MNLO Menlo Therapeutics Inc.

1.69
-0.01  -1%
Previous Close 1.7
Open 1.69
52 Week Low 1
52 Week High 7.48
Market Cap $283,281,695
Shares 167,622,305
Float 142,819,496
Enterprise Value $238,120,918
Volume 2,068,066
Av. Daily Volume 5,872,709
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Drug Pipeline

Drug Stage Notes
FCD105
Acne
Phase 2
Phase 2
Phase 2 data released June 2, 2020.
FMX103
Papulopustular rosacea
Approved
Approved
FDA Approval announced May 29, 2020.
Serlopitant
Pruritus associated with prurigo nodularis
Phase 3
Phase 3
Phase 3 data did not meet primary endpoint - April 6, 2020.
FMX101
Acne
Approved
Approved
FDA Approval announced October 18, 2019.
Serlopitant
Pruritus associated with psoriasis
Phase 2
Phase 2
Phase 3 planned.
Serlopitant
Chronic pruritus of unknown origin
Phase 2
Phase 2
Phase 2 trial did not meet primary endpoint - February 26, 2020.
Serlopitant
Refractory chronic cough
Phase 2
Phase 2
Phase 2 data released October 8, 2018. Endpoints not met.
Serlopitant
Pruritus associated with atopic dermatitis
Phase 2
Phase 2
Phase 2 data released April 9, 2018. Endpoints not met.

Latest News

  1. BRIDGEWATER, N.J., June 05, 2020 (GLOBE NEWSWIRE) -- Menlo Therapeutics Inc. ("Menlo") (NASDAQ:MNLO), a specialty pharmaceutical company focused on developing and commercializing proprietary therapies to address unmet needs in dermatology, today announced the pricing of an underwritten public offering of 27,050,000 shares of common stock at a price to the public of $1.85 per share. The gross proceeds from the offering, before deducting underwriting discounts and commissions and estimated offering expenses, are expected to be $50,042,500, excluding any exercise of the underwriters' option to purchase additional shares. All of the shares of common stock to be sold in the offering will be offered by Menlo. In addition, Menlo has granted the underwriters…

    BRIDGEWATER, N.J., June 05, 2020 (GLOBE NEWSWIRE) -- Menlo Therapeutics Inc. ("Menlo") (NASDAQ:MNLO), a specialty pharmaceutical company focused on developing and commercializing proprietary therapies to address unmet needs in dermatology, today announced the pricing of an underwritten public offering of 27,050,000 shares of common stock at a price to the public of $1.85 per share. The gross proceeds from the offering, before deducting underwriting discounts and commissions and estimated offering expenses, are expected to be $50,042,500, excluding any exercise of the underwriters' option to purchase additional shares. All of the shares of common stock to be sold in the offering will be offered by Menlo. In addition, Menlo has granted the underwriters a 30-day option to purchase up to an additional 4,057,500 shares of its common stock. The offering is expected to close on June 9, 2020, subject to customary closing conditions.

    Cowen and Piper Sandler & Co. are acting as joint book-runners for the proposed offering. LifeSci Capital LLC is acting as lead manager.

    A shelf registration statement relating to these securities was previously filed with the Securities and Exchange Commission ("SEC") and declared effective on February 12, 2019. A preliminary prospectus supplement relating to and describing the terms of the offering was filed with the SEC and is available on the SEC's web site at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to these securities may also be obtained, when available, from Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, Attention: Prospectus Department, by email at or by telephone at (833) 297-2926; or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, by telephone at (800) 747-3924 or by email at .

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Menlo Therapeutics  

    Menlo Therapeutics Inc. recently combined with Foamix Pharmaceuticals Ltd. ("Foamix") to form a different type of biopharmaceutical company working to solve some of today's most difficult therapeutic challenges in dermatology and beyond. Foamix is now a wholly-owned subsidiary of Menlo.

    With expertise in topical medicine innovation as a springboard, Menlo 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 now also for ZILXI™ (minocycline) topical foam, 1.5%, the first minocycline product of any kind to be approved by the FDA for use in rosacea.

