Rheumatoid arthritis is a chronic inflammatory disease that causes joint pain, swelling, and disability. Although standard disease-modifying antirheumatic drugs (DMARDs) are effective for many patients, some individuals continue to experience active disease and inflammation. The aim of this study is to evaluate the effectiveness and safety of adding either roflumilast or desloratadine to standard DMARD therapy in patients with rheumatoid arthritis. Participants will be randomly assigned to receive either roflumilast, desloratadine, or placebo in addition to their usual treatment. The study will assess changes in disease activity, inflammatory biomarkers, and patient-reported outcomes over a three-month follow-up period. The results of this study may help identify new add-on treatment options to improve disease control in patients with rheumatoid arthritis.

Start Date23 Apr 2026

Sponsor / Collaborator

Horus University

NCT07560618

/ Not yet recruitingPhase 4

A Phase 4, Open Label Study to Assess Descriptive Classification of Pruritus Over Time With Roflumilast 0.15% Cream in Patients With Atopic Dermatitis

This study is being done to obtain descriptive classifications of pruritus using a patient directed survey system and assess change in pruritus over time in patients with Atopic Dermatitis over 4 weeks with use of topical Roflumilast cream 0.15% QD.

Start Date01 Apr 2026

Sponsor / Collaborator

Integrative Skin Science and Research

[+1]

NCT07263230

/ RecruitingPhase 2IIT

An Open-label Single Center Study Evaluating the Safety and Efficacy of Roflumilast Foam 0.3% in Subjects With Hidradenitis Suppurativa

This study investigates the efficacy of topical roflumilast foam in patients with HS.

Start Date01 Apr 2026

Sponsor / Collaborator

Beth Israel Deaconess Medical Center, Inc.

100 Clinical Results associated with Roflumilast

100 Translational Medicine associated with Roflumilast

100 Patents (Medical) associated with Roflumilast

1,172

Literatures (Medical) associated with Roflumilast

01 Jul 2026·PHARMACOLOGY BIOCHEMISTRY AND BEHAVIOR

Temporal dynamics of PDE4 inhibition in modulating novel object recognition memory consolidation and reconsolidation

Article

Author: Sohn, Jeferson Machado Batista ; Stern, Cristina Aparecida Jark ; Ramalho, Letícia Guidi ; Prickaerts, Jos

Object recognition memory (ORM) allows individuals to discriminate between familiar and novel stimuli, providing a fundamental model for studying non-emotional memory in rodents. ORM reactivation during retrieval in the presence of a new object renders this memory labile and susceptible to interference during reconsolidation, a process with potential translational impact, as it contributes to the maintenance and updating of stored memories. Despite this relevance, the mechanisms underlying ORM reconsolidation are not well understood. Phosphodiesterase-4 (PDE4) regulates cyclic adenosine monophosphate (cAMP) signaling, a key pathway in synaptic plasticity and memory formation. While PDE4 inhibition is known to enhance ORM consolidation, its role in ORM reconsolidation remains unclear. Here, we investigated the effects of PDE4 inhibition with roflumilast (ROF; 0.1 mg/kg, i.p.) on reconsolidation of ORM in male Wistar rats. We used a protocol designed to simultaneously engage reconsolidation of familiar objects and consolidation of novel ones. ROF administered 5 min after retrieval increased the discrimination index 24 h later, suggesting an enhancement of ORM reconsolidation. However, the same treatment reduced the discrimination index of novel objects, indicating an impairment in consolidation. In independent groups of animals, the treatment with ROF 3 h post-retrieval did not affect reconsolidation and improved consolidation. When memory retrieval was omitted, ROF effects on reconsolidation were abolished, while consolidation enhancement persisted when ROF was administered 3 h after training. Moreover, pharmacological blockade of memory destabilization with nimodipine (16 mg/kg, i.p.) abolished the effects of ROF on reconsolidation. Our results demonstrate that PDE4 inhibition modulates ORM in a time-dependent manner, favoring early reconsolidation and late consolidation phases. These results reveal a dynamic role of PDE4 in shaping the temporal boundaries of non-emotional memory processing and highlight its potential as a target for cognitive enhancement therapies.

