Roivant Sciences (ROIV) Company Report

Roivant experienced a transformational 2025, highlighted by positive data from its FcRn franchise and successful Phase III data for brepocitinib in Dermatomyositis (DM).
The company plans to file the New Drug Application (NDA) for brepocitinib in DM in the first half of 2026.
Key catalysts for 2026 include a proof of concept study for brepocitinib in cutaneous sarcoid, multiple FcRn studies, and a large Phase II-B study for mosliciguat in Pulmonary Hypertension-Interstitial Lung Disease (PH-ILD).
Brepocitinib also demonstrated promising Phase II data in Non-infectious Uveitis (NIU), with registrational studies expected to read out in 2027.
A jury trial with Moderna regarding litigation is scheduled for March 2026.

4 days ago

Transcript

Roivant Highlights 2025 Progress and 2026-2027 Catalysts at Jefferies Conference

ROIV

Product Launch

New Projects/Investments

Legal Proceedings

Roivant has transformed in 2025, becoming a $14.5 billion market cap public biopharma company focused on developing late-stage drugs for underserved patient populations.
The company reported positive Phase 3 data in September for brepocitinib in dermatomyositis (DM), hitting all primary and secondary endpoints, and plans to file the NDA in the first half of 2026.
Significant progress was also made in the FCRN franchise, with data supporting its potential as a best-in-class drug for myasthenia gravis and CIDP, and showing clinical remission in Graves' disease.
Key catalysts for 2026 include a Phase 2 study readout for brepocitinib in cutaneous sarcoid, a large Phase 2B study readout for mosliciguat in PH-ILD, and an open-label readout for the Immunovant RA study. Additionally, the Moderna litigation jury trial is scheduled for March 2026. Brepocitinib's registrational studies for non-infectious uveitis (NIU) are expected to read out in 2027.

4 days ago

Transcript

Roivant Highlights 2025 Progress and Outlines Key 2026 Catalysts

ROIV

Product Launch

New Projects/Investments

Legal Proceedings

Roivant (ROIV) has transformed in 2025, now a $14.5 billion market cap public biopharma company, with significant progress in its FCRN franchise and positive Phase 3 data for brepocitinib in dermatomyositis (DM).
The company plans to file the NDA for brepocitinib in DM in the first half of 2026, targeting an orphan disease market with high unmet need and potential for broad adoption.
Key catalysts for 2026 include a cutaneous sarcoid study and multiple FCRN studies, as well as the Phase 2B data for mosliciguat in PH-ILD, which showed 37-38% PVR reductions in prior PAH studies.
The company also anticipates an open-label readout for Immunovant's rheumatoid arthritis (RA) study in 2026 and a jury trial with Moderna in March.

4 days ago

Transcript

Roivant Sciences Provides Updates on Pipeline Progress, Litigation, and Capital Allocation

ROIV

Legal Proceedings

Product Launch

Share Buyback

Brepocitinib (BREPO) for dermatomyositis (DM) is slated for NDA filing in the first half of next year and a 2027 launch, supported by strong efficacy data.
Key pipeline readouts are anticipated in 2026 and 2027, including Phase 3 data for FcRn inhibitors in TED and Graves, and Phase 2 data for Mosley in PH-ILD.
The U.S. Moderna LNP litigation is proceeding to a jury trial in March, with Roivant seeking $5 billion in damages.
Roivant maintains a strong financial position with $4.4 billion in cash and has executed a share buyback program, reducing share count by over 14%, with $500 million remaining for further buybacks.

Nov 11, 2025, 1:00 PM

Transcript

Roivant Sciences Provides Pipeline Updates and Litigation Details at Healthcare Conference

ROIV

New Projects/Investments

Legal Proceedings

Share Buyback

Roivant Sciences is advancing several key assets, including brepocitinib, which is planned for filing next year and launch in 2027 for dermatomyositis, and Immunovant's 1402/batoclimab, with TED data readouts expected by the end of 2025 and in the first half of 2026.
The company reported a cash balance of $4.4 billion as of November 10, 2025, and has a remaining $500 million share buyback authorization, having already reduced its share count by over 14%.
Roivant is involved in LNP litigation, with the US portion of the Moderna trial going to a jury trial in March 2026, where the damages ask is $5 billion. The Pfizer trial is approximately a year behind, and OUS Moderna trials are expected to begin next year.
Additional pipeline readouts include Mosliciguat for PH-ILD next year, and further data for 1402 in CLE and RA, with potential registrational studies for MG, Graves, and CIDP in 2027.

