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AGIOS PHARMACEUTICALS (AGIO)

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Earnings summaries and quarterly performance for AGIOS PHARMACEUTICALS.

Research analysts who have asked questions during AGIOS PHARMACEUTICALS earnings calls.

Tessa Romero

Tessa Romero

JPMorgan Chase & Co.

6 questions for AGIO

Also covers: ACAD, CYTK, EYPT +5 more
Alec Stranahan

Alec Stranahan

Bank of America

5 questions for AGIO

Also covers: ALEC, BEAM, BTAI +12 more
Gregory Renza

Gregory Renza

RBC Capital Markets

5 questions for AGIO

Also covers: ACAD, ADCT, AMGN +12 more
Emily Bodnar

Emily Bodnar

H.C. Wainwright & Co.

4 questions for AGIO

Also covers: AGEN, ATOS, GERN +7 more
ES

Eric Schmidt

Cantor Fitzgerald & Co.

4 questions for AGIO

Also covers: ADCT, BEAM, BIIB +11 more
Andrew Berens

Andrew Berens

Leerink Partners

3 questions for AGIO

Also covers: ARVN, BGNE, BPMC +6 more
DR

Divya Rao

TD Cowen

3 questions for AGIO

Also covers: APLS, PBYI, VRTX +1 more
CR

Christopher Raymond

Piper Sandler

2 questions for AGIO

Also covers: ABBV, AMGN, ARDX +7 more
Gregory Harrison

Gregory Harrison

Scotiabank

2 questions for AGIO

Also covers: APLS, EYPT, GERN +3 more
Lydia

Lydia

Goldman Sachs

2 questions for AGIO

Also covers: RARE
Lydia Erdman

Lydia Erdman

Goldman Sachs

2 questions for AGIO

Also covers: QURE, TSHA
MB

Mark Breidenbach

Oppenheimer & Co. Inc.

2 questions for AGIO

Also covers: ACAD, IMRX, SYBX
Salveen Richter

Salveen Richter

Goldman Sachs

2 questions for AGIO

Also covers: ACAD, ALLO, ALNY +21 more
Samantha Semenkow

Samantha Semenkow

Citigroup Inc.

2 questions for AGIO

Also covers: ALLO, ARGX, BEAM +10 more
Shelby

Shelby

RBC Capital Markets

2 questions for AGIO

Also covers: FULC, NTLA, RARE
Alex Nackenoff

Alex Nackenoff

Raymond James

1 question for AGIO

Also covers: PASG, SAGE
HN

Hiro Nagayumi

Cantor Fitzgerald

1 question for AGIO

Imogen Mansfield

Imogen Mansfield

Cantor Fitzgerald

1 question for AGIO

MF

Marc Frahm

TD Cowen

1 question for AGIO

Also covers: ADAP, BPMC, CRDF +7 more
Matthew Guggenbiller

Matthew Guggenbiller

Bank of America

1 question for AGIO

Also covers: MRNA, NTLA
Theresa Robb

Theresa Robb

Scotiabank

1 question for AGIO

Recent press releases and 8-K filings for AGIO.

