Biotech Stock Arcutis Climbs Into Buy Zone As FDA Mulls Expanded Use For Key Skin Treatment

2026-07-09 13:37:04

Biotech stock Arcutis is in a buy zone and Wall Street is looking for the skin-diseases drugmaker to expand the use of its key cream, Zorvye.

FDA Accepts Supplemental New Drug Application for Arcutis' ZORYVE® (roflumilast) Cream 0.05% for the Treatment of Mild to Moderate Atopic Dermatitis in Infants Down to 3 Months

2026-07-08 08:00:00

FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of February 23, 2027 Application supported by positive results from Phase 2 open-label INTEGUMENT-INFANT study and Phase 1 open-label pharmacokinetic (PK) study 1 million children under the age of 2 are treated topically for atopic dermatitis in the United States, representing 10% of all adults and children treated topically for atopic dermatitis WESTLAKE VILLAGE, Calif., July 08, 2026 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.  (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for ZORYVE® (roflumilast) cream 0.05% to expand the indication for the topical treatment of mild to moderate atopic dermatitis to include infants aged 3 to 24 months.

Arcutis vs. Vertex: Which Pharmaceutical Maker Stock Is a Better Buy in 2026?

2026-07-03 08:37:20

Arcutis doubled revenue last year while Vertex delivered strong profits and cash flow. Explore how each company stacks up on growth, risk, and value.

Arcutis Biotherapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

2026-07-02 16:00:00

WESTLAKE VILLAGE, Calif., July 02, 2026 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.  (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the grant of an aggregate of 61,000 restricted stock units (RSUs) of Arcutis common stock to 9 newly hired employees. These awards were approved by the Compensation Committee of Arcutis' Board of Directors and granted under the Arcutis Biotherapeutics, Inc. 2022 Inducement Plan, with a grant date of July 1, 2026, as a material inducement to the new employees in connection with their commencement of employment with Arcutis, in accordance with Nasdaq Listing Rule 5635(c)(4).

Arcutis Launches New Virtual Health Platform Supporting Access to Care for Individuals Living with Chronic Inflammatory Skin Diseases, Including Approved ZORYVE® (roflumilast) Indications

2026-06-30 09:15:00

Virtual health platform offers an additional pathway to care for the more than 45 million people in the U.S. living with eczema, seborrheic dermatitis, and plaque psoriasis Connects eligible individuals with independent, board-certified dermatologists through a streamlined digital experience for evaluation and to discuss potential treatment options WESTLAKE VILLAGE, Calif., June 30, 2026 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.  (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the launch of a new virtual health platform designed to expand access pathways to its ZORYVE® (roflumilast) portfolio for chronic inflammatory skin diseases.

FDA Approves Arcutis’ ZORYVE® (roflumilast) Cream 0.3% for the Treatment of Plaque Psoriasis in Children as Young as Age 2

2026-06-29 19:06:39

ZORYVE cream 0. 3% is the first once-daily, non-steroidal therapy approved for children with plaque psoriasis as young as 2 years of age ZORYVE cream 0. 3% is safe, effective, and well-tolerated for use anywhere on the body with no restrictions on duration of use Seventh FDA approval for ZORYVE in four years WESTLAKE VILLAGE, Calif.

FDA Approves Arcutis' ZORYVE® (roflumilast) Cream 0.3% for the Treatment of Plaque Psoriasis in Children as Young as Age 2

2026-06-29 19:06:00

ZORYVE cream 0.3% is the first once-daily, non-steroidal therapy approved for children with plaque psoriasis as young as 2 years of age ZORYVE cream 0.3% is safe, effective, and well-tolerated for use anywhere on the body with no restrictions on duration of use Seventh FDA approval for ZORYVE in four years WESTLAKE VILLAGE, Calif., June 29, 2026 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc.  (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) to expand the indication for ZORYVE® (roflumilast) cream 0.3% for the topical treatment of plaque psoriasis, including intertriginous areas, to children down to age 2.

Arcutis Biotherapeutics Touts ZORYVE Growth, FDA Catalysts and Cash-Flow Positive Status

2026-06-09 20:02:56

Arcutis Biotherapeutics NASDAQ: ARQT executives said ZORYVE continues to post strong growth and outlined several regulatory and clinical catalysts expected over the next year, while emphasizing that the company has reached a self-sustaining financial position.