Arcutis Biotherapeutics, Inc. Stock Price, News & Analysis

Arcutis Biotherapeutics announced positive results from the Phase 3 ARRECTOR trial of roflumilast foam 0.3% for scalp and body psoriasis. The study met both co-primary endpoints: 67.3% of participants achieved S-IGA Success versus 28.1% with a vehicle, while 46.5% achieved B-IGA Success compared to 20.8%. Roflumilast foam demonstrated a favorable safety profile, with a majority completing the trial. Arcutis plans to file a New Drug Application based on these results, highlighting the foam's potential to address unmet needs in psoriasis treatment.

Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) announced positive results from two pivotal Phase 3 studies published in JAMA, evaluating its roflumilast cream for chronic plaque psoriasis treatment. In these studies, 40% of treated patients achieved Investigator Global Assessment success at eight weeks, significantly outperforming the vehicle group. Key findings include around 70% achieving intertriginous-IGA success and approximately 40% reaching PASI-75. Roflumilast showed rapid improvements in itch and plaque clearance, with a favorable safety profile.

Arcutis Biotherapeutics has announced positive data from the STRATUM Phase 3 trial of its investigational roflumilast foam for treating seborrheic dermatitis in adults and children 9 and older. The study achieved its primary endpoint, with 80.1% of patients achieving 'IGA Success' compared to 59.2% with vehicle (P<0.0001). Over 60% experienced significant itch relief by week 8. All secondary endpoints also showed statistically significant improvements. Roflumilast foam was well-tolerated, showing no serious adverse events, and an NDA submission is planned for Q1 2023.

LifeArc today announced the acquisition of its portfolio company Ducentis BioTherapeutics by Arcutis Biotherapeutics (NASDAQ: ARQT) for up to $400 million. The deal includes a $16 million upfront cash payment and Arcutis stock valued at $14 million, plus contingent payments linked to development success. Ducentis' lead asset, DS-234, targets the underserved atopic dermatitis market.

Arcutis aims to leverage its expertise in dermatology to accelerate the clinical development of DS-234, enhancing its innovative treatment pipeline.

Arcutis announced the acquisition of Ducentis BioTherapeutics for approximately $30 million in cash and stock, targeting the development of DS-234, a promising treatment for atopic dermatitis. The growing market shows a significant unmet need, and DS-234 aims to be a best-in-class option, complementing Arcutis’ existing therapies. The acquisition leverages Arcutis’ dermatology expertise, with the goal of advancing innovative therapies to address critical patient needs in immune-mediated diseases.

Arcutis Biotherapeutics (Nasdaq: ARQT) announced the presentation of four abstracts for its topical roflumilast program at the EADV Congress from September 7-10, 2022. Key highlights include the oral presentation of data from the STRATUM Phase 3 trial of roflumilast foam in seborrheic dermatitis, scheduled for September 9. The company emphasizes the unmet need for non-steroidal treatments, showcasing the safety and efficacy of ZORYVE (roflumilast cream) for plaque psoriasis. This initiative underscores Arcutis' commitment to addressing dermatological conditions.

Arcutis Biotherapeutics (Nasdaq: ARQT) announced the grant of 96,500 restricted stock units and options for 212,500 shares to 39 new employees as part of its 2022 Inducement Plan. These awards, approved by the Compensation Committee, were granted on September 1, 2022. The restricted stock units vest over four years, while the stock options have a ten-year term with an exercise price of $26.87 per share. This move aligns with Nasdaq Listing Rule 5635(c)(4) and aims to attract top talent amid Arcutis' focus on immuno-dermatology innovations.

Arcutis Biotherapeutics (Nasdaq: ARQT) has appointed Neha Krishnamohan to its Board of Directors, expanding the board to 10 members. Krishnamohan, previously involved in Arcutis' IPO, brings over 12 years of healthcare investment banking experience and currently serves as CFO of Kinnate Biopharma. Her expertise is expected to support Arcutis' growth following the recent commercialization of ZORYVE™ (roflumilast) cream for plaque psoriasis, a significant treatment for patients aged 12 and older. This strategic appointment aims to enhance the company's development pipeline and execution capabilities in dermatology.

Arcutis Biotherapeutics (Nasdaq: ARQT), focused on immuno-dermatology, announced participation in the Morgan Stanley 20th Annual Global Healthcare Conference on September 13, 2022, at 8:00 a.m. EDT. The event will feature a fireside chat with Arcutis management, providing insights into their innovative approach to treating immune-mediated dermatological conditions. A webcast of the conference will be available in the 'Events' section on the Arcutis website, with a replay accessible for 180 days post-event.