Arcutis Biotherapeutics, Inc. Stock Price, News & Analysis

Arcutis Biotherapeutics (Nasdaq: ARQT) announced the completion of enrollment for its INTEGUMENT-2 Phase 3 trial, evaluating roflumilast cream 0.15% for atopic dermatitis in individuals aged six and older. A total of 683 subjects were enrolled in this pivotal study, following the earlier completion of the INTEGUMENT-1 trial. Topline data from both trials is expected by the end of 2022, which could support a supplemental New Drug Application (sNDA) in 2023 if results are favorable. Atopic dermatitis affects approximately 26 million individuals in the U.S., highlighting a significant unmet medical need.

Arcutis Biotherapeutics has launched Arcutis Cares, the first patient assistance program for its topical psoriasis treatment, ZORYVE (roflumilast) cream 0.3%. This initiative offers ZORYVE at no cost to financially eligible individuals who are uninsured or underinsured. The program is open to those aged 12 and older residing in the U.S. and needing ZORYVE for FDA-approved uses. Additionally, a savings card for individuals with commercial insurance allows for reduced out-of-pocket costs. Arcutis aims to enhance accessibility and affordability of its treatment.

Arcutis Biotherapeutics has launched ZORYVE (roflumilast) cream 0.3%, the first topical PDE4 inhibitor for treating plaque psoriasis in patients aged 12 and older. This steroid-free cream rapidly clears plaques and alleviates itch, including in hard-to-treat areas. ZORYVE is available nationwide through pharmacies by prescription. The company emphasizes accessibility through responsible pricing and patient support programs, including Arcutis Cares™ for uninsured patients. FDA approval was granted on July 29, 2022, marking a significant milestone for Arcutis in immuno-dermatology.

Arcutis Biotherapeutics has received FDA approval for ZORYVE™ (roflumilast) cream 0.3%, a steroid-free treatment for plaque psoriasis in individuals aged 12 and older. The company also reported positive topline results from a pivotal Phase 3 trial for roflumilast foam aimed at seborrheic dermatitis, with an NDA submission expected in Q1 2023. Arcutis completed enrollment in the INTEGUMENT-1 trial for atopic dermatitis and bolstered its balance sheet with over $285 million from recent financings. As of June 30, 2022, the company had cash resources of approximately $570 million to support product launches and pipeline development.

Arcutis Biotherapeutics (Nasdaq: ARQT) announced the successful enrollment of 654 participants in the INTEGUMENT-1 Phase 3 trial for roflumilast cream, aimed at treating atopic dermatitis (AD) in adults and children. The trial continues with INTEGUMENT-2, with topline data expected by the end of 2022. If trials prove successful, the company anticipates filing for a supplemental New Drug Application in 2023. Atopic dermatitis affects around 26 million individuals in the U.S., underlying the significance of this potential treatment.

Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) announced the grant of 22,200 restricted stock units and options to purchase 44,500 shares to five new employees. These awards are part of the 2022 Inducement Plan and were approved by the Compensation Committee. Restricted stock units vest over four years, while stock options have a ten-year term with an exercise price of $22.25 per share, reflecting the stock's closing price on the grant date, July 27, 2022. This initiative aligns with Nasdaq Listing Rule 5635(c)(4).

Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) has announced a public offering of 7,500,000 shares at $20.00 per share, with expected proceeds of $150 million. The offering also includes a 30-day option for underwriters to purchase an additional 1,125,000 shares. Proceeds will fund the development and commercialization of its programs, including ZORYVE, along with general corporate purposes. The offering is set to close on August 5, 2022, and follows an effective shelf registration statement filed on February 1, 2021.

Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) has announced the commencement of an underwritten public offering of $150 million of its common stock, with all shares sold by the company. This offering is subject to market conditions, and there is no guarantee regarding its completion or terms. Furthermore, Arcutis plans to give underwriters a 30-day option to purchase an additional 15% of the shares. The offering will be made pursuant to an effective shelf registration statement filed with the SEC. Morgan Stanley, Cowen, and Guggenheim Securities will act as bookrunning managers.

Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) announced FDA approval for ZORYVE (roflumilast) cream 0.3%, targeting plaque psoriasis treatment in patients aged 12 and older. This approval is significant as it addresses the needs of patients with immune-mediated dermatological conditions. The company aims to leverage its innovative development platform, focusing on unmet patient needs in dermatology. A conference call will discuss the FDA approval details and future plans for commercialization, highlighting Arcutis's commitment to advancing dermatological therapies.