The sNDA submission for mitapivat in sickle cell disease is the key near-term catalyst. Monitor for FDA acceptance and any updates on the accelerated approval pathway. The AQVESME launch trajectory (242 prescriptions) provides a real-time demand signal for thalassemia. Cash runway of ~$1.0B supports operations through multiple pipeline readouts.
Price Chart
Executive Summary
Agios reported Q1 2026 revenue of $20.7M, more than doubling from $8.7M a year ago, driven by the U.S. launch of AQVESME in thalassemia. However, the net loss widened to $99.1M from $89.3M, and the company's cash burn continues. The key catalyst is the planned sNDA submission for mitapivat in sickle cell disease under the accelerated approval pathway in Q2 2026.
Key Financial Metrics
Key Facts
- Worldwide mitapivat net revenue of $20.7M in Q1 2026, up 138% YoY from $8.7M
- 242 AQVESME prescriptions written in the U.S. as of March 31, 2026
- Net loss of $99.1M vs $89.3M in Q1 2025
- Cash, cash equivalents, and marketable securities at $1.0B as of March 31, 2026
- Company plans to submit mitapivat sNDA for sickle cell disease in Q2 2026 under accelerated approval pathway
- Phase 2b tebapivat trial in LR-MDS topline results expected in H1 2026
- Phase 2 tebapivat trial in sickle cell disease topline results expected in H2 2026
Financial Impact
Revenue doubled YoY to $20.7M, but net loss widened to $99.1M. Cash burn of ~$119M in Q1 2026.
Risk Factors
- Widening net loss and continued cash burn
- Regulatory risk for mitapivat sNDA in sickle cell disease
- Clinical trial risk for tebapivat Phase 2 readouts
- Commercial execution risk for AQVESME launch
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 6 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001439222-26-000071 |
| Document: agio-20260429.htm | 0001439222-26-000071 |
| Document: 0001439222-26-000071-index-headers.html | 0001439222-26-000071 |
| Document: 0001439222-26-000071-index.html | 0001439222-26-000071 |
| Document: 0001439222-26-000071.txt | 0001439222-26-000071 |
| 8-K Data (Synthetic) | 0001439222-26-000071 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 22, 2026 3d ago | 144 | $37.19 | awaiting T+60 | — | $37.58 (+1.06%) |
Aug 6, 2026 11w ago | Institutional Cluster | $31.95 | awaiting T+60 | — | $37.58 (+17.64%) |
Jul 30, 2026 12w ago | 8-K | $32.75 $37.00 | ▲ +12.98% | ▲ +10.51% | $37.58 (+14.76%) |
Jul 30, 2026 12w ago | Press Release | $32.75 $37.00 | ▲ +12.98% | ▲ +10.51% | $37.58 (+14.76%) |
Jul 7, 2026 15w ago | Press Release | $44.01 $33.25 | ▼ −24.45% | ▼ −26.44% | $37.58 (−14.60%) |
Jun 29, 2026 17w ago | Press Release | $38.04 $34.97 | ▼ −8.07% | ▼ −12.46% | $37.58 (−1.20%) |
Jun 18, 2026 18w ago | 8-K | $35.10 $32.81 | ▼ −6.52% | ▼ −8.27% | $37.58 (+7.08%) |
Jun 13, 2026 19w ago | Press Release | $31.82 $34.63 | ▲ +8.83% | ▲ +7.83% | $37.58 (+18.12%) |
Jun 1, 2026 21w ago | Press Release | $28.00 $33.90 | ▲ +21.07% | ▲ +19.84% | $37.58 (+34.23%) |
May 29, 2026 21w ago | Press Release | $29.40 $32.64 | ▼ −11.02% | ▼ −9.84% | $37.58 (−27.84%) |
US Market Status
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