01 Jun 2026·Bone Reports

Phosphodiesterase inhibitors as emerging therapeutics for skeletal disorders: A comprehensive review of mechanisms and repurposing potential

Review

Author: Ursachi, Vlad-Constantin ; Fafilek, Bohumil ; Horak, Jan

Skeletal disorders such as osteoporosis, osteoarthritis, and rheumatoid arthritis represent major global health burdens with limited therapeutic innovation. Inhibitors of phosphodiesterases (PDEs), enzymes that regulate the intracellular levels of the cyclic nucleotides cAMP and cGMP, are increasingly recognized as potential medications that can improve the health of bone and cartilage. Although they have been used in clinics for decades, their function in bone or cartilage remains unclear. In preclinical models, inhibitors that target PDE3 (e.g., cilostazol, milrinone), PDE4 (roflumilast, apremilast), and PDE5 (e.g., sildenafil, avanafil, vardenafil) exhibit promising anabolic, anticatabolic, and anti-inflammatory effects on skeletal tissues. Broad-spectrum inhibitors such as pentoxifylline and dipyridamole also demonstrate dual benefits in terms of bone regeneration and joint preservation. This review examines the mechanistic basis and therapeutic potential of clinically approved PDE inhibitors-originally developed for cardiovascular, neurological, and inflammatory conditions-for skeletal applications. Understanding the mechanism of action of PDE inhibitors can facilitate their translation into the clinic, help with their application in combined therapies, or minimize their potential adverse effects. This approach offers a cost-effective and viable path toward novel therapies for musculoskeletal health.

01 May 2026·BIOORGANIC CHEMISTRY

Integrating synthesis, pharmacological evaluation, and molecular dynamics simulation of novel 8-substituted theophylline hybrids as potential PDE-4B inhibitors, bronchodilators and antibacterial

Article

Author: Ibrahim, Tarek S ; Beshr, Eman A M ; Salem, Ibrahim M ; Hayallah, Alaa M ; Ali, Taha F S ; Mamdoh, Hend ; Radwan, Mohamed F ; Yani, Marina A O

Methylxanthines, particularly theophylline, have long served as effective bronchodilators for severe asthma. Emerging evidence links bacterial infection to asthma pathogenesis, motivating the search for multifunctional therapeutic agents. In this study, a series of 8-substituted 1,3-dimethylxanthines bearing aryl and heteroaryl groups were synthesized and structurally characterized by NMR, elemental analysis, and HR-ESI-MS. Most compounds exhibited significant bronchodilator activity in an acetylcholine-induced guinea pig model, surpassing theophylline. The compounds demonstrated potent in vitro PDE-4B inhibition relevant to asthma-related inflammation. Several derivatives also showed antibacterial activity against susceptible Gram-positive and Gram-negative strains in asthmatic patients. Molecular docking and 200 ns molecular dynamics simulations revealed strong and stable binding of the most active compounds, 14d and 17 k, within the PDE-4B active site, correlating with their in vivo efficacy. Notably, 17 k displayed superior oral pharmacokinetic properties, high lipophilicity, moderate solubility, and optimal molecular size, comparable to theophylline and roflumilast (standard PDE-4B inhibitor). These findings identify 17 k as a promising lead for the development of orally active dual-acting agents for asthma management.

230

News (Medical) associated with Roflumilast

25 May 2026

·www.sciencedaily.com

Scientists discover why Ozempic and Wegovy weight loss eventually plateaus

New NIH research reveals that semaglutide sparks different responses inside appetite-controlling brain cells, offering fresh insight into why GLP-1 weight-loss drugs don’t work the same for everyone. Scientists also found a possible way to extend the drugs’ effects, potentially helping patients push past weight-loss plateaus.Researchers at the National Institutes of Health (NIH) have uncovered new details about how GLP-1 weight loss drugs such as semaglutide affect brain cells, revealing internal signaling processes that scientists have only begun to understand. The findings, based on experiments in mice, shed light on why these medications work differently from person to person and why their effects often slow down over time. GLP-1 receptor agonists, including drugs like Ozempic and Wegovy, are already known to help reduce appetite and promote weight loss. Scientists have also identified the brain regions involved in those effects. Until now, however, much less was known about what happens inside the neurons targeted by these drugs. "We know much less about the nuts and bolts of what goes on within the neurons that these medications target. By digging into these mechanisms, we're beginning to answer some of these questions," said co-corresponding author Andrew Lutas, Ph.D., an investigator at NIH's National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Brain Cell Signals Linked to Weight Loss The research team used fluorescence imaging to monitor how semaglutide affected living brain tissue from mice. The work was led by first author Claire Gao, Ph.D., a postdoctoral fellow at NIH's National Institute of General Medical Sciences (NIGMS). By blocking or removing specific signaling molecules inside neurons, the scientists were able to determine which cellular pathways played the biggest role in weight loss effects. Their experiments showed that semaglutide's impact depended heavily on increased levels of cyclic adenosine monophosphate, or cAMP, in the area postrema, a part of the brain involved in appetite regulation. However, the response was not the same in every neuron. "It was not an all or nothing phenomenon. We observed that cAMP responses across cells varied on a continuum," said co-corresponding author Michael Krashes, Ph.D., a senior investigator at NIDDK. Why Some GLP-1 Effects Fade Over Time Researchers found that some neurons maintained elevated cAMP levels for longer periods while semaglutide was present. Other neurons showed only temporary increases. According to the authors, some cells may reduce their response by internalizing or breaking down GLP-1 receptors. The team also tested whether they could prolong these signals. Using the drug roflumilast to block PDE4, an enzyme that breaks down cAMP, they were able to shift more neurons toward a longer lasting response. The discovery raises the possibility that future GLP-1 treatments could remain effective for longer periods, potentially reducing how often patients need injections. Scientists also believe this type of cAMP modulation might eventually help people overcome the weight loss plateaus commonly reported with GLP-1 drugs. The researchers caution that much more study is needed before those possibilities can be confirmed. Next Steps for GLP-1 Research One limitation of the study was that researchers could only observe intracellular signaling in brain tissue for a few hours at a time. The team hopes to use newer techniques in future studies to track how GLP-1 drugs affect neurons over days or even weeks. The findings offer a deeper look into the brain chemistry behind GLP-1 medications and may help guide the development of more effective weight loss treatments in the future.

