Recent 8-K filings for AGIO

• April 29, 2026, 7:59 PM ET earnings materiality 0.75 positive item 2.02item 9.01 ◈ Earnings Releases

  Agios Q1 mitapivat revenue $20.7M; 242 AQVESME scrips; sCD sNDA plan in Q2

  Worldwide mitapivat net revenue $20.7M in Q1 2026, up from $8.7M in Q1 2025.

• February 12, 2026, 6:59 PM ET earnings materiality 0.75 neutral item 2.02item 9.01

  Agios Q4 net loss $108M; AQVESME approved for thalassemia, U.S. launch started

  PYRUKYND worldwide net revenue $20M in Q4 ($16M U.S., $4M ex-U.S.), up 49% YoY in U.S.

• January 12, 2026, 6:59 PM ET other material materiality 0.65 positive item 7.01item 9.01

  Agios outlines 2026 milestones: AQVESME launch in thalassemia, potential sNDA for sickle cell disease

  AQVESME (mitapivat) U.S. approval in thalassemia Dec 2025; commercial launch underway, product available late Jan 2026.

• October 30, 2025, 7:59 PM ET earnings materiality 0.70 neutral item 2.02item 9.01

  Agios Q3 PYRUKYND rev $12.9M (+44% YoY); net loss $103.4M; thalassemia PDUFA Dec 7

  Q3 PYRUKYND net revenue $12.9M (+44% YoY vs $9.0M); 149 U.S. patients on therapy.

• August 4, 2025, 7:59 PM ET regulatory materiality 0.60 neutral item 7.01

  Agios responds to analyst report on PYRUKYND safety data; Saudi Arabia approves PYRUKYND for thalassemia

  Analyst report on Aug 4, 2025 references four FAERS cases; Agios says benefit-risk profile unchanged.

• July 31, 2025, 7:59 PM ET earnings materiality 0.70 neutral item 2.02item 9.01

  Agios Q2 2025 net loss $112M; PYRUKYND revenue $12.5M; PDUFA Sept 7 for thalassemia

  Net loss $112.0M vs $96.1M YoY; PYRUKYND net revenue $12.5M, up from $8.6M in Q2 2024.

• May 1, 2025, 7:59 PM ET earnings materiality 0.70 neutral item 2.02item 9.01

  Agios Q1 PYRUKYND revenue $8.7M; PDUFA Sept 7 for thalassemia; net loss $89.3M

  PYRUKYND net revenue $8.7M in Q1 2025 vs $8.2M in Q1 2024; 136 patients on therapy.

• February 13, 2025, 6:59 PM ET earnings materiality 0.70 neutral item 2.02item 9.01

  Agios Q4: PYRUKYND revenue $10.7M, mitapivat PDUFA Sept 7, 2025; cash $1.5B

  PYRUKYND net revenue $10.7M in Q4 (+20% QoQ), full year $36.5M vs $26.8M in 2023.

• January 13, 2025, 6:59 PM ET other material materiality 0.75 positive item 7.01item 9.01

  Agios announces 2025 milestones: PYRUKYND PDUFA Sept 7; RISE UP topline in late 2025

  FDA accepted sNDA for PYRUKYND in thalassemia; PDUFA goal date September 7, 2025.

• January 6, 2025, 6:59 PM ET regulatory materiality 0.60 negative item 7.01

  FDA adds liver injury warning to PYRUKYND label for PK deficiency

  FDA approved update to PYRUKYND USPI: liver injury observed in patients with another condition at higher doses.

• October 31, 2024, 7:59 PM ET earnings materiality 0.85 positive item 2.02item 9.01

  Agios reports Q3 net income of $947.9M on $1.1B milestone payments; PYRUKYND rev $9.0M

  Net income $947.9M vs loss $91.3M YoY; driven by $1.1B payments from Royalty Pharma & Servier.

• August 1, 2024, 7:59 PM ET earnings materiality 0.65 neutral item 2.02item 9.01

  Agios Q2 2024 net loss $96.1M; PYRUKYND rev $8.6M; plans thalassemia sNDA by year-end

  PYRUKYND net revenue $8.6M in Q2 2024, up 5% sequentially; 128 patients on therapy.

• May 28, 2024, 7:59 PM ET other material materiality 0.80 positive item 1.01item 8.01item 9.01

  Agios sells vorasidenib royalty rights to Royalty Pharma for $905M upfront upon FDA approval

  Royalty Pharma pays $905M to Agios upon FDA approval of vorasidenib (PDUFA date Aug 20, 2024).

• May 2, 2024, 7:59 PM ET earnings materiality 0.60 neutral item 2.02item 9.01 ◈ Earnings Releases

  Agios Q1 2024 PYRUKYND revenue $8.2M; net loss $81.5M; mitapivat ENERGIZE-T readout Q2

  PYRUKYND net revenue $8.2M in Q1 2024, up 15% sequentially; 120 patients on therapy.

Executive changes

Earnings & guidance

Materiality & sentiment trend

Max materiality 0.85 · Median 0.68 · Most common event earnings

5 positive 1 negative 12 neutral

source · AGIO on sec.gov