AGIO faces uncertainty as the FDA misses its Dec. 7 deadline related to the sNDA for Pyrukynd in thalassemia and offers no new timeline.
Agios slides to a 52-week low after mixed phase III RISE UP data show a hemoglobin boost but no significant cut in pain crises.
Agios Pharmaceuticals, Inc. ( AGIO ) Discusses Topline Results from RISE UP Phase 3 Trial of Mitapivat in Sickle Cell Disease November 19, 2025 8:00 AM EST Company Participants Morgan Sanford Brian Goff - CEO & Director Sarah Gheuens - Chief Medical Officer and Head of Research & Development Tsveta Milanova - Chief Commercial Officer Conference Call Participants Biree Andemariam Eric Schmidt - Cantor Fitzgerald & Co., Research Division Salveen Richter - Goldman Sachs Group, Inc., Research Division Ellen Horste - TD Cowen, Research Division Alec Stranahan - BofA Securities, Research Division Emily Bodnar - H.C. Wainwright & Co, LLC, Research Division Tessa Romero - JPMorgan Chase & Co, Research Division Luca Issi - RBC Capital Markets, Research Division Presentation Operator Good morning, and welcome to the Agios Pharmaceuticals Investor Conference Call and Webcast.
Agios Pharmaceuticals said on Wednesday its sickle cell drug met one of its two main goals in a late-stage study of patients aged 16 and older, but failed to show a statistically significant reduction in pain crises.
Agios Pharmaceuticals delivered strong Q3'25 results, with revenue up 44% year-over-year and continued momentum in its rare-disease pipeline. AGIO's key catalysts include the FDA decision on Pyrukynd's thalassemia sNDA in December 2025 and topline data from the 'RISE UP' sickle cell trial. Despite premium valuation, the company maintains a robust balance sheet and is positioned for significant growth if regulatory approvals and market expansion materialize.
Agios posts a narrower-than-expected third-quarter loss as Pyrukynd drives a 44% revenue rise, with potential label expansions on the horizon.
Agios Pharmaceuticals, Inc. ( AGIO ) Q3 2025 Earnings Call October 30, 2025 8:00 AM EDT Company Participants Morgan Sanford Brian Goff - CEO & Director Cecilia Jones - Chief Financial Officer Tsveta Milanova - Chief Commercial Officer Sarah Gheuens - Chief Medical Officer and Head of Research & Development Conference Call Participants Eric Schmidt - Cantor Fitzgerald & Co., Research Division Alec Stranahan - BofA Securities, Research Division Marc Frahm - TD Cowen, Research Division Tessa Romero - JPMorgan Chase & Co, Research Division Presentation Operator Good morning, and welcome to Agios Pharmaceuticals Third Quarter 2025 Conference Call. [Operator Instructions] Please be advised that this call is being recorded at Agios' request.
Agios Pharmaceuticals (AGIO) came out with a quarterly loss of $1.78 per share versus the Zacks Consensus Estimate of a loss of $1.93. This compares to earnings of $4.2 per share a year ago.
Agios shares tank as the FDA extends the review period for Pyrukynd in thalassemia by three months, pushing the final ruling to Dec. 7, 2025.
Agios Pharmaceuticals, Inc. (NASDAQ:AGIO ) Q2 2025 Earnings Call July 31, 2025 8:00 AM ET Company Participants Brian M. Goff - CEO & Director Cecilia Jones - Chief Financial Officer Sarah Gheuens - Chief Medical Officer and Head of Research & Development Tsveta Milanova - Chief Commercial Officer Morgan Sanford - Vice President, Investor Relations Conference Call Participants Andrew Scott Berens - Leerink Partners LLC, Research Division Emily Claudia Bodnar - H.C.
Agios Pharmaceuticals (AGIO) came out with a quarterly loss of $1.93 per share versus the Zacks Consensus Estimate of a loss of $1.74. This compares to a loss of $1.69 per share a year ago.
AGIO's earnings beat estimates in the first quarter of 2025, while revenues miss the same.