Roivant Highlights Continued Pipeline Progress and Outlook for Company’s Next Phase of Growth at 2025 Investor Day

Rhea-AI Summary

Roivant (Nasdaq: ROIV) outlined accelerated late‑stage timelines and commercialization plans at its 2025 Investor Day, forecasting 3+ launches, 4+ NDA/BLA filings, 8+ pivotal and 3+ proof‑of‑concept readouts over the next three years.

Key updates: brepocitinib NDA for dermatomyositis expected in early 2026 with launch planned early 2027; brepocitinib topline data for non‑infectious uveitis now expected H2 2026; cutaneous sarcoidosis PoC topline H1 2026; IMVT‑1402 D2T RA topline data expected in 2026. Roivant‑led Immunovant financing raised ~$550 million, extending Immunovant cash runway to IMVT‑1402 launch. Ongoing litigation schedules include a US Moderna jury trial in March 2026.

Positive

• Guidance: 3+ product launches expected over next three years
• Pipeline scale: 4+ NDA/BLA filings planned in next three years
• Readout cadence: 8+ pivotal and 3+ PoC readouts forecast over three years
• Immunovant financing generated ~$550 million gross proceeds
• Brepocitinib DM NDA filing expected early 2026 with launch early 2027

Negative

• High event concentration: multiple pivotal readouts clustered over three years
• Legal timeline: US Moderna jury trial scheduled for March 2026

Key Figures

Planned launches 3+ product launches Expected over the next three years

NDA/BLA filings 4+ NDA/BLA filings Expected over the next three years

Pivotal readouts 8+ pivotal study readouts Expected over the next three years

PoC readouts 3+ proof-of-concept readouts Expected over the next three years

Immunovant financing approximately $550 million Gross proceeds to Immunovant in Roivant-led financing

Mosliciguat combo trial size n=20 patients Planned Phase 2 mosliciguat plus inhaled treprostinil in PH-ILD

Genevant US trial date March 2026 Scheduled jury trial in US Moderna litigation

Brepocitinib NDA timing Early 2026 Planned NDA filing in dermatomyositis

Market Reality Check

$20.24 Last Close

Volume Volume 4,824,515 is below the 20-day average of 6,109,273 (relative volume 0.79x) ahead of the Investor Day news. normal

Technical Shares at $20.24 are trading above the 200-day MA of $13.36 and within ~6% of the 52-week high of $21.475.

Peers on Argus

ROIV was down 0.93% while key biotech peers showed mixed, mostly modest moves: MRNA up 2.87%, HALO up 0.89%, VRNA up 0.06%, BPMC up 0.09%, and MDGL down 0.09%. This points to stock‑specific positioning rather than a broad sector move.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Nov 10	Earnings and update	Positive	+2.7%	Q2 results with strong cash and positive brepocitinib and Immunovant updates.
Oct 27	Earnings preview	Neutral	-2.1%	Scheduling announcement for upcoming Q2 results and business update webcast.
Sep 17	Phase 3 data	Positive	+7.8%	Breakthrough Phase 3 VALOR results for brepocitinib in dermatomyositis.
Sep 11	Workplace award	Positive	-2.3%	Inclusion on Fortune and Great Place To Work 2025 Best Workplaces list.
Sep 03	Clinical remission data	Positive	+1.6%	Immunovant proof‑of‑concept remission data in uncontrolled Graves’ disease.

Pattern Detected

ROIV has tended to trade higher on substantive clinical or earnings updates, while softer or non-core news has sometimes seen muted or negative reactions.

Recent Company History

This announcement builds on several recent milestones. In September 2025, Roivant and Priovant reported positive Phase 3 VALOR dermatomyositis data for brepocitinib, followed by Q2 results on November 10, 2025 highlighting a strong cash position of about $4.4B and continued pipeline investment. Earlier, Immunovant shared encouraging Graves’ disease remission data, and Roivant received workplace recognition in biopharma. Today’s Investor Day reiterates brepocitinib’s path to NDA and expands on IMVT‑1402 and other late‑stage assets, framing the next multi‑year growth phase.

Regulatory & Risk Context

Active S-3 Shelf Registration 2025-10-03

$400.0 million registered capacity

Roivant has an effective S-3ASR shelf dated October 3, 2025, allowing issuance of common shares up to an aggregate $400.0 million under a Sales Agreement; as of filing, $0 had been used, while a share repurchase program was also in place. This provides flexibility for future capital raises alongside buybacks.

Market Pulse Summary

This announcement mapped Roivant’s next phase with 3+ launches, 4+ NDA/BLA filings, and 8+ pivotal readouts targeted over three years, anchored by brepocitinib and IMVT‑1402. The update also detailed a $550 million Immunovant financing and multiple 2026 catalysts, including brepocitinib NDA timing and Genevant litigation. Historically, ROIV reacted most to substantive clinical and earnings news. Investors may watch execution versus these timelines, potential use of the $400.0 million shelf, and ongoing insider activity.

