{"success":true,"data":{"pressRelease":{"id":"75977","rtpr_id":"nGNX4MRjx5","ticker":"ARQT","exchange":"NASDAQ","all_tickers":["ARQT"],"title":"FDA Approves Arcutis’ ZORYVE® (roflumilast) Cream 0.3% for the Treatment of Plaque Psoriasis in Children as Young as Age 2","author":"Globe Newswire","published_at":"2026-06-29T23:06:39.127Z","article_body":"* ZORYVE cream 0.3% is the first once-daily, non-steroidal therapy approved\nfor children with plaque psoriasis as young as 2 years of age\n* ZORYVE cream 0.3% is safe, effective, and well-tolerated for use anywhere on\nthe body with no restrictions on duration of use\n* Seventh FDA approval for ZORYVE in four years\nWESTLAKE VILLAGE, Calif., June 29, 2026 (GLOBE NEWSWIRE) -- Arcutis\nBiotherapeutics, Inc.\n(https://www.globenewswire.com/Tracker?data=ecaSUa_E1P8Ey8KyVF3jOhN-bW1QvMGQZBtvkvRLIjk61hRa8TzJC9GYSLokHfFOufymOBVW3wwBtz404CBN7oGVpODJMuDcN6xN2ExfYkA=) (Nasdaq:\nARQT), a commercial-stage biopharmaceutical company focused on developing\nmeaningful innovations in immuno-dermatology, today announced that the U.S.\nFood and Drug Administration (FDA) has approved the supplemental New Drug\nApplication (sNDA) to expand the indication for ZORYVE(®) (roflumilast) cream\n0.3% for the topical treatment of plaque psoriasis, including intertriginous\nareas, to children down to age 2. ZORYVE cream 0.3% is a once-daily,\nsteroid-free topical that is safe, effective, and well tolerated, and is\nsuitable for use anywhere on the body with no limitations on duration of\nuse. \n\nPlaque psoriasis is a chronic, immune-mediated inflammatory skin disease that\ncan begin early in life and persist for decades. Plaque psoriasis can appear\nas raised, red, or discolored areas of skin covered with silvery scales.\n\n“Young children with plaque psoriasis face unique challenges, including\ndisease involvement on sensitive skin, such as the face and skin folds.\nAlthough topical steroids are commonly used to treat pediatric plaque\npsoriasis, they are not recommended on sensitive areas or for long-term,\ncontinuous use,” said Lisa Swanson, MD, FAAD, board-certified pediatric\ndermatologist and clinical trial investigator, Ada West Dermatology. “In\nclinical studies, ZORYVE cream 0.3% demonstrated consistent safety and\nefficacy in improving the signs and symptoms of plaque psoriasis as seen in\nadults and adolescents, and was safe and well tolerated in children as young\nas age 2. This approval provides physicians and caregivers a targeted topical\ntherapy that can be used anywhere on the body for any duration of time.”\n\n“Parents and caregivers of young children with plaque psoriasis have faced a\nsignificant treatment gap for years, with very limited options, even though\nthis skin condition can have a profound impact on the child and the entire\nfamily,” said Leah Howard, president and chief executive officer, National\nPsoriasis Foundation. “The FDA approval of a once-daily, steroid-free\ntopical treatment for children as young as 2 introduces an important new\ntreatment option for a largely overlooked population and represents a\nsignificant advancement in pediatric psoriasis care.”\n\n(https://www.globenewswire.com/Tracker?data=31XU-Ko74bEUNMMMBnOY8NIWHj8ndPAGJBIKh80FLCH9u9Yevgaxu3FjeOxc0DNLL1bvze8n-XYsoh-kZV-YN283CYSRCwejKsFb4kGirOM=)\n\nA Media Snippet accompanying this announcement is available by clicking on\nthis link.\n(https://www.globenewswire.com/Tracker?data=Z6-i21EY-5vsHlKO57AxGdGIbzgFiXE3WMun4MbTxxQw6dESKfjq9zE9a3FRqmc9lOPU8vWCG5_NpWoK3Y4rZNVYMLiHtRRri7wnq2nVXhLXSfweD3c77Ple7L_4AdEds6fuK1Gfkjvzr16V9sPA6FCTAFBBJckSIEyPBm1wo9YqKLsBFhu6FjyCN6b-dMuYBYqzlYfES3uDoDpKzGq0ahtpE3fHiHSyFgCj6hbj41c=)\n\nZORYVE cream 0.3% was previously approved for the treatment of plaque\npsoriasis in adults and children down to age 6. The approval of the expanded\nindication is based on data from a 4-week Maximal Usage Systemic Exposure\n(MUSE) study (ARQ-151-216) evaluating ZORYVE cream 0.3% in children ages 2 to\n5 years with plaque psoriasis. This open-label study assessed\npharmacokinetics, safety, tolerability, and exploratory efficacy in children\nwith plaque psoriasis involving at least 2% body surface area. Supportive\nlong-term safety data were derived from an open-label extension study\n(ARQ-151-306), which evaluated the long-term safety, tolerability, and\nefficacy of ZORYVE cream 0.3% in individuals ages 2 to 5 years with plaque\npsoriasis for up to 24 weeks of treatment. Results demonstrated safety and\nefficacy profiles that were generally consistent with those observed in the\nDERMIS-1 and DERMIS-2 pivotal Phase 3 trials in adolescents and adults.