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FDA Approves Roflumilast Foam for Scalp, Body Psoriasis
FDA Approves Roflumilast Foam for Scalp, Body Psoriasis

Medscape

time22-05-2025

  • Health
  • Medscape

FDA Approves Roflumilast Foam for Scalp, Body Psoriasis

The foam formulation of the phosphodiesterase-4 (PDE4) inhibitor roflumilast has been approved by the US Food and Drug Administration (FDA) for treating plaque psoriasis of the scalp and body in adults and adolescents aged 12 years and older, according to an announcement from the manufacturer Arcutis Biotherapeutics. The 0.3% foam formulation of roflumilast (Zoryve) was previously approved for the treatment of seborrheic dermatitis in adults and children aged 9 years and older. The company has since then filed a supplemental New Drug Application with the FDA in September 2024. A 0.3% cream version is approved as a topical treatment for plaque psoriasis in adults and children aged 6 years and older. And the 0.15% cream formulation of roflumilast is approved for treatment of mild-to-moderate atopic dermatitis for the same population. Approval is based on data from phase 2b and 3 studies. In the pivotal phase 3 ARRECTOR study recently published in JAMA Dermatology , 432 patients with scalp and body psoriasis aged 12 years and older were randomized to once-daily application of 0.3% roflumilast foam or a vehicle for 8 weeks. Medscape also reported the findings. Significantly more patients in the roflumilast group vs the vehicle group achieved the primary endpoints of Scalp-Investigator Global Assessment (S-IGA) and Body-IGA (B-IGA) success — defined as clear or almost clear — plus two or more grades of improvement from baseline after 8 weeks of treatment (66.4% vs 27.8% for S-IGA; 45.5% vs 20.1% for B-IGA; P < .001 for both). In addition, significantly more patients who received roflumilast achieved a clinically significant reduction of itch (defined as a change of ≥ 4 points from baseline on the Scalp Itch-Numeric Rating Scale) compared with those on the vehicle after 8 weeks (65.3% vs 30.3%). Significantly more roflumilast-treated patients with baseline scalp itch also showed significant improvement compared with placebo patients after 2 weeks and 4 weeks of treatment (25.2% vs 8.0%; 46.2% vs 16.8%, respectively; P < .001 for all). Body itch scores also improved significantly in the roflumilast patients compared to those in the vehicle group. Rates of adverse events were similar and low in both treatment and placebo groups, as were treatment-emergent adverse events and rates of discontinuation because of adverse events, the researchers noted. The most common adverse events reported among patients treated with 0.3% roflumilast foam were headache (1.1%), nausea (1.3%), and nasopharyngitis (1.5%), according to the company's press release. It is contraindicated in patients with moderate-to-severe liver impairment (Child-Pugh B or C).

Arcutis' ZORYVE® (roflumilast) Topical Foam 0.3% Approved by U.S. FDA for the Treatment of Plaque Psoriasis in Adults and Adolescents Ages 12 and Older
Arcutis' ZORYVE® (roflumilast) Topical Foam 0.3% Approved by U.S. FDA for the Treatment of Plaque Psoriasis in Adults and Adolescents Ages 12 and Older

Yahoo

time22-05-2025

  • Health
  • Yahoo

Arcutis' ZORYVE® (roflumilast) Topical Foam 0.3% Approved by U.S. FDA for the Treatment of Plaque Psoriasis in Adults and Adolescents Ages 12 and Older

