Arcutis Biotherapeutics, Inc. Stock Price, News & Analysis

Arcutis Biotherapeutics reported net revenues of $3.0 million for ZORYVE® in Q4 2022, marking its first full quarter since launch in August 2022. The company secured expanded payer coverage and announced positive trial results for atopic dermatitis. A New Drug Application for roflumilast foam was submitted for seborrheic dermatitis, and the first patient was enrolled in a study for alopecia areata. Arcutis ended 2022 with approximately $410 million in cash. Although R&D expenses increased year-over-year primarily due to the Ducentis acquisition, the company aims for long-term growth through a broad pipeline.

Arcutis Biotherapeutics (Nasdaq: ARQT) submitted a New Drug Application (NDA) to the FDA for roflumilast foam 0.3%, targeting moderate to severe seborrheic dermatitis, affecting over 10 million people in the U.S. If approved, it would be the first topical treatment with a new mechanism in over 20 years. The pivotal Phase 3 trial showed that 80% of participants achieved 'IGA Success' at week 8, with significant improvements in itch, scaling, and erythema. Roflumilast foam demonstrated a favorable safety profile, with over 90% treatment adherence. The foam aims to simplify treatment for this chronic condition.

Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) has announced a quarterly investor conference call scheduled for February 28, 2023, at 4:30 p.m. ET, where it will present its fourth quarter and full year financial results along with a business update. The company is also set to participate in the Cowen 43rd Annual Healthcare Conference on March 7, with a fireside chat and a dermatology panel discussion scheduled. Arcutis is focused on developing innovations in immuno-dermatology, with a robust pipeline addressing various inflammatory dermatological conditions.

Arcutis Biotherapeutics (Nasdaq: ARQT) announced the grant of 50,250 restricted stock units and options to purchase 8,000 shares to seven new employees, as part of the 2022 Inducement Plan. These awards were approved by the Compensation Committee and are aimed at attracting talent in the company's early commercial-stage environment, effective February 1, 2023. The stock options have a ten-year term and an exercise price of $16.84 per share. The restricted stock units vest over four years, with a 25% annual vesting schedule. Arcutis is committed to addressing urgent needs in immuno-dermatology through its innovative therapies and clinical programs.

Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) has announced promising long-term data from its Phase 2 study of roflumilast cream (0.3%), an FDA-approved treatment for chronic plaque psoriasis. The study, presented at the Winter Clinical dermatology meeting, showed that 57.1% of participants achieved an Investigator Global Assessment (IGA) score of clear or almost clear, with a median duration of 40.1 weeks. Efficacy remained consistent over 52 weeks, and the cream was well-tolerated with low discontinuation rates. Key findings included sustained IGA success across different patient cohorts and no signs of tachyphylaxis, reinforcing roflumilast cream's position as a preferred treatment for psoriasis.

On January 5, 2023, Arcutis Biotherapeutics (Nasdaq: ARQT) announced the granting of 17,050 restricted stock units and options for 33,550 shares to five new employees. These awards, approved by the Compensation Committee, are part of the 2022 Inducement Plan and are intended to incentivize new hires. The restricted stock units will vest over four years, while the stock options will also vest over the same period with specific vesting schedules. The options have a ten-year term with an exercise price of $14.77, reflecting the stock's closing price on the grant date.

Arcutis Biotherapeutics (Nasdaq: ARQT) has submitted a supplemental new drug application (sNDA) to the FDA for ZORYVE (roflumilast) cream 0.3%, seeking expanded approval for treating plaque psoriasis in children aged 2 to 11. The submission is supported by positive results from two 4-week studies demonstrating ZORYVE's safety and tolerability, with minimal local site reactions. If approved, ZORYVE will become the first steroid-free topical PDE4 inhibitor for this pediatric population, enhancing treatment options for children suffering from this common skin condition.

Arcutis Biotherapeutics (Nasdaq: ARQT) reported positive topline results from its INTEGUMENT-2 Phase 3 trial of roflumilast cream 0.15% for mild to moderate atopic dermatitis. The primary endpoint was met, with 28.9% achieving IGA Success versus 12.0% for vehicle (P<0.0001). Significant improvements included 42.0% achieving EASI-75 and 30.2% with a reduction in itch at Week 4. The cream showed favorable safety and tolerability. Following these results, Arcutis plans to file a supplemental new drug application with the FDA in the second half of 2023.

Arcutis Biotherapeutics (Nasdaq: ARQT) announced the grant of 8,000 restricted stock units and options to purchase 18,000 shares of common stock to two new employees. This was approved by the Compensation Committee under the 2022 Inducement Plan, effective December 1, 2022. The stock options have a ten-year term with an exercise price of $17.08 per share. The restricted stock units vest over four years, while the stock options vest similarly over four years, contingent on continuous employment.