Roivant Says Three New Drugs Could Hit the Market in the Next Three Years, Speeds Up Trial Timelines as It Prepares for Major Product Launches ,

Roivant (NASDAQ:ROIV) today is hosting an Investor Day in New York City. Roivant leadership will highlight key pipeline updates and provide an update on the Company's strategy for long-term value creation.

"We are at transformational moment for Roivant. We have a unique opportunity to execute on three major potential products, each of which represents a pipeline-in-a-product opportunity, each with multiple blockbuster-potential indications. I'm proud of the clinical execution across our teams, and we have accelerated timing guidance for topline readouts in three significant programs. We have an opportunity for three meaningful first-in-class commercial launches over the next three years," said Matt Gline, CEO of Roivant. "First among them is brepocitinib in DM, where the Phase 3 data generated earlier this year represents a significant step forward for patients in need. We remain well-positioned to generate shareholder value, and we are excited to share updates across our late-stage pipeline and long-term strategy at our Investor Day today."

Program-Specific Highlights and Updates

Brepocitinib

• Preparation for commercial launch of brepocitinib in DM is underway; NDA filing expected in early calendar year 2026 with potential commercial launch early in calendar year 2027
• Phase 3 trial for brepocitinib in NIU is fully enrolled ahead of schedule with topline data expected in the second half of calendar year 2026, previously expected in the first half of calendar year 2027
• Proof-of-concept trial for brepocitinib in CS is fully enrolled ahead of schedule with topline data expected in the first half of calendar year 2026, previously expected in the second half of calendar year 2026
  
   

IMVT-1402

• Roivant-led Immunovant financing alongside key institutional investors generated gross proceeds to Immunovant of approximately $550 million, extending Immunovant's cash runway to the launch of IMVT-1402 in GD
• Potentially registrational trial for IMVT-1402 in D2T RA topline data now expected in calendar year 2026; previously expected Period 1 data in calendar year 2026 and topline data in calendar year 2027
• All other clinical development timelines remain on track, including potentially registrational trials in GD, myasthenia gravis (MG), chronic inflammatory demyelinating polyneuropathy (CIDP) and Sjögren's disease (SjD), and a proof-of-concept trial in cutaneous lupus erythematosus (CLE)
  
   

Mosliciguat

• Enrollment in the ongoing Phase 2 trial of mosliciguat in pulmonary hypertension associated with interstitial lung disease (PH-ILD) remains on track; Pulmovant plans to report topline data in the second half of calendar year 2026
• Pulmovant also expects to imminently initiate a Phase 2 study (n=20) evaluating mosliciguat in combination with inhaled treprostinil in patients with PH-ILD

Genevant

• In the US Moderna litigation, a jury trial has been scheduled for March 2026. Awaiting court scheduling in the Pfizer/BioNTech litigation
• Initial court hearings and rulings in the ex-US Moderna litigation expected in calendar year 2026