Agios Pharmaceuticals, Inc. Aktie News

Agios faces a pivotal FDA decision on 7 December for mitapivat's thalassemia expansion, with a good chance of approval based on strong Phase 3 data. The stock has lagged typical pre-PDUFA momentum, offering an attractive entry point for risk-tolerant investors ahead of a potential catalyst. Safety concerns exist but are likely manageable with enhanced monitoring; Agios' robust cash position pro...

Agios Pharmaceuticals, Inc. faces a three-month FDA review delay for mitapivat in thalassemia due to safety concerns, but no new efficacy or safety data was requested. Despite the setback, I remain confident in mitapivat's strong efficacy and competitive oral profile, expecting eventual FDA approval in December. Agios is financially robust with $1.3bn cash, and approval could unlock blockbuster...

PDUFA goal date extended by three months from September 7, 2025, to December 7, 2025 CAMBRIDGE, Mass., Sept. 04, 2025 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription...

Agios Pharmaceuticals today announced that the Saudi Food and Drug Authority has approved PYRUKYND® for the treatment of adult patients with thalassemia

Agios Pharmaceuticals (AGIO -6.15%), a biotechnology company focused on therapies for rare blood disorders, released its second quarter 2025 earnings on July 31, 2025. The headline was a notable revenue beat: This quarter showcased clear progress on sales for its lead product PYRUKYND, with GAAP net product revenue of $12.5 million, yet also highlighted the company's increasing cost base as it ...

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 Beren...

$12.5 million in second quarter PYRUKYND® (mitapivat) net revenues; ended second quarter with $1.3 billion dollars in cash, cash equivalents and marketable securities PYRUKYND sNDA for thalassemia under active review, with FDA PDUFA goal date of September 7, 2025 Topline results from RISE UP Phase 3 trial of mitapivat in sickle cell disease on track by year-end with potential U.S. commercial la...

CAMBRIDGE, Mass., July 14, 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 company will host a conference call and live webcast on Thursday, July 31, 2025, at 8:00 a.m.