Today’s early trading session reveals a notable rise for Roivant Sciences Ltd. (NASDAQ: ROIV). Roivant shares, as of the last check, were exhibiting a remarkable 5.47% increase, reaching $11.00 on the US stock chart. A positive clinical study outcome caused the ROIV shares to surge.
Roivant and Priovant Therapeutics have disclosed positive outcomes from their Phase 2 trial, NEPTUNE, evaluating brepocitinib for non-anterior non-infectious uveitis (NIU), marking the most compelling efficacy data in NIU to date. Alongside these results, Roivant has authorized a share repurchase initiative for up to $1.5 billion, including the repurchase of all 71.3 million shares owned by Sumitomo Pharma at $9.10 per share, totaling around $648.4 million and reducing Roivant’s outstanding shares by roughly 9%.
The robust NIU data highlights Roivant’s dedication to addressing unmet medical needs, particularly for patients at risk of vision impairment. This commitment is further underscored by the share repurchase program, aimed at enhancing shareholder exposure to ongoing developments in NIU and other clinical endeavors.
In the NEPTUNE study, 26 subjects with active NIU were randomized to receive brepocitinib at varying doses. The primary efficacy endpoint, Treatment Failure rate at week 24, revealed significant benefits, with lower failure rates indicating greater treatment efficacy compared to existing therapies.
Secondary efficacy endpoints, including visual acuity and macular thickness, also showed positive and dose-dependent responses. Safety profiles remained consistent with previous studies, supporting brepocitinib’s potential as a treatment option.
In the later part of 2024, Priovant intends to start a Phase 3 study for NIU, demonstrating their belief in the therapeutic potential of brepocitinib. Furthermore, it is predicted that enrollment in the current Phase 3 research of brepocitinib in dermatomyositis would end by the third quarter of 2024, with findings expected in 2025.
The $1.5 billion common share buyback program has been approved by Roivant’s board with the goal of using available cash and equivalents. Opportunities for investment and the state of the market are two factors that affect when and how much repurchases happen. The purchase of all of Sumitomo Pharma’s common shares is covered by a share buyback agreement that was signed; the deal is expected to be completed by early April 2024.
