Priovant Announces Positive Phase 2 Results for Brepocitinib in Cutaneous Sarcoidosis (CS)

Rhea-AI Summary

Priovant (Nasdaq: ROIV) announced positive Phase 2 BEACON results for brepocitinib in cutaneous sarcoidosis (CS), showing clinically meaningful and statistically significant benefit versus placebo at Week 16.

Key results: brepocitinib 45 mg achieved a -22.3 mean CSAMI-A change (∆21.6 vs placebo; P<0.0001), 100% ≥10-point CSAMI-A responses, 62% functional remission (CSAMI-A<5), and 69% IGA two-point improvements. No SAEs; AEs mild/moderate. Priovant plans Phase 3 initiation in 2026 following FDA engagement.

Positive

• CSAMI-A mean change -22.3 at Week 16 (45 mg)
• 100% of 45 mg patients achieved ≥10-point CSAMI-A improvement
• 69% achieved two-point IGA improvement to Clear/Almost Clear
• 62% functional remission (CSAMI-A <5) in 45 mg arm
• Statistically significant separation vs placebo as early as Week 4
• No serious adverse events; AEs mild or moderate

Negative

• Small trial size: 31 patients across three arms
• Some key endpoints for 15 mg vs placebo lacked statistical significance (functional remission P=0.1013)
• 45 mg arm comprised more treatment‑refractory patients, complicating cross-arm comparisons

Market Reaction

+19.58% $25.28 2.4x vol

15m delay 21 alerts

+19.58% Since News

$25.28 Last Price

$23.97 $25.49 Day Range

+$2.88B Valuation Impact

$17.58B Market Cap

2.4x Rel. Volume

Following this news, ROIV has gained 19.58%, reflecting a significant positive market reaction. Our momentum scanner has triggered 21 alerts so far, indicating elevated trading interest and price volatility. The stock is currently trading at $25.28. This price movement has added approximately $2.88B to the company's valuation. Trading volume is elevated at 2.4x the average, suggesting notable buying interest.

Data tracked by StockTitan Argus (15 min delayed). Upgrade to Silver for real-time data.

Key Figures

CSAMI-A improvement 45 mg: 22.3-point mean improvement vs 0.7 placebo CSAMI-A responder rate 45 mg: 100% vs 14% placebo (≥10-point reduction) Functional remission 45 mg: 62% vs 0% placebo (CSAMI-A <5) +5 more

8 metrics

CSAMI-A improvement 45 mg 22.3-point mean improvement vs 0.7 placebo Phase 2 BEACON cutaneous sarcoidosis, Week 16

CSAMI-A responder rate 45 mg 100% vs 14% placebo (≥10-point reduction) Phase 2 BEACON cutaneous sarcoidosis, Week 16

Functional remission 45 mg 62% vs 0% placebo (CSAMI-A <5) Phase 2 BEACON cutaneous sarcoidosis, Week 16

IGA clear/almost clear 45 mg 69% vs 0% placebo (P=0.0047) Investigator’s Global Assessment, Phase 2 BEACON

PGI-C improvement 45 mg 100% vs 29% placebo (P=0.0014) Patient’s Global Impression of Change, Phase 2 BEACON

Study size 31 patients across 15 U.S. sites Phase 2 BEACON cutaneous sarcoidosis

Dose cohorts 45 mg (n=13), 15 mg (n=11), placebo (n=7) Randomization 3:2:2 in BEACON study

Disease prevalence ≈40,000 adults affected in U.S. Cutaneous sarcoidosis patient population

Market Reality Check

Price: $21.14 Vol: Volume 5,084,082 is 0.91x...

normal vol

$21.14 Last Close

Volume Volume 5,084,082 is 0.91x the 20-day average 5,568,902, suggesting no unusual trading activity ahead of this news. normal

Technical Shares at $21.14 are trading above the 200-day MA $15.62 and sit 11.59% below the 52-week high and 142.15% above the 52-week low.