Once-daily ZORYVE foam provides powerful clearance and rapid itch relief from head to toe with no limitation on duration of use More than half of the nearly 9 million people in the United States with plaque psoriasis experience scalp involvement Healthcare providers and individuals with plaque psoriasis can now choose ZORYVE foam or cream to treat plaque psoriasis anywhere it appears on the body Fifth FDA approval for ZORYVE in less than three years Management will host an investor event with a key opinion leader on Monday, June 2 at 8:00 am ET/5:00 am PT WESTLAKE VILLAGE, Calif., May 22, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for ZORYVE® (roflumilast) topical foam 0.3% for the treatment of plaque psoriasis of the scalp and body in adult and pediatric patients 12 years of age and older. ZORYVE foam is a once-daily, steroid-free topical and is now widely available as a treatment for plaque psoriasis. Nearly 9 million people in the United States are living with plaque psoriasis, with over half having scalp involvement and even more presenting with the disease in other hair-bearing areas. These lesions may be difficult to treat with cream or ointments, which can be inconvenient and messy to apply to skin when hair is present. Itch is the most burdensome symptom of psoriasis and can occur anywhere on the body, but occurs more commonly in patients with scalp disease where it is particularly challenging to manage. In clinical trials, ZORYVE foam 0.3% demonstrated significant improvements in signs and symptoms of psoriasis on both the body and scalp, with positive results across all efficacy endpoints, and was safe and well tolerated. 'Treating plaque psoriasis in areas like the scalp, face, and groin is especially challenging. A safe, effective foam offers a much-needed solution,' said Jennifer Soung, MD, director of clinical research at Southern California Dermatology, and clinical trial investigator. 'In clinical trials, ZORYVE foam not only effectively cleared psoriasis plaques on the body and scalp, but also provided rapid itch relief. ZORYVE can be safely used for any duration and offers two highly convenient formulations, cream or foam, for healthcare providers to choose from. ZORYVE foam allows patients to treat their whole body with one prescription, transforming the treatment landscape for scalp and body psoriasis.' 'Individuals living with psoriasis, a chronic inflammatory skin disease, want treatments that are not only safe and effective for long-term use but also convenient. With approval for cream and now the foam formulations, individuals and clinicians can choose their preferred administration of ZORYVE with powerful, long-term relief of plaques and itch anywhere on the body, including hair-bearing areas, with no limitation on duration of use,' said Frank Watanabe, president and chief executive officer of Arcutis. 'Leveraging our deep medical dermatology expertise, we intentionally formulated ZORYVE to meet the needs of individuals with psoriasis, including hard-to-treat areas from head to toe. This is the fifth approval for ZORYVE in less than three years and furthers our mission to deliver new treatment options that address the urgent needs of individuals suffering from chronic inflammatory skin diseases.' "Living with plaque psoriasis can have a profound impact on people's emotional well-being, quality of life, and social relationships. This can be even further exacerbated when psoriasis appears on the face, scalp, or thin-skinned areas," said Leah Howard, president and chief executive officer, National Psoriasis Foundation. "We are pleased to see new advancements and innovation in treatments for the millions afflicted with this serious skin disease, that can be used long-term and anywhere the disease presents." ZORYVE foam 0.3% is also approved for the treatment of seborrheic dermatitis and is widely available today via key wholesaler and dermatology pharmacy channels. Arcutis is dedicated to ensuring predictable access for the entire ZORYVE portfolio of products, with one simple copay and fulfillment process. The ZORYVE® Direct Program helps patients access their prescribed Arcutis medication. Specifically, this patient support program helps those who have been prescribed ZORYVE to navigate the payer process, assists patients with adherence, and includes the ZORYVE Direct Savings Card Program, which can help reduce out-of-pocket costs for eligible commercially insured patients.† Arcutis will also continue to offer the Arcutis Cares™ patient assistance program (PAP) that provides ZORYVE at no cost for financially eligible patients who are uninsured or underinsured.