\n\n“Children with plaque psoriasis under age 6 have historically had few\ntreatment options that are appropriate for long‑term use, forcing families\nand clinicians to navigate care for a chronic, progressive skin condition with\nlimited choices,” said Frank Watanabe, president and chief executive officer\nof Arcutis. “ZORYVE cream 0.3%, a potent and selective PDE4 inhibitor,\ndirectly addresses this treatment gap and is the first once-daily steroid-free\ntreatment for plaque psoriasis approved down to age 2. This seventh FDA\napproval for ZORYVE in four years demonstrates Arcutis’ commitment to\ndelivering meaningful innovation to the youngest children and their\nfamilies.”\n\nZORYVE cream is widely available today via key wholesaler and dermatology\npharmacy channels. Arcutis is committed to ensuring predictable access across\nthe ZORYVE portfolio through a simplified copay and fulfillment process. The\nZORYVE(®) Direct Program supports patients who have been prescribed ZORYVE by\nhelping navigate the insurance process, assisting with adherence, and\nproviding access to the ZORYVE Direct Savings Card Program to help reduce\nout-of-pocket costs for eligible commercially insured patients.(† )The\nCompany also offers the Arcutis Cares™ patient assistance program, which\nprovides ZORYVE at no cost to financially eligible patients who are uninsured\nor underinsured.(‡)\n\nFor more information about ZORYVE, including full Prescribing Information,\nplease visit www.zoryve.com.\n\nAbout Plaque Psoriasis\nPsoriasis is a common, chronic, inflammatory skin disease that affects nearly\n9 million people in the United States. Symptoms include itch, scaling,\nredness, and flaking. On darker skin tones, plaques may appear more grayish,\npurplish, or brown. Psoriasis can appear anywhere on the body, including the\nknees, elbows, torso and thin-skinned areas like the face, genitals and\nintertriginous areas, which are areas where skin touches skin, such as the\narmpits, under the breasts, stomach folds, between the buttocks, and in the\ngroin area.\n\nAbout ZORYVE(®) (roflumilast)\nZORYVE is the number one prescribed branded topical therapy across three major\ninflammatory dermatoses combined — atopic dermatitis, seborrheic dermatitis,\nand plaque psoriasis. ZORYVE is a topical formulation of roflumilast, an\nadvanced targeted topical phosphodiesterase type 4 (PDE4) inhibitor.\nInhibiting PDE4, an intracellular enzyme that is an established target in\ndermatology, decreases the production of pro-inflammatory mediators. This\ndecreases inflammation in the skin and balances the skin’s immune system.\n\nDemonstrating both clinical impact and broad industry recognition, ZORYVE has\nbeen honored with multiple prestigious awards and recommendations. ZORYVE was\nawarded by Allure with the \"2025 Best of Beauty Breakthrough Award,\" making\nit the first FDA-approved medication for atopic dermatitis, plaque psoriasis,\nand seborrheic dermatitis to win this prominent award. ZORYVE cream 0.3% and\nZORYVE foam 0.3% were also awarded the National Psoriasis Foundation’s Seal\nof Recognition — the first FDA-approved prescription brand to receive the\nhonor. Additionally, the American Academy of Dermatology (AAD) issued a\nstrong recommendation for the use of ZORYVE cream 0.15% in adults with mild to\nmoderate atopic dermatitis, according to updated guidelines released in June\n2025, as well as a strong recommendation for the use of ZORYVE cream 0.05% for\nchildren aged 2-5 years and ZORYVE cream 0.15% for children aged 6 years and\nolder with mild to moderate atopic dermatitis from the AAD’s first-ever\npediatric atopic dermatitis guidelines published in April 2026. In 2024,\nZORYVE cream 0.15% was awarded Glamour’s Beauty and Wellness Award for\n“Best Eczema Product.”\n\nINDICATIONS\nZORYVE cream, 0.3%, is indicated for topical treatment of plaque psoriasis,\nincluding intertriginous areas, in adult and pediatric patients 2 years of age\nand older.