Arcutis Biotherapeutics, Inc. - ARQT STOCK NEWS

Arcutis Biotherapeutics (Nasdaq: ARQT) announced that Health Canada has accepted its New Drug Submission (NDS) for roflumilast cream 0.3% to treat plaque psoriasis in adults and adolescents. This cream, if approved by the target action date of April 30, 2023, will be the first topical PDE4 inhibitor available in Canada. The submission is supported by positive results from Phase 3 DERMIS-1 and DERMIS-2 trials, where roflumilast demonstrated significant efficacy over a vehicle treatment. Arcutis is also establishing Canadian operations to support market entry.

Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) has approved the grant of 7,500 restricted stock units and options for 16,500 shares to three new employees as part of their 2022 Inducement Plan. These grants were made to incentivize new hires and are in accordance with Nasdaq Listing Rule 5635(c)(4). The restricted stock units and stock options will vest over four years, contingent on continued employment. The options have an exercise price of $21.73, reflecting the market price on the grant date of July 1, 2022. This initiative is aimed at fostering talent to support Arcutis’ commitment to innovation in immuno-dermatology.

Arcutis Biotherapeutics (Nasdaq: ARQT) reported positive topline results from its pivotal Phase 3 STRATUM trial for roflumilast foam, a topical treatment for moderate to severe seborrheic dermatitis. The study achieved its primary endpoint, with 80.1% of patients showing IGA success at week eight, significantly higher than the 59.2% in the vehicle group (P<0.0001). Over 50% of patients achieved clear skin by week eight, and roflumilast foam exhibited a favorable safety profile. An NDA submission is anticipated in the first half of 2023.

Arcutis Biotherapeutics (Nasdaq: ARQT) announced the grant of 24,000 restricted stock units and options for 64,900 shares to seven newly hired employees on June 1, 2022. This was approved by the Compensation Committee under the 2022 Inducement Plan. Restricted stock units vest over four years, with 25% vesting annually. The options also vest over four years, with a one-year cliff and subsequent monthly vesting, and have an exercise price of $20.29. This action aligns with Nasdaq Listing Rule 5635(c)(4).

Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) reported strong progress as it prepares for the potential launch of roflumilast cream for plaque psoriasis, expected by July 29, 2022. The company completed enrollment for pivotal Phase 3 trials of roflumilast foam for seborrheic dermatitis and scalp psoriasis, with topline data anticipated soon. Financially, Arcutis holds ~$345 million in cash and equivalents, providing a runway into 2024. However, the company's R&D and G&A expenses surged, leading to a net loss of $64.3 million for Q1 2022.

Arcutis Biotherapeutics (Nasdaq: ARQT) announced the grant of 135,900 restricted stock units and options for 324,200 shares to 49 new employees on May 2, 2022. This grant, made under the 2022 Inducement Plan, is designed to attract talent and is compliant with Nasdaq Listing Rule 5635(c)(4). The restricted stock units vest over four years, and stock options have a ten-year term with an exercise price of $21.34. Arcutis focuses on developing innovative treatments for immune-mediated dermatological conditions and has an active pipeline, including an FDA review for a new drug application.

Arcutis Biotherapeutics (Nasdaq: ARQT) announced the completion of subject enrollment in its pivotal Phase 3 ARRECTOR trial for roflumilast foam targeting scalp and body psoriasis. With 432 subjects enrolled, the trial aims to determine the foam's efficacy and safety, as scalp psoriasis affects approximately 40% of individuals with plaque psoriasis. Results are expected by late Q3 or early Q4 2022, potentially paving the way for a supplemental New Drug Application. The unique foam formulation addresses treatment challenges in sensitive areas, offering a much-needed one-daily option.