Roivant Sciences (NASDAQ:ROIV) stock surged on Friday on positive Phase 2 results for brepocitinib in cutaneous sarcoidosis (CS), an inflammatory skin condition with small bumps and broad, raised skin lesions.
BEACON Study Results Shows 100% Response
The BEACON study enrolled 31 patients 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.
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 the 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.
Statistically significant separation was observed as early as Week 4 and maintained at all timepoints thereafter. 100% 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.
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.
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.
Roviant’s unit 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.
Another Vant Completes Enrollment In Lung Disease Trial
Roviant’s another subsidiary, Pulmovant, completed enrollment in the Phase 2 PHocus trial of mosliciguat for pulmonary hypertension associated with interstitial lung disease (PH-ILD). Topline data are expected in the second half of 2026.
Roivant reported an adjusted loss of 24 cents per share, better than the consensus loss of 32 cents. Sales reached around $2 million.
Roivant reported consolidated cash, cash equivalents, restricted cash, and marketable securities of $4.5 billion as of December 31, 2025, supporting cash runway into profitability.
ROIV Price Action: Roivant Sciences shares were up 20.03% at $25.37 at the time of publication on Friday. The stock is trading at a new 52-week high, according to Benzinga Pro data.