07 May 2026

·www.biospace.com

Palvella Therapeutics Reports First Quarter 2026 Financial Results and Provides Corporate Update

FDA Pre-New Drug Application (NDA) meeting granted for QTORIN™ rapamycin for the treatment of microcystic lymphatic malformations, with meeting expected in second quarter of 2026; NDA submission on track for second half of 2026 Accelerating U.S. launch readiness for QTORIN™ rapamycin for microcystic lymphatic malformations; BEYONDmLM.com disease awareness campaign launched to educate, engage, and empower patients, caregivers, and healthcare professionals Initiation of Phase 3 trial of QTORIN™ rapamycin for the treatment of cutaneous venous malformations planned for second half of 2026 Initiation of Phase 2 trial of QTORIN™ pitavastatin for the treatment of disseminated superficial actinic porokeratosis planned for second half of 2026 Phase 2 LOTU trial of QTORIN™ rapamycin for clinically significant angiokeratomas initiated with topline results expected in second half of 2027 Completed upsized, oversubscribed equity financing of $230.0 million in February 2026; cash, cash equivalents and short-term investments of $261.9 million as of March 31, 2026 Company to host conference call at 8:30 a.m. ET today WAYNE, Pa., May 07, 2026 (GLOBE NEWSWIRE) -- Palvella Therapeutics, Inc. (Palvella or “the Company”) (Nasdaq: PVLA), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare skin diseases and vascular malformations for which there are no U.S. Food and Drug Administration (FDA)-approved therapies, today reported financial results for the first quarter ending March 31, 2026 and provided a corporate update. “Following the positive Phase 3 SELVA topline results, we believe Palvella is on a clear path toward near-term NDA submission for QTORIN™ rapamycin in microcystic lymphatic malformations, with the potential for approval and U.S. commercial launch in the first half of 2027,” said Wes Kaupinen, Founder and Chief Executive Officer of Palvella. “Our $230.0 million financing with participation from high-quality new and existing investors meaningfully strengthens our balance sheet, which supports our plan for U.S. commercialization, and enables us to attract key talent as we prepare for a potential first-in-disease launch. At the same time, we continue to rapidly advance our pipeline beyond microcystic LMs, with the goal of expanding our QTORIN™-derived programs across six serious, rare skin diseases and vascular malformations by year-end.” Recent Research and Development Highlights QTORIN™ rapamycin for microcystic lymphatic malformations (microcystic LMs) Reported positive topline data from the Phase 3 SELVA study demonstrating statistically significant results across the primary and all pre-specified secondary endpoints. In collaboration with leading nonprofit and advocacy organizations, launched the “BEYOND mLM” disease awareness campaign and BEYONDmLM.com to educate and engage patients, caregivers, and healthcare professionals on microcystic lymphatic malformations. Announced publication in the Journal of Vascular Anomalies highlighting the distinct biology and significant unmet need in microcystic lymphatic malformations, supporting early intervention and reinforcing the scientific rationale for QTORIN™ rapamycin as a targeted therapeutic approach. Strengthened global intellectual property for QTORIN™ rapamycin with issuance of a European patent covering anhydrous topical compositions and methods of use, providing protection through 2038. Phase 3 SELVA study results to be presented at the International Society for the Study of Vascular Anomalies World Congress 2026 on May 20, 2026, marking the first presentation of these data at a major medical meeting. Pre-New Drug Application (NDA) meeting with the FDA granted; meeting expected in the second quarter of 2026. NDA submission remains on track for the second half of 2026. QTORIN™ rapamycin for cutaneous venous malformations (cutaneous VMs) Phase 2 TOIVA study results to be presented at the International Society for the Study of Vascular Anomalies World Congress 2026 on May 20, 2026; additional data presentation planned at the 83rd Annual Meeting of the Society for Investigative Dermatology on May 12, 2026. Submitted application for FDA Breakthrough Therapy Designation in the second quarter of 2026. Phase 3 study initiation anticipated in the second half of 2026. QTORIN™ rapamycin for clinically significant angiokeratomas Dosed first patients in the Phase 2 LOTU trial, a single-arm, baseline-controlled clinical trial of QTORIN™ rapamycin administered topically once daily for the treatment of clinically significant angiokeratomas. Topline results from LOTU are expected in the second half of 2027. QTORIN™ pitavastatin for disseminated superficial actinic porokeratosis (DSAP) Presented qualitative insights at the 2026 American Academy of Dermatology Annual Meeting from ten in-depth interviews highlighting the significant burden of porokeratosis, a rare genetic skin disease with no FDA-approved therapies. These insights underscore its pre-cancerous nature and substantial physical, functional, and psychosocial impact, reinforcing the need for pathogenesis-directed therapies. Phase 2 trial initiation expected in the second half of 2026. QTORIN™ rapamycin and QTORIN™ platform expansion Plan to announce the third product candidate from the QTORIN™ platform in a serious, rare disease with no FDA-approved therapies in the second half of 2026. Plan to announce the fourth clinical indication for QTORIN™ rapamycin in the second half of 2026. The expansion of QTORIN™ rapamycin into additional indications is supported by comprehensive publications which highlight the broad potential of rapamycin in several difficult-to-treat, mTOR-driven skin diseases while advocating for targeted, topical approaches suited to improve tolerability and safety. Recent Corporate Highlights Closed an upsized and oversubscribed public offering of common stock generating $230.0 million in gross proceeds, including the full exercise of the underwriters’ option to purchase additional shares. Strengthened Palvella’s leadership team with the appointments of Jennifer McDonough, Senior Vice President of Market Access & Patient Services, who previously contributed to the successful launch of VYJUVEK® at Krystal Biotech, and Kent Taylor as Senior Vice President of Sales, who previously led U.S. commercialization efforts for ZORYVE® at Arcutis Biotherapeutics and supported the launch of OPZELURA® at Incyte. Expanded Palvella’s Board of Directors with the appointment of John D. Doux, M.D., M.B.A., a board-certified dermatologist and seasoned life sciences investor with deep expertise in rare skin diseases and biotechnology investing. First Quarter 2026 Financial Results Cash, cash equivalents, and short-term investments as of March 31, 2026 were $261.9 million, which reflects net proceeds of $215.8 million from a February 2026 equity financing. Research and development expenses for the three months ended March 31, 2026 were $9.3 million, as compared to $4.1 million for the three months ended March 31, 2025. The increase was primarily due to increased spending for manufacturing activities and costs resulting from increased headcount and consulting services in 2026. General and administrative expenses for the three months ended March 31, 2026 were $5.5 million, as compared to $3.8 million for the three months ended March 31, 2025. The increase was primarily due to increased headcount in 2026, as