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29.05.2024 - Following a recently completed Type B meeting with the FDA, Immunovant is on track to initiate 4 to 5 potentially registrational studies for its lead asset IMVT-1402 in endocrinology, neurology, and other therapeutic areas over this fiscal year . ....
22.05.2023 - Investigational New Drug (IND) application and Clinical Trial Application (CTA) for IMVT-1402 cleared by the FDA and MEDSAFE, respectivelyPhase 1 clinical trial in healthy subjects initiated in New ZealandPhase 2 proof-of-concept clinical trial of . ....
Urovant Sciences Provides Merger Update and Reports Third Quarter Fiscal Year 2020 Results SEC reviewing preliminary proxy statement for the previously announced merger of the Company with Sumitovant Biopharma Special General Meeting of Shareholders to approve the merger is expected to occur by the end of 1Q CY2021 U.S. commercial launch of GEMTESA (vibegron) to treat OAB is on track for late-Q1 CY2021, following U.S. FDA approval in December 2020 Urovant Sciences (Nasdaq: UROV) today reported financial results for its fiscal quarter ended December 31, 2020. The third quarter of fiscal 2020 was transformational for Urovant. In November, we announced the signing of a definitive merger agreement with Sumitovant Biopharma, the majority shareholder of Urovant. Under the terms of the definitive agreement, Urovant will be acquire by Sumitovant Biopharma at a 96% premium to the closing price of our shares prior to the agreement being announced. We look forward t ....