Arcutis Biotherapeutics, Inc. Stock Price, News & Analysis

Arcutis Biotherapeutics (ARQT) announced positive results from the INTEGUMENT-PED phase 3 trial of ZORYVE® (roflumilast) cream 0.05% for treating mild to moderate atopic dermatitis in children aged 2-5 years. The trial, involving 652 children, demonstrated significant improvements across all primary and secondary efficacy endpoints.

Key results include: 25.4% of treated children achieved vIGA-AD Success versus 10.7% for vehicle (P<0.0001); 39.4% achieved EASI-75 compared to 20.6% for vehicle; and improvement in itch was observed within 24 hours. The treatment was well-tolerated with low incidence of adverse events, mainly including upper respiratory tract infection, diarrhea, and vomiting.

The company has submitted a supplemental New Drug Application (sNDA) to the FDA, targeting approximately 1.8 million children aged 2-5 with atopic dermatitis in the US who receive topical treatment.

Arcutis Biotherapeutics (Nasdaq: ARQT), a commercial-stage biopharmaceutical company specializing in immuno-dermatology innovations, has announced its upcoming participation in the TD Cowen 45th Annual Health Care Conference. The company will engage in a fireside chat scheduled for Tuesday, March 4, 2025, at 9:50 am EST.

The conference is set to take place from March 3-5, 2025. Interested parties can access the webcast through the 'Events' section of Arcutis' website, with the recording remaining available for 180 days after the conference.

Arcutis Biotherapeutics (ARQT) has announced the grant of 62,000 restricted stock units to eight newly hired employees. The awards were approved by the company's Compensation Committee and granted under the Arcutis Biotherapeutics 2022 Inducement Plan, with a grant date of February 3, 2025. The stock units are designed as an employment inducement in compliance with Nasdaq Listing Rule 5635(c)(4).

The restricted stock units feature a four-year vesting schedule, with 25% vesting occurring on each annual anniversary of the vesting commencement date. Continued employment with Arcutis is required for vesting eligibility.

Arcutis Biotherapeutics (NASDAQ: ARQT) has partnered with professional football player Odell Beckham Jr. to raise awareness about seborrheic dermatitis and promote ZORYVE® (roflumilast) topical foam, 0.3%. The condition affects over 10 million Americans and is the third most common skin condition affecting Blacks.

ZORYVE foam, indicated for seborrheic dermatitis treatment in patients 9 years and older, demonstrated significant efficacy in clinical trials. Nearly 80% of 458 patients achieved clear or almost clear skin at Week 8, compared to 53% in the vehicle group. Additionally, 63% of patients experienced significant itch relief. The treatment is the first new mechanism of action approved for seborrheic dermatitis in over two decades.

The once-daily, steroid-free topical foam is formulated for use anywhere on the body, including hair-bearing areas. The most common side effects include common cold, nausea, and headache.

Arcutis Biotherapeutics (Nasdaq: ARQT), a commercial-stage biopharmaceutical company specializing in immuno-dermatology innovations, has announced its upcoming participation in the Guggenheim SMID Cap Biotech Conference. The company will engage in a fireside chat scheduled for Thursday, February 6, 2025, at 1:00 pm ET.

The event, taking place from February 5-6, 2025, will be accessible to viewers through a webcast available in the 'Events' section of Arcutis's website. The webcast recording will remain available for 180 days after the conference concludes.

Arcutis Biotherapeutics (ARQT) announced preliminary unaudited financial results for Q4 and full-year 2024. Q4 2024 product revenue is expected to reach approximately $63 million, showing a 366% increase compared to Q4 2023 and 41% growth from Q3 2024. Full-year 2024 product revenue is anticipated at approximately $160 million, up 449% from 2023.

The company's growth was driven by strong demand across all ZORYVE® (roflumilast) indications, maintaining similar gross-to-net (GTN) levels as the previous quarter. As of December 31, 2024, preliminary cash, cash equivalents, restricted cash, and marketable securities stood at approximately $229 million. The company previously repaid $100 million of long-term debt to SLR Investment Corp., with an option to re-draw approximately $100 million by first half 2026, bringing total liquidity to approximately $329 million.

Arcutis Biotherapeutics (Nasdaq: ARQT) has announced the grant of 75,500 restricted stock units to eight newly hired employees. The awards were approved by the company's Compensation Committee and granted under the Arcutis Biotherapeutics 2022 Inducement Plan on January 2, 2025. The stock units are structured with a four-year vesting schedule, with 25% vesting annually on each anniversary of the vesting commencement date. The grants were made as employment inducements in compliance with Nasdaq Listing Rule 5635(c)(4), and continued employment is required for vesting.

Arcutis Biotherapeutics (ARQT) has submitted a supplemental New Drug Application (sNDA) to the FDA for ZORYVE® (roflumilast) cream 0.05% to treat mild to moderate atopic dermatitis in children aged 2-5 years. The submission is supported by positive Phase 3 trial results involving 652 children, where 25.4% of treated patients achieved vIGA-AD Success compared to 10.7% with vehicle at Week 4.

The cream demonstrated rapid itch reduction, with 35.3% of treated children achieving a four-point reduction in Worst Itch Numeric Scale at Week 4 versus 18.0% for vehicle. The treatment showed a favorable safety profile over 56 weeks, with common side effects including upper respiratory infection, diarrhea, and vomiting. The potential market includes approximately 1.8 million children with atopic dermatitis aged 2-5 who are topically treated in the US.

Arcutis Biotherapeutics (ARQT) has granted a total of 44,000 restricted stock units (RSUs) to six newly hired employees. The grants were approved by the company's Compensation Committee and issued under the 2022 Inducement Plan on December 2, 2024. The RSUs will vest over a four-year period, with 25% vesting annually, contingent on continuous employment. This action complies with Nasdaq Listing Rule 5635(c)(4), which governs inducement grants for new employees.