    Forward-Looking Statements

    This press 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 Menlo's products and product candidates and other statements regarding the future expectations, plans and prospects of Menlo. All statements in this press release which are not historical facts are forward-looking statements. Any forward-looking statements are based on Menlo'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 risks and uncertainties include, but are not limited to, the COVID-19 pandemic and its impact on our business operations; adverse events associated with the commercialization of our products; the outcome and cost of clinical trials for current and future product candidates; determination by the FDA that results from Menlo's clinical trials are not sufficient to support registration or marketing approval of product candidates; the outcome of pricing, coverage and reimbursement negotiations with third party payors for AMZEEQ®, ZILXI™ or any other products or product candidates that Menlo may commercialize in the future; whether, and to what extent, third party payors impose additional requirements before approving AMZEEQ® or ZILXI™ prescription reimbursement; the eligible patient base and commercial potential of AMZEEQ®, ZILXI™ or any of Menlo's other product or product candidates; risks that Menlo's intellectual property rights, such as patents, may fail to provide adequate protection, may be challenged and one or more claims may be revoked or interpreted narrowly or will not be infringed; risks that any of Menlo's patents may be held to be narrowed, invalid or unenforceable or one or more of Menlo's patent applications may not be granted and potential competitors may also seek to design around Menlo's granted patents or patent applications; additional competition in the acne and dermatology markets; risks related to our indebtedness; inability to raise additional capital on favorable terms or at all; Menlo's ability to recruit and retain key employees; and Menlo's ability to stay in compliance with applicable laws, rules and regulations. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Menlo's actual results to differ from those contained in the forward-looking statements, see the section titled "Risk Factors" in Menlo'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 Menlo's subsequent filings with the SEC. Although Menlo believes these forward-looking statements are reasonable, they speak only as of the date of this announcement and Menlo undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law. Given these risks and uncertainties, you should not rely upon forward-looking statements as predictions of future events.

    Media Relations:

    Bridgette Potratz

    Zeno Group

    312-755-5462, x5516

    Investor Relations:

    Joyce Allaire

    LifeSci Advisors, LLC

    646-889-1200

     

    Primary Logo

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  2. BRIDGEWATER, N.J., June 04, 2020 (GLOBE NEWSWIRE) -- Menlo Therapeutics Inc. ("Menlo") (NASDAQ:MNLO), a specialty pharmaceutical company focused on developing and commercializing proprietary therapies to address unmet needs in dermatology, today announced that it intends to offer and sell, subject to market conditions, shares of its common stock in an underwritten public offering. All of the common stock to be sold in the offering will be offered by Menlo. In addition, Menlo expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed…

    BRIDGEWATER, N.J., June 04, 2020 (GLOBE NEWSWIRE) -- Menlo Therapeutics Inc. ("Menlo") (NASDAQ:MNLO), a specialty pharmaceutical company focused on developing and commercializing proprietary therapies to address unmet needs in dermatology, today announced that it intends to offer and sell, subject to market conditions, shares of its common stock in an underwritten public offering. All of the common stock to be sold in the offering will be offered by Menlo. In addition, Menlo expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering.

    Cowen and Piper Sandler & Co. are acting as joint book-runners for the proposed offering. LifeSci Capital LLC is acting as lead manager.

    A shelf registration statement relating to these securities was previously filed with the Securities and Exchange Commission ("SEC") and declared effective on February 12, 2019. A preliminary prospectus supplement relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC's web site at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to these securities may also be obtained, when available, from Cowen and Company, LLC c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, Attention: Prospectus Department, by email at or by telephone at (833) 297-2926; or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, by telephone at (800) 747-3924 or by email at .

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Menlo Therapeutics  

    Menlo Therapeutics Inc. recently combined with Foamix Pharmaceuticals Ltd. ("Foamix") to form a different type of biopharmaceutical company working to solve some of today's most difficult therapeutic challenges in dermatology and beyond. Foamix is now a wholly-owned subsidiary of Menlo.

    With expertise in topical medicine innovation as a springboard, Menlo 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 now also for ZILXI™ (minocycline) topical foam, 1.5%, the first minocycline product of any kind to be approved by the FDA for use in rosacea.

    Forward-Looking Statements

    This press 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 Menlo's products and product candidates and other statements regarding the future expectations, plans and prospects of Menlo. All statements in this press release which are not historical facts are forward-looking statements. Any forward-looking statements are based on Menlo'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 risks and uncertainties include, but are not limited to, the COVID-19 pandemic and its impact on our business operations; adverse events associated with the commercialization of our products; the outcome and cost of clinical trials for current and future product candidates; determination by the FDA that results from Menlo's clinical trials are not sufficient to support registration or marketing approval of product candidates; the outcome of pricing, coverage and reimbursement negotiations with third party payors for AMZEEQ®, ZILXI™ or any other products or product candidates that Menlo may commercialize in the future; whether, and to what extent, third party payors impose additional requirements before approving AMZEEQ® or ZILXI™ prescription reimbursement; the eligible patient base and commercial potential of AMZEEQ®, ZILXI™ or any of Menlo's other product or product candidates; risks that Menlo's intellectual property rights, such as patents, may fail to provide adequate protection, may be challenged and one or more claims may be revoked or interpreted narrowly or will not be infringed; risks that any of Menlo's patents may be held to be narrowed, invalid or unenforceable or one or more of Menlo's patent applications may not be granted and potential competitors may also seek to design around Menlo's granted patents or patent applications; additional competition in the acne and dermatology markets; risks related to our indebtedness; inability to raise additional capital on favorable terms or at all; Menlo's ability to recruit and retain key employees; and Menlo's ability to stay in compliance with applicable laws, rules and regulations. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Menlo's actual results to differ from those contained in the forward-looking statements, see the section titled "Risk Factors" in Menlo'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 Menlo's subsequent filings with the SEC. Although Menlo believes these forward-looking statements are reasonable, they speak only as of the date of this announcement and Menlo undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law. Given these risks and uncertainties, you should not rely upon forward-looking statements as predictions of future events.

