Roivant Sciences Releases Preliminary Data from 1402 Study
Written by Emily J. Thompson, Senior Investment Analyst
Updated: May 20 2026
0mins
Source: Yahoo Finance
- Breakthrough Therapy Designation: Roivant's brepocitinib has received FDA breakthrough therapy designation for refractory granulomatous diseases, with a planned launch by the end of September, marking a significant advancement in treatment options for patients.
- Clinical Data Highlights: In the open-label phase of the 1402 study, 73% of patients achieved ACR20 responses, with over 50% achieving ACR50 responses, demonstrating significant efficacy in refractory patients and the potential to change existing treatment paradigms.
- Financial and Settlement Progress: The company has reached a $2.25 billion settlement with Moderna, expecting to receive $950 million upfront in July, which will bolster its financial position and support future R&D activities.
- Future Outlook: Roivant plans to launch brepocitinib within the next 12 months and release top-line data from the CLE study in the second half of the year, showcasing strong execution across multiple projects and market potential.
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Analyst Views on ROIV
Wall Street analysts forecast ROIV stock price to fall
8 Analyst Rating
7 Buy
1 Hold
0 Sell
Strong Buy
Current: 29.880
Low
22.00
Averages
27.63
High
33.00
Current: 29.880
Low
22.00
Averages
27.63
High
33.00
About ROIV
Roivant Sciences Ltd. is a biopharmaceutical company focused on improving the lives of patients by accelerating the development and commercialization of medicines that matter. The Company’s pipeline includes brepocitinib, a potent small molecule inhibitor of TYK2 and JAK1 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. It also incubates discovery-stage companies and health technology startups complementary to its biopharmaceutical business.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Roivant Sciences Q4 2025 Earnings Call Insights Highlight Key Developments
- Clinical Data Highlights: Roivant's IMVT-1402 study in D2T RA reported that 73% of patients achieved ACR 20 responses, with over half reaching ACR 50, indicating strong efficacy that is likely to enhance the company's market share in rheumatoid arthritis.
- New Drug Progress: Brepocitinib has received breakthrough therapy and breakthrough designation, with a planned launch in dermatomyositis by the end of September, which, if FDA approved, will significantly enhance Roivant's product portfolio and market competitiveness.
- Financial Status Update: As of March 31, Roivant reported $4.3 billion in cash and cash equivalents with no debt, and is expected to receive $950 million from the Moderna settlement in July, which will bolster the company's financial flexibility and support future R&D investments.
- Future Outlook: Management anticipates that the Phase IIb study of mosliciguat in PH-ILD will release top-line data in the second half of 2026, while significant updates on D2T RA and IMVT-1402 are expected later this year, demonstrating ongoing progress across multiple key areas.
See More
Roivant (ROIV) Q4 2025 Earnings Transcript
See More
Roivant Sciences Releases Preliminary Data from 1402 Study
- Breakthrough Therapy Designation: Roivant's brepocitinib has received FDA breakthrough therapy designation for refractory granulomatous diseases, with a planned launch by the end of September, marking a significant advancement in treatment options for patients.
- Clinical Data Highlights: In the open-label phase of the 1402 study, 73% of patients achieved ACR20 responses, with over 50% achieving ACR50 responses, demonstrating significant efficacy in refractory patients and the potential to change existing treatment paradigms.
- Financial and Settlement Progress: The company has reached a $2.25 billion settlement with Moderna, expecting to receive $950 million upfront in July, which will bolster its financial position and support future R&D activities.
- Future Outlook: Roivant plans to launch brepocitinib within the next 12 months and release top-line data from the CLE study in the second half of the year, showcasing strong execution across multiple projects and market potential.
See More
Roivant Sciences Reports $355.7M Net Income, Shares Surge
- Litigation Windfall: Roivant Sciences reported a $770.2 million gain from a litigation settlement with Moderna, resulting in a net income of $355.7 million for Q4, a significant turnaround from a $252.4 million loss a year earlier, indicating strong financial recovery.