Peers on Argus

ROIV was down 2.36% while key biotech peers were mixed: MDGL (-3.23%), MRNA (-2....

ROIV was down 2.36% while key biotech peers were mixed: MDGL (-3.23%), MRNA (-2.76%), but HALO, VRNA, and BPMC were slightly positive. This points to a stock-specific reaction rather than a coordinated sector move.

Previous Clinical trial Reports

5 past events · Latest: Sep 17 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Sep 17	Dermatomyositis Phase 3	Positive	+7.8%	Positive Phase 3 VALOR results for brepocitinib in dermatomyositis with strong efficacy.
Dec 03	Sarcoidosis trial fail	Negative	-2.9%	Namilumab Phase 2 RESOLVE-Lung in pulmonary sarcoidosis failed primary and secondary endpoints.
Dec 03	Sarcoidosis trial fail	Negative	-2.9%	Roivant disclosed namilumab Phase 2 RESOLVE-Lung failure in chronic pulmonary sarcoidosis.
Sep 10	Pulmonary HTN PoC	Positive	-2.5%	Positive Phase 1b proof-of-concept data for Mosliciguat in pulmonary hypertension.
Apr 25	Trial enrollment	Neutral	-0.2%	Completion of enrollment in RESOLVE-Lung Phase 2 study evaluating namilumab in sarcoidosis.

Pattern Detected

Clinical trial headlines for Roivant and affiliates have mostly seen price moves aligned with the news tone, but there is at least one instance of positive data coinciding with a negative reaction.

Recent Company History

Across recent clinical trial updates, Roivant and its affiliates reported both strong successes (e.g., positive Phase 3 VALOR dermatomyositis data on Sep 17, 2025) and failures (namilumab RESOLVE-Lung readout on Dec 3, 2024). Most events saw price moves in the expected direction, with declines on trial failures and gains on clear wins. Today’s positive Phase 2 cutaneous sarcoidosis data for brepocitinib extends the franchise’s footprint into another autoimmune indication, following earlier dermatomyositis progress.

Historical Comparison

clinical trial

-0.1 %

Average Historical Move

Historical Analysis

Roivant’s clinical-trial headlines have historically produced an average move of about -0.13%, with both strong gains and declines. Today’s positive Phase 2 cutaneous sarcoidosis data fits the pattern of meaningful catalysts but does not guarantee a consistent directional reaction.

Typical Pattern

Brepocitinib progressed from positive Phase 3 dermatomyositis results in 2025 to positive Phase 2 proof-of-concept in cutaneous sarcoidosis, broadening its late-stage autoimmune disease portfolio.

Regulatory & Risk Context

Active S-3 Shelf · $400.0 million

Shelf Active

Active S-3 Shelf Registration 2025-10-03

$400.0 million registered capacity

Roivant has an effective Form S-3ASR base shelf dated Oct 3, 2025, including capacity to issue up to $400.0 million in common shares under a Sales Agreement, with $0 utilized as of filing. This provides flexibility for future capital raises alongside an existing share repurchase program.

Market Pulse Summary

The stock is surging +19.6% following this news. A strong positive reaction aligns with the clearly ...

Analysis

The stock is surging +19.6% following this news. A strong positive reaction aligns with the clearly favorable Phase 2 BEACON results, including a 22.3-point CSAMI-A improvement and 100% responder rate at 45 mg. Historically, Roivant’s major clinical wins, such as the VALOR dermatomyositis readout, have drawn positive moves, though not uniformly across all programs. Investors would still need to weigh future financing flexibility from the $400.0 million shelf and the small Phase 2 sample size when assessing durability of any large upside move.

Key Terms

investigator’s global assessment (iga), serious adverse events (saes), adverse events (aes), tyk2, +3 more

7 terms

investigator’s global assessment (iga) medical

"On the Investigator’s Global Assessment (IGA), 69% of brepocitinib 45 mg patients..."

