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Roivant Sciences - ROIVW STOCK NEWS

Welcome to our dedicated page for Roivant Sciences news (Ticker: roivw), a resource for investors and traders seeking the latest updates and insights on Roivant Sciences stock.

Riovant Sciences Ltd. is a commercial-stage biopharmaceutical company focused on accelerating the development and commercialization of medicines that matter. The company's pipeline includes VTAMA®, a topical treatment for psoriasis and atopic dermatitis, IMVT-1402 and batoclimab, fully human monoclonal antibodies targeting the neonatal Fc receptor in autoimmune indications, and brepocitinib, a small molecule inhibitor for dermatomyositis and non-infectious uveitis. Through creating nimble subsidiaries, Roivant aims to advance its therapies and technologies, while also nurturing discovery-stage companies and health tech startups.

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Roivant (Nasdaq: ROIV) unveiled mosliciguat, a potential first-in-class inhaled once-daily soluble Guanylate Cyclase (sGC) activator for pulmonary hypertension associated with interstitial lung disease (PH-ILD). The Phase 1b ATMOS study showed clinically meaningful reductions in pulmonary vascular resistance (PVR) of up to ~38% in PH patients. Mosliciguat was generally well-tolerated with low rates of adverse events.

The global Phase 2 'PHocus' study in ~120 PH-ILD patients is set to begin soon. PH-ILD affects ~200,000 patients in the U.S. and Europe, with treatment options. Roivant acquired worldwide rights to mosliciguat from Bayer for an upfront payment of ~$14.0 million, with potential additional payments of up to $280 million and tiered royalties.

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Immunovant (Nasdaq: IMVT) reported positive results from its Phase 2a trial of batoclimab in Graves' Disease. Key findings include:

- 76% response rate with high-dose batoclimab at week 12
- 56% ATD-free response rate at week 12
- Strong correlation between IgG lowering and clinical outcomes

Market research indicates 25-30% of Graves' Disease patients are uncontrolled on antithyroid drugs (ATDs) annually. Immunovant received FDA clearance for IMVT-1402's IND, with a pivotal trial expected to start by year-end 2024. The company believes these results validate the unmet medical need and demonstrate strong response rates in patients uncontrolled on ATDs, potentially positioning IMVT-1402 as a first-in-class and best-in-class treatment for Graves' Disease.

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Roivant (Nasdaq: ROIV) reported financial results for Q1 2024 and provided a business update. Key highlights include:

- Immunovant completed enrollment in batoclimab pivotal myasthenia gravis trial
- Brepocitinib advancing to Phase 3 in non-infectious uveitis
- VTAMA net product revenue of $18.4M for Q1
- Consolidated cash of $5.7B as of June 30, 2024

Upcoming milestones:
- VTAMA PDUFA for atopic dermatitis in Q4 2024
- Namilumab Phase 2 data in sarcoidosis in Q4 2024
- Brepocitinib Phase 3 data in dermatomyositis in 2H 2025
- Multiple Immunovant clinical readouts expected through 2025

Q1 2024 financials:
- R&D expenses: $133.2M
- SG&A expenses: $148.5M
- Net income: $57.5M ($0.13 per share)

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Roivant (Nasdaq: ROIV) has announced it will host a live conference call and webcast on Thursday, August 8, 2024, at 8:00 a.m. ET to report its financial results for the first quarter ended June 30, 2024, and provide a business update. Interested parties can register for the conference call online. The presentation and webcast details will be available in the Investors section of Roivant's website under 'Events & Presentations'. An archived version of the webcast will be accessible on the company's website after the conference call concludes.

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Roivant (Nasdaq: ROIV) reported its Q4 and FY2024 results, highlighting strong performance in clinical trials and significant debt reductions.

Key points include:

  • Brepocitinib showed the best treatment failure rates in non-infectious uveitis (NIU), supporting a pivotal program initiation in H2 2024.
  • VTAMA net product revenue reached $75.1M, with over 385,000 prescriptions since launch.
  • Roivant renegotiated Dermavant’s debt, reducing potential cash payments by over $300M, with $225M savings expected over the next three fiscal years.
  • The company has $6.6B in cash, supporting a runway into profitability.
  • A $1.5B share repurchase program was approved, reducing outstanding shares by 9%.
  • Net loss for Q4 was $108M, while annual R&D expenses decreased by $23.5M.
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Roivant (Nasdaq: ROIV) announced a live conference call and webcast scheduled for 8:00 a.m. ET on May 30, 2024, to discuss its fourth-quarter and fiscal year results ending March 31, 2024. The company will also provide a business update during this session. Investors can register online for the conference call. The presentation will be available under the 'Events & Presentations' section of Roivant’s website, where the archived webcast will also be accessible post-call.

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Roivant (ROIV) announces a $1.5 billion share repurchase program and positive Phase 2 study results for brepocitinib in non-infectious uveitis (NIU). The repurchase includes buying back Sumitomo Pharma's stake, reducing shares outstanding by 9%. NEPTUNE study shows promising efficacy data, with Treatment Failure rates of 29% for 45 mg and 44% for 15 mg. Brepocitinib demonstrates potential as a multi-blockbuster franchise in specialty autoimmunity.
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Roivant (ROIV) reports strong financial results for Q3 2023, completes $7.1B sale of Telavant to Roche, and achieves positive clinical trial results for Batoclimab and VTAMA products. The company maintains a healthy cash position of $6.7B, supporting future growth and profitability.
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Roivant (ROIV) will host a live conference call and webcast to report its financial results for the third quarter ended December 31, 2023, and provide a business update on February 13, 2024. The conference call details can be accessed on the Roivant website.
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Immunovant, Inc. (Nasdaq: IMVT) announced promising results from the initial cohort of patients in a 24-week Phase 2 clinical trial of batoclimab in patients with Graves’ disease. The trial demonstrated a meaningful response rate of over 50%, with potential best-in class IgG reduction of up to 87% after 12 weeks of treatment. The primary and secondary outcome measurements of the trial are being measured at weeks 12 and 24, showing a dose response on efficacy between different regimens of batoclimab. The treatment was generally well-tolerated with no new safety signals observed.
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FAQ

What is Roivant Sciences Ltd. focused on?

Roivant Sciences Ltd. is focused on accelerating the development and commercialization of medicines that matter, with a pipeline of innovative treatments for various conditions.

What are some products in Roivant Sciences Ltd.'s pipeline?

Roivant Sciences Ltd.'s pipeline includes VTAMA®, IMVT-1402, batoclimab, and brepocitinib, targeting autoimmune diseases and other conditions.

How does Roivant Sciences Ltd. advance its pipeline?

Roivant Sciences Ltd. advances its pipeline by creating nimble subsidiaries or 'Vants' to develop and commercialize its medicines and technologies.

What additional initiatives does Roivant Sciences Ltd. undertake?

In addition to therapeutics, Roivant Sciences Ltd. incubates discovery-stage companies and health technology startups that complement its biopharmaceutical business.

What is the significance of Roivant Sciences Ltd.'s latest achievements?

Roivant Sciences Ltd. has recently achieved positive results in Phase 2 studies, such as the NEPTUNE study, showing the efficacy of brepocitinib in non-anterior non-infectious uveitis, indicating potential transformative benefits for patients.
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