Agios Pharmaceuticals, Inc. (AGIO)

Price$33.10Cached quoteAs of 2026-09-06 07:37 UTC

AI: Fair-priced

Price checkCash meaningfully cushions valuation, but the operating business still carries substantial regulatory expectations.

Agios Pharmaceuticals, Inc. trades on Nasdaq as AGIO. Using about 59.7 million shares outstanding in late July, equity value is roughly $2.1 billion. Against $964.8 million of cash, cash equivalents, and marketable securities and no funded debt appearing on the June balance sheet, investors are paying about $1.1 billion for the operating business and pipeline. That is not cheap versus current product sales, but it is not extreme if thalassemia growth persists and sickle cell approval expands the franchise.

Big pictureRevenue is accelerating sharply, yet losses and cash burn remain the central valuation constraint.

Second-quarter product revenue reached $44.7 million, up from $12.5 million a year earlier, mainly from AQVESME's U.S. thalassemia launch. The quarter still produced a $100.7 million net loss, while operating cash use was $176.2 million for the first half. At that simple burn pace, June liquidity covers roughly 2.7 years before considering rising sales, new launch costs, or milestones; management formally says existing resources should fund at least the next twelve months. Rare-disease demand is not highly economic-cycle sensitive, but biotech valuations are catalyst-driven.

Business strengthA growing approved franchise and strong liquidity offset concentration, execution risk, and modest ongoing dilution.

Mitapivat is already commercial in PK deficiency and thalassemia across several markets, giving Agios real revenue rather than a pipeline-only story. The balance sheet shows no funded borrowings, so liquidity is unusually strong for a loss-making biotech. Capital allocation is active: Agios paid $25 million upfront for cevidoplenib and faces potential development milestones on licensed programs. Shares outstanding rose about 2% from year-end through June, while first-half stock-based compensation was $31.5 million, so dilution is manageable today but worth watching.

What could change the storyApproval and uptake could unlock upside; regulatory disappointment or persistent spending could quickly reverse the case.

The bull case assumes AQVESME keeps scaling, the FDA approves mitapivat for sickle cell disease, and new programs add credible future value; under those assumptions, today's roughly $1.1 billion operating valuation looks modest. The bear case assumes slower thalassemia uptake, a rejection or restrictive label in sickle cell disease, and continued research and launch spending near recent levels. That would shrink the cash cushion and make future equity financing more plausible. Because both paths are credible and near-term catalysts are binary, Fair-priced is the most balanced verdict.

AI: News

Q2 Sales AccelerateMitapivat revenue surged year over year, while losses remained large and the cash balance declined.

On July 30, Agios reported second-quarter 2026 product revenue of $44.7 million versus $12.5 million a year earlier, driven mainly by AQVESME's U.S. thalassemia launch. Net loss improved to $100.7 million from $112.0 million, but the company remained heavily loss-making. Cash, equivalents, and marketable securities stood at $964.8 million at quarter-end, down from $1.2 billion at year-end as development and commercialization spending continued.

FDA Sets November DecisionFDA Priority Review puts mitapivat's sickle cell expansion on a near-term regulatory decision path.

On July 7, the FDA accepted Agios's supplemental application for accelerated approval of mitapivat in sickle cell disease and granted Priority Review, with a PDUFA goal date of November 1, 2026. If approved, Agios says mitapivat could become the first oral PK activator for this population. The required REIGNITE confirmatory Phase 3 trial is already underway, making the decision a major near-term catalyst but not eliminating post-approval clinical risk.

Tebapivat SCD Program StoppedAgios discontinued tebapivat in sickle cell disease after Phase 2 results lacked meaningful differentiation.

On July 21, Agios said it would stop developing tebapivat for sickle cell disease after a 59-patient Phase 2 study failed to show enough differentiation from other PK activators. Hemoglobin improvements were seen, but response patterns did not justify further investment. The decision removes a potential backup or follow-on asset in sickle cell disease, while also demonstrating portfolio discipline and allowing management to direct capital toward mitapivat and other programs.

Cevidoplenib Deal Expands PipelineThe Oscotec deal adds a late-stage hematology asset, but brings milestone payments and additional development spending.

On June 1, Agios licensed global rights to cevidoplenib from Oscotec for immune thrombocytopenia and other autoimmune indications. Agios paid $25 million upfront and may owe up to $140 million in U.S. and European development and regulatory milestones, plus commercial milestones and tiered royalties. The company plans Phase 3 development in ITP in the first half of 2028 after additional manufacturing work, adding diversification but also future capital commitments.