- Stock Surge: Following the Q4 profit report, Roivant shares soared nearly 15% in pre-market trading, positioning the stock to potentially break above $9 and end a three-day losing streak, which could mark the largest single-day gain in over three months, reflecting optimistic market sentiment.
- Upcoming Milestones: Roivant and its subsidiaries are set to launch Brepocitinib by late September 2026 and report Phase 2 data for Mosliciguat in late 2026, showcasing the company's ongoing investment in autoimmune and pulmonary disease research and development.
- Market Sentiment Shift: Retail sentiment for Roivant on Stocktwits shifted from 'bearish' to 'bullish' amid high message volumes, indicating increased investor confidence in the company's future performance, further driving the stock's upward momentum.
See More
Immunovant's Phase 2 Trial Results Show Promising Efficacy for IMVT-1402
- Clinical Trial Results: Immunovant's IMVT-1402 demonstrated a 72.7% ACR20 response rate in its Phase 2 trial for rheumatoid arthritis, indicating significant efficacy in improving patient outcomes and potentially offering new treatment options for difficult-to-treat patients.
- Dose Response Analysis: The open-label phase showed that a weekly injectable dose of 600 mg of IMVT-1402 achieved 54.5% and 35.8% ACR50 and ACR70 responses, respectively, highlighting the drug's strong performance across various efficacy measures and enhancing its market potential.
- Safety Assessment: Immunovant reported no new drug-related safety events during the trial, indicating that IMVT-1402 was well-tolerated among participants, which lays a solid foundation for its future clinical applications.
- Positive Market Reaction: JPMorgan analyst Brian Cheng welcomed the trial results, reiterating his Overweight rating on Roivant, noting that the data exceeded expectations and supports the drug's potential in treating rheumatoid arthritis.
See More
Roivant Sciences Q4 Earnings Beat Expectations
- Earnings Performance Exceeds Expectations: Roivant Sciences reported a Q4 GAAP EPS of $0.28, beating expectations by $0.62, indicating positive progress in profitability despite ongoing revenue challenges.
- Significant Revenue Decline: The company reported revenue of $2.52 million, a 66.7% year-over-year decline, missing expectations by $1.39 million, reflecting a tough market environment and weak product sales.
- Strong Cash Reserves: As of March 31, 2026, Roivant holds $4.3 billion in cash, cash equivalents, and marketable securities, ensuring sufficient liquidity to support operations until profitability, thereby boosting investor confidence.
- Optimistic Future Outlook: Despite current revenue declines, Roivant is actively expanding its Brepocitinib program and showcasing its latest clinical data at the upcoming Global Healthcare Conference, indicating a strategic focus on future growth opportunities.
See More
Roivant Sciences Q4 2025 Earnings Call Insights Highlight Key Developments
- Clinical Data Highlights: Roivant's IMVT-1402 study in D2T RA reported that 73% of patients achieved ACR 20 responses, with over half reaching ACR 50, indicating strong efficacy that is likely to enhance the company's market share in rheumatoid arthritis.
- New Drug Progress: Brepocitinib has received breakthrough therapy and breakthrough designation, with a planned launch in dermatomyositis by the end of September, which, if FDA approved, will significantly enhance Roivant's product portfolio and market competitiveness.
- Financial Status Update: As of March 31, Roivant reported $4.3 billion in cash and cash equivalents with no debt, and is expected to receive $950 million from the Moderna settlement in July, which will bolster the company's financial flexibility and support future R&D investments.
- Future Outlook: Management anticipates that the Phase IIb study of mosliciguat in PH-ILD will release top-line data in the second half of 2026, while significant updates on D2T RA and IMVT-1402 are expected later this year, demonstrating ongoing progress across multiple key areas.