Investigator’s Global Assessment (IGA) is a clinician’s single-number rating that summarizes how severe a patient’s condition appears and how it changes during a clinical trial, commonly used in dermatology studies. Investors watch IGA results because they provide a clear, comparable snapshot of a drug’s effectiveness—like a referee’s scorecard—helping judge whether a treatment works and how that could affect regulatory approval, market potential, and sales forecasts.

serious adverse events (saes) medical

"Brepocitinib was well tolerated... with no Serious Adverse Events (SAEs)..."

Serious adverse events (SAEs) are significant negative outcomes, such as severe health issues, hospitalizations, or death, that occur during a medical study or treatment. For investors, SAEs matter because they can signal potential risks associated with a product or company, potentially affecting its reputation, regulatory approval, or financial performance. Recognizing SAEs helps gauge the safety and reliability of medical-related investments.

adverse events (aes) medical

"and all Adverse Events (AEs) graded mild or moderate in severity."

Adverse events (AEs) are any unwanted medical problems or side effects that occur in people taking a drug, vaccine, or undergoing a medical procedure, whether or not the treatment caused them. Think of AEs like warning lights on a dashboard: a few minor blips may be manageable, but frequent or serious lights can signal bigger problems that affect patient safety, regulatory approvals, and a product’s commercial prospects — all key concerns for investors.

tyk2 medical

"bepocitinib, a dual selective inhibitor of TYK2 and JAK1."

TYK2 is a protein inside immune cells that helps send signals telling the body to ramp up or calm down inflammation; think of it as a switchboard operator for certain immune messages. It matters to investors because drugs that block or modulate TYK2 can treat autoimmune and inflammatory diseases, so success or failure in developing and approving TYK2-targeting medicines can strongly affect a biotech or pharmaceutical company’s value and future revenue prospects.

jak1 medical

"bepocitinib, a dual selective inhibitor of TYK2 and JAK1."

JAK1 is a protein inside cells that acts like a on/off switch for signals controlling immune response and cell growth; drugs that block JAK1 can dial down overactive inflammation or immune attacks. Investors care because JAK1-targeting medicines are a class of therapies in development for conditions like autoimmune diseases and some cancers, and results from clinical trials, safety findings, or regulatory decisions can strongly affect a drugmaker’s future revenue and valuation.

nda regulatory

"Brepocitinib recently generated positive Phase 3 data in dermatomyositis, and an NDA submission is planned..."

An NDA, or nondisclosure agreement, is a legal contract that keeps certain information private between parties. It’s like a promise not to share sensitive details, helping protect business ideas, strategies, or data from being leaked or used without permission. For investors, NDAs help ensure that confidential information remains secure, enabling trust and open communication during business discussions.

phase 3 medical

"Priovant plans to progress CS to a pivotal program with a Phase 3 study starting..."

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

AI-generated analysis. Not financial advice.

• Brepocitinib 45 mg significantly improved cutaneous sarcoidosis disease activity, achieving a 22.3-point improvement in mean CSAMI-A at Week 16 versus a 0.7-point improvement in placebo (Δ 21.6 P<0.0001)
• All brepocitinib 45 mg patients achieved a clinically meaningful response, with 100% demonstrating at least a 10-point improvement on CSAMI-A
• On the Investigator’s Global Assessment (IGA), 69% percent of brepocitinib 45 mg patients compared to 0% of placebo patients achieved the gold standard two-point improvement to “Clear” (0) or “Almost Clear” (1) (Δ 69% P=.0047)
• Brepocitinib 15 mg patients also improved considerably, with numerically similar improvement to the 45 mg arm on lower-bar endpoints and evidence of dose-dependent benefit seen on higher bar endpoints and patient reported outcomes
• Brepocitinib was well tolerated during the study treatment period, with no Serious Adverse Events (SAEs) and all Adverse Events (AEs) graded mild or moderate in severity
• 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

DURHAM, N.C., Feb. 06, 2026 (GLOBE NEWSWIRE) -- Priovant Therapeutics today announced positive results from the Phase 2 BEACON study evaluating brepocitinib in cutaneous sarcoidosis (CS). CS is a highly morbid, chronic, and disfiguring condition with no approved therapies, and the BEACON study is the first ever industry-sponsored placebo-controlled trial in the indication to read out positively.