    Media Relations:
    Bridgette Potratz
    Zeno Group
    312-755-5462, x5516

    Investor Relations:
    Joyce Allaire
    LifeSci Advisors, LLC
    646-889-1200

    Primary Logo

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  3. BRIDGEWATER, N.J., June 02, 2020 (GLOBE NEWSWIRE) -- Menlo Therapeutics Inc. (NASDAQ:MNLO) ("Menlo" or the "Company"), a specialty pharmaceutical company focused on developing and commercializing proprietary therapies to address unmet needs in dermatology, today announced positive results from a Phase 2 clinical trial evaluating the preliminary safety and efficacy of FCD105 (3% minocycline / 0.3% adapalene foam), the first ever topical minocycline-based combination product, for the treatment of moderate-to-severe acne vulgaris. Study FX2016-40 enrolled 447 patients in the United States who were randomized to either FCD105 foam, 3% minocycline foam, 0.3% adapalene foam, or vehicle foam. The Company has begun preparations to conduct an End of…

    BRIDGEWATER, N.J., June 02, 2020 (GLOBE NEWSWIRE) -- Menlo Therapeutics Inc. (NASDAQ:MNLO) ("Menlo" or the "Company"), a specialty pharmaceutical company focused on developing and commercializing proprietary therapies to address unmet needs in dermatology, today announced positive results from a Phase 2 clinical trial evaluating the preliminary safety and efficacy of FCD105 (3% minocycline / 0.3% adapalene foam), the first ever topical minocycline-based combination product, for the treatment of moderate-to-severe acne vulgaris. Study FX2016-40 enrolled 447 patients in the United States who were randomized to either FCD105 foam, 3% minocycline foam, 0.3% adapalene foam, or vehicle foam. The Company has begun preparations to conduct an End of Phase 2 meeting with the FDA before the end of this year.

    FCD105 showed a highly statistically significant improvement compared to vehicle for the endpoints of (1) Investigator's Global Assessment (IGA) treatment success (IGA score "0" or "1" and at least a two-grade improvement from baseline) and (2) absolute change from baseline in mean inflammatory counts at Week 12. The proportion of patients achieving IGA treatment success in the FCD105 treatment group was 35.9% compared to 15.7% of patients in the vehicle treatment group (p=0.0003). Absolute reduction in inflammatory lesion counts at Week 12 was -19.4 (-64.1%) for the FCD105 treatment group compared to -15.58 (-50.9%) for the vehicle treatment group (p=0.0020).

    The trial was not originally powered to demonstrate a statistical difference between FCD105 and either 3% minocycline foam or 0.3% adapalene foam treatments; however, the majority of these comparisons did show a statistically significant improvement of FCD105 at Week 12. Numerical improvement was observed for FCD105 on all efficacy endpoints for these comparisons at Week 12.

    Absolute reduction in non-inflammatory lesion counts at Week 12 was also assessed with a mean lesion count reduction of -24.94 (-51.0%) for the FCD105 treatment group compared to -22.87 (-45.9%) for the vehicle treatment group. Although numerical improvement was shown, this was not statistically significant, which has been attributed to outlier results affecting both FCD105 and vehicle treatment groups. Conversely, absolute reduction in non-inflammatory lesion counts at Week 12 for FCD105 did show a statistically significant improvement compared to each of (1) 3% minocycline foam and (2) 0.3% adapalene foam.

    The most commonly reported treatment-emergent adverse event in the trial was upper respiratory tract infection (4.9% in the vehicle treatment group) with dry skin being the most commonly reported cutaneous adverse event (3.6% in the 0.3% adapalene treatment group). The majority of adverse events were assessed as mild in severity. There were no serious adverse events. 

    FCD105 was comparably tolerated to vehicle in all local skin tolerability assessments with 93% or greater of severity scores being assessed as "none" or "mild" for burning/stinging, itching, dryness, scaling, erythema and hyperpigmentation.

    "We are pleased with the results of this study. The data suggests FCD105 has the potential to be a best-in-class treatment for patients with acne and could provide an important new treatment option for this challenging condition," said Dr. Iain Stuart, Chief Scientific Officer of Menlo. "We look forward to engaging with the FDA on these data and our plans for the Phase 3 program."