well as increased professional services related to operating as a publicly-traded company. Net loss was $15.8 million, or $1.20 per basic and diluted share, for the three months ended March 31, 2026, as compared to net loss of $8.2 million, or $0.74 per basic and diluted share, for the three months ended March 31, 2025. Shares outstanding were 15,738,543 as of May 1, 2026, including 14,342,844 shares of common stock and 1,394,761 common share equivalents assuming conversion of outstanding pre-funded warrants. Conference Call Details Palvella will host a conference call and live audiovisual webcast to discuss the Company's full year 2025 financial results and provide a corporate update at 8:30 a.m. ET today. To access the live webcast, including slides, please click here or visit the “Events & Presentations” section of Palvella’s website. To join the conference call by phone, dial 800-715-9871 (domestic) or +1 646-307-1963 (international) and provide Conference ID 9970701. Participants are encouraged to dial in approximately 15 minutes prior to the start of the call. A replay of the webcast will be available approximately 2 hours after the conclusion of the call and archived for 90 days under the "Events & Presentations" section of the Company's website at . About Palvella Therapeutics Founded and led by rare disease biotech veterans, Palvella Therapeutics, Inc. (Nasdaq: PVLA) is a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare skin diseases and vascular malformations for which there are no FDA-approved therapies. Palvella is developing a broad pipeline of product candidates based on its patented QTORIN™ platform, with an initial focus on serious, rare skin diseases and vascular malformations, many of which are lifelong in nature. Palvella’s lead product candidate, QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin), is currently being developed for the treatment of microcystic lymphatic malformations, cutaneous venous malformations, and clinically significant angiokeratomas. Palvella’s second product candidate, QTORIN™ pitavastatin, is currently being developed for the treatment of disseminated superficial actinic porokeratosis. For more information, please visit or follow Palvella on LinkedIn or X (formerly known as Twitter). QTORIN™ rapamycin and QTORIN™ pitavastatin are for investigational use only and neither has been approved by the FDA or by any other regulatory agency for any indication. Forward-Looking Statements This press release contains forward-looking statements (including within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended (Securities Act)). These statements may discuss goals, intentions, and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the management of Palvella, as well as assumptions made by, and information currently available to, the management of Palvella. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” and other similar expressions or the negative or plural of these words, or other similar expressions that are predictions or indicate future events or prospects, although not all forward-looking statements contain these words. Statements that are not historical facts are forward-looking statements. Forward-looking statements include, but are not limited to, statements regarding the expected timing of the presentation of data from clinical trials, Palvella’s clinical development plans and related anticipated development milestones, Palvella’s plans to pursue Breakthrough Therapy Designation, Palvella’s plans to meet with regulatory authorities, Palvella’s expectations regarding the benefits of orphan drug designation and potential benefit of orphan drug exclusivity for QTORIN™ rapamycin for the treatment of microcystic lymphatic malformations, Palvella’s cash, financial resources and expected runway, Palvella’s expectations regarding its programs, including QTORIN™ rapamycin and QTORIN™ pitavastatin, and its research-stage opportunities, including its expected therapeutic potential and market opportunity. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the ability to raise additional capital to finance operations; the ability to advance product candidates through preclinical and clinical development; the ability to obtain regulatory approval for, and ultimately commercialize, Palvella’s product candidates, including QTORIN™ rapamycin and QTORIN™ pitavastatin; the outcome of early clinical trials for Palvella’s product candidates, including the ability of those trials to satisfy relevant governmental or regulatory requirements; the fact that data and results from clinical studies may not necessarily be indicative of future results; Palvella’s limited experience in designing clinical trials and lack of experience in conducting clinical trials; Palvella’s limited experience in commercial manufacturing; the ability to identify and pivot to other programs, product candidates, or indications that may be more profitable or successful than Palvella’s current product candidates; the substantial competition Palvella faces in discovering, developing, or commercializing products; the negative impacts of global events on operations, including ongoing and planned clinical trials and ongoing and planned preclinical studies; the ability to attract, hire, and retain skilled executive officers and employees; the ability of Palvella to protect its intellectual property and proprietary technologies; reliance on third parties, contract manufacturers, and contract research organizations; and the risks and uncertainties described in the filings made by Palvella with the Securities and Exchange Commission (SEC), including the annual report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, filed with or furnished to the SEC and available at . The events and circumstances reflected in our forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that Palvella may face. Except as required by applicable law, Palvella does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. This press release contains hyperlinks to information that is not deemed to be incorporated by reference into this press release. Contact Information Investors Wesley H. Kaupinen Founder and CEO, Palvella Therapeutics wes.kaupinen@palvellatx.com Media Marcy Nanus Managing Partner, Trilon Advisors LLC mnanus@trilonadvisors.com PALVELLA THERAPEUTICS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (in thousands, except share and per share amounts) Three Months Ended March 31, 2026 2025 Operating expenses: Research and development $ 9,334 $ 4,074 General and administrative 5,521 3,797 Total operating expenses 14,855 7,871 Loss from operations (14,855 ) (7,871 ) Total other income (expense), net (912 ) (314 ) Net loss $ (15,767 ) $ (8,185 ) Net loss per share of Common Stock — basic and diluted $ (1.20 ) $ (0.74 ) Weighted-average shares used in computing net loss per share of Common Stock — basic and diluted 13,085,271 11,013,697 PALVELLA THERAPEUTICS, INC. CONDENSED CONSOLIDATED BALANCE SHEET INFORMATION (in thousands) March 31, December 31, 2026 2025 Assets Cash and cash equivalents $ 206,394 $ 57,982 Short-term investments 55,459 — Other current assets 1,378 1,005 Total current assets 263,231 58,987 Non-current assets 528 572 Total assets $ 263,759 $ 59,559 Liabilities and Stockholders' Equity Current liabilities $ 9,115 $ 11,344 Non-current liabilities 22,331 20,232 Total liabilities 31,446 31,576 Total stockholders' equity 232,313 27,983 Total liabilities and stockholders’ equity $ 263,759 $ 59,559