\n\nZORYVE topical foam, 0.3%, is indicated for the treatment of plaque psoriasis\nof the scalp and body in adult and pediatric patients 12 years of age and\nolder. \n\nZORYVE topical foam, 0.3%, is indicated for the treatment of seborrheic\ndermatitis in adult and pediatric patients 9 years of age and older.\n\nZORYVE cream, 0.15%, is indicated for topical treatment of mild to moderate\natopic dermatitis in adult and pediatric patients 6 years of age and older. \n\nZORYVE cream, 0.05%, is indicated for topical treatment of mild to moderate\natopic dermatitis in pediatric patients 2 to 5 years of age.\n\nIMPORTANT SAFETY INFORMATION\nZORYVE is contraindicated in patients with moderate to severe liver impairment\n(Child-Pugh B or C).\n\nFlammability: The propellants in ZORYVE foam are flammable. Avoid fire,\nflame, and smoking during and immediately following application. \n\nThe most common adverse reactions reported (≥1%) for ZORYVE cream 0.3% for\nplaque psoriasis were diarrhea (3.1%), headache (2.4%), insomnia (1.4%),\nnausea (1.2%), application site pain (1.0%), upper respiratory tract infection\n(1.0%), and urinary tract infection (1.0%). \n\nThe most common adverse reactions reported (≥1%) for ZORYVE foam 0.3% for\nplaque psoriasis were headache (3.1%), diarrhea (2.5%), nausea (1.7%), and\nnasopharyngitis (1.3%). \n\nThe most common adverse reactions reported (≥1%) for ZORYVE foam 0.3% for\nseborrheic dermatitis were nasopharyngitis (1.5%), nausea (1.3%), and headache\n(1.1%). \n\nThe most common adverse reactions reported (≥1%) for ZORYVE cream 0.15% for\npatients with atopic dermatitis 6 years of age or older were headache (2.9%),\nnausea (1.9%), application site pain (1.5%), diarrhea (1.5%), and vomiting\n(1.5%).\n\nThe most common adverse reactions reported (≥1%) for ZORYVE cream 0.05% for\npediatric patients with atopic dermatitis 2 to 5 years of age were upper\nrespiratory tract infection (4.1%), diarrhea (2.5%), vomiting (2.1%), rhinitis\n(1.6%), conjunctivitis (1.4%), and headache (1.1%).\n\nPlease see full Prescribing Information\n(https://www.globenewswire.com/Tracker?data=ALbvjbgjc_8AjA98aWfSrcJGhJ7OQzQhvgIPqqQkNwksUQEJXtkg-8qJJm0R0eyO3-Uos7gjcnivcfC_Ow0rA2vLT-XedVO4qZn_nZOnd5AOIMGK-JCUcQBb5Gr6S8WB) for\nZORYVE cream and full Prescribing Information\n(https://www.globenewswire.com/Tracker?data=ALbvjbgjc_8AjA98aWfSrcJGhJ7OQzQhvgIPqqQkNwmrDqMhAuxXsigrya4w9IMIAPTkM-buLU_tpHdHlByauxOcVqJAEb1HoDWnbrYxS9Gb5UlbKpKHeG5nn7Mf8mgJ) for\nZORYVE foam.\n\nZORYVE is for topical use only and not for ophthalmic, oral, or intravaginal\nuse.\n\nAbout Arcutis\nArcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a commercial-stage medical\ndermatology company delivering meaningful innovation to address the needs of\nindividuals living with chronic inflammatory skin diseases. Over the\npast decade, Arcutis has successfully developed a robust portfolio of\nadvanced targeted topicals approved to treat three major inflammatory skin\ndiseases, driven by a commitment to solving the most persistent patient\nchallenges in dermatology. Arcutis’ unique dermatology development\nplatform, built on established scientific pathways and coupled with deep\nclinical dermatology and commercial expertise, enables us to efficiently\ndevelop, scale, and deliver our differentiated therapies while advancing a\ngrowing pipeline across a range of inflammatory dermatological conditions. For\nmore information, visit www.arcutis.com or follow Arcutis on LinkedIn\n(https://www.globenewswire.com/Tracker?data=qtp6pj9t_mtVeRsJ_yfcNUzroZljsfStKH-MmNm_yuFyJGq5C61dO6tCdCH_JEtj_vjUWrKmc3akC0w6k123JuXSpW2pBUwagWbnh_Op53Q2HdHX5pstokLf1jNAiODT), Facebook\n(https://www.globenewswire.com/Tracker?data=5WfMw_3x0uszIl9ts55HgZaTXh0Z6zDgoYCMopaPo6RZp2VPgqrYcriXx77Qt9LhYqtcGslUismOtcmKeH35K10FJQXfX6CHQZiF2IPAsfk=), Instagram\n(https://www.globenewswire.com/Tracker?data=CeBOVGLKDYkFTbWI2zxyNI_6ync3Mfj6Dkri9xU2VbfpibJkZRwR37AjiIvAwgu1swz_9Vmv_0dgzUtAW-S7BUqRLpvYazOZ8G2JodfHm6I=),\nand X\n(https://www.globenewswire.com/Tracker?data=J85Z-aRfRqR0elyZ9bz_nV8M9m8Ms141ghEv0HAi-uuVH5jz5evM1OUmkJtLf2TRoxtCx6R_QG7lRLQ-U-Aiqg==). \n\nForward-Looking Statements\nThis press release contains forward-looking statements within the meaning of\nSection 27A of the Securities Act of 1933, as amended, and Section 21E of the\nSecurities Exchange Act of 1934, as amended. For example, statements contained\nin this press release regarding matters that are not historical facts are\nforward-looking statements. These statements are based on the Company’s\ncurrent beliefs and expectations. Such forward-looking statements include, but\nare not limited to, statements regarding the potential real-world use results\nof ZORYVE cream 0.3%, and the potential for ZORYVE cream to advance the\nstandard of care in plaque psoriasis including this young patient population.