#ROIV

Priovant Announces FDA Acceptance and Priority Review of New Drug Application for Brepocitinib in Dermatomyositis Priovant Therapeutics (NASDAQ:ROIV) announced FDA acceptance of its NDA for brepocitinib in dermatomyositis with Priority Review and a PDUFA target action date in Q3 2026. The company expects a U.S. launch at the end of September 2026 if approved.Priority Review was supported by positive Phase 3 VALOR results (N=241), described as the first positive 52-week placebo-controlled trial in dermatomyositis; approval would represent the first targeted therapy for the disease.

1 week ago

#ROIV #ROIVW Priovant Announces FDA Acceptance and Priority Review of New Drug Application for Brepocitinib in Dermatomyositis

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Beautify Data

@beautifydata.com

2 months ago

Ramaswamy Vivek - Insider Non-Derivative Transactions at Roivant Sciences Ltd. (ROIV) - (SEC) Ramaswamy Vivek - Insider Non-Derivative Transactions at Roivant Sciences Ltd. (ROIV) - (SEC)

As at September 2025, #VivekRamaswamy (ten percent owner of #Roivant Sciences Ltd) owns 35,508,359 shares of #ROIV common shares.

www.beautifydata.com/us-sec/insid...

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Nasdaq

@nasdaq.activitypub.awakari.com.ap.brid.gy

3 months ago

Why Is Roivant Sciences Stock Gaining Thursday? - Roivant Sciences (NASDAQ:ROIV) Roivant (NASDAQ: ROIV) outlined accelerated timelines and expanded commercial ambitions for several late-stage programs.

Roivant Signals Major Pipeline Momentum With Accelerated Timelines Roivant (NASDAQ: ROIV) outlined accelerated timelines and expanded commercial ambitions for several late-stage programs. read more

#Biotech #IMVT #MRNA #News #ROIV #why #it's #moving #Health #Care #Top

Origin | Interest | Match

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

3 months ago

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

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4 months ago

#ROIV #ROIVW Roivant Reports Financial Results for the Second Quarter Ended September 30, 2025, and Provides Business Update

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Market Wire News

@marketwirenews.com

5 months ago

NEWS: ( NASDAQ: #ROIV ) Why Roivant Sciences Stock Is Soaring Today

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Roivant Unveils Durability and Treatment-Free Six-month Remission Data with Potential to Change Treatment Paradigm for Uncontrolled Graves' Disease Patients Immunovant (Nasdaq: IMVT) has revealed promising six-month remission data for batoclimab in treating uncontrolled Graves' disease. In a proof-of-concept study, approximately 80% (17/21) of patients maintained normal thyroid function six months after treatment cessation, with 50% (8/17) of responders achieving anti-thyroid drug (ATD) free remission.The study involved a 24-week treatment period with batoclimab administered subcutaneously, followed by a 24-week off-treatment follow-up. The treatment demonstrated strong durability, with an additional 30% (5/17) of responding patients requiring only minimal ATD doses. Safety and tolerability were consistent with previous batoclimab studies.Two potentially registrational trials for IMVT-1402, the company's lead compound, are currently enrolling patients, with topline results expected in 2027.

6 months ago

#ROIV #ROIVW Roivant Unveils Durability and Treatment-Free Six-month Remission Data with Potential to Change Treatment Paradigm for Uncontrolled Graves' Disease Patients

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Roivant Reports Financial Results for the First Quarter Ended June 30, 2025, and Provides Business Update Roivant Sciences (Nasdaq: ROIV) reported Q1 2025 financial results and business updates. The company maintained a strong financial position with $4.5 billion in consolidated cash and marketable securities as of June 30, 2025. Key highlights include completion of a $1.5 billion share repurchase program, reducing outstanding shares by over 15%, and board approval for an additional $500 million buyback program.Financial results showed R&D expenses increased to $152.9 million from $120.5 million year-over-year, while G&A expenses rose to $134.0 million. The company reported a net loss from continuing operations of $273.9 million ($0.33 per share).Clinical progress remains on track with multiple milestone readouts expected, including brepocitinib's Phase 3 VALOR study in dermatomyositis in H2 2025 and IMVT-1402's advancement in six indications.