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Financial statements

	2025	2024	2023	2022	2021	2020	2019	2018	2017	2016	2015	2014	2013	2012	2011
Revenue	$54.0M	$36.5M	$26.8M	$14.2M	$0	$0	$117.9M	$94.4M	$43.0M	$69.9M	$59.1M	$65.4M	$25.5M	$25.1M	$21.8M
Gross profit	$47.7M	$32.3M	$23.9M	$12.5M	$0	$0	$116.6M	$93.0M	$43.0M	$69.9M	—	—	—	—	—
Gross margin	88.26%	88.59%	89.26%	88.03%	—	—	98.88%	98.52%	100.00%	100.00%	—	—	—	—	—
Research & development	$339.5M	$301.3M	$295.5M	$279.9M	$257.0M	$220.8M	$214.3M	$341.3M	$292.7M	$220.2M	$141.8M	$100.4M	$54.5M	$41.0M	$31.3M
Operating expenses	$526.2M	$462.2M	$418.3M	$403.3M	$378.4M	$335.9M	$432.9M	$456.9M	$363.8M	$270.9M	$177.8M	$119.5M	$64.4M	$48.1M	$38.5M
Operating income	−$472.1M	−$425.7M	−$391.5M	−$389.0M	−$378.4M	−$335.9M	−$316.3M	−$362.5M	−$320.8M	−$201.0M	−$118.7M	−$54.1M	−$38.9M	−$23.0M	−$16.6M
Operating margin	−873.87%	−1,166.47%	−1,459.52%	−2,732.07%	—	—	−268.22%	−384.03%	−745.84%	−287.57%	−200.78%	−82.83%	−152.20%	−91.59%	−76.16%
EBITDA	−$466.9M	−$420.0M	−$384.9M	−$380.6M	−$369.6M	−$326.5M	−$308.2M	−$355.3M	−$314.4M	−$195.3M	−$115.4M	−$52.8M	−$37.4M	−$21.8M	−$15.8M
EBITDA margin	−864.24%	−1,150.85%	−1,434.91%	−2,673.08%	—	—	−261.37%	−376.44%	−730.89%	−279.40%	−195.13%	−80.73%	−146.56%	−86.90%	−72.49%
Net income	−$412.8M	$673.7M	−$352.1M	−$231.8M	$1.60B	−$327.4M	−$411.5M	−$346.0M	−$314.7M	−$198.5M	−$117.7M	−$53.5M	−$39.4M	−$20.1M	−$23.7M
Net profit margin	−764.01%	1,845.92%	−1,312.63%	−1,627.82%	—	—	−348.97%	−366.61%	−731.60%	−283.97%	−199.14%	−81.86%	−154.25%	−80.07%	−108.56%
Basic EPSper basic share	-$7.12	$11.86	-$6.33	-$4.23	$26.55	-$4.74	-$6.86	-$6.03	-$6.75	-$5.07	-$3.15	-$1.59	-$2.83	-$8.02	-$8.90
Diluted EPSper diluted share	-$7.12	$11.64	-$6.33	-$4.23	$26.55	-$4.74	-$6.86	-$6.03	-$6.75	-$5.07	-$3.15	-$1.59	-$2.83	-$8.02	-$8.90

Review official source filings ↗

Owners

Reported shareholders

Reference date Jun 30, 2026

10.83%of listed shares

BlackRock, Inc.6.46M shares · Jun 30, 2026

View holders

Top 20 reported holders of AGIO
Holder	% owned
BlackRock, Inc.	10.83%6.46M shares
FARALLON CAPITAL MANAGEMENT, L.L.C.	9.93%5.92M shares
STATE STREET CORP	5.93%3.53M shares
Lynx1 Capital Management LP	5.72%3.41M shares
D. E. Shaw & Co., Inc.	5.21%3.11M shares
VANGUARD PORTFOLIO MANAGEMENT LLC	4.86%2.9M shares
VANGUARD CAPITAL MANAGEMENT LLC	4.50%2.68M shares
ARMISTICE CAPITAL, LLC	4.03%2.4M shares
Erste Asset Management GmbH	3.62%2.15M shares
NOMURA ASSET MANAGEMENT INTERNATIONAL INC.	3.54%2.11M shares
GEODE CAPITAL MANAGEMENT, LLC	2.64%1.57M shares
SUSQUEHANNA INTERNATIONAL GROUP, LLP	2.31%1.38M shares
ADAR1 Capital Management, LLC	2.16%1.29M shares
BNP PARIBAS ASSET MANAGEMENT Holding S.A.	2.15%1.28M shares
DIMENSIONAL FUND ADVISORS LP	2.10%1.25M shares
GW&K Investment Management, LLC	2.02%1.21M shares
GOLDMAN SACHS GROUP INC	1.93%1.15M shares
UBS Group AG	1.65%985.83K shares
MORGAN STANLEY	1.62%963.26K shares
Nuveen, LLC	1.47%873.56K shares

Percentages use 59.6M shares of this listed class outstanding on Jun 30, 2026.

Gray completes the 100% scale. Reported positions may overlap; holders have different reporting dates.

Source: SEC Form 13F ↗Updated Sep 29, 2026 · Quarterly data

Insider buys & sells

Jul 1, 2024–Jun 30, 2026

Buys0$0.00 disclosed value

Sells (SEC code S)84$10.57M disclosed value

Transaction	Insider	Type	Shares	Price	Value	Owned after
Apr 2, 2026Form 4 · 10b5-1	Burns James WilliamChief Legal Officer	SellCommon stock	3.3K	$34.71	$113.8K	49.3K
Apr 2, 2026Form 4 · 10b5-1	Gheuens SarahChief Medical Officer	SellCommon stock	2.9K	$34.71	$102.0K	80.3K
Apr 2, 2026Form 4 · 10b5-1	Jones CeciliaChief Financial Officer	SellCommon stock	3.1K	$34.71	$109.0K	55.0K
Apr 2, 2026Form 4 · 10b5-1	Milanova TsvetaChief Commercial Officer	SellCommon stock	3.3K	$34.71	$113.2K	46.8K
Apr 2, 2026Form 4 · 10b5-1	Viswanadhan KrishnanChief Corp Dev & Strategy	SellCommon stock	3.0K	$34.71	$102.7K	10.3K

Review ownership filings at SEC.gov ↗

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Agios Pharmaceuticals, Inc. (AGIO)

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