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AGIO · AGIOS PHARMACEUTICALS, INC.

Company guidance, FDA catalysts, dilution risk and cash runway, built from SEC, FDA and ClinicalTrials.gov filings and updated every day.

$964.8M Cash on Hand

32.8mo Cash Runway

12.8% Short Interest

$46.25 Analyst Target (8)

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💊 Upcoming FDA Decisions

PDUFA Date	Drug	Indication	Type	PoA	Options-implied move
2026-11-01	—		sNDA	86%	±25% by Nov 20

Options-implied move = price of the at-the-money straddle for the first option expiry after the PDUFA date, as a share of the stock price (Yahoo Finance quotes, Oct 2). It prices every move until that expiry, not only the FDA decision.

PoA = estimated probability of approval: base rates calibrated against BioRadar's verified FDA outcomes, adjusted for application type, modality, therapy area and cash runway. Not investment advice. See the full PDUFA calendar →

📣 What AGIO Says Is Next

second half of 2026 · AG-181: “Data from this trial are expected in the second half of 2026.”
Company press release, Jul 30, 2026 · SEC filing
second half of 2026 · AG-236: “Based on these results, Agios will advance AG-236 into a Phase 2/3 development program in polycythemia vera, with initiation of the Phase 2 portion expected in the second half of 2026.”
Company press release, Jul 30, 2026 · SEC filing
first half of 2028 · “The addition of cevidoplenib diversifies Agios’ rare hematology portfolio and represents an opportunity to unlock up to $1.0 billion in peak U.S. sales potential in this indication. o Agios expects to advance cevidoplenib into Phase 3 development for ITP in the first half of 2028, following completion of additional chemistry, manufacturing, and controls (CMC) development work.”
Company press release, Jul 30, 2026 · SEC filing

Quoted word for word from the company's press releases filed with the SEC. Timing is the company's own guidance, not a BioRadar estimate.

🧪 Trial & FDA Catalysts

May 2027 · N/A · Active Trial · Pyruvate Kinase Deficiency Global Longitudinal Registry
Registry primary completion date, not a results date
Jan 2028 · Phase 1 · Recruiting · A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AG-181
Registry primary completion date, not a results date
Mar 2029 · Phase 3 · Recruiting · A Study to Investigate the Efficacy, Pharmacokinetics, and Safety of Mitapivat in Pediatri
Registry primary completion date, not a results date
Jun 2029 · Phase 3 · Recruiting · A Study to Investigate the Efficacy, Pharmacokinetics, and Safety of Mitapivat in Pediatri
Registry primary completion date, not a results date
Aug 2029 · Phase 4 · Enrolling · A Study to Provide Access to Mitapivat for Participants Who Previously Participated in an
Registry primary completion date, not a results date
Aug 2029 · Phase 3 · Recruiting · A Study to Investigate the Effect of Mitapivat on Transfusion Burden in Subjects With Sick
Registry primary completion date, not a results date

📊 Drug Pipeline

Drug	Indication	Most advanced trial	Status
Mitapivat (AG-348) FDA approved Feb 2022 · Pyrukynd	Pyruvate Kinase Deficiency	Phase 4 · NCT05777993	Enrolling by invitation
Enasidenib	Hematologic Neoplasms	Phase 1/2 · NCT01915498	Completed
Ivosidenib (AG-120)	Chondrosarcoma	Phase 2 · NCT04278781	Active not recruiting
Tebapivat (AG-946)	Myelodysplastic Syndromes	Phase 2 · NCT05490446	Active not recruiting
[13C2,15N3]-tebapivat	Healthy Participants	Phase 1 · NCT06745271	Completed
Vorasidenib (AG881)	Healthy Volunteers	Phase 1 · NCT04128787	Completed
Dihydroorotate Dehydrogenase Inhibitor A	Lymphoma	Phase 1 · NCT03834584	Terminated
AG-236	Healthy Participants	Phase 1 · NCT07075640	Active not recruiting
AG-181	Phenylketonuria	Phase 1 · NCT07241234	Recruiting
[14C]-tebapivat	Healthy Participants	Phase 1 · NCT06745271	Completed
[13C6]AG-348	Healthy Volunteers	Phase 1 · NCT03703505	Completed
[13C315N3]AG-881	Healthy Male Participants	Phase 1 · NCT03960502	Completed

Also used in these trials (approved or third-party drugs, not AGIO's own candidates): Omeprazole, Rifampin, Midazolam Hydrochloride, Lamotrigine, Itraconazole.

Source: ClinicalTrials.gov trials sponsored by the company, one row per candidate at its most advanced registered trial. FDA approvals: Drugs@FDA. Wrong or missing drug? Report it

💰 Cash Runway & Dilution Risk

AGIO holds $964.8M in cash and short-term investments (as of Jun 30, 2026) and burns about $88.1M/quarter from operations, an estimated runway of 32.8 months at that rate (BioRadar estimate, not company guidance).

Dilution pressure: 25 · Moderate

Cash runway 33 months
Shelf registration (S-3ASR, Feb 2026) +10
FDA decision in 29 days +15

Recent financing filings on SEC EDGAR:

Feb 12, 2026 · Shelf registration · S-3ASR

Source: SEC EDGAR (XBRL cash flow and financing filings). Dilution Watch: every company ranked → · Get an alert when AGIO files for a raise →

👥 Who Owns AGIO

Insiders 1.1% Other 5%+ holders 8.6% Institutions (319 holders) 90.3% Public and other holders 0%

Holder	Type	Shares	% of shares	As of
Blackrock Inc.	Institution (13F)	6,455,997	10.81%	2026-06-30
Farallon Capital Management, L.L.C.	Institution (13G, 5%+)	5,917,400	9.91%	2026-06-30
Farallon Capital Management LLC	Institution (13F)	5,917,400	9.91%	2026-06-30
Dapice Joshua J.	5%+ holder (13G)	5,159,505	8.64%	2025-12-31
STATE STREET CORPORATION	Institution (13G, 5%+)	3,108,145	5.21%	2025-12-31
Vanguard Capital Management	Institution (13G, 5%+)	3,088,169	5.17%	2026-03-31
D. E. Shaw & Co., L.P.	Institution (13G, 5%+)	3,034,031	5.08%	2026-06-25
Lynx1 Capital Management LP	Institution (13G, 5%+)	3,013,949	5.05%	2026-04-29
Vanguard Portfolio Management LLC	Institution (13F)	2,898,197	4.85%	2026-06-30
Armistice Capital, LLC	Institution (13F)	2,400,000	4.02%	2026-06-30
Erste Asset Management GmbH	Institution (13F)	2,154,900	3.61%	2026-06-30
Nomura Asset Management International In	Institution (13F)	2,110,809	3.54%	2026-06-30

Share count 59,701,882 (latest 10-Q/10-K). Insiders: each officer's, director's and 10% owner's latest Form 3, 4 or 5, direct and indirect shares; options are not counted. 5%+ holders: latest Schedule 13D or 13G of each holder above 5%. Institutions: the total held by all 13F filers (Yahoo Finance); the table lists the largest (13F quarter ending 2026-06-30). Sources have different dates, so the split is approximate. Source: SEC EDGAR.

📈 Recent Insider Activity (Form 4)

Trade date	Insider	Transaction	Shares	Price	Owned after
2026-08-04 filed 2026-08-06	Gheuens Sarah	Sale (S)	30,000	$30.48	54,645
2026-07-08 filed 2026-07-10	Backstrom Jay T.	Option exercise (M)	1,447	–	–
2026-07-08 filed 2026-07-10	Backstrom Jay T.	Award (A)	1,447	–	1,447
2026-07-01 filed 2026-07-02	Gheuens Sarah	Option exercise (M)	8,375	–	–
2026-07-01 filed 2026-07-02	Gheuens Sarah	Sale (S)	4,007	$37.56	84,645

Only open-market purchases (P) and sales (S) are trading decisions. Awards (A), option exercises (M) and tax withholding (F) are compensation mechanics. Source: SEC Form 4.

📅 Past FDA Decisions & Stock Reactions

Date	Drug	Type	Run-up 30d	Decision 1d	After 5d
2025-12-07	AQVESME	sNDA	-31.6%	-1.6%	-1.7%
2025-09-07	PYRUKYND	sNDA	-4.5%	+1.1%	+2.1%

Browse all historical PDUFA outcomes →

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Data: SEC EDGAR, FDA, ClinicalTrials.gov, Yahoo Finance • Informational purposes only, not investment advice. • All tracked stocks A–Z