brepocitinib (PF-06700841) / Pfizer, Priovant Therap - LARVOL DELTA

Once-daily oral ritlecitinib or brepocitinib versus placebo in patients with moderate-to-severely active Crohn's disease (PIZZICATO): an international, randomised, phase 2a trial. (PubMed, EClinicalMedicine) - P2 | "Further studies are required for both molecules and to better understand responder and non-responder populations. Pfizer Inc."

Journal • P2a data • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Hepatocellular Cancer • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Novel Coronavirus Disease • Oncology • Pain • Respiratory Diseases • Solid Tumor • ICAM3 • JAK3 • TYK2

Comparative Efficacy and Safety of Novel Biologics and Small-Molecule Therapies for Moderate-to-Severe Hidradenitis Suppurativa: A Systematic Review and Network Meta-Analysis (AAD 2026) - "Background Current FDA-approved systemic therapies for moderate-to-severe hidradenitis suppurativa (HS) include TNF-α inhibitors (adalimumab) and IL-17 inhibitors (bimekizumab, secukinumab) (1). Conclusions This NMA identifies JAK1 (porvocitinib, brepocitinib, and upadacitinib) and C5a (vilobelimab) inhibitors as promising investigational treatments for moderate-to-severe HS, representing potential future treatment alternatives for patients refractory to or intolerant of current therapies. However, the small-to-moderate sample sizes and short-term follow-up of such studies highlight the need for future larger, longer-term trials."

Retrospective data • Review • Dermatology • Hidradenitis Suppurativa • Immunology • IL17A • IL23A • JAK1

Brepocitinib Achieves Rapid and Sustained Control of Cutaneous Disease Activity, Itch, and Skin-Related Quality of Life in Dermatomyositis: Results From the Phase 3 VALOR Trial (AAD 2026) - No abstract available

HEOR • Late-breaking abstract • P3 data • Dermatomyositis • Immunology • Myositis

Brepocitinib Demonstrates Consistent Benefit on Combined Measures of Clinical Response and Sustained Corticosteroid Tapering in Dermatomyositis Patients at One Year (EULAR 2026) - No abstract available

Clinical • Dermatomyositis • Immunology • Myositis

Rapid, Clinically Meaningful Improvement in Skin Disease with Brepocitinib in Dermatomyositis: Results from the Phase 3 VALOR Trial (EULAR 2026) - No abstract available

Clinical • P3 data • Dermatology • Dermatomyositis • Immunology • Myositis

Priovant Announces FDA Acceptance and Priority Review of New Drug Application for Brepocitinib in Dermatomyositis (The Manila Times) - "The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date in the third quarter of calendar year 2026. The company expects to launch the drug in the United States at the end of September 2026...The Priority Review designation was supported by the significant unmet medical need in dermatomyositis and the results from the Phase 3 VALOR study evaluating brepocitinib in DM."

FDA filing • Launch US • PDUFA • Priority review • Dermatomyositis

Dual TYK2/JAK1 Inhibition by Brepocitinib Reprograms Synoviocyte Pathobiology: Mechanistic Insights Into Targeted Therapy for Rheumatoid Arthritis. (PubMed, Iran J Pharm Res) - "Brepocitinib maintained ≥ 85% cell viability across all doses, compared with ~20% viability in doxorubicin-treated controls. Brepocitinib exerts multi-faceted effects on RA synoviocytes by simultaneously inhibiting inflammatory signaling, suppressing cytokine expression, restoring apoptotic sensitivity, and reducing migratory potential. These findings provide mechanistic support for brepocitinib as a targeted therapeutic agent in RA."

IO biomarker • Journal • Immunology • Inflammation • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • BAX • BCL2 • CASP3 • IFNG • IL6 • JAK1 • STAT1 • STAT3 • TNFA • TYK2

Safety and efficacy of different JAK inhibitors in the treatment of inflammatory bowel disease: a network meta-analysis. (PubMed, Front Pharmacol) - "This network meta-analysis aimed to compare the efficacy and safety of various JAK inhibitors, including brepocitinib, filgotinib, ivarmacitinib, peficitinib, ritlecitinib, tofacitinib, and upadacitinib, in patients with IBD. Long-term studies are needed to confirm these results. https://www.crd.york.ac.uk/PROSPERO/view/CRD42024595343, Identifier CRD42024595343."

Journal • Retrospective data • Review • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

New Drug Application (NDA) was submitted to the FDA for brepocitinib in dermatomyositis (DM). (The Manila Times)

FDA filing • Dermatomyositis

Priovant plans to progress CS to a pivotal program with a Phase 3 study starting in calendar year 2026 following engagement with the FDA, representing the third indication with a pivotal program for brepocitinib. (The Manila Times) - "Topline data from the Phase 3 trial of brepocitinib in NIU are expected in the second half of calendar year 2026."