‡ Management will host a virtual Key Opinion Leader Event for investors and analysts on Monday, June 2 at 8:00 am ET, featuring a leading dermatology and immune-mediated skin disease expert who will discuss the unmet need and current treatment landscape for individuals with plaque psoriasis. A registration link for the call is available on the 'Events' section of the Company's Investor website. An archived version of the webcast and slides will be available on the Arcutis website after the call. A Media Snippet accompanying this announcement is available in this link. Clinical Data The approval is supported by positive results from Arcutis' Phase 2 and pivotal Phase 3 trials in plaque psoriasis. The 'A Randomized tRial Employing topiCal roflumilasT foam to treat scalp psORiasis' (ARRECTOR) and the Phase 2 (Trial 204) were multicenter, randomized, double-blind, vehicle-controlled studies evaluating the safety and efficacy of ZORYVE foam 0.3% in plaque psoriasis. Together the two studies enrolled 736 adults and adolescents ages 12 years and older with mild to severe plaque psoriasis of scalp and body. In each trial, subjects were randomized 2:1 to receive ZORYVE foam 0.3% or vehicle foam applied once daily for 8 weeks. The ARRECTOR study met its co-primary endpoints of Scalp-Investigator Global Assessment (S-IGA) Success and Body-Investigator Global Assessment (B-IGA) Success. For Scalp-IGA, 66.4% of individuals treated with ZORYVE foam compared to 27.8% of individuals treated with a matching vehicle foam achieved Scalp-IGA Success at Week 8 (P<0.0001). For Body-IGA, 45.5% of individuals treated with ZORYVE foam compared to 20.1% of individuals treated with a matching vehicle foam achieved Body-IGA Success at Week 8 (P<0.0001). IGA Success was defined as an IGA score of 'clear' or 'almost clear' plus a 2-point improvement from baseline. Trial 204 met its primary endpoint with 56.7% of individuals treated with ZORYVE foam achieving S-IGA Success compared to 11.0% of individuals treated with a matching vehicle foam at Week 8 (P<0.0001). In addition, 39.0% of individuals treated with ZORYVE foam achieved B-IGA Success compared to 7.4% of individuals treated with a matching vehicle foam at Week 8 (P<0.0001). ZORVYE foam provided a clinically meaningful improvement in itch. In ARRECTOR, two thirds (65.3%) of individuals treated with ZORYVE achieved a clinically significant reduction in scalp itch compared to approximately one third (30.3%) of individuals treated with vehicle at Week 8 (P<0.0001) as measured by a ≥ 4-point change from baseline in Scalp Itch-Numeric Rating Scale (SI-NRS). Importantly, a greater improvement in scalp itch was observed 24 hours following the first application with ZORYVE foam compared to vehicle (as measured by mean SI-NRS change from baseline, relative to vehicle; P=0.0164). The improvement in scalp itch was consistent in Trial 204, with a higher percentage of individuals achieving SI-NRS Success at Week 8 with ZORYVE foam compared to vehicle (67.3% vs. 20.7%). In addition, the ZORYVE foam also provided improvement in body itch as measured by the Worst Itch-Numeric Rating Scale (WI-NRS), with 63.1% of those treated with ZORYVE foam achieving a ≥ 4-point reduction in WI-NRS compared to 30.1% of those treated with vehicle at Week 8 (P<0.0001) in ARRECTOR. ZORYVE foam 0.3% was well tolerated. The incidence of Treatment Emergent Adverse Events (TEAEs) was low and generally similar between active treatment and vehicle, with most TEAEs assessed as mild to moderate severity. Overall, the most common adverse reactions for ZORYVE foam for plaque psoriasis in the Phase 3 and Phase 2 studies combined (≥1%) included headache (3.1%), diarrhea (2.5%), nausea (1.7%), and nasopharyngitis (1.3%). Rates of discontinuation due to adverse events were low and similar among ZORYVE-treated and vehicle-treated patients in pooled vehicle-controlled studies. About Plaque PsoriasisPsoriasis is a common, chronic, inflammatory skin disease that affects nearly 9 million people in the United States. Symptoms include itch, scaling, redness, and flaking. On darker skin tones, plaques may appear more grayish, purplish, or brown. Psoriasis can appear anywhere on the body, including the knees, elbows, torso and thin-skinned areas like the face, genitals and intertriginous areas, which are areas where skin touches skin, such as the armpits, under the breasts, stomach folds, between the buttocks, and in the groin area. In addition, scalp psoriasis sometimes extends to the forehead, back of the neck, or behind or inside the ears. Scalp psoriasis can also be associated with hair loss, likely due to damage to the hair from excessive scratching, rubbing, or combing of the affected area. About ZORYVE (roflumilast)ZORYVE is a next generation topical phosphodiesterase-4 (PDE4) inhibitor. PDE4 – an established target in dermatology – is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators. Roflumilast cream 0.3% (ZORYVE®) is approved by the FDA for the topical treatment of plaque psoriasis, including intertriginous areas, in patients 6 years of age and older. Roflumilast cream 0.15% (ZORYVE®) is approved by the FDA for the topical treatment of mild to moderate atopic dermatitis in patients 6 years of age and older. In 2024, ZORYVE cream 0.15% was awarded Glamour's Beauty and Wellness Award for 'Eczema Product.' ZORYVE (roflumilast) topical foam 0.3% is uniquely formulated for use anywhere on the body, including hair-bearing areas, and is indicated for treatment of plaque psoriasis of the scalp and body in patients 12 years of age and older, as well as seborrheic dermatitis in patients 9 years of age and older. ZORYVE is the first and only branded topical therapy for three major inflammatory dermatoses - including atopic dermatitis, seborrheic dermatitis, and plaque psoriasis. INDICATIONS ZORYVE topical foam, 0.3%, is indicated for the treatment of plaque psoriasis of the scalp and body in adult and pediatric patients 12 years of age and older. ZORYVE topical foam, 0.3%, is indicated for the treatment of seborrheic dermatitis in adult and pediatric patients 9 years of age and older. ZORYVE cream, 0.3%, is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 6 years of age and older. ZORYVE cream, 0.15%, is indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 6 years of age and older. IMPORTANT SAFETY INFORMATION ZORYVE is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C). Flammability: The propellants in ZORYVE foam are flammable. Avoid fire, flame, and smoking during and immediately following application. The most common adverse reactions (≥1%) for ZORYVE foam 0.3% for plaque psoriasis include headache (3.1%), diarrhea (2.5%), nausea (1.7%), and nasopharyngitis (1.3%). The most common adverse reactions (≥1%) for ZORYVE foam 0.3% for seborrheic dermatitis include nasopharyngitis (1.5%), nausea (1.3%), and headache (1.1%). The most common adverse reactions (≥1%) for ZORYVE cream 0.3% for plaque psoriasis include diarrhea (3.1%), headache (2.4%), insomnia (1.4%), nausea (1.2%), application site pain (1.0%), upper respiratory tract infection (1.0%), and urinary tract infection (1.0%). The most common adverse reactions (≥1%) for ZORYVE cream 0.15% for atopic dermatitis include headache (2.9%), nausea (1.9%), application site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%). Please see full Prescribing Information for ZORYVE foam and full Prescribing Information for ZORYVE cream. About ArcutisArcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a commercial-stage medical dermatology company that champions meaningful innovation to address the urgent needs of individuals living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis has a growing portfolio of advanced targeted topicals approved to treat three major inflammatory skin diseases. Arcutis' unique dermatology development platform coupled with our dermatology expertise allows us to invent differentiated therapies against biologically validated targets, and has produced a robust pipeline with multiple follow-on clinical programs for a range of inflammatory dermatological conditions including atopic dermatitis and alopecia areata. For more information, visit or follow Arcutis on LinkedIn, Facebook, Instagram, and X. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. For example, statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company's current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the potential real-world use results of ZORYVE foam and the potential for ZORYVE to advance the standard of care in plaque psoriasis, atopic dermatitis and seborrheic dermatitis. These statements are subject to substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in our business, reimbursement and access to our products, the impact of competition and other important factors discussed in the 'Risk Factors' section of our Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on February 25, 2025, as well as any subsequent filings with the SEC. Any forward-looking statements that the company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, we undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. † Subject to eligibility criteria and maximum program limitation. This offer is not valid for patients without commercial drug insurance or whose prescription claims are eligible to be reimbursed, in whole or in part, by any government program. ‡ Subject to financial eligibility requirements. Other terms and restrictions apply. Contacts:MediaAmanda Sheldon, Head of Corporate Communicationsmedia@ InvestorsLatha Vairavan, Chief Financial Officerir@ in to access your portfolio

