VYNE Therapeutics Announces FDA Approval of AMZEEQ (R) (Minocycline) Label Update. WELCOME TO THE STOCKGURU TEAM!!! AMZEEQ is flammable and fire, flame, and smoking must be avoided when applying and right after applying AMZEEQ. VYNE may use its website to comply with its disclosure obligations under Regulation FD. Resistant strains of P. acnes are common although primarily linked to the macrolide and lincosamide class of antibiotic use (erythromycin and clindamycin respectively); there is little evidence of cross-resistance development to the tetracycline class of antibiotics such as minocycline.2, VYNE’s Antimicrobial Characterization Program. VYNE Therapeutics Inc. (VYNE), a specialty pharmaceutical company focused on developing and commercializing proprietary th... VYNE Therapeutics Announces FDA Approval of AMZEEQ® (Minocycline) Label Update Indication AMZEEQ is a topical form of the antibiotic minocycline for the treatment of pimples and red bumps (non-nodular inflammatory lesions) that happen with moderate to severe acne in adults and children 9 years of age and older. AMZEEQ is a topical foam that contains minocycline, a tetracycline medicine. If a woman becomes pregnant while using AMZEEQ, she should talk to her doctor. The most common side effect of AMZEEQ is headache. Therefore, investors should monitor VYNE’s website in addition to following its press releases, filings with the U.S. Securities and Exchange Commission, public conference calls, and webcasts. Press release content from Globe Newswire. AMZEEQ is flammable and fire, flame, and smoking must be avoided when applying and right after applying AMZEEQ. Seeking Alpha - VYNE Therapeutics (NASDAQ:VYNE) has gained ~38.9% since the company announced last week that the FDA has authorized the inclusion of new information … VYNE Therapeutics surged ~39% since FDA approval for label update (NASDAQ:VYNE) - … However, tetracyclines, when taken by mouth (capsules or tablets), may cause serious side effects, including: diarrhea which may be caused by an infection and can cause watery or bloody stools; loss of appetite; tiredness; yellowing of the skin or eyes (jaundice); bleeding more easily than normal; confusion; sleepiness; vision changes, including blurred vision, double vision, or permanent vision loss; unusual headaches; fever; rash; joint pain; body weakness; discoloration or darkening of the skin, scars, teeth, or gums. About VYNE Therapeutics Inc. VYNE Therapeutics’ mission is to improve the lives of patients by developing proprietary, innovative and differentiated therapies in dermatology and beyond. © 2021 Vyne Therapeutics Inc. All Rights Reserved, VYNE Therapeutics Announces Closing of $50 Million Registered Direct Offering of Common Stock and Provides Corporate Update, Vyne Therapeutics Inc. All Rights Reserved. The FDA approval of ZILXI is primarily supported by data from two clinical trials in 1,522 patients 18 years of age and older. AMZEEQ® label update includes new information indicating the low propensity of Propionibacterium acnes (more commonly known as “P. It is not known if AMZEEQ is safe and effective in children under 9 years of age. The reverse stock split was previously approved by … If approved, FMX103 is targeted to be the first FDA-approved minocycline treatment for rosacea ever. With expertise in topical medicine innovation as a springboard, VYNE is working to develop and commercialize a variety of solutions using its proprietary Molecule Stabilizing Technology (MST)™, and has received FDA approval for AMZEEQ® (minocycline) topical foam, 4%, the world’s first topical minocycline, and for ZILXI® (minocycline) topical foam, 1.5%, the first minocycline product of any kind to be approved by the FDA for use in rosacea. “We are pleased that the inclusion of this valuable additional information for AMZEEQ will support prescribers in making informed decisions on both their choice of antibiotic and administration route when selecting a treatment for acne.”