    About Study FX2016-40
    Study FX2016-40 is a prospective, randomized, double-blind, vehicle-controlled Phase 2 trial that enrolled patients aged 12 years and older with a clinical diagnosis of moderate-to-severe acne vulgaris. Patients were randomized to one of four treatment arms: FCD105 foam, 3% minocycline foam, 0.3% adapalene foam, or vehicle foam and self-applied their assigned treatment once daily for 12 weeks. The primary efficacy endpoints were: (1) the proportion of patients achieving treatment success at Week 12 based on an Investigator's Global Assessment (success is defined as a score of 0 "clear" or 1 "minimal" and at least a two-grade improvement from baseline), (2) the mean change from baseline in inflammatory lesion counts in each treatment group at Week 12, and (3) the mean change from baseline in non-inflammatory lesion counts in each treatment group at Week 12. Safety evaluations include reported adverse events, local skin tolerability assessments, physical examinations and vital signs.

    About Acne Vulgaris
    Acne is a chronic, inflammatory skin condition that affects the skin's oil glands and hair follicles. It is characterized by both inflammatory lesions (papules and pustules) and non-inflammatory lesions (open and closed comedones) affecting primarily the face and other areas of the body. Acne affects approximately 40 to 50 million people in the U.S. alone, of whom approximately 10 million have moderate-to-severe disease that significantly impacts self-esteem and quality of life. For most people, acne diminishes over time and tends to disappear or decrease, by age 25. However, some individuals, particularly women, can experience acne much later in life.

    About FCD105
    FCD105 is Menlo's proprietary 3% minocycline, 0.3% adapalene combination foam formulation intended for the treatment of moderate-to-severe acne vulgaris. FCD105 combines the bacteriostatic and anti-inflammatory properties of minocycline with the third-generation retinoid, adapalene, which acts in regulating the differentiation of follicular epithelial cells. Oral minocycline and topical adapalene products are approved for use in the treatment of acne vulgaris in the United States, with the latter available in combination and as monotherapy. Pending a successful development program, the FCD105 new drug application is intended to be filed under the FDA's 505(b)(2) regulatory pathway.

    About Menlo
    Menlo Therapeutics Inc. recently combined with Foamix Pharmaceuticals Ltd. to form a different type of biopharmaceutical company working to solve some of today's most difficult therapeutic challenges in dermatology and beyond.

    With expertise in topical medicine innovation as a springboard, the Company 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 now also for ZILXI™ (minocycline) topical foam, 1.5%, the first minocycline product of any kind to be approved by the FDA for use in rosacea.

    For more information about Menlo or its investigational products, visit www.menlotherapeutics.com. Menlo may use its website to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor Menlo's website in addition to following its press releases, filings with the U.S. Securities and Exchange Commission, public conference calls, and webcasts.

    Cautionary Statement Regarding Forward-Looking Statements
    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 expectations with respect to the financial results of Menlo and statements regarding the development and commercialization of Menlo's products and product candidates and other statements regarding the future expectations, plans and prospects of Menlo. All statements in this press release which are not historical facts are forward-looking statements. Any forward-looking statements are based on Menlo'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 risks and uncertainties include, but are not limited to the COVID-19 pandemic and its impact on our business operations; adverse events associated with the commercialization of our products; the outcome and cost of clinical trials for current and future product candidates; determination by the FDA that results from Menlo's clinical trials are not sufficient to support registration or marketing approval of product candidates; the outcome of pricing, coverage and reimbursement negotiations with third party payors for AMZEEQ, ZILXI or any other products or product candidates that Menlo may commercialize in the future; whether, and to what extent, third party payors impose additional requirements before approving AMZEEQ or ZILXI prescription reimbursement; the eligible patient base and commercial potential of AMZEEQ, ZILXI or any of Menlo's other product or product candidates; risks that Menlo's intellectual property rights, such as patents, may fail to provide adequate protection, may be challenged and one or more claims may be revoked or interpreted narrowly or will not be infringed; risks that any of Menlo's patents may be held to be narrowed, invalid or unenforceable or one or more of Menlo's patent applications may not be granted and potential competitors may also seek to design around Menlo's granted patents or patent applications; additional competition in the acne and dermatology markets; risks related to our indebtedness; inability to raise additional capital on favorable terms or at all; Menlo's ability to recruit and retain key employees; and Menlo's ability to stay in compliance with applicable laws, rules and regulations. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Menlo's actual results to differ from those contained in the forward-looking statements, see the section titled "Risk Factors" in Menlo'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 Menlo's subsequent filings with the U.S. Securities and Exchange Commission. Although Menlo believes these forward-looking statements are reasonable, they speak only as of the date of this announcement and Menlo undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law. Given these risks and uncertainties, you should not rely upon forward-looking statements as predictions of future events.