\nThese statements are subject to substantial known and unknown risks,\nuncertainties, and other factors that may cause our actual results, levels of\nactivity, performance, or achievements to be materially different from the\ninformation expressed or implied by these forward-looking statements. Risks\nand uncertainties that may cause our actual results to differ include risks\ninherent in our business, reimbursement and access to our products, the impact\nof competition and other important factors discussed in the “Risk Factors”\nsection of our Form 10-K filed with the U.S. Securities and Exchange\nCommission (SEC) on February 25, 2026, as well as any subsequent filings with\nthe SEC. Any forward-looking statements that the Company makes in this press\nrelease are made pursuant to the Private Securities Litigation Reform Act of\n1995, as amended, and speak only as of the date of this press release. Except\nas required by law, we undertake no obligation to revise or update information\nherein to reflect events or circumstances in the future, even if new\ninformation becomes available.\n\n† Subject to eligibility criteria and maximum program limitation. This offer\nis not valid for patients without commercial drug insurance or whose\nprescription claims are eligible to be reimbursed, in whole or in part, by any\ngovernment program.\n\n‡ Subject to financial eligibility requirements. Other terms and\nrestrictions apply.\n\nContacts:\nMedia\nAmanda Sheldon, Head of Corporate Communications\nmedia@arcutis.com\n\nInvestors\nBrian Schoelkopf, Head of Investor Relations\nir@arcutis.com\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/1b166f47-afb1-44f1-91be-2d73e97c0ec3)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNX4MRjx5","title":"FDA Approves Arcutis’ ZORYVE® (roflumilast) Cream 0.3% for the Treatment of Plaque Psoriasis in Children as Young as Age 2","author":"Globe Newswire","ticker":"ARQT","created":"2026-06-29T23:06:39.127Z","tickers":["ARQT"],"exchange":"NASDAQ","article_body":"* ZORYVE cream 0.3% is the first once-daily, non-steroidal therapy approved\nfor children with plaque psoriasis as young as 2 years of age\n* ZORYVE cream 0.3% is safe, effective, and well-tolerated for use anywhere on\nthe body with no restrictions on duration of use\n* Seventh FDA approval for ZORYVE in four years\nWESTLAKE VILLAGE, Calif., June 29, 2026 (GLOBE NEWSWIRE) -- Arcutis\nBiotherapeutics, Inc.\n(https://www.globenewswire.com/Tracker?data=ecaSUa_E1P8Ey8KyVF3jOhN-bW1QvMGQZBtvkvRLIjk61hRa8TzJC9GYSLokHfFOufymOBVW3wwBtz404CBN7oGVpODJMuDcN6xN2ExfYkA=) (Nasdaq:\nARQT), a commercial-stage biopharmaceutical company focused on developing\nmeaningful innovations in immuno-dermatology, today announced that the U.S.\nFood and Drug Administration (FDA) has approved the supplemental New Drug\nApplication (sNDA) to expand the indication for ZORYVE(®) (roflumilast) cream\n0.3% for the topical treatment of plaque psoriasis, including intertriginous\nareas, to children down to age 2. ZORYVE cream 0.3% is a once-daily,\nsteroid-free topical that is safe, effective, and well tolerated, and is\nsuitable for use anywhere on the body with no limitations on duration of\nuse. \n\nPlaque psoriasis is a chronic, immune-mediated inflammatory skin disease that\ncan begin early in life and persist for decades. Plaque psoriasis can appear\nas raised, red, or discolored areas of skin covered with silvery scales.\n\n“Young children with plaque psoriasis face unique challenges, including\ndisease involvement on sensitive skin, such as the face and skin folds.