secwatch / observer

8-K filed June 26, 2024, 7:59 PM ET ticker VIR CIK 0001706431

regulatory confidence high sentiment positive materiality 0.70

Vir Biotech gets FDA IND clearance & Fast Track for hepatitis delta combo therapy

Vir Biotechnology, Inc.

FDA cleared IND and granted Fast Track for tobevibart + elebsiran for chronic hepatitis delta.
Phase 2 SOLSTICE 24-week data expected Q4 2024; preliminary data showed high virologic response.
Company plans ECLIPSE trial to support potential registration, comparing combo to standard of care.
CEO Marianne De Backer says IND clearance underscores potential to transform treatment landscape.
Hepatitis delta affects at least 12 million people globally; considered most severe viral hepatitis.

item 8.01 item 9.01

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accession: 0001193125-24-168554
form_type: 8-K
ticker: VIR
cik: 0001706431
company_name: Vir Biotechnology, Inc.
filed_at: 2024-06-26T23:59:59+00:00
discovered_at: 2026-05-14T18:03:19.675565+00:00
generated_at: 2026-06-01T01:38:31.116563+00:00
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event_type: regulatory
sentiment: positive
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confidence: high
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