“The BEACON study is a watershed moment for the sarcoidosis field, and most importantly, for our patients,” said Dr. Misha Rosenbach, MD, Professor of Dermatology and Rheumatology and Director of the Cutaneous Sarcoidosis Program at the Hospital of the University of Pennsylvania. “This is an incredible milestone for a historically neglected disease – the study drug showed a clear difference in patients who received the medication compared to placebo, both from the patient and the physician perspective, and appeared to be well tolerated. This is the sort of data you dream of seeing when you look at trial results – and I would call this a transformational moment for sarcoidosis.”

The BEACON study enrolled 31 patients across 15 sites in the United States, randomized 3:2:2 to once daily brepocitinib 45 mg, 15 mg, or placebo with a 16-week treatment period. The brepocitinib 45 mg arm comprised the most treatment-refractory group, with the highest percentage of patients with longstanding disease, damage, and difficult-to-treat plaque-predominant morphology. Despite this, patients in the 45 mg arm achieved meaningful clinical improvement compared to placebo, including 100% response rates on multiple endpoints. Brepocitinib 15 mg patients also improved considerably, with numerically similar improvement to the 45 mg arm on lower-bar endpoints and evidence of dose-dependent benefit seen on higher bar endpoints and patient reported outcomes. Placebo patients experienced almost no improvement, consistent with natural disease course.

On the Cutaneous Sarcoidosis Activity and Morphology Instrument – Activity score (CSAMI-A), brepocitinib 45 mg achieved a 22.3-point mean improvement at Week 16 versus a 0.7-point improvement in placebo (Δ21.6 P<0.0001). Statistically significant separation was observed as early as Week 4 and maintained at all timepoints thereafter. One hundred percent of brepocitinib 45 mg patients achieved at least a 10-point improvement on CSAMI-A compared to 14% of placebo patients, and 62% of brepocitinib 45 mg patients achieved CSAMI-A <5 (functional remission), compared to 0% of placebo patients.

Treatment Arm	Mean CSAMI-A Change from Baseline at Week 16	Achievement of CSAMI-A ≥ 10-point Reduction at Week 16		Achievement of CSAMI-A < 5 (Functional Remission) at Week 16
45 mg (n = 13)	-22.3	100%		62%
15 mg (n = 11)	-22.2	73%		46%
Placebo (n = 7)	-0.7	14%		0%
45 mg vs. placebo	∆ -21.6; P<0.0001	∆ 86%; P=0.0002		∆ 62%; P=0.0147
15 mg vs. placebo	∆ -21.5; P<0.0001	∆ 58%; P=0.0498		∆ 46%; P=0.1013

On the Investigator’s Global Assessment (IGA), 69% of brepocitinib 45 mg patients achieved the gold standard two-point improvement to Clear (0) / Almost Clear (1), compared to 0% of placebo patients (Δ 69% P=.0047). Brepocitinib 45 mg also demonstrated statistically significant improvement over placebo on key patient reported outcomes, including the King’s Sarcoidosis Questionnaire (KSQ) Skin Domain, the Skindex-16, and the Patient’s Global Impression of Change (PGI-C). On PGI-C, 100% of patients receiving the 45 mg dose reported improvement from baseline, compared to 29% of placebo patients (Δ 71% P=.0014).  

Brepocitinib was well tolerated during the study treatment period, with no Serious Adverse Events (SAEs) and all Adverse Events (AEs) graded mild or moderate in severity. Brepocitinib has been evaluated in more than 1,500 patients and subjects, with an observed safety profile consistent with approved JAK1 and TYK2 inhibitors.

Priovant plans to initiate a Phase 3 program in CS in calendar year 2026, following engagement with FDA.

