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Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a commercial-stage medical dermatology company based in Westlake Village, California, specializing in developing and commercializing treatments for dermatological diseases. Founded in 2016, Arcutis leverages recent advances in immunology and inflammation to create differentiated therapies targeting immune-mediated dermatological conditions.
Arcutis' lead product, ZORYVE (roflumilast) cream, is a topical treatment for plaque psoriasis and atopic dermatitis. The company has recently launched ZORYVE topical foam for seborrheic dermatitis and scalp psoriasis. Both formulations utilize roflumilast, a potent and selective phosphodiesterase-4 (PDE4) inhibitor that has shown significant improvement in clinical trials.
Arcutis is also advancing its pipeline with ARQ-252, a selective topical small molecule inhibitor of janus kinase type 1 for hand eczema, and ARQ-255 for alopecia areata. The company champions meaningful innovation to address the urgent needs of patients living with chronic, immune-mediated skin conditions, aiming to improve treatment options and patient outcomes.
In recent developments, Arcutis has been actively participating in industry conferences, securing strategic collaborations, and expanding its workforce. The company's financial health is robust, with a strong cash position bolstered by a recent public offering and a strategic licensing agreement in Japan. Arcutis continues to focus on long-term growth and innovation, with multiple ongoing clinical programs targeting various inflammatory dermatological conditions.
For more information, visit www.arcutis.com or follow Arcutis on LinkedIn, Facebook, Instagram, and X.
Arcutis Biotherapeutics (Nasdaq: ARQT), a commercial-stage biopharmaceutical company specializing in immuno-dermatology innovations, has announced its plans to release second quarter 2024 financial results on August 14, 2024. The company will disclose its financial performance and provide a business update after the U.S. financial markets close on that day. Additionally, Arcutis will host a conference call and webcast at 4:30 p.m. ET to discuss the results. Investors and interested parties can access the live webcast and presentation materials through the 'Events' section of the company's website. An archived version of the webcast will be made available on the Arcutis investor website following the conference call.
Arcutis Biotherapeutics (Nasdaq: ARQT) has announced a co-promotion agreement with Kowa Pharmaceuticals America for ZORYVE® (roflumilast). This partnership will leverage Kowa's 200-person primary care sales force to promote ZORYVE cream and foam to primary care practitioners and pediatricians for all FDA-approved indications. The agreement aims to expand ZORYVE's total addressable market, providing access to a significant portion of the 7.4 million patients treated outside dermatology offices.
Key points of the agreement include:
- 5-year term with Kowa promoting ZORYVE in priority position
- Arcutis retains responsibility for manufacturing and dermatology sales
- Arcutis will recognize all revenue and pay Kowa a commission on sales
- Expected to drive incremental revenue while maintaining Arcutis' focus on dermatology
Arcutis Biotherapeutics (ARQT) has launched ZORYVE® (roflumilast) cream 0.15% for treating mild to moderate atopic dermatitis in adults and children aged 6 and older in the US. This once-daily, steroid-free cream offers rapid disease clearance and significant itch reduction, designed for long-term disease control. ZORYVE can be used anywhere on the body for any duration to maintain clear skin.
The product is now commercially available in pharmacies, with immediate insurance coverage through two commercial PBM contracts. Arcutis emphasizes responsible pricing and affordable access, offering patient support programs including the ZORYVE® Direct Program and Arcutis CaresTM patient assistance program.
Arcutis Biotherapeutics (Nasdaq: ARQT) has submitted a supplemental New Drug Application (sNDA) for ZORYVE® (roflumilast) foam to the FDA for treating scalp and body psoriasis in adults and adolescents ages 12 and over. The once-daily foam significantly improved both scalp and body psoriasis in Phase 2b and Phase 3 trials, with 67% of participants achieving Scalp-Investigator Global Assessment Success at 8 weeks. The treatment also showed rapid reduction in scalp itch within 24 hours and demonstrated a favorable safety profile.
This submission marks Arcutis' fifth topical roflumilast regulatory submission in the U.S. in less than three years. The company believes ZORYVE foam has great potential for adoption in scalp and body psoriasis, building on its success in seborrheic dermatitis treatment.
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.
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