Agios Pharmaceuticals Reports Q4 and Full Year 2025 Results, Outlines 2026 Strategic Priorities
AGIO
Earnings
Product Launch
Guidance Update
  • Agios Pharmaceuticals reported Q4 2025 net revenues of $20.0 million and FY 2025 net revenues of $54.0 million, with a net loss of $(108.0) million for Q4 2025 and $(412.8) million for FY 2025. The company held $1.2 billion in cash, cash equivalents, and marketable securities at Q4 2025.
  • The U.S. launch of AQVESME™ (mitapivat) for thalassemia is underway following FDA approval on December 23, 2025, with 44 prescriptions through January 30, 2026. The drug has a Wholesale Acquisition Cost (WAC) of $425,000 per patient per year and targets 4,000 addressable patients at launch in the U.S..
  • Key strategic priorities for 2026 include executing the high-impact launch for AQVESME in thalassemia and expanding the PK activation franchise into sickle cell disease and lower-risk myelodysplastic syndrome (LR-MDS).
  • Significant pipeline catalysts expected in 2026 include a Mitapivat Pre-sNDA meeting for Sickle Cell Disease in Q1, Tebapivat Phase 2b topline data for LR-MDS in H1, and Tebapivat Phase 2 topline data for Sickle Cell Disease in H2.
  • The company anticipates 2026 operating expenses to be flat compared to 2025.
Feb 12, 2026, 1:00 PM
Agios Pharmaceuticals Reports Q4 and Full-Year 2025 Results, Initiates ACTIVASE U.S. Launch
AGIO
Earnings
Product Launch
Guidance Update
  • Agios Pharmaceuticals reported $20 million in PYRUKYND net revenue for Q4 2025, contributing to a full-year 2025 revenue of $54 million.
  • The company ended 2025 with approximately $1.2 billion in cash, cash equivalents, and marketable securities.
  • The U.S. launch of ACTIVASE (Pyrukynd) for thalassemia is underway following FDA approval on December 23, 2025. Early demand shows 44 prescriptions from REMS-certified physicians up to January 30th.
  • For 2026, the company anticipates U.S. PK deficiency revenues to be in the range of $45-$50 million and expects operating expenses to be roughly flat with 2025.
  • Key pipeline catalysts for 2026 include a pre-sNDA meeting for mitapivat in sickle cell disease, top-line results for tebapivat in lower-risk MDS in the first half of 2026, and in sickle cell disease in the second half of 2026.
Feb 12, 2026, 1:00 PM
Agios Pharmaceuticals Reports Q4 2025 Results and Provides 2026 Outlook
AGIO
Earnings
Product Launch
Guidance Update
  • Agios Pharmaceuticals reported $20 million in net revenue for PYRUKYND in Q4 2025, bringing the full-year 2025 revenue to $54 million. The company ended 2025 with approximately $1.2 billion in cash, cash equivalents, and marketable securities.
  • The company received FDA approval for ACTIVASE (mitapivat) for thalassemia just before the end of 2025, and the U.S. launch is currently underway.
  • Key pipeline catalysts for 2026 include top-line results from the phase II sickle cell disease trial of tebapivat in the second half of 2026 and top-line data from the phase IIB lower-risk myelodysplastic syndrome (MDS) trial in the first half of 2026. A pre-sNDA meeting with the FDA for mitapivat in sickle cell disease is also anticipated in Q1 2026.
  • For 2026, Agios Pharmaceuticals expects U.S. PK deficiency revenues to be in the range of $45-$50 million and anticipates operating expenses to be roughly flat with 2025.
Feb 12, 2026, 1:00 PM
Agios Pharmaceuticals Reports Strong Q4 2025 Results and Initiates ACTIVASE U.S. Launch
AGIO
Earnings
Product Launch
Guidance Update
  • Agios Pharmaceuticals reported Q4 2025 worldwide PYRUKYND revenue of $20 million, an 86% increase compared to Q4 2024, bringing full-year 2025 revenue to $54 million. The company ended 2025 with approximately $1.2 billion in cash, cash equivalents, and marketable securities.
  • The U.S. launch of ACTIVASE for thalassemia is underway following FDA approval just before the end of 2025. As of January 30, 2026, 44 prescriptions have been written, with an initial expected time from prescription to treatment initiation of 10-12 weeks.
  • For 2026, the company expects U.S. PK deficiency revenues to be in the range of $45-$50 million and anticipates operating expenses to be roughly flat with 2025.
  • Key pipeline catalysts for 2026 include a pre-sNDA meeting with the FDA for mitapivat in sickle cell disease in Q1, top-line results for tebapivat in sickle cell disease in the second half, and phase 2b top-line data for tebapivat in lower-risk MDS in the first half.
Feb 12, 2026, 1:00 PM
Agios Pharmaceuticals Reports Q4 and Full Year 2025 Financial Results and Provides Business Update
AGIO
Earnings
Product Launch
New Projects/Investments
  • Agios Pharmaceuticals reported PYRUKYND worldwide net revenues of $20.0 million for the fourth quarter of 2025 and $54.0 million for the full year 2025. The company's net loss for Q4 2025 was $108.0 million, with $1.2 billion in cash, cash equivalents, and marketable securities as of December 31, 2025.
  • AQVESME™ (mitapivat) for thalassemia is now available in the U.S. following its FDA approval in December 2025.
  • Agios will have a pre-sNDA meeting with the FDA in the first quarter of 2026 for mitapivat in sickle cell disease, and expects topline results from the Phase 2 tebapivat trial in sickle cell disease in the second half of 2026.
Feb 12, 2026, 11:32 AM
Agios Pharmaceuticals Reports Q4 and Full Year 2025 Results and Provides Business Update
AGIO
Earnings
Product Launch
New Projects/Investments
