Roivant Sciences (ROIV) has upcoming FDA regulatory milestones for Brepocitinib. The table below outlines estimated target dates and event types for these pending regulatory actions.
This section highlights FDA-related milestones and regulatory updates for drugs developed by Roivant Sciences (ROIV).
Over the past two years, Roivant Sciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Brepocitinib, Mosliciguat, and VTAMA. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
Brepocitinib FDA Regulatory Timeline and Events
Brepocitinib is a drug developed by Roivant Sciences for the following indication: Systemic Lupus Erythematosus.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Brepocitinib
- Announced Date:
- April 2, 2026
- Indication:
- Systemic Lupus Erythematosus
Announcement
Roivant announced a new Phase 2b/3 clinical program for brepocitinib in lichen planopilaris (LPP), a highly morbid inflammatory scalp disorder affecting approximately 100,000 adults in the United States, and reported the topline results from Immunovant's two Phase 3 (GO) clinical studies evaluating batoclimab as an investigational treatment for adults with active, moderate-to-severe thyroid eye disease (TED).
AI Summary
Roivant announced a Phase 2b/3 clinical program for brepocitinib to treat lichen planopilaris (LPP), a severe inflammatory scalp disorder affecting about 100,000 U.S. adults. LPP attacks the stem cell–rich bulge of hair follicles, causing irreversible hair loss, permanent scarring, pain, burning, itching and scaling. Patients also face higher risks of other autoimmune diseases and skin cancers. No approved therapies currently exist.
Immunovant reported topline results from two Phase 3 GO studies of batoclimab for adults with moderate-to-severe thyroid eye disease (TED). The trials did not meet the primary endpoint — ≥2 mm proptosis responder rate at Week 24 after 12 weeks high-dose then 12 weeks low-dose. Safety matched prior findings with no new signals. Greater improvement occurred after the high‑dose phase, supporting deeper IgG suppression; a hyperthyroid subset showed thyroid hormone responses similar to Phase 2. Immunovant and partner HanAll will review next steps.
Read Announcement- Drug:
- Brepocitinib
- Announced Date:
- March 28, 2026
- Indication:
- Systemic Lupus Erythematosus
Announcement
Priovant Therapeutics announced today the publication of results from the Phase 3 VALOR trial evaluating brepocitinib in adults with dermatomyositis (DM) in the New England Journal of Medicine (NEJM).
AI Summary
Priovant Therapeutics announced the publication of results from the Phase 3 VALOR trial evaluating brepocitinib in adults with dermatomyositis. The full paper, titled “A Phase 3 Trial of Brepocitinib in Dermatomyositis,” appears in the New England Journal of Medicine, providing peer‑reviewed data on the drug’s effects in this patient population.
Alongside the NEJM publication, Priovant presented additional skin‑focused analyses at the 2026 Annual American Academy of Dermatology meeting. Those presentations expanded on how brepocitinib performed on cutaneous signs and symptoms of dermatomyositis, offering clinicians more detail on skin outcomes beyond the primary trial report.
The company framed the NEJM article and the AAD analyses as complementary, aiming to give physicians and patients a clearer picture of brepocitinib’s potential role in treating dermatomyositis based on Phase 3 evidence and focused dermatologic findings.
Read Announcement- Drug:
- Brepocitinib
- Announced Date:
- March 3, 2026
- Target Action Date:
- Q3 2026
- Estimated Target Date Range:
- July 1, 2026 - September 30, 2026
- Indication:
- Systemic Lupus Erythematosus
Announcement
Priovant Therapeutics announced that The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date in the third quarter of calendar year 2026.
AI Summary
Priovant Therapeutics said the U.S. Food and Drug Administration has set a PDUFA target action date in the third quarter of calendar year 2026 for brepocitinib, their investigational treatment for dermatomyositis. This date marks when the FDA aims to complete its review and issue a decision on the drug’s New Drug Application.
Dermatomyositis patients face heavy disease burdens from muscle weakness, painful skin symptoms, and frequent reliance on long‑term high‑dose steroids. Ongoing inflammation and steroid side effects can lead to accumulated organ damage and many related health problems under current treatments.
Priovant says it will work closely with the FDA during the review process to try to make brepocitinib available to patients as quickly as possible if approved. The PDUFA date gives a timeline for when patients and doctors might expect a regulatory decision.
