Press Releases

VYNE Therapeutics Enrolls First Patient in Clinical Trial of FMX114 for the Treatment of Mild-to-Moderate Atopic Dermatitis

October, 19 2021

Important milestone achieved as part of the Company’s new corporate strategy to develop treatments for immuno-inflammatory diseases Topline results anticipated in early Q1 2022 BRIDGEWATER, N.J., Oct. 19, 2021 (GLOBE NEWSWIRE) — VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”) today announced that it has enrolled the first patient in its Phase 1b/2a clinical trial evaluating FMX114 for the treatment of mild-to-moderate atopic dermatitis (AD). FMX114 is VYNE’s proprietary investigational combination gel formulation of tofacitinib and fingolimod. The product is being developed to address both the source and cause of inflammation in AD by developing a distinct combination of…

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VYNE Therapeutics Announces its China Partner’s Enrollment of First Patient in Phase 3 Study of AMZEEQ® in Patients with Moderate to Severe Acne

October, 05 2021

BRIDGEWATER, N.J., Oct. 05, 2021 (GLOBE NEWSWIRE) — VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”) today announced that the first patient has been enrolled in a Phase 3 study in China evaluating AMZEEQ® (minocycline) topical foam, 4% in moderate to severe acne. The study is being conducted by the Company’s partner, Cutia Therapeutics (“Cutia”), for the purposes of seeking regulatory approval for AMZEEQ in China. “We are pleased that Cutia has reached this important clinical development milestone for AMZEEQ and look forward to the continued progress in securing regulatory approval of AMZEEQ in China,” said David Domzalski, President…

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VYNE Therapeutics Reports Second Quarter 2021 Financial Results and Announces New Strategic Direction to Develop Treatments for Immunological and Inflammatory Diseases

August, 12 2021

Company announced license agreement with In4Derm Limited for BETi platform earlier this morning Company has initiated a process to explore a sale or license of its topical minocycline franchise Phase 2a results for FMX114 expected by year end and VYN201 and VYN202 to enter the clinic in 2022 Company has prepaid the entirety of its outstanding debt and expects to significantly reduce operating expenses Conference call and live webcast today at 8:30 am Eastern Time BRIDGEWATER, N.J., Aug. 12, 2021 (GLOBE NEWSWIRE) — VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”) today announced financial results for the second quarter…

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VYNE Therapeutics Announces Licensing of BET Inhibitor Platform for Immuno-Inflammatory Conditions with In4Derm Limited

August, 12 2021

VYNE will have exclusive access to a library of new chemical entities VYNE will prioritize initial development efforts on rare skin diseases and major immunology and inflammatory conditions with high unmet needs VYNE expects to enter VYN201 and VYN202 into the clinic in 2022 Further details will be discussed on VYNE’s second quarter earnings call this morning at 8:30am EDT BRIDGEWATER, N.J., Aug. 12, 2021 (GLOBE NEWSWIRE) — VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”) today announced that it has entered into an exclusive license agreement (the “License Agreement”) with In4Derm Limited (“In4Derm”), a spin-out of the University…

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VYNE Therapeutics Announces Approval of AMZEEQ® (Minocycline) and ZILXI® (Minocycline) in Chinese Economic Pilot Zone

August, 02 2021

BRIDGEWATER, N.J., Aug. 02, 2021 (GLOBE NEWSWIRE) — VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”) today announced that its products AMZEEQ® (minocycline) topical foam, 4%, and ZILXI® (minocycline) topical foam, 1.5%, have been approved for commercial sale in a pilot program in Hainan Boao Lecheng, China. The drug will be sold in the region by Cutia Therapeutics, which licensed the exclusive rights to market AMZEEQ and ZILXI in Greater China. The Boao Lecheng International Medical Tourism Pilot Zone was established with the approval of the Chinese State Council as a unique area in China where certain drugs and…

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VYNE Therapeutics Announces Initiation of Investigator Initiated Trial Evaluating AMZEEQ® (Minocycline) with Oral Isotretinoin in Patients with Moderate to Severe Acne

July, 19 2021

BRIDGEWATER, N.J., July 19, 2021 (GLOBE NEWSWIRE) — VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”) today announced the initiation of an investigator initiated trial (“IIT” or “study”) evaluating the safety and efficacy of AMZEEQ® (minocycline) topical foam, 4%, as a companion treatment with oral isotretinoin in patients with moderate to severe acne. The study is supported by VYNE and is being conducted by the Austin Institute for Clinical Research in Texas. “Isotretinoin has been widely used for the management of severe or scarring acne since its introduction as Accutane® in the 1980s. However, its teratogenic properties means that patients…

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