    Media Relations:
    Bridgette Potratz
    Zeno Group
    312-755-5462, x5516
    bridgette.potratz

    Investor Relations:
    Joyce Allaire
    LifeSci Advisors, LLC
    646-889-1200
     

    Primary Logo

    View Full Article Hide Full Article
  4. BRIDGEWATER, N.J., May 29, 2020 /PRNewswire/ -- Menlo Therapeutics Inc. (NASDAQ:MNLO) ("Menlo" or the "Company"), a specialty pharmaceutical company focused on developing and commercializing proprietary therapies to address unmet needs in dermatology, today announced that the U.S. Food and Drug Administration (FDA) has approved ZILXI™ (minocycline) topical foam, 1.5%, for the treatment of inflammatory lesions of rosacea in adults. ZILXI, developed as FMX103 by Menlo's wholly-owned subsidiary Foamix Pharmaceuticals Ltd. ("Foamix"), is the first minocycline product of any kind to be approved by the FDA for use in rosacea.

    "This approval is welcome news for clinicians and patients who seek novel options for this difficult to treat skin disorder," said David Domzalski, Chief Executive Officer of Menlo. "ZILXI is a potential turning point in rosacea treatment, providing millions of people with a new treatment option that is well-tolerated and effective."

    Rosacea is a diverse skin condition that most commonly presents with symptoms such as deep facial redness, spider veins (telangiectasia) and acne-like inflammatory lesions (papules and pustules).

    Minocycline is one of several broad-spectrum antibiotics known as tetracyclines with anti-inflammatory properties; their use in some patients is limited due to systemic side effects when taken orally. In ZILXI, Menlo has once more leveraged its proprietary Molecule Stabilizing Technology (MST™) platform to effectively deliver minocycline in a foam-based vehicle.

    "This is the only product containing minocycline approved by the FDA for rosacea," said Iain Stuart, PhD, Chief Scientific Officer of Menlo. "The availability of a novel topical formulation of this molecule underscores our efforts to provide innovative treatment options for patients who suffer from difficult to treat skin conditions."

    The FDA approval of ZILXI is primarily supported by data from two clinical trials in 1,522 patients 18 years of age and older. In each 12-week multicenter, randomized, double-blind, vehicle-controlled trial, subjects with inflammatory lesions of rosacea were treated once daily with ZILXI or vehicle. No other topical or systemic medication affecting the course of inflammatory lesions of rosacea was permitted for use during these trials. The co-primary efficacy endpoints were (a) the absolute change from baseline in inflammatory lesion counts at Week 12 and (b) the proportion of subjects with treatment success at Week 12 defined as an IGA score of 0 ("clear") or 1 ("almost clear"), and at least a two-grade improvement (decrease) from baseline at Week 12. ZILXI met both co-primary endpoints in each clinical trial, demonstrating statistically significant improvements in inflammatory lesion count and Investigator Global Assessment (IGA) treatment success. No treatment-related serious adverse events were reported. The most common adverse reaction reported by ≥1% of subjects treated with ZILXI and more frequently than in subjects treated with vehicle was diarrhea (1% vs. 0%), respectively.

    Menlo anticipates having ZILXI available for prescribing by 4th quarter of this year.

    About ZILXI™

    INDICATIONS AND USAGE

    ZILXI™ (minocycline) topical foam, 1.5% is a topical form of the antibiotic minocycline for the treatment of adults with pimples and bumps caused by a condition called rosacea. ZILXI is available by prescription only.

    ZILXI should not be used for the treatment of infections. It is not known if ZILXI is safe and effective in children. ZILXI is for use on skin only (topical use). ZILXI is not for use in the mouth, eyes or vagina.

    Important Safety Information

    • ZILXI should not be used in people who are allergic to ZILXI or any tetracycline medicine. Use of ZILXI should be stopped right away if a rash or other allergic symptom occurs.
    • ZILXI should not be used in women who are pregnant, may become pregnant or are nursing. If a woman becomes pregnant while using ZILXI, she should talk to her doctor. 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.
    • ZILXI is flammable and fire, flame, and smoking must be avoided when applying and right after applying ZILXI.
    • People should protect their skin from the sun while using ZILXI and avoid sunlight or artificial sunlight such as sunlamps or tanning beds. Use of ZILXI should be stopped if skin is sunburned.
    • When taken by mouth, minocycline may cause feelings of lightheadedness, dizziness or spinning. People should not drive or operate dangerous machinery if they have these symptoms.

    ZILXI is a topical foam that contains minocycline, a tetracycline medicine. It is not taken by mouth. However, tetracyclines, when taken by mouth (capsules or tablets), may cause serious side effects, including: diarrhea, including  watery or bloody stools;  loss of appetite; tiredness; yellowing of the skin or eyes; 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. People should call their doctor right away if these side effects occur.

