Arcutis Biotherapeutics, Inc.

Arcutis Biotherapeutics announced the grant of inducement awards to 24 newly hired employees. These awards include 143,500 restricted stock units (RSUs) and options to purchase 37,000 shares of common stock. The grants were made under the 2022 Inducement Plan, with RSUs vesting over four years annually and stock options vesting over four years with an exercise price of $25.94 per share.

Arcutis Biotherapeutics reported strong second-quarter 2026 financial results, with product revenue, net, increasing 59.3% to $129.9 million. The company achieved a net income of $15.0 million, or $0.11 diluted earnings per share, a significant improvement from a net loss in the prior year period. For the six months ended June 30, 2026, product revenue, net, grew 59.6% to $235.3 million, resulting in a net income of $3.7 million. The company also highlighted continued commercial launches and regulatory progress for its ZORYVE product line across various indications and age groups.

Arcutis Biotherapeutics reported strong second-quarter 2026 financial results, achieving a net income of $15.0 million and product revenue of $129.9 million, a 59% increase year-over-year. The company raised its full-year 2026 net product sales guidance to $525 million–$540 million. Additionally, Chief Commercial Officer L. Todd Edwards resigned, effective August 21, 2026, and Robert Lisicki was appointed interim Executive Vice President and Chief Commercial Officer. The company also announced FDA approval for ZORYVE cream 0.3% for pediatric plaque psoriasis and progress in its pipeline.

Arcutis Biotherapeutics reported strong Q2 2026 financial results with net product revenue of $129.9 million, a 59% increase year-over-year. The company raised its full-year 2026 net product sales guidance to $525 million–$540 million. Key developments include FDA approval for ZORYVE cream 0.3% for plaque psoriasis in children down to age 2, and FDA acceptance of an sNDA for ZORYVE cream 0.05% for infants with atopic dermatitis, with a target action date of February 23, 2027. The company also maintained positive operating cash flow and advanced its pipeline.

Arcutis Biotherapeutics, Inc. announced the appointment of Christopher Peetz to its Board of Directors, effective July 15, 2026. Mr. Peetz, currently the co-founder and CEO of Mirum Pharmaceuticals, brings extensive experience in leading biopharmaceutical companies through periods of expansion, product development, and commercialization. His strategic insight and operational expertise are expected to be invaluable as Arcutis focuses on growing its ZORYVE franchise and expanding its pipeline.

Arcutis Biotherapeutics, Inc. announced it will report its second quarter 2026 financial results and provide a business update after the U.S. financial markets close on Wednesday, August 5, 2026. The company will host a conference call and webcast at 4:30 p.m. ET on the same day. A live webcast and related presentation materials will be accessible on the "Events" section of the company's website.

Arcutis Biotherapeutics announced that the FDA has accepted its supplemental New Drug Application (sNDA) for ZORYVE® (roflumilast) cream 0.05%. This sNDA aims to expand the indication for the topical treatment of mild to moderate atopic dermatitis to include infants aged 3 to 24 months. The FDA has set a PDUFA target action date of February 23, 2027. The application is supported by positive results from the Phase 2 open-label INTEGUMENT-INFANT study and a Phase 1 pharmacokinetic study, demonstrating a well-tolerated profile and rapid disease clearance.

Arcutis Biotherapeutics, Inc. announced the grant of 61,000 restricted stock units (RSUs) to 9 newly hired employees. These awards, approved by the Compensation Committee, were made under the 2022 Inducement Plan on July 1, 2026, as a material inducement for their employment. The RSUs will vest over four years, with 25 percent vesting on each annual anniversary of the vesting commencement date, contingent on continued employment.

Arcutis Biotherapeutics, Inc. announced the launch of a new virtual health platform aimed at expanding access to its ZORYVE (roflumilast) portfolio for chronic inflammatory skin diseases. This platform connects individuals with independent, board-certified dermatologists through a streamlined digital experience, offering an additional pathway to care for conditions like eczema, seborrheic dermatitis, and plaque psoriasis. It is designed to complement traditional in-office care by reducing barriers to specialist treatment and facilitating access to ZORYVE where appropriate.

Arcutis Biotherapeutics 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 to children down to age 2. ZORYVE cream 0.3% is a once-daily, steroid-free topical therapy that is safe, effective, and well-tolerated for use anywhere on the body with no limitations on duration of use. This approval addresses a significant treatment gap for young children with plaque psoriasis and represents the seventh FDA approval for ZORYVE in four years.