Arcutis Biotherapeutics, Inc. - ARQT STOCK NEWS

Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) has announced a conference call and webcast set for May 9, 2023, at 4:30 p.m. ET to discuss its first quarter financial results. The press release detailing these results will be available after the market closes on the same day. Investors can access the live webcast and subsequent archive through the company’s investor website. Arcutis focuses on developing innovative treatments for immune-mediated dermatological diseases, boasting a robust pipeline targeting conditions like psoriasis and atopic dermatitis. Investors are advised to stay tuned for the upcoming earnings call and associated materials.

Arcutis Biotherapeutics (Nasdaq: ARQT) announced that the FDA has accepted its New Drug Application (NDA) for roflumilast foam 0.3% aimed at treating seborrheic dermatitis in individuals aged 9 and older. The FDA set a target action date of December 16, 2023. If approved, this foam would be the first topical treatment for this condition with a new mechanism of action in over two decades. The NDA is supported by positive results from Phase 2 and pivotal Phase 3 trials, with the latter showing a 79.5% success rate in treating patients, compared to 58.0% for the vehicle. Roflumilast foam was well-tolerated with low adverse events. The company aims to address the significant unmet need for effective treatments for seborrheic dermatitis.

Arcutis Biotherapeutics (Nasdaq: ARQT), a leader in immuno-dermatology, announced its participation in the 22nd Annual Needham Virtual Healthcare Conference. The fireside chat is scheduled for April 18, 2023, at 11:45 a.m. ET. Investors and stakeholders can access the webcast via the company’s website, with a replay available for 90 days post-event. Arcutis specializes in innovative therapies for various dermatological conditions such as psoriasis and eczema. The company's commitment to addressing patient needs has led to a robust pipeline of clinical programs targeting immune-mediated skin diseases. This announcement highlights Arcutis’ strategy to engage with investors and showcase its ongoing developments in the field.

Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) announced on April 7, 2023, the grant of 83,250 restricted stock units and options for 33,000 shares to 10 newly hired employees. These awards are part of the 2022 Inducement Plan, approved by the Compensation Committee of the Board of Directors. The restricted stock units will vest over four years, with 25% vesting annually, while the stock options will also vest over four years, with 25% vesting after one year and the remainder in monthly installments. The options have an exercise price of $11.15 per share. Arcutis is committed to developing innovative solutions for immune-mediated dermatological conditions, backed by a robust pipeline of clinical programs.

Arcutis Biotherapeutics (Nasdaq: ARQT) announced ZORYVE's coverage expansion for plaque psoriasis, with eight additional national and regional health plans now covering the treatment without prior authorization, effective April 1, 2023. This brings commercial coverage to over 110 million lives in the U.S. ZORYVE, a steroid-free topical cream, is designed for all affected body areas and offers rapid results for difficult regions. The company's responsible pricing strategy is gaining traction among payers, and they aim to enhance dermatology adoption. ZORYVE is available by prescription only, with patient assistance programs in place for eligible uninsured or underinsured patients.

Arcutis Biotherapeutics (ARQT) announced significant data from its pivotal Phase 3 INTEGUMENT-1 and INTEGUMENT-2 studies for roflumilast cream 0.15% in treating atopic dermatitis (AD). Results indicated rapid and notable improvements in itch relief within 24 hours of the first application. The studies demonstrated a 75% reduction in Eczema Area and Severity Index (EASI-75) in over 40% of subjects by Week 4, with favorable safety outcomes. Roflumilast cream also met the primary endpoint of IGA Success, showing a vIGA-AD score improvement. The company plans to submit a supplemental new drug application (sNDA) to the FDA later this year.

Arcutis Biotherapeutics (Nasdaq: ARQT) announced six presentations at the 2023 American Academy of Dermatology (AAD) annual meeting in New Orleans, from March 17-21, 2023. Key highlights include late-breaking data on roflumilast cream 0.15% for atopic dermatitis from Phase 3 trials INTEGUMENT-1 and INTEGUMENT-2. Additional insights from national surveys on seborrheic dermatitis were shared, covering disease burden and treatment patterns. Roflumilast is a PDE4 inhibitor being developed for multiple dermatological conditions, including psoriasis and seborrheic dermatitis. Presentations will feature clinical safety and efficacy data, enhancing Arcutis' commitment to innovation in immuno-dermatology.