New Consensus Statements on Impact of Genital Psoriasis on Patients from Genital Psoriasis Wellness Consortium Published in Journal of the European Academy of Dermatology and Venereology Clinical Practice
New Consensus Statements on Impact of Genital Psoriasis on Patients from Genital Psoriasis Wellness Consortium Published in Journal of the European Academy of Dermatology and Venereology Clinical Practice

Associated Press

time15-05-2025

  • Health
  • Associated Press

New Consensus Statements on Impact of Genital Psoriasis on Patients from Genital Psoriasis Wellness Consortium Published in Journal of the European Academy of Dermatology and Venereology Clinical Practice

WESTLAKE VILLAGE, Calif., May 15, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the publication of 14 consensus statements from the Genital Psoriasis Wellness Consortium on the impact of genital psoriasis on patients in the Journal of the European Academy of Dermatology and Venereology (JEADV) Clinical Practice. The consensus statements are aimed at providing expert, multidisciplinary guidance in three key areas: (1) physical diagnosis and patient conversations, (2) impact on quality of life and interpersonal relationships, and (3) treatment decisions. 'Despite affecting an estimated six million Americans, genital psoriasis is often underreported and undertreated due to the uniquely sensitive and private nature of the afflicted areas, and uncertainty for how to begin the conversation. Relative to psoriasis in other areas of the body, genital psoriasis also has a greater impact on psychological well-being and quality of life, interpersonal relationships, intimacy, feelings of stigmatization, and rates of depression,' said Jennifer C. Cather, MD, FAAD, Medical Director and Founder of Mindful Dermatology and Modern Research Associates in Dallas, Texas, Genital Psoriasis Consortium member, and manuscript author. 'With the current lack of formal guidelines around genital psoriasis, the goal of convening the Consortium was to bridge the gaps in clinician-patient communication, develop tools and processes that aid in identification and diagnosis, and better-informed shared treatment decisions.' To formulate the consensus statements, a PubMed literature search was conducted, and a total of 78 unique publications were reviewed. Consortium members used a modified Delphi process, including a nominal group technique. The process included two rounds of virtual subcommittee meetings focused on the three key areas, followed by surveys to obtain anonymous feedback, and concluded with a final meeting to discuss and finalize the language of the consensus recommendations. 'Normalizing conversations and improving shared decision-making are critical first steps to improving outcomes. Implementation of the Consortium's new guidelines could provide consistent, streamlined care practices that don't currently exist for this condition,' said Patrick Burnett, MD, PhD, FAAD, chief medical officer of Arcutis. 'Arcutis is proud to support the Consortium's efforts to challenge the status quo to improve care for those with genital psoriasis.' Below are the 14 consensus statements outlined in the publication: About Arcutis Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a commercial-stage medical dermatology company that champions meaningful innovation to address the urgent needs of individuals living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis has a growing portfolio of advanced targeted topicals approved to treat three major inflammatory skin diseases. Arcutis' unique dermatology development platform coupled with our dermatology expertise allows us to invent differentiated therapies against biologically validated targets, and has produced a robust pipeline with multiple follow-on clinical programs for a range of inflammatory dermatological conditions including atopic dermatitis and alopecia areata. For more information, visit or follow Arcutis on LinkedIn, Facebook, Instagram, and X. Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. For example, statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company's current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the potential real-world use results of ZORYVE foam and the potential for ZORYVE to advance the standard of care in plaque psoriasis, atopic dermatitis and seborrheic dermatitis. These statements are subject to substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in our business, reimbursement and access to our products, the impact of competition and other important factors discussed in the 'Risk Factors' section of our Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on February 25, 2025, as well as any subsequent filings with the SEC. Any forward-looking statements that the company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, we undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. † Subject to eligibility criteria and maximum program limitation. This offer is not valid for patients without commercial drug insurance or whose prescription claims are eligible to be reimbursed, in whole or in part, by any government program. ‡ Subject to financial eligibility requirements. Other terms and restrictions apply. Contacts: Media Amanda Sheldon, Head of Corporate Communications [email protected] Investors Latha Vairavan, Chief Financial Officer [email protected]

Psoriasis Clinical Trials and Studies 2025: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies
Psoriasis Clinical Trials and Studies 2025: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies

Globe and Mail

time08-04-2025

  • Business
  • Globe and Mail

Psoriasis Clinical Trials and Studies 2025: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies

DelveInsight's, ' Psoriasis Pipeline Insight 2025 ' report provides comprehensive insights about 80+ companies and 80+ pipeline drugs in Psoriasis pipeline landscape. It covers the Psoriasis pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Psoriasis pipeline therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. Discover the latest drugs and treatment options in the Psoriasis Pipeline. Dive into DelveInsight's comprehensive report today! @ Psoriasis Pipeline Outlook Key Takeaways from the Psoriasis Pipeline Report In April 2025, Alumis Inc. announced a study in Patients With Moderate to Severe Plaque Psoriasis to Evaluate the Long-term Safety, Efficacy, and Durability of Response to ESK-001. Patients will enter the long-term extension study following completion of one of the parent studies (ESK-001-016 or ESK-001-017) and will receive open-label ESK-001 twice daily for 24 weeks. DelveInsight's Psoriasis pipeline report depicts a robust space with 80+ active players working to develop 80+ pipeline therapies for Psoriasis treatment. The leading Psoriasis Companies such as Mylan, Biocad, Bristol-Myers Squibb, Celltrion, Coherus BioSciences, Janssen Pharmaceuticals, Can-Fite Biopharma, Arcutis Biotherapeutics, Amgen, Iltoo Pharma, GlaxoSmithKline, Galectin Therapeutics, Evelo Biosciences, Galderma, BioMimetix JV, Menlo Therapeutics Inc., Aristea Therapeutics, UNION Therapeutics, MetrioPharm, Sienna Biopharmaceuticals and others. Promising Psoriasis Pipeline Therapies such as Hypericin, Cetaphil, EDP1815, AX-158, Calcipotriol, MP1032, Risankizumab, Certolizumab Pegol, and others. Stay ahead with the most recent pipeline outlook for Psoriasis. Get insights into clinical trials, emerging therapies, and leading companies with DelveInsight @ Psoriasis Treatment Drugs Psoriasis Emerging Drugs Profile Topical roflumilast: Arcutis Biotherapeutics Topical roflumilast cream (ARQ-151) is a small molecule inhibitor of phosphodiesterase type 4 (PDE4), an intracellular enzyme that increases the production of proinflammatory mediators and decreases production of anti-inflammatory mediators, and has been implicated in a wide range of inflammatory diseases including psoriasis, eczema, and chronic obstructive pulmonary disease (COPD). The therapy is in Phase III clinical development for the treatment of Plaque Psoriasis. GSK2982772: GlaxoSmithKline GSK2982772 is an ATP competitive receptor-interacting protein-1 (RIP1) kinase (RIPK1) inhibitor with the IC50 value of 16 nM. GSK2982772 potently binds to RIP1 with exquisite kinase specificity and has excellent activity in blocking many TNF-dependent cellular responses. RIP1 has emerged as an important upstream kinase that has been shown to regulate inflammation through both scaffolding and kinase specific functions. The molecule is in Phase I clinical development for the treatment of Psoriasis. The Psoriasis Pipeline Report Provides Insights into The report provides detailed insights about companies that are developing therapies for the treatment of Psoriasis with aggregate therapies developed by each company for the same. It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Psoriasis Treatment. Psoriasis Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects. Psoriasis Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type. Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Psoriasis market Explore groundbreaking therapies and clinical trials in the Psoriasis Pipeline. Access DelveInsight's detailed report now! @ New Psoriasis Drugs Psoriasis Companies Mylan, Biocad, Bristol-Myers Squibb, Celltrion, Coherus BioSciences, Janssen Pharmaceuticals, Can-Fite Biopharma, Arcutis Biotherapeutics, Amgen, Iltoo Pharma, GlaxoSmithKline, Galectin Therapeutics, Evelo Biosciences, Galderma, BioMimetix JV, Menlo Therapeutics Inc., Aristea Therapeutics, UNION Therapeutics, MetrioPharm, Sienna Biopharmaceuticals and others. Psoriasis pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as Oral Parenteral Intravitreal Subretinal Topical. Molecule Type Psoriasis Products have been categorized under various Molecule types such as Monoclonal Antibody Peptides Polymer Small molecule Gene therapy Product Type Unveil the future of Psoriasis Treatment. Learn about new drugs, pipeline developments, and key companies with DelveInsight's expert analysis @ Psoriasis Market Drivers and Barriers Scope of the Psoriasis Pipeline Report Coverage- Global Psoriasis Companies- Mylan, Biocad, Bristol-Myers Squibb, Celltrion, Coherus BioSciences, Janssen Pharmaceuticals, Can-Fite Biopharma, Arcutis Biotherapeutics, Amgen, Iltoo Pharma, GlaxoSmithKline, Galectin Therapeutics, Evelo Biosciences, Galderma, BioMimetix JV, Menlo Therapeutics Inc., Aristea Therapeutics, UNION Therapeutics, MetrioPharm, Sienna Biopharmaceuticals and others. Psoriasis Pipeline Therapies- Hypericin, Cetaphil, EDP1815, AX-158, Calcipotriol, MP1032, Risankizumab, Certolizumab Pegol, and others. Psoriasis Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination Psoriasis Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Get the latest on Psoriasis Therapies and clinical trials. Download DelveInsight's in-depth pipeline report today! @ Psoriasis Companies, Key Products and Unmet Needs Table of Content Introduction Executive Summary Psoriasis: Overview Pipeline Therapeutics Therapeutic Assessment Psoriasis – DelveInsight's Analytical Perspective In-depth Commercial Assessment Psoriasis Collaboration Deals Late Stage Products (Phase III) CT-P43: Celltrion Drug profiles in the detailed report….. Mid Stage Products (Phase II) EDP1815: Evelo Biosciences Drug profiles in the detailed report….. Early Stage Products (Phase I) AZD0284: AstraZeneca Drug profiles in the detailed report….. Early Stage Products (Preclinical) AZD0284: AstraZeneca Drug profiles in the detailed report….. Inactive Products Psoriasis Key Companies Psoriasis Key Products Psoriasis- Unmet Needs Psoriasis- Market Drivers and Barriers Psoriasis- Future Perspectives and Conclusion Psoriasis Analyst Views Psoriasis Key Companies Appendix About Us DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve.

