This is an early pipeline expansion with no revenue or earnings data. Monitor for FDA feedback on the pre-IND meeting and initiation of Phase 2 studies in late 2026/early 2027.
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Executive Summary
Assembly Biosciences announced plans to expand clinical development of ABI-6250, its oral NTCP inhibitor, from chronic hepatitis delta virus (HDV) into primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC). A Phase 2 HDV study is expected in Q4 2026, and a Phase 2 basket study in PBC/PSC is expected in Q1 2027, supported by completed Phase 1a data and a constructive pre-IND meeting with the FDA.
Key Facts
- ABI-6250 is an oral small-molecule NTCP inhibitor being developed for HDV, PBC, and PSC.
- Phase 1a trial in healthy participants completed; target engagement shown via dose-dependent plasma bile acid elevations.
- Chronic toxicology studies completed, supporting longer-term dosing in Phase 2.
- Phase 2 HDV study planned for Q4 2026; Phase 2 basket study in PBC/PSC expected Q1 2027, subject to regulatory feedback.
- Pre-IND meeting with FDA held; official minutes pending but company describes discussion as constructive.
- No approved therapies exist for PSC; significant unmet need remains in PBC despite available treatments.
- ABI-6250 has not been approved anywhere; safety and efficacy not established.
Financial Impact
No financial figures disclosed in the filing.
Risk Factors
- ABI-6250 is preclinical for PBC/PSC; clinical failure risk is high.
- No approved therapies for PSC means regulatory path is uncertain.
- Company may need additional capital to fund multiple Phase 2 trials; dilution risk exists.
- Pre-IND meeting minutes pending; FDA could impose additional requirements.
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 4 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001193125-26-235469 |
| Document: asmb-ex99_1.htm | 0001193125-26-235469 |
| Document: 0001193125-26-235469-index-headers.html | 0001193125-26-235469 |
| Document: 0001193125-26-235469.txt | 0001193125-26-235469 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Aug 15, 2026 10w ago | Institutional Cluster | $30.01 $35.28 | ▲ +17.56% | ▲ +18.75% | $20.30 (−32.36%) |
Aug 13, 2026 10w ago | Press Release | $32.95 $34.38 | ▲ +4.34% | ▲ +5.71% | $20.30 (−38.39%) |
Jun 11, 2026 19w ago | Institutional Cluster | $22.53 $24.15 | ▲ +7.19% | ▲ +6.76% | $20.30 (−9.90%) |
Jun 5, 2026 20w ago | 8-K | $22.56 $23.34 | ▲ +3.48% | ▲ +1.37% | $20.30 (−10.00%) |
May 22, 2026 22w ago | 424B5 | $28.75 $26.92 | ▲ +6.37% | ▲ +7.45% | $20.30 (+29.39%) |
May 22, 2026 22w ago | 8-K | $28.34 $26.92 | ▼ −5.01% | ▼ −6.67% | $20.30 (−28.37%) |
May 22, 2026 22w ago | Press Release | $28.34 $26.92 | ▼ −5.01% | ▼ −6.67% | $20.30 (−28.37%) |
May 7, 2026 24w ago | Press Release | $29.74 $30.30 | ▲ +1.88% | ▲ +0.42% | $20.30 (−31.74%) |
Mar 30, 2026 30w ago | EFFECT | $26.64 $28.53 | ▲ +7.09% | ▲ +2.79% | $20.30 (−23.80%) |
Mar 19, 2026 31w ago | Press Release | $28.46 $27.70 | ▼ −2.67% | ▼ −0.52% | $20.30 (−28.67%) |
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