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(State or Other Jurisdiction of Incorporation)
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(Commission File Number)
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(I.R.S. Employer Identification No.)
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Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Title of each class
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Trading Symbol(s)
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Name of each exchange on which registered
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Item 8.01.
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Other Events.
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Item 9.01. |
Financial Statements and Exhibits.
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Exhibit No.
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Description of Exhibit
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Press Release dated April 2, 2024
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104
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Cover Page Interactive Data File (embedded with Inline XBRL document)
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ROIVANT SCIENCES LTD.
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By:
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/s/ Matt Maisak
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Name: Matt Maisak
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Title: Authorized Signatory
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Dated: April 2, 2024
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• |
Roivant’s board of directors has approved a share repurchase program for up to $1.5 billion of the company’s common shares, including an agreed repurchase of the entire Sumitomo Pharma stake for
$648 million
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• |
Sumitomo Pharma repurchase reduces shares outstanding by 9%
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• |
In the Phase 2 NEPTUNE study of once-daily oral brepocitinib in non-infectious uveitis (NIU), the 45 mg results represent the best Treatment Failure rates observed to date among active NIU studies
measuring this registrational endpoint
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• |
29% of subjects receiving brepocitinib 45 mg and 44% of subjects receiving brepocitinib 15 mg met the pre-specified primary efficacy endpoint of Treatment Failure at week 24 (lower failure rates
reflect greater treatment benefit). The Treatment Failure rate from disease activity (discontinuations censored) was 18% in the brepocitinib 45 mg arm
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• |
All secondary efficacy endpoints were also positive and dose responsive, including measurements of potential benefit on prevention and treatment of uveitic macular edema
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NEPTUNE represents the seventh positive Phase 2 study for brepocitinib with over 1,400 subjects and patients treated with brepocitinib in clinical trials. Brepocitinib was generally safe and
well-tolerated in the study; no new safety and tolerability signals were identified
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Brepocitinib is well positioned to support a potential multi-blockbuster franchise in specialty autoimmunity with an ongoing pivotal study in dermatomyositis on track to read out in calendar year
2025 and expected initiation of a pivotal program in NIU in the second half of calendar year 2024
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Roivant will host an investor call to discuss the updates at 8 a.m. EDT on Tuesday, April 2, 2024
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Document and Entity Information |
Apr. 02, 2024 |
---|---|
Cover [Abstract] | |
Document Type | 8-K |
Amendment Flag | false |
Document Period End Date | Apr. 02, 2024 |
Entity File Number | 001-40782 |
Entity Registrant Name | Roivant Sciences Ltd. |
Entity Central Index Key | 0001635088 |
Entity Incorporation, State or Country Code | D0 |
Entity Tax Identification Number | 98-1173944 |
Entity Address, Address Line One | 7th Floor |
Entity Address, Address Line Two | 50 Broadway |
Entity Address, City or Town | London |
Entity Address, Country | GB |
Entity Address, Postal Zip Code | SW1H 0DB |
City Area Code | 207 |
Local Phone Number | 400-3347 |
Title of 12(b) Security | Common Shares, $0.0000000341740141 per share |
Trading Symbol | ROIV |
Security Exchange Name | NASDAQ |
Entity Emerging Growth Company | false |
Written Communications | false |
Soliciting Material | false |
Pre-commencement Tender Offer | false |
Pre-commencement Issuer Tender Offer | false |
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