secwatch / observer

8-K filed May 22, 2026, 7:15 AM ET ticker ASMB CIK 0001426800

other material confidence high sentiment positive materiality 0.65

Assembly Biosciences expands ABI-6250 into PBC and PSC; Phase 2 basket study planned Q1 2027

ASSEMBLY BIOSCIENCES, INC.

ABI-6250, oral NTCP inhibitor, to be studied in PBC and PSC basket Phase 2 starting Q1 2027.
Phase 1a completed; data show dose-dependent bile acid elevations confirming target engagement.
Chronic tox studies support longer-term dosing; Phase 2 in HDV remains on track for Q4 2026.
Pre-IND FDA meeting constructive; company views feedback as helpful for advancement.
PSC has no approved therapies; PBC has significant unmet need despite existing treatments.

item 7.01 item 8.01 item 9.01

Machine-readable event card

schema_version: secwatch.filing_event.v1
accession: 0001193125-26-235469
form_type: 8-K
ticker: ASMB
cik: 0001426800
company_name: ASSEMBLY BIOSCIENCES, INC.
filed_at: 2026-05-22T11:15:16+00:00
discovered_at: 2026-05-22T11:20:00.296662+00:00
generated_at: 2026-05-22T11:20:50.645595+00:00
sec_items: ["7.01", "8.01", "9.01"]
event_type: other_material
sentiment: positive
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: high
secwatch_canonical_url: https://secwatch.observer/filing/0001193125-26-235469
json_url: https://secwatch.observer/filing/0001193125-26-235469.json
markdown_url: https://secwatch.observer/filing/0001193125-26-235469.md
text_url: https://secwatch.observer/filing/0001193125-26-235469.txt
edgar_index_url: https://www.sec.gov/Archives/edgar/data/1426800/000119312526235469/0001193125-26-235469-index.htm
edgar_primary_document_url: https://www.sec.gov/Archives/edgar/data/1426800/000119312526235469/asmb-20260522.htm
generated_by_model: deepseek-v4-flash:cloud@v2
review_status: machine_generated
human_reviewed: false
corrected: false
correction_note: null
correction_timestamp: null
superseded_by: null

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