Key Terms

nda regulatory

"Brepocitinib NDA filing in dermatomyositis (DM) now expected in early calendar year 2026"

An NDA, or nondisclosure agreement, is a legal contract that keeps certain information private between parties. It’s like a promise not to share sensitive details, helping protect business ideas, strategies, or data from being leaked or used without permission. For investors, NDAs help ensure that confidential information remains secure, enabling trust and open communication during business discussions.

phase 3 medical

"Brepocitinib Phase 3 trial in non-infectious uveitis (NIU) fully enrolled"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

proof-of-concept medical

"3+ proof-of-concept study readouts expected over the next three years"

A proof-of-concept is a demonstration that shows a new idea or method can work as intended, serving as a small-scale test before full development. For investors, it signals that a concept has been successfully tested in principle, reducing uncertainty about whether it can be practically implemented. This helps determine if further investment or effort is justified to develop the idea further.

interstitial lung disease medical

"mosliciguat in pulmonary hypertension associated with interstitial lung disease (PH-ILD)"

A group of lung conditions that cause inflammation and scarring of the thin tissue between the air sacs, which makes it harder for oxygen to pass into the blood; imagine the lungs’ fine filters becoming stiff and less effective. Investors care because reports of interstitial lung disease can affect a drug’s safety profile, trigger regulatory warnings or label changes, and shift demand for treatments or create liability risks that influence a company’s valuation.

treprostinil medical

"study (n=20) evaluating mosliciguat in combination with inhaled treprostinil in patients"

Treprostinil is a prescription drug that widens and relaxes the small blood vessels in the lungs to lower high blood pressure there and help people breathe and move more easily; it comes in several forms such as injection, infusion, inhalation or tablets. For investors it matters because approval status, patent protection, manufacturing complexity, competition from other treatments, and ongoing clinical trials directly affect a company’s sales potential, regulatory risk, and long-term revenue—think of it as a product line whose market success depends on safety, access, and differentiation.

AI-generated analysis. Not financial advice.

• Roivant enters new phase of corporate journey with 3+ launches, 4+ NDA/BLA filings, 8+ pivotal and 3+ proof-of-concept study readouts expected over the next three years
• Highlighting clinical execution, Roivant announces positive updates to timing guidance across four key programs:
  • Brepocitinib NDA filing in dermatomyositis (DM) now expected in early calendar year 2026; commercial preparation underway with launch expected early in calendar year 2027
  • Brepocitinib Phase 3 trial in non-infectious uveitis (NIU) fully enrolled with topline data now expected in the second half of calendar year 2026
  • Brepocitinib proof-of-concept trial in cutaneous sarcoidosis (CS) fully enrolled with topline data now expected in the first half of calendar year 2026
  • IMVT-1402 potentially registrational trial in difficult-to-treat rheumatoid arthritis (D2T RA) topline data now expected in calendar year 2026
• 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 Graves’ disease (GD); Roivant cash balance continues to support runway into profitability
• All other pipeline programs remain on track with previously communicated timelines
• Roivant will host our Investor Day today at 8:00 a.m. ET to discuss our progress and next chapter in detail
  

BASEL, Switzerland and LONDON and NEW YORK, Dec. 11, 2025 (GLOBE NEWSWIRE) -- 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

Investor Day Webcast Information

Roivant will host an Investor Day in New York City at 8:00 a.m. ET on Thursday, December 11, 2025. The event will be webcasted for those unable to attend in person.

To access the webcast, please register online using this registration link. The presentation and webcast details will also be available under “Events & Presentations” in the Investors section of the Roivant website at https://investor.roivant.com/news-events/events. The archived webcast will be available on Roivant’s website after the event.

About Roivant

Roivant (Nasdaq: ROIV) is a biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Roivant’s pipeline includes brepocitinib, a potent small molecule inhibitor of JAK1 and TYK2 in development for the treatment of dermatomyositis, non-infectious uveitis and cutaneous sarcoidosis; IMVT-1402 and batoclimab, fully human monoclonal antibodies targeting FcRn in development across several IgG-mediated autoimmune indications; and mosliciguat, an inhaled sGC activator in development for pulmonary hypertension associated with interstitial lung disease. We advance our pipeline by creating nimble subsidiaries or “Vants” to develop and commercialize our medicines and technologies. Beyond therapeutics, Roivant also incubates discovery-stage companies and health technology startups complementary to its biopharmaceutical business. For more information, visit https://roivant.com.

Roivant Forward-Looking Statements

This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which are usually identified by the use of words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and variations of such words or similar expressions. The words may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act.

Our forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future, and statements that are not historical facts, including statements about the clinical and therapeutic potential of our product candidates, the availability and success of topline results from our ongoing clinical trials and any commercial potential of our product candidates following applicable regulatory approvals. In addition, any statements that refer to projections, forecasts or other characterizations of future events, results or circumstances, including any underlying assumptions, are forward-looking statements. Actual results may differ materially from those contemplated in these statements due to a variety of risks, uncertainties and other factors.

Although we believe that our plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, those risks set forth in the Risk Factors section of our filings with the U.S. Securities and Exchange Commission. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of our management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts:

Investors
Keyur Parekh
keyur.parekh@roivant.com

Media
Stephanie Lee
stephanie.lee@roivant.com

FAQ

What key pipeline milestones did Roivant (ROIV) announce for 2026–2027?

Roivant expects 4+ NDA/BLA filings, 3+ launches, and multiple topline readouts including brepocitinib DM NDA early 2026 and launch early 2027.

When will brepocitinib topline data for non‑infectious uveitis (NIU) affect ROIV timelines?

Topline data for brepocitinib in NIU is expected in the second half of 2026, ahead of prior guidance.

How much financing did Roivant‑led Immunovant raise and what is the impact?

The Roivant‑led financing generated approximately $550 million gross proceeds, extending Immunovant’s cash runway to the IMVT‑1402 launch.

When is IMVT‑1402 topline data for difficult‑to‑treat rheumatoid arthritis expected for ROIV investors?

Topline data for IMVT‑1402 in D2T RA is now expected in calendar year 2026.

Does Roivant have any scheduled litigation dates investors should note?

Yes; a US Moderna jury trial has been scheduled for March 2026, with other ex‑US Moderna hearings expected in 2026.