Phase 3Breakthrough TherapyExecutive ChangeFinancial StatementClinical Result

06 May 2026

·investors.arcutis.com

Arcutis Announces First Quarter 2026 Financial Results and Provides Business Update

Q1 2026 net product revenue for ZORYVE® (roflumilast) was $105.4 million, a 65% increase compared to Q1 2025, and a 17% decrease compared to Q4 2025 Continued strong demand for ZORYVE despite typical Q1 seasonality, with continued growth in share of branded non-steroidal topical treatments Submitted supplemental New Drug Application (sNDA) for ZORYVE cream 0.05% to the U.S. Food and Drug Administration (FDA) to expand the indication for the treatment of atopic dermatitis in infants ages 3 to 24 months Completed enrollment in ZORYVE foam 0.3% Maximum Usage Systemic Exposure (MUSE) trial in children with plaque psoriasis of the scalp and body ages 2 to 11 years Initiated Phase 1a/1b, first-in-human study to evaluate safety and tolerability for investigational ARQ-234 in healthy volunteers and adults with moderate to severe atopic dermatitis Completed expansion of dermatology sales force at the beginning of May, and initiated the build-out of a primary care and pediatrics-focused organization including the hiring of the head of Primary Care Franchise Maintained positive operating cash flow for the quarter WESTLAKE VILLAGE, Calif., May 06, 2026 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today reported financial results for the quarter ended March 31, 2026, and provided a business update. “Strong product revenue in the first quarter was driven by continued robust demand for ZORYVE, which remains the leading prescribed branded topical across its three approved indications. During the quarter, we also advanced our pipeline with the initiation of a Phase 1 trial for ARQ‑234, our biologic candidate for atopic dermatitis, submission of an sNDA to the FDA to expand the ZORYVE cream indication in atopic dermatitis to patients as young as 3 months, and progress on our Phase 2 proof-of-concept studies of ZORYVE in potential new indications,” said Frank Watanabe, president and chief executive officer. “We also continued to generate positive cash flow, underscoring our focus on financial and operational discipline as we continue to advance our corporate strategy.” First Quarter 2026 Financial Results and Business HighlightsCommercial HighlightsZORYVE — a highly potent and selective phosphodiesterase-4 (PDE4) inhibitor in once-daily cream and foam formulations, approved in the United States and Canada for the treatment of plaque psoriasis, atopic dermatitis, and seborrheic dermatitis. ZORYVE net product sales for the first quarter of 2026 were $105.4 million, reflecting a 17% sequential decline versus the fourth quarter of 2025 and 65% year-over-year growth. The sequential decline was primarily due to typical first-quarter patient deductible resets and insurance changes. The dermatology sales force expansion has been completed, with representatives in the field at the beginning of May, to optimize prescriber targeting and call frequency in order to deepen adoption of ZORYVE. Began the build-out of an internal, targeted sales team dedicated to primary care and pediatric healthcare providers with the hiring of Katie Swolfs as the head of Primary Care Franchise. Katie brings an incredible breadth and depth of commercial experience to the role, having held a series of strategic and operational senior leadership positions for dermatology-focused companies. Clinical and Regulatory Developments Submitted an sNDA for ZORYVE cream 0.05% to the FDA to expand the indication for the treatment of mild to moderate atopic dermatitis in infants ages 3 to 24 months. Presented new results from the INTEGUMENT-INFANT Phase 2 trial in infants with atopic dermatitis in a late-breaking session at the 2026 American Academy of Dermatology (AAD) Annual Meeting, highlighting that investigational ZORYVE cream 0.05% was well tolerated, improved signs and symptoms of mild to moderate atopic dermatitis, and demonstrated a rapid improvement in itch in as little as 10 minutes in nearly half of infants, as reported by caregivers. Prescription Drug User Fee Act target action date for ZORYVE cream 0.3% for the treatment of plaque psoriasis down to 2 years of age is assigned for June 29, 2026. Completed enrollment in the 0.3% ZORYVE foam MUSE trial in children with plaque psoriasis of the scalp and body ages 2 to 11 years intended to serve as the basis for an sNDA submission to expand the indication for this age group. The Company continues to enroll patients in Phase 2 proof-of-concept studies with ZORYVE foam 0.3% for the treatment of vitiligo and hidradenitis suppurativa, and expects to report results, as well as decisions on program advancement in these indications, in the fourth quarter of 2026 and the first quarter of 2027, respectively. Initiated Phase 1a/1b, first-in-human study to evaluate safety and tolerability for investigational ARQ-234, a