New P3 trial • P3 data: top line • Sarcoidosis • Uveitis

In February 2026, Priovant announced positive Phase 2 results for brepocitinib in cutaneous sarcoidosis (CS). Brepocitinib 45 mg significantly improved CS disease activity, achieving a 22.3-point improvement in mean CSAMI-A at Week 16 versus a 0.7-point improvement in placebo (The Manila Times)

P2 data • Sarcoidosis

CLARITY: A Study of Brepocitinib in Adults With Active, Non-Infectious, Non-Anterior Uveitis (clinicaltrials.gov) - P3 | N=371 | Active, not recruiting | Sponsor: Priovant Therapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Ocular Inflammation • Ophthalmology • Uveitis

Brepocitinib, a selective TYK2/JAK1 inhibitor, mitigates neutrophilic inflammation and glucocorticoid receptor-β expression in COPD. (PubMed, Am J Physiol Lung Cell Mol Physiol) - "Overall, these findings demonstrate that TYK2/JAK1 inhibition mitigates IL-23/IL-17A-induced neutrophil-driven inflammation and GRβ upregulation in COPD. This highlights the JAK/STAT pathway as a promising therapeutic target to overcome severe airway inflammation and restore GRα/GRβ balance in neutrophils."

Journal • Chronic Obstructive Pulmonary Disease • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • CXCL8 • IL17A • IL23A • JAK2 • NR3C1 • TYK2

Program-Specific Highlights and Updates (GlobeNewswire) - "Preparation for commercial launch of brepocitinib in DM is underway; NDA filing expected in early calendar year 2026 with potential commercial launch early in calendar year 2027; Phase 3 trial for brepocitinib in NIU is fully enrolled ahead of schedule with topline data expected in the second half of calendar year 2026, previously expected in the first half of calendar year 2027; Proof-of-concept trial for brepocitinib in CS is fully enrolled ahead of schedule with topline data expected in the first half of calendar year 2026, previously expected in the second half of calendar year 2026."

Clinical data • FDA filing • Launch US • Dermatomyositis • Sarcoidosis • Uveitis

P114 Efficacy and safety of oral Janus kinase, tyrosine kinase 2 and phosphodiesterase 4 inhibitors in the treatment of chronic plaque psoriasis: a network meta-analysis. (PubMed, Br J Dermatol) - "After 16-24 weeks of treatment, tofacitinib and deucravacitinib had the highest efficacy, followed by apremilast, orismilast, upadacitinib and brepocitinib. Zasocitinib, a new highly selective allosteric TYK2 inhibitor, has recently demonstrated promising efficacy in the treatment of psoriasis, with 33% of patients achieving PASI 100 (complete clearance of psoriasis lesions) after just 12 weeks of treatment. In conclusion, oral TYK2 inhibitors have shown efficacy in the treatment of chronic plaque psoriasis comparable with adalimumab, with newer agents demonstrating enhanced effectiveness and surpassing PDE-4 inhibitors in therapeutic outcomes. JAK inhibitors, particularly tofacitinib, exhibit comparable efficacy to some TYK2 and PDE-4 inhibitors."

Clinical • Journal • Retrospective data • Review • Dermatology • Immunology • Psoriasis • TYK2

Efficacy and Safety of Brepocitinib in Patients with Active Dermatomyositis: Results from a Randomized, Double-Blind, Multicenter, Placebo-Controlled, Phase III (VALOR) Trial (ISDS 2025) - P3 | "For participants receiving oral corticosteroids (OCS) at baseline, there was a mandatory taper between weeks 12 and 36 to prednisone ≤ 5 mg QD. VALOR is the first positive, randomized, double-blind, placebo-controlled study of a targeted oral therapeutic in DM, distinguished by its 52-week duration and largest enrolled clinical trial population to date. BREPO 30 mg QD achieved statistically significant and clinically meaningful efficacy, with rapid, consistent, and sustained benefits across skin, muscle, and QOL outcome measures. Safety was consistent with prior BREPO studies and supports a favorable benefit-risk profile."

Clinical • P3 data • Dermatology • Dermatomyositis • Immunology • Myositis • JAK1 • TYK2

Major Upcoming Milestones (GlobeNewswire) - "Priovant plans to file an NDA for brepocitinib in DM in the first half of calendar year 2026. Topline data from the ongoing Phase 3 trial of brepocitinib in NIU and proof-of-concept trial in CS are expected in the first half of calendar year 2027 and second half of calendar year 2026, respectively."

Clinical data • FDA filing • Dermatomyositis • Sarcoidosis • Uveitis

Brepocitinib Inhibits Key Pathogenic Cytokine Signaling in Dermatomyositis Patients (ACR Convergence 2025) - P3 | "Previous data has suggested that brepocitinib 30 mg may demonstrate superior inhibition of DM-relevant cytokine signaling in vitro compared to tofacitinib, a JAK1/JAK3 inhibitor.1 The purpose of this study was to evaluate the ability of brepocitinib to inhibit pathogenic cytokine signaling ex vivo in peripheral blood mononuclear cells (PBMCs) from patients with DM and healthy donors. PBMCs were isolated from whole blood from six participants with a diagnosis of DM according to the 2017 EULAR/ACR Classification Criteria for Idiopathic Inflammatory Myopathies and screened for baseline responsiveness to cytokine stimulation. Brepocitinib demonstrated potent inhibition of proinflammatory cytokine signaling in PBMCs at exposures achieved with brepocitinib 30 mg QD. This inhibition was more potent in samples from patients with DM than healthy donors, which may reflect pathologic overactivation of JAK-STAT signaling in DM. These results confirm findings from previous work..."

