roivw - ROIVW STOCK NEWS

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.

Roivant (ROIV) reported a definitive agreement with Roche for the sale of Telavant for $7.1B upfront and a milestone payment of $150M. IMVT-1402 SC doses achieved peak IgG reductions similar to batoclimab. VTAMA® cream generated $18.4M in net product revenue for the quarter. Cash, cash equivalents, and restricted cash were approximately $1.4B at September 30, 2023, expected to reach $7.0B with pending sale proceeds. Mayukh Sukhatme, M.D. appointed to the Board of Directors.

Roivant (Nasdaq: ROIV) appoints Mayukh Sukhatme, M.D., as a new member of its Board of Directors, expanding the board to eight members. Dr. Sukhatme's extensive experience in the pharmaceutical industry and his role in driving positive Phase 3 studies and FDA approvals make him a valuable addition to the board.