fusion protein that is a potent and highly selective checkpoint agonist of the CD200 receptor, in healthy volunteers and adults with moderate to severe atopic dermatitis. Corporate Updates ZORYVE cream 0.05% received a strong recommendation in the AAD Clinical Practice Guidelines for the management of pediatric atopic dermatitis. Sustained positive cash flow, generating $2.2 million of positive cash flow from operating activities in Q1 2026. First Quarter 2026 Summary Financial ResultsNet Product revenues for the quarter ended March 31, 2026 were $105.4 million compared to $63.8 million for the corresponding period in 2025. Revenues for the quarter were $32.7 million for ZORYVE (roflumilast) cream 0.3%, $49.6 million for ZORYVE (roflumilast) topical foam 0.3%, $21.7 million for ZORYVE (roflumilast) cream 0.15%, and $1.4 million for ZORYVE (roflumilast) cream 0.05%. Year-over-year increases were due to strong unit demand as well as improvements in gross-to-net sales deductions. In addition, the first quarter of 2025 included Other revenues of $2.0 million related to license revenues received in connection with the Huadong Pharmaceutical collaboration and licensing agreement covering China and Greater Asia. Cost of sales for the quarter ended March 31, 2026 were $9.8 million compared to $8.8 million for the corresponding period in 2025, due to increased ZORYVE sales. Research and development (R&D) expenses for the quarter ended March 31, 2026 were $30.6 million compared to $17.5 million for the corresponding period in 2025. The year-over-year increase was primarily due to the $10.0 million milestone obligation to former stockholders of Ducentis triggered by the dosing of the first patient in the ARQ-234 Phase 1a/1b trial. Selling, general, and administrative (SG&A) expenses for the quarter ended March 31, 2026 were $74.1 million compared to $64.0 million for the corresponding period in 2025. The year-over-year increase was primarily due to compensation and personnel-related expenses and to higher sales and marketing expenses related to the Company’s continued commercialization efforts for ZORYVE. Net loss was $11.3 million, or $0.09 per basic and diluted share, for the quarter ended March 31, 2026 compared to $25.1 million, or $0.20 per basic and diluted share, for the corresponding period in 2025. Cash, cash equivalents, restricted cash, and marketable securities were $224.3 million as of March 31, 2026, compared to $221.3 million as of December 31, 2025. Net cash provided by operating activities was $2.2 million during the first quarter. Financial GuidanceThe Company continues to anticipate net product revenue of between $480 million and $495 million for the full year 2026. Conference Call and WebcastArcutis management will host a conference call and webcast today at 4:30 PM ET to discuss the financial results for the quarter and provide a business update. The webcast for this conference call may be accessed in the “Events” section of the Company’s website. A replay of the webcast will be available on the Arcutis website following the call. 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 develop differentiated therapies against biologically validated targets, and has produced a robust pipeline for a range of inflammatory dermatological conditions. For more information, visit www.arcutis.com 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 to address large markets with significant unmet need; the development, submission, and potential approval, and potential commercialization of product candidates and expanded indications; the potential commercial success and growth of ZORYVE in plaque psoriasis, seborrheic dermatitis, and atopic dermatitis; anticipated net product sales for 2026; the expansion of the Company's dermatology sales force and the success of the Company's efforts in primary care and pediatric health care providers; the Company's ability to maintain positive operating cash flow on a quarterly basis; the building and advancement of the Company's pipeline; and the timing of regulatory filings. These statements involve 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 and you should not place undue reliance on our forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in the clinical development process and regulatory approval process, the timing of regulatory filings, the timing, expenses, and success of our commercialization efforts, including uncertainty of future commercial sales and related items that can impact net sales, and our ability to defend our intellectual property. For a further description of the risks and uncertainties applicable to our business, see the “Risk Factors” section of our Form 10-K filed with U.S. Securities and Exchange Commission (SEC) on February 25, 2026, 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. Contacts: MediaAmanda Sheldon, head of Corporate Communicationsmedia@arcutis.com InvestorsBrian Schoelkopf, head of Investor Relationsir@arcutis.com

