Financial Performance - PYRUKYND generated net revenue of $8.7 million in Q1 2025, up from $8.2 million in Q1 2024, representing a year-over-year increase of 6.1%[3] - The net loss for Q1 2025 was $89.3 million, compared to a net loss of $81.5 million in Q1 2024, reflecting an increase of 9.8%[7] - Cash, cash equivalents, and marketable securities totaled $1.4 billion as of March 31, 2025, down from $1.5 billion at the end of 2024[8] Expenses - Research and Development (R&D) expenses for Q1 2025 were $72.7 million, an increase of 5.2% compared to $68.6 million in Q1 2024[5] - Selling, General and Administrative (SG&A) expenses rose to $41.5 million in Q1 2025, compared to $31.0 million in Q1 2024, marking a 33.9% increase[7] Patient Enrollment - The total number of unique patients who completed prescription enrollment forms for PYRUKYND increased by 5% from Q4 2024, reaching 234 patients[3] Regulatory and Clinical Developments - The FDA accepted the supplemental New Drug Application (sNDA) for PYRUKYND for thalassemia treatment, with a PDUFA goal date of September 7, 2025[2] - The Phase 3 RISE UP study for mitapivat in sickle cell disease is on track, with topline results expected in late 2025 and a potential U.S. commercial launch in 2026[2] - Agios plans to file an Investigational New Drug Application for AG-236, targeting TMPRSS6 for polycythemia vera, in mid-2025[5] Strategic Focus - The company is advancing its pipeline with a focus on transformative therapies for rare diseases, aiming to create significant value for shareholders[2]

– U.S. Regulatory Filing Under Active Review for Approval of PYRUKYND® (mitapivat) in Thalassemia, with PDUFA Goal Date of September 7, 2025 – – Phase 3 RISE UP Study of Mitapivat in Sickle Cell Disease On Track, with Topline Results Expected in Late 2025; Potential U.S. Commercial Launch in 2026 – – Tebapivat Advancing in Clinical Trials for Lower-Risk Myelodysplastic Syndromes (LR-MDS) and Sickle Cell Disease – – PYRUKYND Net Revenue of $8.7 Million in Q1; Cash, Cash Equivalents and Marketable Securities ...

Here are three stocks added to the Zacks Rank #5 (Strong Sell) List today:Agios Pharmaceuticals, Inc. (AGIO) is a biopharmaceutical company. The Zacks Consensus Estimate for its current year earnings has been revised 19.7% downward over the last 60 days.Chegg, Inc. (CHGG) is an individualized learning support provider. The Zacks Consensus Estimate for its current year earnings has been revised 96.8% downward over the last 60 days.Equifax Inc. (EFX) is a data, analytics, and technology company.The Zacks Cons ...

CAMBRIDGE, Mass., March 05, 2025 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in cellular metabolism and pyruvate kinase (PK) activation pioneering therapies for rare diseases, today announced the grant of inducement equity awards outside of the Company's 2023 Stock Incentive Plan to its newly appointed Chief Corporate Development & Strategy Officer, Krishnan Viswanadhan. The grants were approved by the Board of Directors effective as of March 5, 2025, as inducements material to M ...

CAMBRIDGE, Mass., March 05, 2025 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in cellular metabolism and pyruvate kinase (PK) activation pioneering therapies for rare diseases, today announced the grant of inducement equity awards outside of the Company’s 2023 Stock Incentive Plan to its newly appointed Chief Corporate Development & Strategy Officer, Krishnan Viswanadhan. The grants were approved by the Board of Directors effective as of March 5, 2025, as inducements material to ...

CAMBRIDGE, Mass., March 04, 2025 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in cellular metabolism and PK activation pioneering therapies for rare diseases, today announced that its management team is scheduled to present at the following conferences: Leerink Global Healthcare Conference 2025: Fireside chat on Tuesday, March 11, 2025, at 10:50 a.m. ETBarclays 27th Annual Global Healthcare Conference: Fireside chat on Wednesday, March 12, 2025, at 12:30 p.m. ET The live webcast ...

CAMBRIDGE, Mass., Feb. 20, 2025 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in cellular metabolism and PK activation pioneering therapies for rare diseases, today announced that its management team is scheduled to present at the TD Cowen 45th Annual Healthcare Conference on Monday, March 3, 2025, at 10:30 a.m. ET. The live webcast will be accessible on the Investors section of the company's website (www.agios.com) under the “Events & Presentations” tab. A replay of the webcast w ...

Agios Pharmaceuticals (AGIO) incurred a loss of $1.74 per share in the fourth quarter of 2024, wider than the Zacks Consensus Estimate of a loss of $1.73. In the year-ago quarter, the company had reported a loss per share of $1.72.See the Zacks Earnings Calendar to stay ahead of market-making news.AGIO reported revenues of $10.7 million for the fourth quarter, which marginally beat the Zacks Consensus Estimate of $10 million. Revenues increased 51% from the year-ago quarter’s figure of $7.1 million.In the p ...

Agios Pharmaceuticals, Inc. (NASDAQ:AGIO) Q4 2024 Earnings Conference Call February 13, 2025 8:00 AM ET Company Participants Brian Goff - CEO Sarah Gheuens - CMO & Head OF R&D Tsveta Milanova - CCO Cecilia Jones - CFO Chris Taylor - VP, IR & Corporate Communications Conference Call Participants Eric Schmidt - Cantor Fitzgerald Divya Rao - TD Cowen Gregory Renza - RBC Capital Markets Greg Harrison - Scotiabank Chris Raymond - Piper Sandler Alec Stranahan - Bank of America Lydia Erdman - Goldman Sachs Tessa R ...

Q4 2024 Financial Results and Business Update February 13, 2025 1 Agios Conference Call Participants | TOPIC | PARTICIPANT | | --- | --- | | Introduction | Chris Taylor, VP Investor Relations and Corporate | | | Communications | | Business Update | Brian Goff, Chief Executive Officer | | R&D Update | Sarah Gheuens, M.D., Ph.D., Chief Medical Officer, | | | Head of R&D | | Commercial Update | Tsveta Milanova, Chief Commercial Officer | | Third Quarter 2024 Financial Results | Cecilia Jones, Chief Financial O ...