\nAlthough topical steroids are commonly used to treat pediatric plaque\npsoriasis, they are not recommended on sensitive areas or for long-term,\ncontinuous use,” said Lisa Swanson, MD, FAAD, board-certified pediatric\ndermatologist and clinical trial investigator, Ada West Dermatology. “In\nclinical studies, ZORYVE cream 0.3% demonstrated consistent safety and\nefficacy in improving the signs and symptoms of plaque psoriasis as seen in\nadults and adolescents, and was safe and well tolerated in children as young\nas age 2. This approval provides physicians and caregivers a targeted topical\ntherapy that can be used anywhere on the body for any duration of time.”\n\n“Parents and caregivers of young children with plaque psoriasis have faced a\nsignificant treatment gap for years, with very limited options, even though\nthis skin condition can have a profound impact on the child and the entire\nfamily,” said Leah Howard, president and chief executive officer, National\nPsoriasis Foundation. “The FDA approval of a once-daily, steroid-free\ntopical treatment for children as young as 2 introduces an important new\ntreatment option for a largely overlooked population and represents a\nsignificant advancement in pediatric psoriasis care.”\n\n(https://www.globenewswire.com/Tracker?data=31XU-Ko74bEUNMMMBnOY8NIWHj8ndPAGJBIKh80FLCH9u9Yevgaxu3FjeOxc0DNLL1bvze8n-XYsoh-kZV-YN283CYSRCwejKsFb4kGirOM=)\n\nA Media Snippet accompanying this announcement is available by clicking on\nthis link.\n(https://www.globenewswire.com/Tracker?data=Z6-i21EY-5vsHlKO57AxGdGIbzgFiXE3WMun4MbTxxQw6dESKfjq9zE9a3FRqmc9lOPU8vWCG5_NpWoK3Y4rZNVYMLiHtRRri7wnq2nVXhLXSfweD3c77Ple7L_4AdEds6fuK1Gfkjvzr16V9sPA6FCTAFBBJckSIEyPBm1wo9YqKLsBFhu6FjyCN6b-dMuYBYqzlYfES3uDoDpKzGq0ahtpE3fHiHSyFgCj6hbj41c=)\n\nZORYVE cream 0.3% was previously approved for the treatment of plaque\npsoriasis in adults and children down to age 6. The approval of the expanded\nindication is based on data from a 4-week Maximal Usage Systemic Exposure\n(MUSE) study (ARQ-151-216) evaluating ZORYVE cream 0.3% in children ages 2 to\n5 years with plaque psoriasis. This open-label study assessed\npharmacokinetics, safety, tolerability, and exploratory efficacy in children\nwith plaque psoriasis involving at least 2% body surface area. Supportive\nlong-term safety data were derived from an open-label extension study\n(ARQ-151-306), which evaluated the long-term safety, tolerability, and\nefficacy of ZORYVE cream 0.3% in individuals ages 2 to 5 years with plaque\npsoriasis for up to 24 weeks of treatment. Results demonstrated safety and\nefficacy profiles that were generally consistent with those observed in the\nDERMIS-1 and DERMIS-2 pivotal Phase 3 trials in adolescents and adults.\n\n“Children with plaque psoriasis under age 6 have historically had few\ntreatment options that are appropriate for long‑term use, forcing families\nand clinicians to navigate care for a chronic, progressive skin condition with\nlimited choices,” said Frank Watanabe, president and chief executive officer\nof Arcutis. “ZORYVE cream 0.3%, a potent and selective PDE4 inhibitor,\ndirectly addresses this treatment gap and is the first once-daily steroid-free\ntreatment for plaque psoriasis approved down to age 2. This seventh FDA\napproval for ZORYVE in four years demonstrates Arcutis’ commitment to\ndelivering meaningful innovation to the youngest children and their\nfamilies.”\n\nZORYVE cream is widely available today via key wholesaler and dermatology\npharmacy channels. Arcutis is committed to ensuring predictable access across\nthe ZORYVE portfolio through a simplified copay and fulfillment process. The\nZORYVE(®) Direct Program supports patients who have been prescribed ZORYVE by\nhelping navigate the insurance process, assisting with adherence, and\nproviding access to the ZORYVE Direct Savings Card Program to help reduce\nout-of-pocket costs for eligible commercially insured patients.(† )The\nCompany also offers the Arcutis Cares™ patient assistance program, which\nprovides ZORYVE at no cost to financially eligible patients who are uninsured\nor underinsured.(‡)\n\nFor more information about ZORYVE, including full Prescribing Information,\nplease visit www.zoryve.com.