Arcutis Biotherapeutics, Inc. - ARQT STOCK NEWS

Arcutis Biotherapeutics (Nasdaq: ARQT) has announced a virtual Key Opinion Leader (KOL) event to discuss the recent FDA approval of ZORYVE® (roflumilast) cream 0.15% for treating mild to moderate atopic dermatitis (AD) in adults and children aged 6 and above. The event, scheduled for July 29, 2024, at 8:30am ET, will feature a leading dermatology expert who will address the unmet needs and current treatment landscape for AD. The discussion will highlight ZORYVE's differentiating features and Arcutis' commercialization plans for this newly approved treatment. This event marks a significant milestone for Arcutis in the immuno-dermatology field, potentially impacting their market position and future revenue streams.

Arcutis Biotherapeutics announced that the FDA approved ZORYVE (roflumilast) cream 0.15% for treating mild to moderate atopic dermatitis (AD) in patients aged six and older.

ZORYVE, a steroid-free cream, reduces itch and provides rapid disease clearance, showing efficacy and safety in up to 56 weeks of treatment.

Clinical trials demonstrated significant improvements, with 69% of patients showing at least a 50% reduction in symptoms within four weeks.

This marks Arcutis' third FDA approval in two years, with the product available by the end of July.

Arcutis Biotherapeutics has communicated with the FDA regarding its sNDA for roflumilast cream 0.15% aimed at treating mild to moderate atopic dermatitis in adults and children as young as six. The FDA is finalizing the action letter without extending the PDUFA goal date of July 7, 2024. The FDA has not requested additional information, highlighting the completeness of Arcutis' submission. Arcutis anticipates receiving the action letter soon and aims to introduce this innovative treatment to millions suffering from atopic dermatitis.

Arcutis Biotherapeutics (Nasdaq: ARQT) announced the grant of 325,000 restricted stock units and options to purchase 55,000 shares to 43 new employees under the 2022 Inducement Plan. The awards, approved by the Compensation Committee of Arcutis' Board of Directors, were granted on July 1, 2024, as per Nasdaq Listing Rule 5635(c)(4). The restricted stock units vest over four years with 25% vesting annually. Stock options also vest over four years with 25% on the first anniversary and the remaining in 36 equal monthly installments. The options have a ten-year term and an exercise price of $9.56 per share. This move aims to attract and retain talent by providing equity-based incentives.

Arcutis presented new data on their investigational roflumilast cream 0.15% for treating mild to moderate atopic dermatitis (AD) in individuals aged six and above. The study showed that the cream provided sustained improvements in AD symptoms over 56 weeks, with 66.2% of participants achieving a 75% improvement in Eczema Area and Severity Index (EASI-75). Additionally, 56.6% achieved disease clearance with continued use, and those who switched to a proactive twice-weekly application maintained disease control for a median duration of 281 days. The cream was well-tolerated with no new safety issues reported. Adverse events were generally mild to moderate, with only 3% discontinuing due to adverse effects. These results highlight the potential of roflumilast cream as a long-term, steroid-free treatment option for AD.

Arcutis Biotherapeutics (Nasdaq: ARQT) announced the grant of 57,500 restricted stock units to six new employees. These units were approved by the Compensation Committee and are part of the Arcutis Biotherapeutics 2022 Inducement Plan, effective June 3, 2024. The grants are intended to attract new talent, as stipulated under Nasdaq Listing Rule 5635(c)(4). The units will vest over four years, with 25% vesting each year, contingent upon ongoing employment with the company.

Arcutis Biotherapeutics (Nasdaq: ARQT) will present five abstracts at the Revolutionizing Alopecia Areata, Vitiligo, and Eczema Conference from June 8-10, 2024, in Chicago, IL. The presentations include new long-term safety and efficacy data of roflumilast cream 0.15% for mild to moderate atopic dermatitis in patients aged 6 and above. Preclinical data on ARQ-234, a CD200 receptor agonist for atopic dermatitis, will also be showcased. Additional presentations will cover the consistent tolerability profile of topical roflumilast in psoriasis, seborrheic dermatitis, and atopic dermatitis. The company aims to advance the standard of care for chronic, immune-mediated skin diseases.

Arcutis Biotherapeutics (Nasdaq: ARQT) announced its participation in the Goldman Sachs 45th Annual Global Healthcare Conference from June 10-13, 2024. The event will feature a fireside chat on June 12 at 1:20 pm ET, accessible via webcast on the company's website. The replay will remain available for 180 days post-conference. Arcutis specializes in innovations in immuno-dermatology, aiming to provide significant advancements in this field.

Arcutis Biotherapeutics reported a strong performance in Q1 2024, with net product revenues of $21.6M for its ZORYVE® franchise, showing a 675% year-over-year growth. ZORYVE cream and foam contributed $15M and $6.5M, respectively. The company expects further GTN improvements and is preparing for a key FDA decision on July 7, 2024, regarding roflumilast cream for treating atopic dermatitis. Arcutis raised $172.5M from a public offering and secured a strategic licensing agreement in Japan. The company also reported a net loss of $35.4M, an improvement from the $80.1M loss in Q1 2023.