Welcome to our dedicated page for Arcutis Biotherapeutics news (Ticker: ARQT), a resource for investors and traders seeking the latest updates and insights on Arcutis Biotherapeutics stock.
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 announced the enrollment of the first patient in a Phase 2a trial for ARQ-252, a selective JAK1 inhibitor, as a potential treatment for vitiligo, affecting approximately 1.3 million U.S. patients. This double-blind, vehicle-controlled study will evaluate ARQ-252 in combination with narrowband UVB therapy in about 500 subjects. The primary endpoint is ≥ 75% improvement in facial vitiligo area at week 24. Results are expected in the second half of 2023, aiming to provide better efficacy for patients dissatisfied with current off-label treatments.
Arcutis Biotherapeutics (Nasdaq: ARQT) announced new data for roflumilast cream, focusing on long-term safety and efficacy outcomes in adults with chronic plaque psoriasis. The presentations at the Innovations in Dermatology virtual conference highlighted results from a Phase 2 long-term safety study and the Phase 3 studies' positive topline data. The cream aims to address limitations of existing treatments by offering a favorable profile for chronic use. The company plans to submit a New Drug Application soon, potentially revolutionizing treatment standards for various dermatological conditions.
Arcutis Biotherapeutics (Nasdaq: ARQT), a late-stage biopharmaceutical company, will present at the Cowen 41st Annual Health Care Conference scheduled for March 1-4, 2021. The presentation will occur on March 1 at 12:20 p.m. PT / 3:20 p.m. ET and will focus on their advancements in immuno-dermatology. Interested parties can access the presentation via webcast on the company’s website, with an archived replay available for 30 days post-conference. Arcutis aims to address unmet needs in dermatological treatments, highlighting their lead candidate for various skin conditions.
On February 18, 2021, Arcutis Biotherapeutics (Nasdaq: ARQT) announced that Courtney Barton joins as Chief Compliance Officer and Chief of Staff. Barton brings over 17 years of experience in corporate and healthcare compliance, having previously served as Vice President at Cipla Therapeutics. Her role will enhance Arcutis' compliance and data privacy efforts, aligning with the company's goal to establish itself as a leading innovation-driven medical dermatology firm. This strategic appointment is expected to support Arcutis' growth and commitment to integrity in operations.
Arcutis Biotherapeutics (NASDAQ: ARQT) announced positive Phase 3 results for its topical roflumilast cream targeting plaque psoriasis, with a New Drug Application (NDA) submission expected in H2 2021. The company plans to advance three additional programs into pivotal Phase 3 trials in 2021. Financially, Arcutis holds over $470 million in cash, providing a runway into 2023. R&D expenses rose significantly due to the initiation of multiple clinical trials, with a net loss of $135.7 million for 2020. The company aims to address unmet medical needs affecting over 20 million patients, with potential revenue opportunities of $3 to $8 billion.
Arcutis Biotherapeutics (Nasdaq: ARQT) announced the completion of a public offering, raising approximately $221.4 million by selling a total of 6,325,000 shares of common stock at $35 per share. The offering included the exercise of an overallotment option for an additional 825,000 shares. The funds are intended to support the development of Arcutis' pipeline, which focuses on immuno-dermatology treatments. Major underwriters for the offering included Morgan Stanley, Cowen, and Guggenheim Securities.
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) announced a successful public offering of 5,500,000 shares at $35.00 each, aiming to raise $192.5 million before expenses. This upsized offering includes a 30-day option for underwriters to purchase an additional 825,000 shares. The proceeds will support the development of key programs, including ARQ-151 for psoriasis, and general operational needs. The offering is expected to close on February 5, 2021. Morgan Stanley, Cowen, and Guggenheim Securities are managing the offering.
Arcutis Biotherapeutics (Nasdaq: ARQT) has announced a public offering of $150 million in common stock, with all shares being sold by the company. The offering is subject to market conditions and includes a 30-day option for underwriters to purchase an additional 15% of the shares. The offering will be made under an automatic shelf registration statement filed with the SEC. Morgan Stanley, Cowen, and Guggenheim Securities are leading the offering, while details are available on the SEC’s website.
Arcutis Biotherapeutics announced positive results from its pivotal Phase 3 studies (DERMIS-1 and DERMIS-2) for roflumilast cream, a treatment for plaque psoriasis. The cream showed statistically significant improvement over a vehicle with an IGA Success rate of 42.4% and 37.5% in the respective studies (P<0.0001). With a favorable safety profile, only 1.7% and 0.3% of subjects discontinued due to adverse events. The company anticipates submitting a New Drug Application (NDA) to the FDA in the second half of 2021. Roflumilast cream could be the leading non-steroidal treatment for the 8.6 million plaque psoriasis patients in the U.S.
Arcutis Biotherapeutics (Nasdaq: ARQT) has announced the advancement of its topical roflumilast foam (ARQ-154) into Phase 3 development for treating seborrheic dermatitis, following a successful End-of-Phase 2 meeting with the FDA. This pivotal trial is expected to start in Q2 or Q3 2021. Roflumilast foam has shown statistically significant improvement in clinical trials and possesses a favorable safety profile. Affecting over 10 million patients in the U.S., seborrheic dermatitis presents a significant market opportunity for this treatment, which could become a new standard of care.
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