Brepocitinib

Bengaluru: Roivant and partner Priovant Therapeutics said on Wednesday that their experimental drug for a rare disease affecting skin and muscles has shown promising results in a late-stage clinical trial . Shares of Roivant were up over 13% at $16.05, set for an all-time closing high if gains hold. The drug, brepocitinib , was being tested for dermatomyositis , a condition that causes painful skin rashes and progressive muscle weakness. Left untreated, the disease can severely reduce a patient's quality of life. The companies said the drug showed improvement in both skin and muscle symptoms, reducing or stopping the need for steroids that are commonly used, but can cause long-term side effects. In the trial, patients receiving a daily 30 mg oral dose of brepocitinib achieved a mean total improvement score of 46.5 after 52 weeks, compared with 31.2 for placebo. The difference was statistically significant, with benefits seen as early as week four, companies said. Drug development scene for dermatomyositis has been a "bit of a graveyard," said Ben Zimmer, chief executive of Priovant . Roivant CEO Matt Gline added that the brepocitinib trial marked the "first successful registrational trial for a targeted therapy" in the disease. J.P.Morgan analyst Brian Cheng said the depth and speed of response could position brepocitinib as the "new gold standard" in treating dermatomyositis. Cheng estimates non-risk-adjusted peak sales of $1.6 billion from dermatomyositis alone by 2037. Pfizer in 2021 licensed brepocitinib to Priovant Therapeutics, a joint company created with Roivant. The companies plan to file for U.S. approval in the first half of 2026. According to the National Institutes of Health, dermatomyositis affects fewer than 5,000 people in the U.S. Octapharma's Octagam 10% is the only FDA-approved treatment for the condition. (Reporting by Kamal Choudhury in Bengaluru; Editing by Vijay Kishore and Sahal Muhammed)

Joint pain anatomy medical concept iStock, Cinefootage Visuals Brepocitinib remains “ahead of competition” in the dermatomyositis space, according to analysts at Leerink, who projected that the drug candidate could hit $2 billion in sales in 2032. Roivant’s TYK2/JAK1 dual inhibitor brepocitinib hit its primary and all nine key secondary endpoints in patients with dermatomyositis in the Phase III VALOR trial. With these data, Roivant and its Pfizer-backed subsidiary Priovant are heading to the FDA with an expected filing in the front half of 2026. Based on these plans, Leerink Partners told investors on Wednesday that Roivant is “on track to be launching a blockbuster drug” in the first quarter of 2027. The analysts were bullish about brepocitinib’s market prospects, raising their 2032 sales projection from a previous estimate of $1.4 billion to $2 billion. “Brepocitinib is ahead of competition” in dermatomyositis, Leerink wrote, including Argenx’s subcutaneous efgartigimod, AstraZeneca’s anifrolumab and even Pfizer’s own dazukibart. All three assets have late-stage readouts planned for the second half of 2026 or later, the analysts added. Shares of Roivant were up 7.76% at close of trading Wednesday . Results announced on Wednesday demonstrated that brepocitinib elicited significantly stronger clinical response than placebo, as measured by the Total Improvement Score (TIS). Patients treated with the investigational drug hit a mean TIS of 46.5 at 52 weeks, versus 31.2 in patients who received placebo. This effect was statistically significant, with “nearly twice as many patients” on brepocitinib able to discontinue background steroid treatment. Brepocitinib’s therapeutic benefits were evident as early as week 4, according to Wednesday’s release, and the drug hit all nine key secondary endpoints, including skin, motor strength and functional performance. Leerink in its investor note did say that brepocitinib’s outcomes came “slightly below our initial hope” of a 20-point advantage on the TIS scale. Still, the analysts said the overall pro brepocitinib is good “given the totality of the data.” In particular, the firm pointed to the high rate of steroid discontinuation in the brepocitinib group. The analysts added that the drug also “demonstrated compelling muscle efficacy, a key driver for clinical adoption and commercial success.” VALOR data on Wednesday also pointed to an overall favorable safety profile. Side effects of interest, such as malignancies and cardiovascular events, were balanced between brepocitinib and placebo arms. Dermatomyositis is a rare inflammatory condition that causes muscle weakness and skin irritation. It occurs in about 13 of every 100,000 people . Designed to be taken orally, brepocitinib is a dual inhibitor of the TYK2 and JAK1 pathways, giving it potent anti-inflammatory effects. In June 2022, Roivant and Pfizer tied up to launch Priovant Therapeutics, a subsidiary dedicated to the clinical development of brepocitinib.