Cambridge biotech tracker · Cambridge
Agios Pharmaceuticals
Listed on Nasdaq as AGIO, filed under SEC industry code 2834 (pharmaceutical preparations). Fiscal year ends in December. Numbers below are from the company’s own SEC filings through Q3 '26.
- Cash & investments
- $907M
- Q3 '26 · Sep 30, 2026
- Burn per quarter
- $82.9M
- avg. operating cash flow, 4 qtrs
- Runway
- 2.7 yrs
- 24 to 36 months
- Net loss
- $65.0M
- Q3 '26
- R&D expense
- $73.5M
- 55% of opex
- Raised, last 4 qtrs
- +$12.0M
- net financing cash flow
- FDA decision
- Feb 2027
- FDA decision · cash past the catalyst
Cash & investments
Quarter-end balance
Operating cash flow
Per quarter; below zero is burn
R&D expense
Per quarter
Two views of the runway
Compare across the clusterThe outside view
2.7 years
Cash at Q3 '26 divided by the average burn of the last four quarters, $27.6M a month.
Management’s own date
12+ months
The latest filing states only the going concern minimum, that cash covers at least twelve months from issuance. No sharper date was filed.
Cash against the calendar
What the runway has to reach.
Feb 1, 2027
FDA target action date (PDUFA)
Disclosed in the 8-K filed Nov 5, 2026Does the cash reach it?
Cash past the catalyst
- Runway
- 2.7 years
- Time to the date
- 3 months
It is about 3 months out. At the current burn there is roughly 30 months of cash left on the far side of it, which is enough room to raise on the result rather than ahead of it.
Catalysts ahead
- Feb 2027FDA decisionFDA target action date (PDUFA)
- Jan 2028Phase 1A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AG-181 in Subjects With Phenylketonuria
- Mar 2029Phase 3A Study to Investigate the Efficacy, Pharmacokinetics, and Safety of Mitapivat in Pediatric Participants With α- or β-Non-Transfusion-Dependent Thalassemia
- Jun 2029Phase 3A Study to Investigate the Efficacy, Pharmacokinetics, and Safety of Mitapivat in Pediatric Participants With Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-TDT)
- Aug 2029Phase 3A Study to Investigate the Effect of Mitapivat on Transfusion Burden in Subjects With Sickle Cell Disease (SCD)
- Aug 2030Phase 2/3A Study to Investigate AG-236 in Subjects ≥18 Years of Age With Polycythemia Vera
FDA decision dates disclosed in filings
“…on in mitapivat for patients with sickle cell disease is grounded in the robust efficacy and safety data generated to date and we are launch-ready ahead of our PDUFA goal date of February 1, 2027. With this commercial infrastructure, alongside a strong balance sheet and a disciplined operating model, Agios is well positioned for sustained…”
Pulled from the company’s own filing text. An approval decision is a financing event as much as a clinical one, since the commercial build-out has to be funded months before any revenue from it arrives.
Pipeline
15 active trials, through phase 4.
Phase 3 · 7Phase 2 · 3Phase 2/3 · 2Phase 1 · 2Phase 4 · 1
Interventional studies where this company is the lead sponsor, from ClinicalTrials.gov. Primary completion is when the last patient is measured on the primary endpoint, which is when the data exists rather than when it is announced. Extension, rollover and healthy-volunteer studies are listed but marked as non-catalysts, because they finish long after the result that mattered. Sponsors revise these dates as enrollment moves, so an estimate is a plan rather than a promise.
The controller’s read
What the filings say.
Generated from the numbers above using the same questions I ask when I open a client’s books: how long the cash lasts, what is driving the gap between loss and burn, and where the accounting judgment sits.
Get this read on your companyThe cash clears the next catalyst
The next dated event is a FDA target action date in Feb 2027, about 3 months out. That leaves roughly 30 months of cash afterwards, which is the position you want: the raise can be negotiated on the data instead of on the calendar.
About 2.7 years of runway
Cash and investments of $907M at Q3 '26 against an average operating cash burn of $82.9M per quarter over the last four reported quarters runs out around May 2029. More than two years of runway means the finance conversation is about deployment, not survival.
Cash position down $625M since Q4 '24
Net financing inflows of $12.0M over the last four quarters, from equity, debt, or ATM sales, partly offset operating burn. The balance is the number the board watches; the trend is the number the auditors watch.
R&D is 55% of operating expenses
$73.5M of R&D against $133M of total operating expenses in Q3 '26, with G&A at $56.5M. For a clinical-stage company, the accounting questions live inside that R&D line: CRO and CMC accruals, milestone recognition, and what gets capitalized versus expensed under ASC 730.
Revenue of $55.4M in Q3 '26
Collaboration and license revenue under ASC 606 and ASC 808 is the single most judgment-heavy area in biotech accounting: performance obligations, variable consideration on milestones, and the split between revenue and cost-sharing.
Accumulated deficit of $827M
Total losses since inception. It is also roughly the size of the net operating loss carryforward the tax provision has to track, subject to Section 382 limits after each ownership change.
Quarterly detail, eight quarters
| Quarter | Cash & inv. | Op. cash flow | Net income | R&D | G&A | Revenue | Stock comp | Financing |
|---|---|---|---|---|---|---|---|---|
| Q4 '24 · Dec 31, 24 | $1.53B | −$133M | −$96.2M | $82.8M | $51.7M | $10.7M | $10.9M | $4.8M |
| Q1 '25 · Mar 31, 25 | $1.42B | −$111M | −$89.3M | $72.7M | $41.5M | $8.7M | $11.4M | $1.6M |
| Q2 '25 · Jun 30, 25 | $1.34B | −$77.1M | −$112M | $91.9M | $45.9M | $12.5M | $14.7M | $65K |
| Q3 '25 · Sep 30, 25 | $1.26B | −$88.2M | −$103M | $86.8M | $41.3M | $12.9M | $12.4M | $4.4M |
| Q4 '25 · Dec 31, 25 | $1.16B | −$96.2M | −$108M | $88.1M | $51.6M | $20.0M | $14.1M | $2.6M |
| Q1 '26 · Mar 31, 26 | $1.05B | −$119M | −$99.1M | $81.1M | $48.3M | $20.7M | $15.5M | $2.1M |
| Q2 '26 · Jun 30, 26 | $965M | −$57.3M | −$101M | $101M | $51.5M | $44.7M | $15.9M | $3.1M |
| Q3 '26 · Sep 30, 26 | $907M | −$59.2M | −$65.0M | $73.5M | $56.5M | $55.4M | $16.7M | $4.2M |
Source: SEC EDGAR XBRL company facts, latest filed value for each period. Fourth quarters are derived from annual less nine-month figures; quarterly cash flows are derived from year-to-date amounts. Not investment advice. If a figure disagrees with the filing, the filing is right.