# LISRAYA (brepocitinib) 30 mg PDUFA Event: Dermatomyositis

Canonical URL: https://biopharmsignal.com/pdufa-calendar/ROIV/brepocitinib-dermatomyositis

Ticker: ROIV

Company: Roivant

Event date: 2026-08-27

Event type: FDA Decision

Stage: PDUFA

Result: Approved

Result date: 2026-08-27

Application type: NDA

FDA approved LISRAYA for adults with dermatomyositis. FDA approved once-daily oral LISRAYA 30 mg for the treatment of dermatomyositis in adults. FDA describe...

## Event Timeline

### August 27, 2026 — FDA approved LISRAYA for adults with dermatomyositis

FDA approved once-daily oral LISRAYA 30 mg for the treatment of dermatomyositis in adults. FDA described it as the first approved oral treatment option for the disease and confirmed that the application received Priority Review and Orphan Drug designations.

[FDA — Approval of LISRAYA for adults with dermatomyositis](https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-drug-indicated-treat-dermatomyositis-adults)

### August 26, 2026 — VALOR skin-specific outcomes published in JAMA Dermatology

The publication reported skin-specific secondary outcomes from the Phase 3 VALOR trial, further characterizing the effect of brepocitinib on cutaneous disease activity in adults with dermatomyositis.

[Roivant — JAMA Dermatology publication of VALOR skin outcomes](https://investor.roivant.com/news-releases/news-release-details/jama-dermatology-publishes-skin-specific-outcomes-phase-3-valor)

### March 28, 2026 — Phase 3 VALOR results published in NEJM

The peer-reviewed publication reported that brepocitinib 30 mg was superior to placebo on the primary endpoint and all nine key secondary endpoints, including measures of overall disease activity, muscle strength, skin disease, physical function and corticosteroid reduction.

[Roivant — NEJM publication of Phase 3 VALOR results](https://investor.roivant.com/news-releases/news-release-details/new-england-journal-medicine-publishes-positive-phase-3-valor/)

### March 3, 2026 — FDA accepted the NDA with Priority Review

FDA accepted the dermatomyositis NDA and granted Priority Review based on unmet need and the Phase 3 VALOR results.

[Roivant — NDA acceptance and Priority Review](https://investor.roivant.com/news-releases/news-release-details/priovant-announces-fda-acceptance-and-priority-review-new-drug)

### September 17, 2025 — VALOR reported positive Phase 3 results

Brepocitinib met the primary endpoint and all nine key secondary endpoints in the 52-week placebo-controlled VALOR trial, with a safety profile consistent with prior studies.

[Roivant — Positive Phase 3 VALOR results](https://investor.roivant.com/news-releases/news-release-details/roivant-and-priovant-announce-positive-phase-3-valor-study/)

### October 31, 2022 — Phase 3 VALOR study started

The pivotal VALOR trial began evaluating brepocitinib versus placebo in adults with dermatomyositis.

[ClinicalTrials.gov — VALOR study record (NCT05437263)](https://clinicaltrials.gov/study/NCT05437263)

## Regulatory Designations

- Priority Review FDA: [Roivant — NDA acceptance and Priority Review](https://investor.roivant.com/news-releases/news-release-details/priovant-announces-fda-acceptance-and-priority-review-new-drug)

- Orphan Drug FDA: [FDA — LISRAYA approval and Orphan Drug designation](https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-drug-indicated-treat-dermatomyositis-adults)

## Related Pages

- ROIV PDUFA calendar: https://biopharmsignal.com/pdufa-calendar/ROIV.md

- ROIV company profile: https://biopharmsignal.com/company/ROIV.md

- PDUFA calendar: https://biopharmsignal.com/pdufa-calendar.md

## Related News

- 2026-09-06 — Roivant to Present Topline Results from the Phase 2 PHocus Study of Mosliciguat in Patients with Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD) at the ERS Congress 2026 on Tuesday, September 8, 2026, and Host Investor Call: https://biopharmsignal.com/news/ROIV/roivant-to-present-topline-results-from-the-phase-2-phocus-study-of-mosliciguat--bf1ea553.md

- 2026-08-27 — Roivant Announces FDA Approval of LISRAYA™ (brepocitinib) for Adults with Dermatomyositis; Now Available in the U.S.: https://biopharmsignal.com/news/ROIV/roivant-announces-fda-approval-of-lisraya-brepocitinib-for-adults-with-dermatomy-c41f2ccf.md

- 2026-08-27 — Priovant Announces FDA Approval of LISRAYA™ (brepocitinib) for Adults with Dermatomyositis; Now Available in the U.S.: https://biopharmsignal.com/news/ROIV/priovant-announces-fda-approval-of-lisraya-brepocitinib-for-adults-with-dermatom-aeb72f3d.md

- 2026-08-26 — JAMA Dermatology Publishes Skin-Specific Outcomes from Phase 3 VALOR Trial Of Brepocitinib in Dermatomyositis: https://biopharmsignal.com/news/ROIV/jama-dermatology-publishes-skin-specific-outcomes-from-phase-3-valor-trial-of-br-9823c862.md

- 2026-08-06 — Priovant Announces First Patients Enrolled in Phase 3 Study (BEACON+) of Brepocitinib in Cutaneous Sarcoidosis (CS): https://biopharmsignal.com/news/ROIV/priovant-announces-first-patients-enrolled-in-phase-3-study-beacon-of-brepocitin-65eb89c6.md