being evaluated in a pivotal Phase 3 clinical trial for Fragile X syndrome (the RECONNECT Trial) and has shown positive results in a Phase 2 trial for 22q11.2 deletion syndrome (the INSPIRE Trial).

How will the acquisition by Harmony Biosciences benefit Zynerba?

The acquisition by Harmony Biosciences will provide Zynerba with enhanced resources, scale, and commercial expertise to potentially bring Zygel to market and maximize its value. This strategic fit aims to address high unmet medical needs in rare neuropsychiatric disorders.

What financial terms were involved in the acquisition by Harmony Biosciences?

Harmony Biosciences offered an upfront cash payment of $1.1059 per share, totaling $60 million, plus a contingent value right (CVR) per share, which could lead to additional payments up to $140 million based on achieving certain milestones.

What does the future hold for Zynerba Pharmaceuticals post-acquisition?

Post-acquisition, Zynerba Pharmaceuticals will become a wholly owned subsidiary of Harmony Biosciences. The focus will remain on advancing Zygel and other pipeline products to address unmet medical needs in rare neuropsychiatric disorders.

Zynerba Pharmaceuticals, Inc.

Nasdaq:ZYNE

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ZYNE Stock Data

70.12M
52.79M
6.07%
12.13%
0.78%
Drug Manufacturers - Specialty & Generic
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United States
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