\n\nAbout Plaque Psoriasis\nPsoriasis is a common, chronic, inflammatory skin disease that affects nearly\n9 million people in the United States. Symptoms include itch, scaling,\nredness, and flaking. On darker skin tones, plaques may appear more grayish,\npurplish, or brown. Psoriasis can appear anywhere on the body, including the\nknees, elbows, torso and thin-skinned areas like the face, genitals and\nintertriginous areas, which are areas where skin touches skin, such as the\narmpits, under the breasts, stomach folds, between the buttocks, and in the\ngroin area.\n\nAbout ZORYVE(®) (roflumilast)\nZORYVE is the number one prescribed branded topical therapy across three major\ninflammatory dermatoses combined — atopic dermatitis, seborrheic dermatitis,\nand plaque psoriasis. ZORYVE is a topical formulation of roflumilast, an\nadvanced targeted topical phosphodiesterase type 4 (PDE4) inhibitor.\nInhibiting PDE4, an intracellular enzyme that is an established target in\ndermatology, decreases the production of pro-inflammatory mediators. This\ndecreases inflammation in the skin and balances the skin’s immune system.\n\nDemonstrating both clinical impact and broad industry recognition, ZORYVE has\nbeen honored with multiple prestigious awards and recommendations. ZORYVE was\nawarded by Allure with the \"2025 Best of Beauty Breakthrough Award,\" making\nit the first FDA-approved medication for atopic dermatitis, plaque psoriasis,\nand seborrheic dermatitis to win this prominent award. ZORYVE cream 0.3% and\nZORYVE foam 0.3% were also awarded the National Psoriasis Foundation’s Seal\nof Recognition — the first FDA-approved prescription brand to receive the\nhonor. Additionally, the American Academy of Dermatology (AAD) issued a\nstrong recommendation for the use of ZORYVE cream 0.15% in adults with mild to\nmoderate atopic dermatitis, according to updated guidelines released in June\n2025, as well as a strong recommendation for the use of ZORYVE cream 0.05% for\nchildren aged 2-5 years and ZORYVE cream 0.15% for children aged 6 years and\nolder with mild to moderate atopic dermatitis from the AAD’s first-ever\npediatric atopic dermatitis guidelines published in April 2026. In 2024,\nZORYVE cream 0.15% was awarded Glamour’s Beauty and Wellness Award for\n“Best Eczema Product.”\n\nINDICATIONS\nZORYVE cream, 0.3%, is indicated for topical treatment of plaque psoriasis,\nincluding intertriginous areas, in adult and pediatric patients 2 years of age\nand older.\n\nZORYVE topical foam, 0.3%, is indicated for the treatment of plaque psoriasis\nof the scalp and body in adult and pediatric patients 12 years of age and\nolder. \n\nZORYVE topical foam, 0.3%, is indicated for the treatment of seborrheic\ndermatitis in adult and pediatric patients 9 years of age and older.\n\nZORYVE cream, 0.15%, is indicated for topical treatment of mild to moderate\natopic dermatitis in adult and pediatric patients 6 years of age and older. \n\nZORYVE cream, 0.05%, is indicated for topical treatment of mild to moderate\natopic dermatitis in pediatric patients 2 to 5 years of age.\n\nIMPORTANT SAFETY INFORMATION\nZORYVE is contraindicated in patients with moderate to severe liver impairment\n(Child-Pugh B or C).\n\nFlammability: The propellants in ZORYVE foam are flammable. Avoid fire,\nflame, and smoking during and immediately following application. \n\nThe most common adverse reactions reported (≥1%) for ZORYVE cream 0.3% for\nplaque psoriasis were diarrhea (3.1%), headache (2.4%), insomnia (1.4%),\nnausea (1.2%), application site pain (1.0%), upper respiratory tract infection\n(1.0%), and urinary tract infection (1.0%). \n\nThe most common adverse reactions reported (≥1%) for ZORYVE foam 0.3% for\nplaque psoriasis were headache (3.1%), diarrhea (2.5%), nausea (1.7%), and\nnasopharyngitis (1.3%). \n\nThe most common adverse reactions reported (≥1%) for ZORYVE foam 0.3% for\nseborrheic dermatitis were nasopharyngitis (1.5%), nausea (1.3%), and headache\n(1.1%). \n\nThe most common adverse reactions reported (≥1%) for ZORYVE cream 0.15% for\npatients with atopic dermatitis 6 years of age or older were headache (2.9%),\nnausea (1.9%), application site pain (1.5%), diarrhea (1.5%), and vomiting\n(1.5%).\n\nThe most common adverse reactions reported (≥1%) for ZORYVE cream 0.05% for\npediatric patients with atopic dermatitis 2 to 5 years of age were upper\nrespiratory tract infection (4.1%), diarrhea (2.5%), vomiting (2.1%), rhinitis\n(1.6%), conjunctivitis (1.4%), and headache (1.1%).