  • Agios Pharmaceuticals reported $54.0 million in worldwide net revenues for PYRUKYND for the full year 2025, including $20.0 million in the fourth quarter, and held $1.2 billion in cash, cash equivalents, and marketable securities as of December 31, 2025.
  • The company announced the U.S. availability of AQVESME™ (mitapivat) for thalassemia, following its FDA approval in December 2025.
  • Agios expects a pre-sNDA meeting with the FDA for mitapivat in sickle cell disease in the first quarter of 2026 and anticipates topline results from the Phase 2 tebapivat trial in sickle cell disease in the second half of 2026.
Feb 12, 2026, 11:30 AM
Agios Highlights Recent Thalassemia Approval and Pipeline Progress at J.P. Morgan Healthcare Conference
AGIO
Product Launch
Guidance Update
New Projects/Investments
  • Agios announced the FDA approval of Acvezmi for thalassemia on December 23rd last year, with a U.S. price of $425,000 per patient per year and an addressable U.S. launch population of approximately 4,000 adult patients. The worldwide market potential for Acvezmi is over $1 billion.
  • The company is pursuing regulatory clarity for mitapivat in sickle cell disease with a pre-SNDA meeting with the FDA in Q1 2026, following positive Phase 3 RISE UP study results.
  • Key pipeline readouts for 2026 include Phase 2b results for tevapivat in low-risk MDS in the first half and Phase 2 data for tevapivat in sickle cell disease in the second half.
  • Agios projects a total estimated global market size for its current pipeline indications of over $10 billion by 2030, with a commitment to financial discipline by keeping 2026 operating expenses flat to 2025 and a clear path to profitability.
Jan 14, 2026, 4:15 PM
Agios Discusses Recent Thalassemia Approval, Pipeline Advancements, and 2026 Outlook
AGIO
Product Launch
New Projects/Investments
Guidance Update
  • Agios announced the recent FDA approval of Aqvesme for thalassemia at the end of 2025, with a U.S. price point of $425,000 per patient per year and an addressable market of approximately 4,000 adult patients in the U.S.. The company is focused on a high-impact launch, with drug availability expected by the end of January 2026.
  • The company's pyruvate kinase (PK) activator franchise is expanding, with mitapivat (Pyrukynd) already approved for pyruvate kinase deficiency and thalassemia, and pursuing sickle cell disease. The RISE UP Phase 3 study for mitapivat in sickle cell disease showed a strong anti-hemolytic profile, and Agios plans to discuss this data with the FDA in a pre-sNDA meeting in Q1 2026.
  • Agios is also advancing tebapivat, a more potent PK activator, for sickle cell disease (Phase 2 data expected in H2 2026) and low-risk Myelodysplastic Syndromes (MDS) (Phase 2b results expected in H1 2026). The total market potential for these pipeline indications (thalassemia, sickle cell disease, and low-risk MDS) is estimated to exceed $7 billion worldwide by 2030.
  • The company projects a clear path to profitability based on its current commercial portfolio (Pyrukynd and Aqvesme) and is guiding towards keeping 2026 operating expenses flat to 2025.
  • Key 2026 catalysts include the pre-sNDA meeting with the FDA for mitapivat in sickle cell disease, Phase 2b readout for tebapivat in low-risk MDS, Phase 1 healthy volunteer data for AG236 (polycythemia vera) in H1 2026, and tebapivat Phase 2 data for sickle cell disease and Phase 1b proof of mechanism data for AG-181 (phenylketonuria) in H2 2026.
Jan 14, 2026, 4:15 PM
Agios Provides 2026 Outlook and Pipeline Updates at J.P. Morgan Healthcare Conference
AGIO
Product Launch
Guidance Update
New Projects/Investments
  • Agios announced the FDA approval of Acvezmi for thalassemia on December 23, 2025, with a worldwide market potential exceeding $1 billion. The U.S. launch is underway, targeting 4,000 adult patients at a price of $425,000 per patient per year.
  • The company is expanding its PK activation franchise into sickle cell disease and low-risk MDS, which together represent a worldwide market potential exceeding $7 billion by 2030.
  • Key pipeline milestones for 2026 include a pre-SNDA meeting with the FDA for mitapivat in sickle cell disease in Q1, Phase 2b data for tevapivat in low-risk MDS in H1, and Phase 2 data for tevapivat in sickle cell disease in H2.
  • Agios is committed to financial discipline, guiding towards keeping 2026 operating expenses flat to 2025, and anticipates a clear path to profitability from its current commercial portfolio.
Jan 14, 2026, 4:15 PM
Agios Announces AQVESME Approval and Pipeline Advancements
AGIO
Product Launch
New Projects/Investments
Guidance Update
  • Agios received FDA approval for AQVESME™ (mitapivat) in thalassemia in December 2025, with a broad label for alpha- or beta-thalassemia, targeting 4,000 addressable U.S. patients at launch and an annual U.S. WAC of $425k.
  • The company anticipates a pre-sNDA meeting with the FDA for mitapivat in Sickle Cell Disease in Q1 2026, following positive Phase 3 RISE UP data in Q4 2025.
  • Key pipeline catalysts for 2026 include tebapivat Phase 2b topline data for Lower-Risk MDS in H1 2026 and tebapivat Phase 2 topline data for Sickle Cell Disease in H2 2026.
  • Agios aims for a clear path to profitability with its existing commercial portfolio, having generated approximately $35M Net Revenues in 2025 as of Q3 from PYRUKYND in PK Deficiency.
  • AQVESME carries a boxed warning for hepatocellular injury and requires liver monitoring at baseline and every 4 weeks for the first 24 weeks of treatment.
Jan 14, 2026, 4:15 PM