“We are thrilled with the results of the BEACON study and are excited to rapidly move brepocitinib into Phase 3 development for cutaneous sarcoidosis,” said Ben Zimmer, Priovant CEO. “I would like to thank all of the patients, investigators, and site staff who participated in the study and made this result possible. With the brepocitinib CS program now moving into Phase 3 alongside the dermatomyositis and non-infectious uveitis programs, Priovant continues to advance our goal of developing brepocitinib as a potentially transformational therapy for patients with highly morbid autoimmune diseases underserved by existing treatment options.”

About Cutaneous Sarcoidosis

Cutaneous sarcoidosis (CS) is an inflammatory granulomatous skin disease affecting approximately 40,000 adults in the United States. CS lesions are frequently chronic, may involve extensive body surface area, and are often profoundly disfiguring, leading to substantial psychosocial distress and impaired quality-of-life. Despite this significant unmet therapeutic need, no treatments are currently approved for CS. As a result, many patients rely on prolonged off-label treatment with systemic corticosteroids, immunosuppressants, and biologics, which offer limited efficacy and carry meaningful treatment-related toxicity.

About Priovant

Priovant Therapeutics is a biotechnology company dedicated to developing novel therapies for autoimmune diseases with high morbidity and few available treatment options. The company's lead asset is brepocitinib, a dual selective inhibitor of TYK2 and JAK1. Through dual TYK2/JAK1 inhibition, brepocitinib distinctively suppresses key cytokines linked to autoimmunity—including type I IFN, type II IFN, IL-6, IL-12, and IL-23—with a single, targeted, once-daily oral therapy. Brepocitinib recently generated positive Phase 3 data in dermatomyositis, and an NDA submission is planned for early 2026. Brepocitinib is also being evaluated in a Phase 3 program in non-infectious uveitis and recently generated positive Phase 2 data in cutaneous sarcoidosis, with a Phase 3 study to begin in calendar year 2026.   Priovant Therapeutics is a Roivant (Nasdaq: ROIV) company. 

Contact

Daniel Herz Roiphe, daniel.herz-roiphe@priovant.com

FAQ

What were the primary Phase 2 BEACON results for Priovant's ROIV brepocitinib in cutaneous sarcoidosis?

Brepocitinib 45 mg produced a -22.3 mean CSAMI-A change at Week 16 versus -0.7 for placebo (∆21.6; P<0.0001). According to the company, 100% of 45 mg patients reached ≥10-point improvement and 62% achieved functional remission (CSAMI-A <5).

How did brepocitinib 45 mg perform on Investigator’s Global Assessment in the ROIV Phase 2 trial?

Sixty-nine percent of brepocitinib 45 mg patients achieved a two-point IGA improvement to Clear/Almost Clear. According to the company, this compared to 0% for placebo (∆69%; P=0.0047), indicating a strong physician-assessed response signal.

What safety findings did Priovant report for brepocitinib in the cutaneous sarcoidosis study (ROIV)?

No serious adverse events were reported and all adverse events were mild or moderate during treatment. According to the company, this safety profile aligns with prior brepocitinib experience in over 1,500 subjects evaluated previously.

Will Priovant (ROIV) advance brepocitinib to Phase 3 for cutaneous sarcoidosis and when?

Priovant plans to begin a Phase 3 program in cutaneous sarcoidosis in calendar year 2026 following FDA engagement. According to the company, Phase 3 initiation follows the positive Phase 2 BEACON readout.

How did the brepocitinib 15 mg arm compare to 45 mg and placebo in the BEACON trial (ROIV)?

Brepocitinib 15 mg showed considerable improvement with a -22.2 mean CSAMI-A change, similar on lower-bar endpoints but weaker on higher-bar outcomes. According to the company, dose-dependent benefits favored 45 mg on stricter endpoints and patient-reported outcomes.

What patient-reported outcomes improved with brepocitinib in the Priovant CS Phase 2 trial (ROIV)?

Brepocitinib 45 mg showed statistically significant improvements in KSQ Skin Domain, Skindex-16, and PGI-C. According to the company, 100% of 45 mg patients reported PGI-C improvement versus 29% with placebo (∆71%; P=0.0014).