\n\nPlease see full Prescribing Information\n(https://www.globenewswire.com/Tracker?data=ALbvjbgjc_8AjA98aWfSrcJGhJ7OQzQhvgIPqqQkNwksUQEJXtkg-8qJJm0R0eyO3-Uos7gjcnivcfC_Ow0rA2vLT-XedVO4qZn_nZOnd5AOIMGK-JCUcQBb5Gr6S8WB) for\nZORYVE cream and full Prescribing Information\n(https://www.globenewswire.com/Tracker?data=ALbvjbgjc_8AjA98aWfSrcJGhJ7OQzQhvgIPqqQkNwmrDqMhAuxXsigrya4w9IMIAPTkM-buLU_tpHdHlByauxOcVqJAEb1HoDWnbrYxS9Gb5UlbKpKHeG5nn7Mf8mgJ) for\nZORYVE foam.\n\nZORYVE is for topical use only and not for ophthalmic, oral, or intravaginal\nuse.\n\nAbout Arcutis\nArcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a commercial-stage medical\ndermatology company delivering meaningful innovation to address the needs of\nindividuals living with chronic inflammatory skin diseases. Over the\npast decade, Arcutis has successfully developed a robust portfolio of\nadvanced targeted topicals approved to treat three major inflammatory skin\ndiseases, driven by a commitment to solving the most persistent patient\nchallenges in dermatology. Arcutis’ unique dermatology development\nplatform, built on established scientific pathways and coupled with deep\nclinical dermatology and commercial expertise, enables us to efficiently\ndevelop, scale, and deliver our differentiated therapies while advancing a\ngrowing pipeline across a range of inflammatory dermatological conditions. For\nmore information, visit www.arcutis.com or follow Arcutis on LinkedIn\n(https://www.globenewswire.com/Tracker?data=qtp6pj9t_mtVeRsJ_yfcNUzroZljsfStKH-MmNm_yuFyJGq5C61dO6tCdCH_JEtj_vjUWrKmc3akC0w6k123JuXSpW2pBUwagWbnh_Op53Q2HdHX5pstokLf1jNAiODT), Facebook\n(https://www.globenewswire.com/Tracker?data=5WfMw_3x0uszIl9ts55HgZaTXh0Z6zDgoYCMopaPo6RZp2VPgqrYcriXx77Qt9LhYqtcGslUismOtcmKeH35K10FJQXfX6CHQZiF2IPAsfk=), Instagram\n(https://www.globenewswire.com/Tracker?data=CeBOVGLKDYkFTbWI2zxyNI_6ync3Mfj6Dkri9xU2VbfpibJkZRwR37AjiIvAwgu1swz_9Vmv_0dgzUtAW-S7BUqRLpvYazOZ8G2JodfHm6I=),\nand X\n(https://www.globenewswire.com/Tracker?data=J85Z-aRfRqR0elyZ9bz_nV8M9m8Ms141ghEv0HAi-uuVH5jz5evM1OUmkJtLf2TRoxtCx6R_QG7lRLQ-U-Aiqg==). \n\nForward-Looking Statements\nThis press release contains forward-looking statements within the meaning of\nSection 27A of the Securities Act of 1933, as amended, and Section 21E of the\nSecurities Exchange Act of 1934, as amended. For example, statements contained\nin this press release regarding matters that are not historical facts are\nforward-looking statements. These statements are based on the Company’s\ncurrent beliefs and expectations. Such forward-looking statements include, but\nare not limited to, statements regarding the potential real-world use results\nof ZORYVE cream 0.3%, and the potential for ZORYVE cream to advance the\nstandard of care in plaque psoriasis including this young patient population.\nThese statements are subject to substantial known and unknown risks,\nuncertainties, and other factors that may cause our actual results, levels of\nactivity, performance, or achievements to be materially different from the\ninformation expressed or implied by these forward-looking statements. Risks\nand uncertainties that may cause our actual results to differ include risks\ninherent in our business, reimbursement and access to our products, the impact\nof competition and other important factors discussed in the “Risk Factors”\nsection of our Form 10-K filed with the U.S. Securities and Exchange\nCommission (SEC) on February 25, 2026, as well as any subsequent filings with\nthe SEC. Any forward-looking statements that the Company makes in this press\nrelease are made pursuant to the Private Securities Litigation Reform Act of\n1995, as amended, and speak only as of the date of this press release. Except\nas required by law, we undertake no obligation to revise or update information\nherein to reflect events or circumstances in the future, even if new\ninformation becomes available.\n\n† Subject to eligibility criteria and maximum program limitation. This offer\nis not valid for patients without commercial drug insurance or whose\nprescription claims are eligible to be reimbursed, in whole or in part, by any\ngovernment program.\n\n‡ Subject to financial eligibility requirements. Other terms and\nrestrictions apply.