Phase 2Clinical ResultPhase 3Financial StatementDrug Approval

100 Deals associated with Roflumilast

External Link

KEGG	Wiki	ATC	Drug Bank
D05744	Roflumilast	R03DX07	DB01656

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Dermatitis, Atopic	United States	Arcutis Biotherapeutics, Inc.	10 Jul 2024
Dermatitis, Seborrheic	United States	Arcutis Biotherapeutics, Inc.	15 Dec 2023
Plaque psoriasis	Canada	Arcutis Biotherapeutics, Inc.	20 Dec 2019
Pulmonary Disease, Chronic Obstructive	European Union	AstraZeneca AB	05 Jul 2010
Pulmonary Disease, Chronic Obstructive	Iceland	AstraZeneca AB	05 Jul 2010
Pulmonary Disease, Chronic Obstructive	Liechtenstein	AstraZeneca AB	05 Jul 2010
Pulmonary Disease, Chronic Obstructive	Norway	AstraZeneca AB	05 Jul 2010

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Mild Atopic Dermatitis	Phase 3	China	Hangzhou Zhongmeihuadong Pharmaceutical Co., Ltd.	21 Nov 2024
Mild Atopic Dermatitis	Phase 3	China	Arcutis Biotherapeutics, Inc.	21 Nov 2024
Moderate Atopic Dermatitis	Phase 3	China	Arcutis Biotherapeutics, Inc.	21 Nov 2024
Moderate Atopic Dermatitis	Phase 3	China	Hangzhou Zhongmeihuadong Pharmaceutical Co., Ltd.	21 Nov 2024
Psoriasis of scalp	Phase 3	United States	Arcutis Biotherapeutics, Inc.	24 Aug 2021
Psoriasis of scalp	Phase 3	Canada	Arcutis Biotherapeutics, Inc.	24 Aug 2021
Chronic large plaque psoriasis	Phase 3	United States	Arcutis Biotherapeutics, Inc.	12 Feb 2020
Chronic large plaque psoriasis	Phase 3	Canada	Arcutis Biotherapeutics, Inc.	12 Feb 2020
Chronic large plaque psoriasis	Phase 3	Dominican Republic	Arcutis Biotherapeutics, Inc.	12 Feb 2020
Asthma	Phase 3	United States	AstraZeneca PLC	01 Nov 2003