. AMZEEQ is a topical foam that contains minocycline, a tetracycline medicine. AMZEEQ® label update includes new information indicating the low propensity of Propionibacterium acnes (more commonly known as “P. BRIDGEWATER, N.J., Feb. 01, 2021 (GLOBE NEWSWIRE) — VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a specialty pharmaceutical company focused on developing and commercializing proprietary therapies to address unmet needs in dermatology, today announced approval … Menlo Therapeutics Announces Corporate Name Change To Vyne Therapeutics. BRIDGEWATER, N.J., Feb. 01, 2021 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (NASDAQ:VYNE) ("VYNE" or the "Company"), a specialty pharmaceutical company focused on developing and commercializing proprietary therapies to address unmet needs in dermatology, today announced approval by the U.S. Food and Drug Administration ("FDA") to include new … AMZEEQ is available by prescription only. The most common side effect of AMZEEQ is headache. People are encouraged to report negative side effects of prescription drugs to the FDA. People are encouraged to report negative side effects of prescription drugs to the FDA. BRIDGEWATER, N.J., Feb 01, 2021 (GLOBE NEWSWIRE via COMTEX) -- BRIDGEWATER, N.J., Feb. 01, 2021 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE… For a complete copy of the AMZEEQ product label, including the recent update, please see AMZEEQ full Prescribing Information. AMZEEQ should not be used for the treatment of infections. AMZEEQ is indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in adults and pediatric patients 9 years of age and older. “We are pleased that the inclusion of this valuable additional information for AMZEEQ will support prescribers in making informed decisions on both their choice of antibiotic and administration route when selecting a treatment for acne.”. “We believe the label update will be well-received.”, P. acnes, recently renamed Cutibacterium acnes, is an anaerobic bacterium that resides within the pilosebaceous unit in the skin and is the primary microbial initiator and propagator in the development of acne. People should contact their doctor for medical advice about side effects and be sure to tell their doctor about all of their medical conditions and medicines they take before using AMZEEQ. The studies concluded that on-target potency remained consistently high (MIC90 = 0.25µg/ml) when tested in clinical isolates of P. acnes. ... More articles issued by VYNE Therapeutics … Amongst other objectives, the antimicrobial characterization program conducted by VYNE to support this label update evaluated on-target potency of AMZEEQ and minocycline against P. acnes and further evaluated the potential for the development of minocycline-resistant strains that could reduce the potency of AMZEEQ in the treatment of acne. J. Sutcliffe, R. McLaughlin, G. Webster, A. F. Read, K. Drlica, R. Elliot and I. Stuart. Specifically, the FDA-approved AMZEEQ label now provides that with respect to resistance, P. acnes strains displayed a low propensity for the development of resistance to minocycline, with spontaneous mutation frequencies occurring <10−8 (or 1 in 100 million) at 2 to 16 times the minimum inhibitory concentration (MIC). Vyne Therapeutics Inc (VYNE): * VYNE THERAPEUTICS ANNOUNCES FDA APPROVAL OF AMZEEQ® LABEL UPDATE Source text for Eikon: Further company coverage: VYNE Therapeutics Announces FDA Approval of AMZEEQ® (Minocycline) Label Update GlobeNewswire – 02/01/2021 VYNE Therapeutics Inc. (VYNE), a specialty pharmaceutical … VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”) announced that its Board of Directors has approved a reverse stock split of the Company’s common stock at a ratio of 1-for-4. AMZEEQ should not be used for the treatment of infections. With every problem we take on, our approach is the same: question traditional assumptions and find a better solution. acnes”) to develop resistance to minocyclineBRIDGEWATER, N.J., Feb. 01, 2021 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE… People should protect their skin from the sun while using AMZEEQ and avoid sunlight or artificial sunlight such as sunlamps or tanning beds. BRIDGEWATER, N.J., Feb. 01, 2021 (GLOBE NEWSWIRE) — VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a specialty pharmaceutical company focused on developing and commercializing proprietary therapies to address unmet needs in dermatology, today announced approval by the U.S. Food and Drug Administration (“FDA”) to include new information in the product label for AMZEEQ® (minocycline) topical foam, 4% referencing the low propensity of P. acnes strains to develop resistance to minocycline, the active ingredient in AMZEEQ. Trending now. For a discussion of other risks and uncertainties, and other important factors, any of which could cause VYNE’s actual results to differ from those contained in the forward-looking statements, see the section titled “Risk Factors” in VYNE’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, as well as discussions of potential risks, uncertainties, and other important factors in VYNE’s subsequent filings with the U.S. Securities and Exchange Commission. IndicationAMZEEQ is a topical form of the antibiotic minocycline for the treatment of pimples and red bumps (non-nodular inflammatory lesions) that happen with moderate to severe acne in adults and children 9 years of age and older. VYNE Therapeutics Inc. (VYNE), a specialty pharmaceutical company focused on developing and commercializing proprietary th... VYNE Therapeutics Announces FDA Approval of AMZEEQ® (Minocycline) Label Update People should contact their doctor for medical advice about side effects and be sure to tell their doctor about all of their medical conditions and medicines they take before using AMZEEQ. Any forward-looking statements are based on VYNE’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions that could cause actual results to differ materially and adversely from those set forth or implied by such forward-looking statements. These are not all of the possible side effects with AMZEEQ. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Any forward-looking statements are based on VYNE’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions that could cause actual results to differ materially and adversely from those set forth or implied by such forward-looking statements. GlobeNewswire Mon, Feb. 01. All statements in this press release which are not historical facts are forward-looking statements. However, some individuals, particularly women, can experience acne much later in life. “The risk of antimicrobial resistance is a primary concern for dermatologists or, indeed, any routine prescriber of antibiotics,” said David Domzalski, CEO of VYNE. Antimicrobial Susceptibility and Genetic Characteristics of Propionibacterium Acnes Isolated from Patients with Acne. For a discussion of other risks and uncertainties, and other important factors, any of which could cause VYNE’s actual results to differ from those contained in the forward-looking statements, see the section titled “Risk Factors” in VYNE’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, as well as discussions of potential risks, uncertainties, and other important factors in VYNE’s subsequent filings with the U.S. Securities and Exchange Commission. VYNE Therapeutics Announces FDA Approval of AMZEEQ® (Minocycline) Label Update. VYNE Therapeutics’ mission is to improve the lives of patients by developing proprietary, innovative and differentiated therapies in dermatology and beyond. VYNE may use its website to comply with its disclosure obligations under Regulation FD. acnes”) to develop resistance to minocycline. acnes”) to develop resistance to minocycline. About VYNE Therapeutics Inc. ... 1.5%, the first minocycline product of any kind to be approved by the FDA for use in rosacea. The FDA approval was supported by an extensive antimicrobial characterization program by VYNE for both AMZEEQ and minocycline that was published last … The FDA approval was supported by an extensive antimicrobial characterization program by VYNE for both AMZEEQ and minocycline that was published last year in the peer-reviewed journal Anaerobe.1 The program evaluated the on-target potency of AMZEEQ and minocycline against P. acnes and further evaluated the potential for the development of minocycline-resistant strains that could reduce the potency of AMZEEQ in the treatment of acne. F. Schafer, F. Fich, M. Lam C. C Garate, A Wozniak and P Garcia. The FDA approval was supported by an extensive antimicrobial characterization program by VYNE for both AMZEEQ and … However, some individuals, particularly women, can experience acne much later in life. BRIDGEWATER, N.J., Feb. 01, 2021 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a specialty pharmaceutical company focused on developing and commercializing proprietary therapies to address unmet needs in dermatology, today announced approval by the U.S. Food and Drug Administration (“FDA”) to include new information in the product label for AMZEEQ® (minocycline) topical foam, 4% referencing the low propensity of P. acnes strains to develop resistance to minocycline, the active ingredient in AMZEEQ. The update to the microbiology section in the label further states that although the clinical significance is unknown, the active ingredient in AMZEEQ (minocycline), is proven to be active in vitro against most isolates of P. acnes. People should call their doctor right away if these side effects occur. For most people, acne diminishes over time and tends to disappear or decrease, by age 25. AMZEEQ is available by prescription only. FMX103 is VYNE Therapeutics’s investigational proprietary 1.5% minocycline foam formulation being developed for inflammatory lesions of rosacea in adults. VYNE Therapeutics surged ~39% since FDA approval for label update Benzinga 12d Notable Insider Buys Of The Past Week: Harley-Davidson, Texas Instruments And More About Acne Acne is a chronic, inflammatory skin condition that affects the skin’s sebaceous glands and hair follicles. acnes”) to develop resistance to minocyclineBRIDGEWATER, N.J., Feb. 01, 2021 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a specialty pharmaceutical company focused on … We are here to help you succeed in everything you do and although this is a journey you are taking the first step towards success and we at StockGuru thank you for your continued support. AMZEEQ is for use on skin only (topical use). This release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the development and commercialization of VYNE’s products and product candidates and other statements regarding the future expectations, plans and prospects of VYNE. “The risk of antimicrobial resistance is a primary concern for dermatologists or, indeed, any routine prescriber of antibiotics,” said David Domzalski, CEO of VYNE. 10 min read. NASDAQ 0.40%. BRIDGEWATER, N.J., Feb. 01, 2021 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a specialty pharmaceutical company focused on developing and commercializing proprietary therapies to address unmet needs in dermatology, today announced approval by the U.S. Food and Drug Administration (“FDA”) to include new … Tetracycline medicine when taken by mouth during pregnancy, infancy and/or childhood up to the age of 8 years may permanently discolor teeth (yellow-gray-brown) and may slow the growth of bones. BRIDGEWATER, N.J., … Further, the prevalence of minocycline-resistant strains as assessed by spontaneous mutation frequency was low (range: <2.7×10-9 to <1.30×10-8 colony forming units) when exposed to minocycline at concentrations up to 16-fold higher than the mean minimum inhibitory concentration (MIC). WELCOME TO THE STOCKGURU TEAM!!! The AP news staff was not involved in its creation. VYNE Therapeutics Announces Reverse Stock Split . Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Acne affects approximately 40 to 50 million people in the U.S. alone, of whom approximately 10 million have moderate to severe disease that may impact self-esteem and quality of life. 1 The program evaluated the on-target potency of AMZEEQ and minocycline against P. acnes and further evaluated the potential for the development of minocycline-resistant strains that could reduce the potency of AMZEEQ in the treatment of acne. The update to the microbiology section in the label further states that although the clinical significance is unknown, the active ingredient in AMZEEQ (minocycline), is proven to be active in vitro against most isolates of P. acnes. It is characterized by both inflammatory lesions (papules and pustules) and non-inflammatory lesions (open and closed comedones) affecting primarily the face and truncal areas of the body. acnes”) to develop resistance to minocycline. AMZEEQ should not be used in people who are allergic to AMZEEQ or any tetracycline medicine. VYNE Therapeutics’ mission is to improve the lives of patients by developing proprietary, innovative and differentiated therapies in dermatology and beyond. The FDA approval was supported by an extensive antimicrobial characterization program by VYNE for both AMZEEQ and minocycline that was published last … AMZEEQ is indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in adults and pediatric patients 9 years of age and older. The FDA approval was supported by an extensive antimicrobial characterization program by VYNE for both AMZEEQ and minocycline that was published last … You can read further details here. VYNE Therapeutics Announces FDA Approval Of AMZEEQ Label Update. ... May 22, 2020 9:10 AM ET VYNE Therapeutics Inc. (VYNE) 30 Comments 7 Likes. AMZEEQ should not be used in women who are pregnant, may become pregnant or are nursing. AMZEEQ® label update includes new information indicating the low propensity of Propionibacterium