See More
Roivant (ROIV) Q4 2025 Earnings Transcript
See More
Roivant Sciences Releases Preliminary Data from 1402 Study
- Breakthrough Therapy Designation: Roivant's brepocitinib has received FDA breakthrough therapy designation for refractory granulomatous diseases, with a planned launch by the end of September, marking a significant advancement in treatment options for patients.
- Clinical Data Highlights: In the open-label phase of the 1402 study, 73% of patients achieved ACR20 responses, with over 50% achieving ACR50 responses, demonstrating significant efficacy in refractory patients and the potential to change existing treatment paradigms.
- Financial and Settlement Progress: The company has reached a $2.25 billion settlement with Moderna, expecting to receive $950 million upfront in July, which will bolster its financial position and support future R&D activities.
- Future Outlook: Roivant plans to launch brepocitinib within the next 12 months and release top-line data from the CLE study in the second half of the year, showcasing strong execution across multiple projects and market potential.
See More
Roivant Sciences Reports $355.7M Net Income, Shares Surge
- Litigation Windfall: Roivant Sciences reported a $770.2 million gain from a litigation settlement with Moderna, resulting in a net income of $355.7 million for Q4, a significant turnaround from a $252.4 million loss a year earlier, indicating strong financial recovery.
- Stock Surge: Following the Q4 profit report, Roivant shares soared nearly 15% in pre-market trading, positioning the stock to potentially break above $9 and end a three-day losing streak, which could mark the largest single-day gain in over three months, reflecting optimistic market sentiment.
- Upcoming Milestones: Roivant and its subsidiaries are set to launch Brepocitinib by late September 2026 and report Phase 2 data for Mosliciguat in late 2026, showcasing the company's ongoing investment in autoimmune and pulmonary disease research and development.
- Market Sentiment Shift: Retail sentiment for Roivant on Stocktwits shifted from 'bearish' to 'bullish' amid high message volumes, indicating increased investor confidence in the company's future performance, further driving the stock's upward momentum.
See More
Immunovant's Phase 2 Trial Results Show Promising Efficacy for IMVT-1402
- Clinical Trial Results: Immunovant's IMVT-1402 demonstrated a 72.7% ACR20 response rate in its Phase 2 trial for rheumatoid arthritis, indicating significant efficacy in improving patient outcomes and potentially offering new treatment options for difficult-to-treat patients.
- Dose Response Analysis: The open-label phase showed that a weekly injectable dose of 600 mg of IMVT-1402 achieved 54.5% and 35.8% ACR50 and ACR70 responses, respectively, highlighting the drug's strong performance across various efficacy measures and enhancing its market potential.
- Safety Assessment: Immunovant reported no new drug-related safety events during the trial, indicating that IMVT-1402 was well-tolerated among participants, which lays a solid foundation for its future clinical applications.
- Positive Market Reaction: JPMorgan analyst Brian Cheng welcomed the trial results, reiterating his Overweight rating on Roivant, noting that the data exceeded expectations and supports the drug's potential in treating rheumatoid arthritis.
See More
Roivant Sciences Q4 Earnings Beat Expectations
- Earnings Performance Exceeds Expectations: Roivant Sciences reported a Q4 GAAP EPS of $0.28, beating expectations by $0.62, indicating positive progress in profitability despite ongoing revenue challenges.
- Significant Revenue Decline: The company reported revenue of $2.52 million, a 66.7% year-over-year decline, missing expectations by $1.39 million, reflecting a tough market environment and weak product sales.
- Strong Cash Reserves: As of March 31, 2026, Roivant holds $4.3 billion in cash, cash equivalents, and marketable securities, ensuring sufficient liquidity to support operations until profitability, thereby boosting investor confidence.
- Optimistic Future Outlook: Despite current revenue declines, Roivant is actively expanding its Brepocitinib program and showcasing its latest clinical data at the upcoming Global Healthcare Conference, indicating a strategic focus on future growth opportunities.
See More