    The most common side effect of ZILXI is diarrhea. 

    These are not all of the possible side effects with ZILXI. 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 ZILXI.  

    People are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

    Please see full Prescribing Information.

    About Rosacea

    Rosacea is a diverse skin condition that most commonly presents with symptoms such as deep facial redness, spider veins (telangiectasia) and acne-like inflammatory lesions (papules and pustules). It can create psychosocial burdens, such as embarrassment, anxiety and low self-esteem that can adversely affect quality of life2. Rosacea is most frequently seen in adults between 30 and 50 years of age. It affects more than 16 million people in the United States; up to 28% of these sufferers have rosacea with inflammatory lesions3.

    About Menlo Therapeutics

    Menlo Therapeutics Inc. recently combined with Foamix Pharmaceuticals Ltd. ("Foamix") to form a specialty pharmaceutical company working to solve some of today's most difficult therapeutic challenges in dermatology and beyond. Foamix is now a wholly-owned subsidiary of Menlo.

    With expertise in topical medicine innovation as a springboard, the Company is working to develop and commercialize a variety of solutions using its proprietary Molecule Stabilizing Technology (MST™), and has received FDA approval for the world's first topical minocycline, AMZEEQ™ (minocycline) topical foam, 4%, and now ZILXI™ (minocycline) topical foam, 1.5%

    For more information about Menlo or its investigational products, visit www.menlotherapeutics.com. Menlo may use its website to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor Menlo's website in addition to following its press releases, filings with the U.S. Securities and Exchange Commission, public conference calls, and webcasts.

    Cautionary Statement Regarding Forward-Looking Statements

    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 expectations with respect to the anticipated launch of ZILXI, Menlo's other products and product candidates and other statements regarding the future expectations, plans and prospects of Menlo. All statements in this press release which are not historical facts are forward-looking statements. Any forward-looking statements are based on Menlo'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 risks and uncertainties include, but are not limited to any adverse effects on our business related to the global COVID-19 pandemic,; adverse events associated with the commercialization of ZILXI; the outcome of pricing, coverage and reimbursement negotiations with third party payors for ZILXI or any other products or product candidates that Menlo may commercialize in the future; whether, and to what extent, third party payors impose additional requirements before approving ZILXI prescription reimbursement; the eligible patient base and commercial potential of ZILXI or any of Menlo's other product or product candidates; risks that Menlo's intellectual property rights, such as patents, may fail to provide adequate protection, may be challenged and one or more claims may be revoked or interpreted narrowly or will not be infringed; risks that any of Menlo's patents may be held to be narrowed, invalid or unenforceable or one or more of Menlo's patent applications may not be granted and potential competitors may also seek to design around Menlo's granted patents or patent applications; additional competition in the rosacea and dermatology markets; inability to raise additional capital on favorable terms or at all; Menlo's ability to recruit and retain key employees; and Menlo's ability to stay in compliance with applicable laws, rules and regulations. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Menlo's actual results to differ from those contained in the forward-looking statements, see the sections titled "Risk Factors" in (i) Menlo's most recent annual report on Form 10-K, (ii) Foamix's most recent annual report on Form 10-K and (iii) Menlo's definitive joint proxy statement/prospectus filed with the U.S. Securities and Exchange Commission under Rule 424(b)(3) on January 7, 2020, as well as discussions of potential risks, uncertainties, and other important factors in Menlo's subsequent filings with the U.S. Securities and Exchange Commission. Although Menlo believes these forward-looking statements are reasonable, they speak only as of the date of this announcement and Menlo undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law. Given these risks and uncertainties, you should not rely upon forward-looking statements as predictions of future events.

    Notes:

    1. Aimee Two, MD, et al, JAAD, Volume 72, Issue 5, May 2015
    2. Aksoy, B., Altaykan‐Hapa, A., Egemen, D., Karagöz, F. and Atakan, N. (2010), The impact of rosacea on quality of life: effects of demographic and clinical characteristics and various treatment modalities. British Journal of Dermatology, 163: 719-725.
    3. Gether et al. Incidence and prevalence of rosacea: a systematic review and meta-analysis. British Journal of Dermatology 25 Feb 2018.179: 282-289.

    Media Relations:
    Bridgette Potratz
    Zeno Group
    312-358-2950

    Investor Relations:
    Joyce Allaire
    LifeSci Advisors, LLC
    646-889-1200

    COM-FMX103-US-200004 
    © 2020 Menlo Therapeutics Inc. All rights reserved.
    05-2020

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  5. BRIDGEWATER, N.J., May 29, 2020 (GLOBE NEWSWIRE) -- Menlo Therapeutics Inc. (NASDAQ:MNLO) ("Menlo" or the "Company"), a specialty pharmaceutical company focused on developing and commercializing proprietary therapies to address unmet needs in dermatology, today announced that the U.S. Food and Drug Administration (FDA) has approved ZILXI™ (minocycline) topical foam, 1.5%, for the treatment of inflammatory lesions of rosacea in adults. ZILXI, developed as FMX103 by Menlo's wholly-owned subsidiary Foamix Pharmaceuticals Ltd. ("Foamix"), is the first minocycline product of any kind to be approved by the FDA for use in rosacea.