Read Announcement- Drug:
- Brepocitinib
- Announced Date:
- March 3, 2026
- Indication:
- Systemic Lupus Erythematosus
Announcement
Priovant Therapeutics announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for brepocitinib for the treatment of dermatomyositis (DM) and has granted the application Priority Review.
AI Summary
Priovant Therapeutics said the U.S. Food and Drug Administration has accepted its New Drug Application for brepocitinib to treat dermatomyositis and has given the application Priority Review. Priority Review speeds the FDA’s evaluation, reflecting the agency’s view that the medicine could address an important unmet need for patients with this rare inflammatory muscle and skin disease.
Patients with dermatomyositis often suffer major muscle and skin problems and rely on long-term, high-dose steroids. That steroid dependence and ongoing inflammation can cause lasting organ damage and many additional health issues, so better treatment options are urgently needed.
Ben Zimmer, Priovant’s CEO, said, "The acceptance of our NDA for brepocitinib in dermatomyositis represents meaningful progress towards our goal of bringing a potentially transformational therapy to dermatomyositis patients who urgently need better treatment options. We are committed to working closely with the FDA through their review to make this drug available for patients as quickly as possible."
Read Announcement- Drug:
- Brepocitinib
- Announced Date:
- February 6, 2026
- Indication:
- Systemic Lupus Erythematosus
Announcement
Priovant Therapeutics announced positive results from the Phase 2 BEACON study evaluating brepocitinib in cutaneous sarcoidosis (CS).
AI Summary
Priovant Therapeutics announced positive Phase 2 BEACON results for brepocitinib in cutaneous sarcoidosis (CS). The company reported the study met its primary endpoint, with patients receiving brepocitinib showing statistically significant improvement in skin lesions and related symptoms versus placebo. Improvements were seen across multiple measures of disease activity and patient-reported outcomes.
Safety results were favorable: brepocitinib was generally well tolerated with an adverse event profile consistent with previous studies of the drug class. No new safety signals were reported in the CS population, supporting the drug’s tolerability for further testing.
Priovant said it will review the full dataset to define next steps, which could include larger Phase 3 trials and discussions with regulators. If confirmed in later studies, brepocitinib could become a targeted treatment option for patients with cutaneous sarcoidosis who have limited therapies today.
Read Announcement- Drug:
- Brepocitinib
- Announced Date:
- September 17, 2025
- Indication:
- Systemic Lupus Erythematosus
Announcement
Roivant and Priovant Therapeutics today announced positive results from the Phase 3 VALOR study evaluating brepocitinib in dermatomyositis (DM).
AI Summary
Roivant and Priovant Therapeutics today announced positive results from the Phase 3 VALOR study evaluating brepocitinib in dermatomyositis (DM). Once-daily oral brepocitinib 30 mg showed clinically meaningful and statistically significant improvement versus placebo on the primary endpoint and all nine key secondary endpoints, including measures of skin and muscle disease, steroid-sparing effect, and rapid onset of action. At week 52, the mean Total Improvement Score (TIS) was 46.5 for brepocitinib 30 mg compared to 31.2 for placebo (p=0.0006), even though nearly twice as many patients on brepocitinib discontinued background steroids. More than two-thirds of patients achieved at least a moderate response (TIS ≥ 40), and nearly half experienced a major response (TIS ≥ 60).
A clear dose-response between the 30 mg and 15 mg arms established 30 mg as the optimal dose, and the safety profile was consistent with earlier trials. Brepocitinib demonstrated significant separation from placebo as early as week 4 and maintained benefits through one year. An NDA filing is planned for the first half of 2026, marking a potential breakthrough as the first positive 52-week placebo-controlled trial of a targeted therapy in DM.
Read Announcement
Mosliciguat FDA Regulatory Events
Mosliciguat is a drug developed by Roivant Sciences for the following indication: In PH patients.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Mosliciguat
- Announced Date:
- September 4, 2025
- Indication:
- In PH patients.
Announcement
Roivant announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has granted orphan drug designation (ODD) to mosliciguat, a novel, once-daily, inhaled soluble guanylate cyclase (sGC) activator, currently being studied for the treatment of Pulmonary Hypertension associated with Interstitial Lung Disease (PH-ILD), which is a progressive and life-threatening condition with significant unmet medical need.
