VYNE Therapeutics Inc., a pharmaceutical company, focuses on developing various therapeutics for the treatment of immuno-inflammatory conditions. The company develops FCD105, a topical combination foam that has completed Phase III clinical trials for the treatment of moderate-to-severe acne vulgaris; and FMX114, a combination of tofacitinib, which is in Phase IIa preclinical trial for the treatment of mild-to-moderate atopic dermatitis. It is also developing VYN201, a bromodomain and extra-terminal (BET) inhibitor for various immuno-inflammatory diseases, including skin diseases; and VYN202, BET inhibitor compounds that are selective for bromodomain 2. The company was formerly known as Menlo Therapeutics Inc. and changed its name to VYNE Therapeutics Inc. in September 2020. VYNE Therapeutics Inc. was founded in 2003 and is based in Bridgewater, New Jersey.
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1. A clinical-stage Vertex Pharmaceuticals focused on developing breakthrough drugs for autoimmune and inflammatory diseases.
2. A smaller, clinical-stage Regeneron, aiming to discover novel immunologic therapeutics.
3. An early-stage Amgen, specifically developing novel small molecule therapeutics for autoimmune conditions.
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VYNE Therapeutics' major products are:
- AMZEEQ (minocycline topical foam, 4%): A topical foam approved for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris.
- ZILXI (minocycline topical foam, 1.5%): A topical foam approved for the treatment of rosacea in adults.
- VYN201: An investigational oral pan-BD inhibitor currently in clinical development for dermatological indications, including vitiligo and other autoimmune diseases.
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VYNE Therapeutics (symbol: VYNE) is a pharmaceutical company that develops and commercializes prescription drugs. As such, it sells its products primarily to other companies within the healthcare supply chain, rather than directly to individuals.
The major customers for pharmaceutical companies like VYNE are typically large pharmaceutical wholesalers and distributors. These companies then distribute the drugs to pharmacies, hospitals, clinics, and other healthcare providers, who ultimately dispense them to patients.
Key major customers, representative of the type of entities VYNE would sell to, include:
- McKesson Corporation (NYSE: MCK)
- Cencora, Inc. (formerly AmerisourceBergen Corporation) (NYSE: COR)
- Cardinal Health, Inc. (NYSE: CAH)
These companies act as intermediaries, purchasing drugs in bulk from manufacturers like VYNE and distributing them across the healthcare system.
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David Domzalski, President, Chief Executive Officer and Director
Mr. Domzalski has served as President, Chief Executive Officer, and Director of VYNE Therapeutics since March 2020. Previously, he was Chief Executive Officer and a member of the board of Foamix Pharmaceuticals Ltd. from July 2017 until March 2020, and President of Foamix since April 2014. Foamix Pharmaceuticals Ltd. was acquired through a merger with Menlo Therapeutics Inc., which subsequently became VYNE Therapeutics Inc. Mr. Domzalski also founded and is a PR Consultant at Run The Money and founded and edited Hero Story. He previously owned a Barmetrix franchise and was the Director of Operations for the global Barmetrix company for ten to eleven years.
Tyler Zeronda, Chief Financial Officer, Principal Accounting Officer and Treasurer
Mr. Zeronda was appointed Chief Financial Officer and Treasurer of VYNE Therapeutics Inc. on March 14, 2022. He had previously served as the Company's Interim Chief Financial Officer and Treasurer since June 2021, and before that, as Vice President of Finance.
Dr. Iain A. Stuart, PhD, Chief Scientific Officer
Dr. Stuart serves as the Chief Scientific Officer at VYNE Therapeutics.
Mutya Harsch, J.D., General Counsel, Chief Legal Officer and Secretary
Ms. Harsch holds the positions of General Counsel, Chief Legal Officer, and Secretary at VYNE Therapeutics.
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The key risks to VYNE Therapeutics (VYNE) primarily revolve around the inherent challenges of clinical-stage biopharmaceutical development, its associated financial demands, and regulatory compliance.
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Clinical Trial Setbacks and Regulatory Holds: VYNE Therapeutics has faced significant setbacks with its pipeline candidates. The Phase 2b trial for repibresib gel, a lead candidate for nonsegmental vitiligo, failed to meet its primary and key secondary endpoints. The company attributed this failure to an unexpectedly high treatment effect in the vehicle arm and a high discontinuation rate in the active treatment arms. Consequently, VYNE plans to terminate the trial's extension phase and seek an external partner for further development. Additionally, the Phase 1b trial for VYN202, an oral therapy for moderate-to-severe plaque psoriasis, was placed on clinical hold by the FDA due to observations of testicular toxicity in non-clinical dog studies, halting patient enrollment and dosing. While the hold was partially lifted for certain doses and female patients, these clinical disappointments and regulatory hurdles significantly impact the company's ability to bring products to market.
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Financial Health and Need for Additional Funding: As a clinical-stage biopharmaceutical company, VYNE Therapeutics reports limited royalty revenues ($0.169 million in Q3 2025) and continues to incur substantial net losses ($7.280 million in Q3 2025). While the company maintains a strong current ratio and no debt, its financial stability is highly dependent on the success of its drug pipeline and its ability to secure additional funding. Analyst reports highlight the significant capital requirements and the risk of an inability to obtain sufficient additional capital or the occurrence of dilutive capital raises. The recent clinical trial failures exacerbate these financial challenges, making it potentially harder to attract future investment or collaboration opportunities.