\n\nContacts:\nMedia\nAmanda Sheldon, Head of Corporate Communications\nmedia@arcutis.com\n\nInvestors\nBrian Schoelkopf, Head of Investor Relations\nir@arcutis.com\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/1b166f47-afb1-44f1-91be-2d73e97c0ec3)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-06-29T23:06:39.164267846Z","server_sent_at_ms":1782774399164},"received_at":"2026-06-29T23:06:39.315Z","source_url":"https://www.globenewswire.com/news-release/2026/06/29/3319348/0/en/FDA-Approves-Arcutis-ZORYVE-roflumilast-Cream-0-3-for-the-Treatment-of-Plaque-Psoriasis-in-Children-as-Young-as-Age-2.html"},"analysis":{"id":"65257","press_release_id":"75977","analysis_json":{"industry":{"label":"Biotechnology","sector":"Health Care"},"redFlags":[],"eventType":"fda_approval","narrative":"Arcutis received FDA approval for a supplemental indication of ZORYVE cream 0.3%, expanding its use to treat plaque psoriasis in children as young as 2 years of age.\n\nThe approval is supported by data from a 4-week maximal usage systemic exposure study and an open-label extension study demonstrating safety and efficacy profiles consistent with pivotal trials in older patients.\n\nThis is the seventh FDA approval for the ZORYVE portfolio in four years, establishing it as the first once-daily steroid-free topical therapy approved for this young patient population.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"Seventh FDA approval in four years expands ZORYVE market to pediatric patients ages 2-5."},"keyFigures":{"drugName":"ZORYVE (roflumilast) cream 0.3%"},"quotedText":"This seventh FDA approval for ZORYVE in four years demonstrates Arcutis’ commitment to delivering meaningful innovation to the youngest children and their families.","namedEntities":{"people":[{"name":"Lisa Swanson","role":"board-certified pediatric dermatologist and clinical trial investigator"},{"name":"Leah Howard","role":"president and chief executive officer, National Psoriasis Foundation"},{"name":"Frank Watanabe","role":"president and chief executive officer of Arcutis"}],"products":["ZORYVE","roflumilast"],"companies":[{"name":"Arcutis Biotherapeutics, Inc.","ticker":"ARQT"},{"name":"National Psoriasis Foundation","relationship":"partner/advocate"}],"dollarAmounts":[]},"materialImpact":{"score":5,"reasoning":"FDA approval of a supplemental indication for the lead asset ZORYVE, expanding the addressable market to children as young as age 2. This represents a binary regulatory milestone for the company's flagship commercial product."},"tickerRelevance":{"others":[],"primary":"ARQT"},"globalImportance":50,"audienceRelevance":45,"eventTypeSecondary":[],"importanceComponents":{"assetTier":"flagship_commercial_product","tickerTier":"mid_cap_biotech","eventGravity":"fda_expanded_indication"}},"event_type":"fda_approval","event_type_secondary":null,"sentiment":"bullish","material_impact_score":5,"narrative":"Arcutis received FDA approval for a supplemental indication of ZORYVE cream 0.3%, expanding its use to treat plaque psoriasis in children as young as 2 years of age.\n\nThe approval is supported by data from a 4-week maximal usage systemic exposure study and an open-label extension study demonstrating safety and efficacy profiles consistent with pivotal trials in older patients.\n\nThis is the seventh FDA approval for the ZORYVE portfolio in four years, establishing it as the first once-daily steroid-free topical therapy approved for this young patient population.","key_figures":{"drugName":"ZORYVE (roflumilast) cream 0.3%"},"named_entities":{"people":[{"name":"Lisa Swanson","role":"board-certified pediatric dermatologist and clinical trial investigator"},{"name":"Leah Howard","role":"president and chief executive officer, National Psoriasis Foundation"},{"name":"Frank Watanabe","role":"president and chief executive officer of Arcutis"}],"products":["ZORYVE","roflumilast"],"companies":[{"name":"Arcutis Biotherapeutics, Inc.","ticker":"ARQT"},{"name":"National Psoriasis Foundation","relationship":"partner/advocate"}],"dollarAmounts":[]},"model_name":"qwen3_6_27b_awq","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-06-29T23:09:33.849Z","global_importance":50,"audience_relevance":45,"importance_components":{"assetTier":"flagship_commercial_product","tickerTier":"mid_cap_biotech","eventGravity":"fda_expanded_indication"}},"durationMs":174519,"modelName":"george-droid-qwen-72b"}}