7 months ago

#ROIV #ROIVW Roivant Reports Financial Results for the First Quarter Ended June 30, 2025, and Provides Business Update

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Văzdooh

@vazdooh.bsky.social

8 months ago

#ROIV 12, 14 & 15C for October. Looks like an impending breakout.

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Roivant Reports Financial Results for the Fourth Quarter and Fiscal Year Ended March 31, 2025, and Provides Business Update Roivant (NASDAQ: ROIV) reported financial results for Q4 and fiscal year ended March 31, 2025. The company maintains a strong financial position with $4.9B in consolidated cash and marketable securities. Key highlights include: $1.3B share repurchase program reducing outstanding shares by 14%, continued progress in brepocitinib trials with expected readouts in 2026-2027, and expansion of IMVT-1402 development into six indications. Financial results show R&D expenses increased to $145.2M in Q4 2025 from $107.6M in Q4 2024, while G&A expenses rose to $147.1M from $108.1M. The company reported a loss from continuing operations of $252.4M for Q4 2025. Notable developments include leadership changes at Immunovant and expansion of LNP litigation against Moderna to international markets.

9 months ago

#ROIV #ROIVW Roivant Reports Financial Results for the Fourth Quarter and Fiscal Year Ended March 31, 2025, and Provides Business Update

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11 months ago

🎯 Momentum #Options Activity trade ideas! Heavy institutional #optionsvolume far above daily average with strong consensus on direction.

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Roivant Announces Positive Results for Batoclimab Myasthenia Gravis (MG) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Studies Pivotal study in MG met primary endpoint of change from baseline in MG-ADL in AChR+ population at 12 weeks, with a 5.6 point improvement in the higher dose arm (with 74% mean IgG reduction) and a 4.7 point improvement in the lower dose arm (with 64% mean IgG reduction) Initial CIDP results from

11 months ago

#ROIV #ROIVW Roivant Announces Positive Results for Batoclimab Myasthenia Gravis (MG) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Studies

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Roivant's $5.2B War Chest Fuels Ambitious Clinical Pipeline as Loss Widens in Q3 Roivant reports $5.2B cash position and expands brepocitinib development, while posting $208.9M loss. Key milestones ahead with IMVT-1402 trials and batoclimab results.

1 year ago

#ROIV #ROIVW Roivant Reports Financial Results for the Third Quarter Ended December 31, 2024, and Provides Business Update

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Virtual Dermatology Startup Zest Health Secures $13M to Combat $40B Biologics Crisis Digital health platform Zest Health secures $13M seed funding to revolutionize dermatology care, showing 80% patient improvement rates and targeting $40B+ in excessive biologics spending.

1 year ago

#ROIV #ROIVW Zest Health Announces $13M in Funding to Curb Unnecessary Pharmaceutical Spend through High-Touch Care

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Kinevant Sciences Announces Topline Results from Phase 2 RESOLVE-Lung Study of Namilumab in Chronic Active Pulmonary Sarcoidosis | ROIV Stock News Kinevant Sciences, a clinical-stage

1 year ago

#ROIV #ROIVW Kinevant Sciences Announces Topline Results from Phase 2 RESOLVE-Lung Study of Namilumab in Chronic Active Pulmonary Sarcoidosis

#StockMarket #stocks #investing

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Roivant Sciences' Namilumab Fails Phase 2 Sarcoidosis Trial, Development Halted | ROIV Stock News Roivant's namilumab drug misses primary and secondary endpoints in Phase 2 RESOLVE-Lung study for pulmonary sarcoidosis, leading to discontinuation of development program.

1 year ago

#ROIV #ROIVW Roivant Announces Topline Results from Phase 2 RESOLVE-Lung Study of Namilumab in Chronic Active Pulmonary Sarcoidosis

#StockMarket #news #investing

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1 year ago

🎯 Momentum #Options Activity trade ideas! Heavy institutional #optionsvolume far above daily average with strong consensus on direction.

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1 year ago

🚨 Institutions #optionsvolume surge detected!

PM Top Momentum Activity from 🔥 INSIDERFINANCE.COM 🔥
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3. #SOUN 4.0x
4. #VSH 3.2x
5. #ROIV 3.1x

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1 year ago

🎯 Momentum #Options Activity trade ideas! Heavy institutional #optionsvolume far above daily average with strong consensus on direction.

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