Roivant Sciences Ltd. (NASDAQ:ROIV) set out its long-term vision on Tuesday during its Investor Day, outlining accelerated timelines and expanded commercial ambitions across several late-stage programs.
Chief executive Matt Gline said the company is entering a pivotal period anchored by three major clinical assets, each positioned as a "pipeline-in-a-product" with multiple potential blockbuster indications.
Gline said Roivant is on the verge of an inflection point, noting that the company has advanced several key programs faster than previously projected.
He emphasized that three first-in-class commercial launches could materialize within the next three years, with brepocitinib leading the way.
Brepocitinib
Roivant highlighted strong momentum behind brepocitinib, particularly in dermatomyositis (DM). The company expects to file a new drug application in early 2026, with a possible commercial launch in early 2027.
The company has also accelerated development in additional brepocitinib indications.
The Phase 3 study in non-infectious uveitis (NIU) is fully enrolled earlier than planned, with topline data now expected in the second half of 2026.
A proof-of-concept trial in chronic sinusitis (CS) also completed enrollment ahead of schedule, with results anticipated in the first half of 2026.
IMVT-1402
Roivant reported progress across its broader pipeline, including IMVT-1402, developed through Immunovant Inc. (NASDAQ:IMVT).
A recent financing round led by Roivant and institutional investors raised roughly $550 million, extending Immunovant's cash runway through the anticipated launch of IMVT-1402 in Graves' disease (GD).
Updated guidance now places topline data for a potentially registrational trial in difficult-to-treat rheumatoid arthritis in 2026.
Other Programs
Other development programs, including studies in GD, myasthenia gravis, chronic inflammatory demyelinating polyneuropathy, Sjögren's disease, and cutaneous lupus, remain on track.
In pulmonary hypertension associated with interstitial lung disease, Roivant's Pulmovant subsidiary is advancing mosliciguat through Phase 2, with topline results expected in the second half of 2026. A combination study with inhaled treprostinil is set to begin imminently.
The company also updated ongoing intellectual property litigation involving Genevant, noting that a U.S. jury trial with Moderna Inc. (NASDAQ:MRNA) is scheduled for March 2026, with additional U.S. and ex-U.S. proceedings expected next year.
ROIV Price Action: Roivant Sciences shares were up 7.26% at $21.71 at the time of publication on Thursday. The stock is trading at a new 52-week high, according to Benzinga Pro data.
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