Nov 11, 2025, 1:00 PM

Transcript

Roivant Sciences Provides Updates on Pipeline Development, Litigation, and Financial Position

ROIV

Product Launch

Legal Proceedings

Share Buyback

Roivant Sciences anticipates filing the NDA for brepocitinib (BREPO) in dermatomyositis in the first half of 2026 and plans for a 2027 launch.
Key upcoming data readouts include the first phase three study for batoclimab in TED at the end of 2025, the second study in the first half of 2026, and phase two data for Mosley in PH-ILD next year (2026).
The US portion of the LNP litigation against Moderna is scheduled for a jury trial in March 2026, with a damages ask of $5 billion excluding willful infringement.
The company reported a cash balance of $4.4 billion as of November 10, 2025, and has $500 million remaining on its share buyback authorization, having already reduced its share count by over 14%.

Nov 11, 2025, 1:00 PM

Transcript

Roivant Sciences Ltd. Reports Q2 2026 Financial Results and Provides Business Update

ROIV

Earnings

Legal Proceedings

New Projects/Investments

Roivant Sciences Ltd. reported $4.4 billion in consolidated cash, cash equivalents, restricted cash, and marketable securities as of September 30, 2025, supporting a cash runway into profitability.
The company announced positive Phase 3 VALOR study results for brepocitinib in dermatomyositis, with an NDA filing planned for the first half of calendar year 2026.
Immunovant anticipates sharing topline results from both Phase 3 thyroid eye disease studies concurrently in the first half of calendar year 2026 due to evolving competitive dynamics.
For the three months ended September 30, 2025, the company reported a net loss attributable to Roivant Sciences Ltd. of $113.5 million, an improvement from $230.2 million in the prior year period.
Genevant's LNP litigation continues to progress, with a favorable Markman ruling in the Pfizer/BioNTech case in September 2025 and a jury trial in the U.S. Moderna case scheduled for March 2026.

Nov 10, 2025, 12:21 PM

8-K

Roivant Sciences Discusses BREPO Data, Pipeline, and Litigation at BofA Global Healthcare Conference 2025

ROIV

Product Launch

Legal Proceedings

New Projects/Investments

Roivant announced positive BREPO data for Dermatomyositis (DM), positioning it as the first novel targeted therapy successful in a late-stage study for DM, targeting an estimated 35,000 to 40,000 treated patients. The drug has IP protection through 2039 and is also in registrational studies for non-infectious uveitis (NIU), with data expected H1 2027.
The company is developing RVL-1402 for Graves' disease, with Phase 2 data showing 56% of patients achieved T3/T4 normalization and were off ATDs at week 12. This therapy aims to address a significant prevalent patient population of 330,000 uncontrolled patients on methimazole.
Roivant is engaged in LMP litigation with Moderna, where the applicability of the Section 1498 government contractor defense is a key issue, potentially covering $2.4 billion of the $5 billion in damages. A ruling on this is anticipated from the judge, potentially this fall or early next year. Claim construction rulings in the Pfizer matter were favorable to Roivant.
The company is also advancing its FcRn program in Myasthenia Gravis (MG) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), and its SGC program in PH-ILD, with Phase 2 data for the latter expected H2 2026.

Sep 24, 2025, 9:45 AM

Transcript

Roivant Sciences Announces Positive Phase III VALOR Study Results for Brepocitinib in Dermatomyositis

ROIV

New Projects/Investments

Product Launch

Sep 17, 2025, 12:00 PM

Transcript

Roivant's Priovant Subsidiary Announces Positive Phase 3 Results for Brepocitinib in Dermatomyositis

ROIV

New Projects/Investments

Roivant's Priovant subsidiary announced successful Phase 3 VALOR study results for Brepocitinib in Dermatomyositis (DM), marking the first successful registrational trial for a targeted therapy in DM.
The study demonstrated highly significant, robust, and consistent data across primary and all key secondary endpoints. Brepocitinib 30 mg showed a mean Total Improvement Score (TIS) of 46.5 compared to 31.2 for placebo at week 52 (p=0.0006).
A FDA filing for Brepocitinib in DM is planned for 1H 2026, positioning it as the first novel oral DM drug with a multi-year lead over other late-stage programs.
The safety profile of Brepocitinib 30 mg in VALOR was consistent with prior clinical studies, and responses were rapid, deep, and broad, showing clinically meaningful benefit to both muscle and skin symptoms.

Sep 17, 2025, 12:00 PM

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