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Nasdaq Listing Risk: VYNE Therapeutics received a minimum bid-price deficiency notice in 2025, indicating that its stock price has fallen below the minimum requirement for continued listing on Nasdaq. The company needs to regain compliance by March 10, 2026, to avoid potential delisting. Delisting can lead to a significant decrease in institutional investor interest and overall trading liquidity, further negatively impacting the company's valuation and ability to raise capital.
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The advanced clinical development of competing oral therapies for Chronic Spontaneous Urticaria (CSU), particularly BTK inhibitors such as remibrutinib (Novartis) and fenebrutinib (Genentech/Roche), represents a clear emerging threat. These competitor candidates are currently in Phase 3 clinical trials, significantly ahead of VYNE's lead candidate VYN201 (an oral BET inhibitor), which is in Phase 1b for CSU. If these oral BTK inhibitors demonstrate strong efficacy and safety profiles and gain regulatory approval prior to VYN201, they could establish a strong foothold and potentially become a standard of care for oral treatment options in CSU, thereby substantially limiting the future market opportunity and competitive positioning of VYN201.
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VYNE Therapeutics (symbol: VYNE) focuses on developing and commercializing therapies for immuno-inflammatory conditions. The addressable markets for their main products and product candidates are as follows:
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ZILXI (1.5% minocycline foam) for rosacea: The estimated addressable market size for the treatment of rosacea in adults in the U.S. is approximately $1 billion.
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FMX114 (Tofacitinib and Fingolimod Topical Gel) for mild-to-moderate atopic dermatitis: Atopic dermatitis affects an estimated 30 million patients in the U.S., with 22 million seeking treatment for mild-to-moderate forms. The global atopic dermatitis drugs market was valued at approximately USD 12.1 billion in 2024 and is projected to reach USD 31 billion by 2034. The U.S. atopic dermatitis drug market was valued at USD 3.44 billion in 2023 and is estimated to reach around USD 8.10 billion by 2034.
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VYN202 (oral small molecule BD2-selective inhibitor) for psoriasis: The global psoriasis therapeutics market was valued at $22.9 billion in 2021 and is projected to reach $55.8 billion by 2031.
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Repibresib gel (VYN201) for nonsegmental vitiligo: Null
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Here are 3-5 expected drivers of future revenue growth for VYNE Therapeutics (VYNE) over the next 2-3 years:
- Advancement and Potential Commercialization of VYN202: Despite a partial FDA clinical hold, VYNE Therapeutics is actively working to resolve this by conducting a non-clinical toxicology study for VYN202. Successful resolution of this hold, along with positive results from ongoing and planned clinical trials (including Phase 1b proof-of-concept trials in immuno-inflammatory conditions like psoriasis) and eventual regulatory approval, would be a primary driver of future revenue through product sales. Analysts project significant revenue growth for VYNE, which is likely tied to the potential of pipeline assets such as VYN202.
- Strategic Partnerships and Licensing Agreements: VYNE's Board initiated a strategic review in August 2025 to explore various alternatives, including partnerships, licensing, mergers and acquisitions, and asset sales. These efforts could lead to significant revenue generation through upfront payments, milestone payments, and/or future royalties from collaborations focused on VYN202 or other pipeline assets.
- Expansion of VYN202 into New Indications and Markets: If VYN202 proves successful in its initial target indications, its mechanism of action as a BD2-selective BET inhibitor suggests potential applicability across a broader range of immuno-inflammatory conditions. Expanding the drug's use to new indications and gaining market traction in these areas would significantly increase its total addressable market and contribute to long-term revenue growth.
- Monetization of InhiBET™ Platform Assets and Other Pipeline Programs: Beyond VYN202, VYNE Therapeutics possesses an "InhiBET™ BET Inhibitor Platform" and other discovery programs focused on various conditions, including complement modulation for vascular and autoimmune diseases, and novel small molecules for cardiometabolic and fibrotic pathology. The company's strategic review could lead to the monetization of these additional assets or intellectual property through out-licensing, collaborations, or sales, providing further revenue streams.
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Share Repurchases
No information available regarding share repurchases or authorized share repurchase programs over the last 3-5 years.
Share Issuance
- VYNE Therapeutics completed a Post IPO funding round on November 1, 2023, raising $88.2 million.
- As of September 30, 2025, the company had 31,772,904 common shares issued and outstanding, along with outstanding pre-funded warrants to purchase 11,059,574 shares of common stock.
- The number of shares outstanding increased by 7.41% in the year leading up to August 7, 2025, at which point there were 25.47 million shares outstanding.
Inbound Investments
- On November 1, 2023, VYNE Therapeutics raised $88.2 million in a Post IPO funding round, with Perceptive Advisors and Access Industries among the investors.
- In August 2025, VYNE's Board initiated a strategic review to evaluate various options to maximize shareholder value, including partnerships, licensing, mergers and acquisitions, and asset sales.
Outbound Investments
- VYNE Therapeutics has not made any investments or acquisitions.
Capital Expenditures
- Research and development (R&D) expenses were $5.3 million for the third quarter of 2025, a decrease of $5.0 million or 48.7% compared to $10.2 million in the third quarter of 2024, primarily due to reduced expenses for repibresib and VYN202.
- R&D expenses were $6.1 million for the first quarter of 2025, an increase from $3.7 million in the first quarter of 2024, mainly driven by increased expenses for VYN202 and repibresib for ongoing clinical trials.
- Capital expenditures related to property and equipment, net, were $96,000 as of September 30, 2025, compared to $113,000 as of December 31, 2024.