Clinical • Dermatology • Dermatomyositis • Immunology • Myositis • IFNA1 • IFNB1 • IL6 • JAK1 • JAK3 • STAT1 • TYK2

Efficacy and safety of oral JAK, TYK2 and PDE4 inhibitors in the treatment of chronic plaque psoriasis - a network meta-analysis (EADV 2025) - "After 12-16 weeks of treatment, solcitinib (PASI75 odds ratio [OR] 37.92) had the highest efficacy compared to placebo , followed by zasocitinib (34.59), tofacitinib (22.01), ropsacitinib (16.79), brepocitinib (14.88) and deucravacitinib (14.17). Oral TYK2 inhibitors have shown efficacy in the treatment of chronic plaque psoriasis comparable to adalimumab, with newer agents demonstrating enhanced effectiveness and far surpassing PDE4 inhibitors in therapeutic outcomes. JAK inhibitors, particularly solcitinib and tofacitinib, exhibit comparable efficacy to TYK2 inhibitors. EADV Congress 2025 PARIS"

Retrospective data • Dermatology • Immunology • Psoriasis • TYK2

Rapid Improvement of Cutaneous Dermatomyositis with Brepocitinib: A 12-Week Open-Label Trial (EADV 2025) - P2 | "In a population with recalcitrant, severe cutaneous DM, brepocitinib was associated with rapid, clinically meaningful improvement in CDASI-A in all participants during 12 weeks of treatment. Consistent benefits were observed in other clinician- and patient-reported measures of skin activity. The results of a global phase III, randomized, placebo-controlled, dose-ranging, 52-week trial of brepocitinib in adult DM patients with skin and muscle disease (VALOR, NCT0543726) are forthcoming and will further clarify the potential of brepocitinib for the treatment of DM."

Clinical • Dermatology • Dermatomyositis • Immunology • Infectious Disease • Myositis • IL12A • IL23A • IL6 • JAK1 • TYK2

Roivant and Priovant Announce Positive Phase 3 VALOR Study Results for Brepocitinib in 52-Week Placebo-Controlled Trial in Dermatomyositis (DM) (Roivant Sciences) - "On the primary endpoint, brepocitinib 30 mg achieved a week 52 mean Total Improvement Score (TIS) of 46.5 compared to 31.2 for placebo (p=0.0006​), even with nearly twice as many patients coming off background steroids on brepocitinib 30 mg compared to placebo....Safety profile was consistent with previous clinical trials of brepocitinib and NDA filing is planned for calendar 1H 2026."

FDA filing • P3 data • Dermatomyositis

Unravelling the transcriptomic landscape of primary lymphocytic scarring alopecias: systematic review and meta-analysis. (PubMed, Front Immunol) - "Drug repurposing analyses identified candidate compounds modulating inflammation and metabolism, some reversing inflammatory signatures in brepocitinib-treated samples. This integrated molecular analysis refines our understanding of PLSA subtypes and proposes candidate biomarkers and therapeutic targets, supporting a shift toward biomarker-driven classification and personalized treatment strategies. https://www.crd.york.ac.uk/PROSPERO, identifier CRD42024559969."

Clinical • Journal • Retrospective data • Review • Alopecia • Cardiovascular • Fibrosis • Immunology • Inflammation • Lichen Planus • Metabolic Disorders • IFNG

Recent Developments (GlobeNewswire) - "Phase 3 VALOR study for brepocitinib evaluating its use in patients with DM...last patient last visit completed in July."

Enrollment closed • Dermatomyositis

Major Upcoming Milestones (GlobeNewswire) - "Priovant plans to report topline data from the ongoing Phase 3 trial of brepocitinib in DM in the second half of calendar year 2025 and topline data from the ongoing Phase 3 trial of brepocitinib in NIU in the first half of calendar year 2027. Topline results for the Phase 2 trial in CS are expected in the second half of calendar year 2026."

P2 data • P3 data: top line • Dermatomyositis • Sarcoidosis • Uveitis

Roivant and Priovant to Host Investor Video Conference at 1:00 PM ET on Tuesday, June 17 on Brepocitinib and the Unmet Medical Need in Dermatomyositis (Roivant Sciences) - "Roivant...and Priovant Therapeutics today announced that they will host a live investor video conference at 1:00 PM ET on Tuesday, June 17 on brepocitinib, the unmet medical need for patients with dermatomyositis (DM) and the potential role brepocitinib could play in improving the lives of patients with DM."

Clinical • Dermatomyositis