roivw - ROIVW STOCK NEWS

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.

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.

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.

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.

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.

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.

Roivant (Nasdaq: ROIV) completes the acquisition of Telavant by Roche (SIX: RO, ROG; OTCQX: RHHBY) for $7.1 billion, with an upfront payment and a near-term milestone payment. Telavant holds rights to RVT-3101, a therapy for inflammatory bowel disease in the US and Japan. Roivant previously owned 75% of Telavant's shares. Roche aims to continue RVT-3101's development across multiple indications.

Immunovant, Inc. (IMVT) announced initial data from the 600 mg MAD cohort of a Phase 1 clinical trial of IMVT-1402, showing that four subcutaneously administered doses of 600 mg produced a mean IgG reduction similar to high dose batoclimab, with minimal changes in albumin and LDL-C, confirming the potential of IMVT-1402 as a best-in-class FcRn inhibitor.

Roivant (ROIV) and Priovant announce that the Phase 2 study evaluating oral brepocitinib in adult patients with moderate to severe active lupus did not meet its primary endpoint of Systemic Lupus Erythematosus Responder Index change of 4 (SRI-4) at Week 52. However, Priovant plans to continue progressing the program in indications outside of Systemic Lupus Erythematosus (SLE) due to the drug’s favorable safety and tolerability profile, six other positive phase 2 studies, and active arm performance in this study. Priovant also expects to announce topline results from the Phase 2 POC study of brepocitinib in non-infectious uveitis (NIU) in the first quarter of calendar year 2024 and topline results from the Phase 3 trial in dermatomyositis (DM) in calendar year 2025.