The strong revenue beat and Priority Review for mitapivat in SCD are positive catalysts. Monitor prescription trends and the Nov 1 PDUFA date. The tebapivat discontinuation removes pipeline risk but also reduces optionality. The cevidoplenib license adds a late-stage asset but Phase 3 is not expected until 2028.
Price Chart
Executive Summary
Agios reported Q2 2026 revenue of $44.7M (up 259% YoY, 68% above consensus), driven by the AQVESME launch in thalassemia and EU approval. Net loss narrowed to $100.7M from $112.0M, with EPS of -$1.69 slightly missing consensus of -$1.67. Key catalysts include FDA Priority Review for mitapivat in sickle cell disease (PDUFA Nov 1, 2026) and pipeline expansion via cevidoplenib licensing, offset by discontinuation of tebapivat in two indications.
Key Financial Metrics
Key Facts
- Q2 2026 total revenue $44.7M vs $12.5M YoY (+259%), beating $26.7M consensus by 68%
- Net loss $100.7M vs $112.0M YoY; EPS -$1.69 vs -$1.93 (slight miss vs -$1.67 consensus)
- FDA granted Priority Review for mitapivat sNDA in sickle cell disease; PDUFA Nov 1, 2026
- 442 cumulative AQVESME prescriptions for thalassemia as of June 30, 2026
- Licensed cevidoplenib (SYK inhibitor) for ITP; $25M upfront payment in R&D
- Discontinued tebapivat development in LR-MDS and sickle cell disease after Phase 2 results
- Cash, equivalents and marketable securities $964.8M as of June 30, 2026
Financial Impact
Revenue surged 259% YoY to $44.7M, well above consensus; net loss improved 10% YoY; gross margin ~93%
Risk Factors
- FDA decision on mitapivat sNDA for SCD (binary event)
- Competition from other PK activators and SCD therapies
- Execution risk for cevidoplenib Phase 3 development
- Cash burn rate; $964.8M provides runway but losses continue
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 6 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001439222-26-000115 |
| Document: agio-20260730.htm | 0001439222-26-000115 |
| Document: 0001439222-26-000115-index-headers.html | 0001439222-26-000115 |
| Document: 0001439222-26-000115-index.html | 0001439222-26-000115 |
| Document: 0001439222-26-000115.txt | 0001439222-26-000115 |
| 8-K Data (Synthetic) | 0001439222-26-000115 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 26, 2026 today | 144 | $36.85 | awaiting T+60 | — | $37.00 (+0.41%) |
Oct 22, 2026 4d ago | 144 | $37.00 | awaiting T+60 | — | $37.00 (0.00%) |
Aug 6, 2026 11w ago | Institutional Cluster | $31.95 | awaiting T+60 | — | $37.00 (+15.81%) |
Jul 30, 2026 12w ago | 8-K | $32.75 $37.00 | ▲ +12.98% | ▲ +10.51% | $37.00 (+12.98%) |
Jul 30, 2026 12w ago | Press Release | $32.75 $37.00 | ▲ +12.98% | ▲ +10.51% | $37.00 (+12.98%) |
Jul 7, 2026 15w ago | Press Release | $44.01 $33.25 | ▼ −24.45% | ▼ −26.44% | $37.00 (−15.93%) |
Jun 29, 2026 17w ago | Press Release | $38.04 $34.97 | ▼ −8.07% | ▼ −12.46% | $37.00 (−2.73%) |
Jun 18, 2026 18w ago | 8-K | $35.10 $32.81 | ▼ −6.52% | ▼ −8.27% | $37.00 (+5.41%) |
Jun 13, 2026 19w ago | Press Release | $31.82 $34.63 | ▲ +8.83% | ▲ +7.83% | $37.00 (+16.28%) |
Jun 1, 2026 21w ago | Press Release | $28.00 $33.90 | ▲ +21.07% | ▲ +19.84% | $37.00 (+32.14%) |
US Market Status
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