acnes (more commonly known as “P. AMZEEQ® label update includes new information indicating the low propensity of Propionibacterium acnes (more commonly known as “P. About AcneAcne is a chronic, inflammatory skin condition that affects the skin’s sebaceous glands and hair follicles. Although VYNE believes these forward-looking statements are reasonable, they speak only as of the date of this announcement and VYNE undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law. Menlo's 1st product AMZEEQ was FDA approved/launched in January 2020 (~$200MM estimated peak sales). These are not all of the possible side effects with AMZEEQ. Use of AMZEEQ should be stopped right away if a rash or other allergic symptom occurs. AMZEEQ® label update includes new information indicating the low propensity of Propionibacterium acnes (more commonly known as “P. I discuss VYNE Stock today and how this company called Vyne Therapeutics is up +70% in the premarket earlier today 1-25-2021. This release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the development and commercialization of VYNE’s products and product candidates and other statements regarding the future expectations, plans and prospects of VYNE. Feb 1, 2021. With expertise in topical medicine innovation as a springboard, VYNE is working to develop and commercialize a variety of solutions using its proprietary Molecule Stabilizing Technology (MST)™, and has received FDA approval for AMZEEQ® (minocycline) topical foam, 4%, the world’s first topical minocycline, and for ZILXI® (minocycline) topical foam, 1.5%, the first minocycline product of any kind to be approved by the FDA for use in rosacea. BRIDGEWATER, N.J., Feb. 01, 2021 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) ("VYNE" or the "Company"), a specialty pharmaceutical company focused on developing and commercializing proprietary therapies to address unmet needs in dermatology, today announced approval by the U.S. Food and Drug Administration ("FDA") to include new … AMZEEQ is not for use in the mouth, eyes, or vagina. VYNE Therapeutics surged ~39% since FDA approval for label update Benzinga 12d Notable Insider Buys Of The Past Week: Harley-Davidson, Texas Instruments And More Menlo Therapeutics Q2 Revenue $11.7 Million . Recently in News on February 1, 2021, VYNE Therapeutics Announces FDA Approval of AMZEEQ® (Minocycline) Label Update. VYNE Therapeutics™ is working to solve some of today’s most difficult therapeutic challenges. BRIDGEWATER, N.J., Feb. 01, 2021 (GLOBE NEWSWIRE) — VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a specialty pharmaceutical company focused on developing and commercializing proprietary therapies to address unmet needs in dermatology, today announced approval by the U.S. Food and Drug Administration (“FDA”) to include new … Recently in News on February 1, 2021, VYNE Therapeutics Announces FDA Approval of AMZEEQ® (Minocycline) Label Update. Although VYNE believes these forward-looking statements are reasonable, they speak only as of the date of this announcement and VYNE undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law. Development milestones include: Top-line results released for first two phase 3 pivotal studies Resistant strains of P. acnes are common although primarily linked to the macrolide and lincosamide class of antibiotic use (erythromycin and clindamycin respectively); there is little evidence of cross-resistance development to the tetracycline class of antibiotics such as minocycline.2, VYNE’s Antimicrobial Characterization Program. Media Relations:Bridgette PotratzZeno Group312-358-2950bridgette.potratz@zenogroup.com, Investor Relations:Joyce AllaireLifeSci Advisors, LLC646-889-1200jallaire@lifesciadvisors.com, Andrew SaikChief Financial OfficerVYNE Therapeutics908-731-6180Andrew.Saik@vynetx.com, Cautionary Statement Regarding Forward-Looking Statements. It is not known if AMZEEQ is safe and effective in children under 9 years of age. Acne affects approximately 40 to 50 million people in the U.S. alone, of whom approximately 10 million have moderate to severe disease that may impact self-esteem and quality of life. The use of antibiotics to counteract the effect of this bacterium remains a major cornerstone of acne disease management, although concerns over the development of antibiotic-resistant strains are factors in a prescriber’s choice of antibiotic and route of administration.
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