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06631170 (AAD2026)	Phase 3	Dermatitis, Atopic	354	Roflumilast cream 0.15%	tvijatcgnw(kkvezotsqx) = zdeqomyean oihcetdxvn (uodcjrwbra ) View more	Positive	27 Mar 2026
				Vehicle cream	tvijatcgnw(kkvezotsqx) = abmbrkmbnr oihcetdxvn (uodcjrwbra ) View more
NCT04973228 (STRATUM, AAD2026)	Phase 3	Dermatitis, Seborrheic	457	Roflumilast foam 0.3%	jywciqinod(bfolokuosm) = vpgrxhpnkx gviafydopt (bytgjlrunw ) View more	Positive	27 Mar 2026
				Vehicle	jywciqinod(bfolokuosm) = nhiqswrifl gviafydopt (bytgjlrunw ) View more
NCT04804605 (INTEGUMENT-OLE, AAD2026)	Phase 3	Dermatitis, Atopic	562	Roflumilast cream 0.05%	skvgklnptu(nzoohxxrfa) = oelwlwpjsa jvxajoyvde (towaghkoig ) View more	Positive	27 Mar 2026
NCT04804605 (INTEGUMENT-OLE, Pediatr Dermatol) Manual	Phase 3	Moderate Atopic Dermatitis \| Mild Atopic Dermatitis	562	Roflumilast	uokbqboiqw(doluklpyxu) = clylyxecma rzzbqoflfc (preposvszu ) View more	Positive	08 Mar 2026
				Roflumilast (patients who switched to BIW application)	ptreyysssi(qgkuerhoxy) = ebiqxosjct fantpgykga (tsmahjjdjh )
NCT04845620 (INTEGUMENT-OLE, Pubmed \| Pediatr Dermatol)	Phase 3	Dermatitis, Atopic	562	Roflumilast Cream 0.05%	piympkqrxe(skudjinlqv) = brnjsiujvp yqhpjkzlec (azejniyoct ) View more	Positive	08 Mar 2026
NCT04804605 (INTEGUMENT-OLE, AAAAI2026)	Phase 3	Dermatitis, Atopic	1,220	Roflumilast cream 0.15% (Atopic Dermatitis + ≥12 years)	dwyrvfgxko(waqzbluyko) = 14.8% to 3.7% cnvjtorvsn (xnslcwaoro ) View more	Positive	27 Feb 2026
				Roflumilast cream 0.05% (Atopic Dermatitis + 2-11 years)
NCT06998056 (INTEGUMENT-INFANT, Company_Website) Manual	Phase 2	Moderate Atopic Dermatitis \| Mild Atopic Dermatitis	101	Roflumilast	giptweemaq(lgrivlpcye) = low, with all being mild to moderate in severity scfnksdiex (katkkdeomx )	Positive	02 Feb 2026
NCT04845620 (INTEGUMENT-PED \| INTEGUMENT-OLE, CTgov)	Phase 3	Dermatitis, Atopic	652	Roflumilast Cream 0.05% (Roflumilast Cream 0.05%)	xxtzthtvkb = eivrygexzg djyjgkovcv (muqpugyjjv, vcdsnlamku - kqsodrojxs) View more	-	23 Dec 2025
				Vehicle Cream (Vehicle Cream)	xxtzthtvkb = liznhukzur djyjgkovcv (muqpugyjjv, ucuvzvblcy - yogureljuq) View more
NCT04804605 (INTEGUMENT-OLE, CTgov)	Phase 3	Dermatitis, Atopic	1,220	roflumilast cream (ARQ-151-311/312: RC/RC 0.15% Group)	fkpenkgbei = dqtwyqpuzv oydogvzjfg (qiclqlwgua, kxfjrxwjkz - qybttjyhus) View more	-	23 Dec 2025
				roflumilast (ARQ-151-311/312: VC/RC 0.15% Group)	fkpenkgbei = rlbvdldmnj oydogvzjfg (qiclqlwgua, cdeasekudq - qiexrhkbqd) View more
NCT04211363 \| NCT04211389 (DERMIS-1, Pubmed \| Dermatol Ther (Heidelb))	Phase 3	Plaque psoriasis	398	Roflumilast cream 0.3%	hrrlntttbn(dvlmmayres) = czmypzcixm zdiimrpqat (rzlefnknst ) View more	Positive	01 Dec 2025
				Vehicle	hrrlntttbn(dvlmmayres) = rpauiapwfc zdiimrpqat (rzlefnknst ) View more

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