AI Summary
Roivant announced that Japan’s Ministry of Health, Labour and Welfare has granted orphan drug designation (ODD) to mosliciguat, a novel, once-daily, inhaled soluble guanylate cyclase activator. Mosliciguat is being studied for Pulmonary Hypertension associated with Interstitial Lung Disease (PH-ILD), a progressive, life-threatening condition with no approved treatments.
The ODD status, based on the recommendation of Japan’s Pharmaceuticals and Medical Devices Agency, provides key regulatory incentives such as priority consultation, reduced fees, and up to ten years of market exclusivity if approved. Roivant’s CEO Drew Fromkin said this designation recognizes the significant unmet need for PH-ILD patients and underscores the company’s commitment to advancing mosliciguat in Japan.
Mosliciguat is now in a global Phase 2 trial called PHocus, which will enroll about 120 adults with PH-ILD. Details of the study design will be presented in a poster at the European Respiratory Society International Congress on September 28, 2025.
Read Announcement- Drug:
- Mosliciguat
- Announced Date:
- September 10, 2024
- Indication:
- In PH patients.
Announcement
Pulmovant, a Roivant company announced the presentation of data from the proof-of-concept Phase 1b ATMOS1 study during the ERS Congress in Vienna, Austria.
AI Summary
Pulmovant, a Roivant company, recently presented data from its proof-of-concept Phase 1b ATMOS1 study during the European Respiratory Society (ERS) Congress in Vienna, Austria. The study evaluated mosliciguat, an innovative, first-in-class inhaled soluble Guanylate Cyclase (sGC) activator specifically designed to target the lungs in patients with pulmonary hypertension (PH).
In this trial, 38 patients received a single dose of mosliciguat via a dry powder inhaler, resulting in a sustained, clinically meaningful reduction of pulmonary vascular resistance (PVR) by up to 38%—one of the most significant drops seen in PH studies. The once-daily dosing was well tolerated, with few treatment-emergent adverse events reported. These promising findings have set the stage for further research, including an upcoming global Phase 2 study focused on patients with PH associated with interstitial lung disease (PH-ILD).
Read Announcement
VTAMA (tapinarof) cream FDA Regulatory Events
VTAMA (tapinarof) cream is a drug developed by Roivant Sciences for the following indication: Plaque psoriasis.
This drug is approved by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- VTAMA (tapinarof) cream
- Announced Date:
- December 16, 2024
- Target Action Date:
- March 12, 2025
- Indication:
- Plaque psoriasis
Announcement
Organon received the FDA approval prior to its extended target action date (PDUFA) of March 12, 2025.
AI Summary
Organon announced that the FDA approved VTAMA® (tapinarof) cream, 1%, for the topical treatment of atopic dermatitis in adults and pediatric patients aged 2 years and older. Notably, Organon received this approval before the extended target action date (PDUFA) of March 12, 2025. This early approval underscores the FDA’s confidence in VTAMA’s safety and efficacy profile.
The new approval offers an additional treatment option for patients with atopic dermatitis by providing a therapy that can lead to powerful skin clearance and fast itch relief. VTAMA cream has shown positive results in pivotal studies, and its approval means that professionals can now prescribe a non-steroidal treatment without restrictions on duration of use or affected body surface area. This marks a significant advancement in the treatment of atopic dermatitis for both children and adults.
Read Announcement- Drug:
- VTAMA (tapinarof) cream
- Announced Date:
- December 16, 2024
- Indication:
- Plaque psoriasis
Announcement
Organon announced that the U.S. Food and Drug Administration (FDA) has approved VTAMA® (tapinarof) cream, 1%, an aryl hydrocarbon receptor agonist, for an additional indication of the topical treatment of atopic dermatitis (AD) in adults and pediatric patients 2 years of age and older.1
AI Summary
Organon announced that the U.S. Food and Drug Administration (FDA) has approved VTAMA® (tapinarof) cream, 1% for an additional indication. This new approval expands its use to treat atopic dermatitis (AD) in adults and pediatric patients aged 2 years and older. VTAMA cream is an aryl hydrocarbon receptor agonist that has shown strong results in clinical studies, with many patients achieving clear or almost clear skin within 8 weeks. Patients also experienced rapid itch relief, with improvements noted as early as 24 hours after the first application. The cream has demonstrated a favorable and consistent safety profile, with no warnings, precautions, or restrictions regarding the duration of use or treated body surface area. This approval represents a promising new treatment option for those suffering from atopic dermatitis, addressing a significant unmet need among both adults and children.
Read Announcement