    "This approval is welcome news for clinicians and patients who seek novel options for this difficult to treat skin disorder…

    BRIDGEWATER, N.J., May 29, 2020 (GLOBE NEWSWIRE) -- Menlo Therapeutics Inc. (NASDAQ:MNLO) ("Menlo" or the "Company"), a specialty pharmaceutical company focused on developing and commercializing proprietary therapies to address unmet needs in dermatology, today announced that the U.S. Food and Drug Administration (FDA) has approved ZILXI™ (minocycline) topical foam, 1.5%, for the treatment of inflammatory lesions of rosacea in adults. ZILXI, developed as FMX103 by Menlo's wholly-owned subsidiary Foamix Pharmaceuticals Ltd. ("Foamix"), is the first minocycline product of any kind to be approved by the FDA for use in rosacea.

    "This approval is welcome news for clinicians and patients who seek novel options for this difficult to treat skin disorder," said David Domzalski, Chief Executive Officer of Menlo. "ZILXI is a potential turning point in rosacea treatment, providing millions of people with a new treatment option that is well-tolerated and effective."

    Rosacea is a diverse skin condition that most commonly presents with symptoms such as deep facial redness, spider veins (telangiectasia) and acne-like inflammatory lesions (papules and pustules).

    Minocycline is one of several broad-spectrum antibiotics known as tetracyclines with anti-inflammatory properties; their use in some patients is limited due to systemic side effects when taken orally. In ZILXI, Menlo has once more leveraged its proprietary Molecule Stabilizing Technology (MST™) platform to effectively deliver minocycline in a foam-based vehicle.

    "This is the only product containing minocycline approved by the FDA for rosacea," said Iain Stuart, PhD, Chief Scientific Officer of Menlo. "The availability of a novel topical formulation of this molecule underscores our efforts to provide innovative treatment options for patients who suffer from difficult to treat skin conditions."

    The FDA approval of ZILXI is primarily supported by data from two clinical trials in 1,522 patients 18 years of age and older. In each 12-week multicenter, randomized, double-blind, vehicle-controlled trial, subjects with inflammatory lesions of rosacea were treated once daily with ZILXI or vehicle. No other topical or systemic medication affecting the course of inflammatory lesions of rosacea was permitted for use during these trials. The co-primary efficacy endpoints were (a) the absolute change from baseline in inflammatory lesion counts at Week 12 and (b) the proportion of subjects with treatment success at Week 12 defined as an IGA score of 0 ("clear") or 1 ("almost clear"), and at least a two-grade improvement (decrease) from baseline at Week 12. ZILXI met both co-primary endpoints in each clinical trial, demonstrating statistically significant improvements in inflammatory lesion count and Investigator Global Assessment (IGA) treatment success. No treatment-related serious adverse events were reported. The most common adverse reaction reported by ≥1% of subjects treated with ZILXI and more frequently than in subjects treated with vehicle was diarrhea (1% vs. 0%), respectively.

    Menlo anticipates having ZILXI available for prescribing by 4th quarter of this year.

    About ZILXI™

    INDICATIONS AND USAGE

    ZILXI™ (minocycline) topical foam, 1.5% is a topical form of the antibiotic minocycline for the treatment of adults with pimples and bumps caused by a condition called rosacea. ZILXI is available by prescription only.

    ZILXI should not be used for the treatment of infections. It is not known if ZILXI is safe and effective in children. ZILXI is for use on skin only (topical use). ZILXI is not for use in the mouth, eyes or vagina.

    Important Safety Information

    • ZILXI should not be used in people who are allergic to ZILXI or any tetracycline medicine. Use of ZILXI should be stopped right away if a rash or other allergic symptom occurs.
    • ZILXI should not be used in women who are pregnant, may become pregnant or are nursing. If a woman becomes pregnant while using ZILXI, she should talk to her doctor. 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.
    • ZILXI is flammable and fire, flame, and smoking must be avoided when applying and right after applying ZILXI.
    • People should protect their skin from the sun while using ZILXI and avoid sunlight or artificial sunlight such as sunlamps or tanning beds. Use of ZILXI should be stopped if skin is sunburned.
    • When taken by mouth, minocycline may cause feelings of lightheadedness, dizziness or spinning. People should not drive or operate dangerous machinery if they have these symptoms.       