Why Arcutis Biotherapeutics Inc. (ARQT) Went Up On Wednesday?
Why Arcutis Biotherapeutics Inc. (ARQT) Went Up On Wednesday?

Yahoo

time04-04-2025

  • Business
  • Yahoo

Why Arcutis Biotherapeutics Inc. (ARQT) Went Up On Wednesday?

We recently published a list of . In this article, we are going to take a look at where Arcutis Biotherapeutics Inc. (NASDAQ:ARQT) stands against other top performing stocks on Wednesday. Wall Street's three major indices finished in the green territory on Wednesday as investors continued to digest news of President Donald Trump's tariff rollout on imports. The tech-heavy Nasdaq finished the day strongest, adding 0.87 percent. The S&P 500 grew 0.67 percent, while the Dow Jones was up 0.56 percent. Ten individual stocks mirrored a broader market optimism, closing the day in the green amid a series of corporate developments that sparked buying appetite. In this article, we named Wednesday's top performers and detailed the reasons behind their gains. To come up with the list, we considered only the stocks with a $2-billion market capitalization and $5 million in trading volume. A biotechnologist working in a laboratory, examining the effects of a Janus Kinase type 1 inhibitor on plaque psoriasis. Arcutis Biotherapeutics snapped a six-day losing streak on Wednesday, adding 10.81 percent to finish at $16.60 apiece as investors cheered news that it had halted an ongoing lawsuit over a patent dispute with Padagis Israel Pharmaceuticals Ltd. As part of the joint stipulation agreement, ARQT said that Padagis is required to report to ARQT any US Food and Drug Administration (FDA) correspondence regarding their Abbreviated New Drug Application (ANDA) for their potential generic alternative to ARQT's patented product, ZORYVE (roflumilast) cream 0.3 percent for plaque psoriasis. In addition, the parties agreed to extend by one day the 30-month Hatch-Waxman stay of regulatory approval, for every day the litigation is stayed as of March 24, 2025. In the event the litigation resumes in the future, ARQT will still benefit from the entirety of the stay afforded to it under the Hatch-Waxman Act. Overall, ARQT ranks 3rd on our list of top performing stocks on Wednesday. While we acknowledge the potential of ARQT as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and doing so within a shorter time frame. If you are looking for an AI stock that is as promising as ARQT but trades at less than 5 times its earnings, check out our report about the cheapest AI stock. READ NEXT: 20 Best AI Stocks To Buy Now and 30 Best Stocks to Buy Now According to Billionaires. Disclosure: None. This article is originally published at Insider Monkey. Sign in to access your portfolio

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