    ZILXI is a topical foam that contains minocycline, a tetracycline medicine. It is not taken by mouth. However, tetracyclines, when taken by mouth (capsules or tablets), may cause serious side effects, including: diarrhea, including watery or bloody stools; loss of appetite; tiredness; yellowing of the skin or eyes; 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. People should call their doctor right away if these side effects occur.

    The most common side effect of ZILXI is diarrhea.

    These are not all of the possible side effects with ZILXI. 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 ZILXI.  

    People are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

    Please see full Prescribing Information.

    About Rosacea

    Rosacea is a diverse skin condition that most commonly presents with symptoms such as deep facial redness, spider veins (telangiectasia) and acne-like inflammatory lesions (papules and pustules). It can create psychosocial burdens, such as embarrassment, anxiety and low self-esteem that can adversely affect quality of life2. Rosacea is most frequently seen in adults between 30 and 50 years of age. It affects more than 16 million people in the United States; up to 28% of these sufferers have rosacea with inflammatory lesions3.

    About Menlo Therapeutics

    Menlo Therapeutics Inc. recently combined with Foamix Pharmaceuticals Ltd. ("Foamix") to form a specialty pharmaceutical company working to solve some of today's most difficult therapeutic challenges in dermatology and beyond. Foamix is now a wholly-owned subsidiary of Menlo.

    With expertise in topical medicine innovation as a springboard, the Company is working to develop and commercialize a variety of solutions using its proprietary Molecule Stabilizing Technology (MST™), and has received FDA approval for the world's first topical minocycline, AMZEEQ™ (minocycline) topical foam, 4%, and now ZILXI™ (minocycline) topical foam, 1.5%

    For more information about Menlo or its investigational products, visit www.menlotherapeutics.com. Menlo may use its website to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor Menlo's website in addition to following its press releases, filings with the U.S. Securities and Exchange Commission, public conference calls, and webcasts.

    Cautionary Statement Regarding Forward-Looking Statements

    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 expectations with respect to the anticipated launch of ZILXI, Menlo's other products and product candidates and other statements regarding the future expectations, plans and prospects of Menlo. All statements in this press release which are not historical facts are forward-looking statements. Any forward-looking statements are based on Menlo'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 risks and uncertainties include, but are not limited to any adverse effects on our business related to the global COVID-19 pandemic,; adverse events associated with the commercialization of ZILXI; the outcome of pricing, coverage and reimbursement negotiations with third party payors for ZILXI or any other products or product candidates that Menlo may commercialize in the future; whether, and to what extent, third party payors impose additional requirements before approving ZILXI prescription reimbursement; the eligible patient base and commercial potential of ZILXI or any of Menlo's other product or product candidates; risks that Menlo's intellectual property rights, such as patents, may fail to provide adequate protection, may be challenged and one or more claims may be revoked or interpreted narrowly or will not be infringed; risks that any of Menlo's patents may be held to be narrowed, invalid or unenforceable or one or more of Menlo's patent applications may not be granted and potential competitors may also seek to design around Menlo's granted patents or patent applications; additional competition in the rosacea and dermatology markets; inability to raise additional capital on favorable terms or at all; Menlo's ability to recruit and retain key employees; and Menlo's ability to stay in compliance with applicable laws, rules and regulations. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Menlo's actual results to differ from those contained in the forward-looking statements, see the sections titled "Risk Factors" in (i) Menlo's most recent annual report on Form 10-K, (ii) Foamix's most recent annual report on Form 10-K and (iii) Menlo's definitive joint proxy statement/prospectus filed with the U.S. Securities and Exchange Commission under Rule 424(b)(3) on January 7, 2020, as well as discussions of potential risks, uncertainties, and other important factors in Menlo's subsequent filings with the U.S. Securities and Exchange Commission. Although Menlo believes these forward-looking statements are reasonable, they speak only as of the date of this announcement and Menlo undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law. Given these risks and uncertainties, you should not rely upon forward-looking statements as predictions of future events.

    Notes:

    1. Aimee Two, MD, et al, JAAD, Volume 72, Issue 5, May 2015
    2. Aksoy, B., Altaykan‐Hapa, A., Egemen, D., Karagöz, F. and Atakan, N. (2010), The impact of rosacea on quality of life: effects of demographic and clinical characteristics and various treatment modalities. British Journal of Dermatology, 163: 719-725.
    3. Gether et al. Incidence and prevalence of rosacea: a systematic review and meta-analysis. British Journal of Dermatology 25 Feb 2018.179: 282-289.

    Media Relations:
    Bridgette Potratz
    Zeno Group
    312-358-2950

    Investor Relations:
    Joyce Allaire
    LifeSci Advisors, LLC
    646-889-1200

    COM-FMX103-US-200004
    © 2020 Menlo Therapeutics Inc. All rights reserved.
    05-2020

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