Agios Pharmaceuticals, Inc. Aktie News

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 Al...

$12.9 million in third quarter PYRUKYND® (mitapivat) net revenues PDUFA goal date for PYRUKYND U.S. sNDA in thalassemia set for December 7, 2025 CHMP adopted positive opinion for PYRUKYND in thalassemia; EC decision expected by early 2026 RISE UP Phase 3 trial topline results in sickle cell disease by year-end; potential U.S. commercial launch in 2026 Phase 2b tebapivat trial in lower-risk MDS ...

AMSTERDAM--(BUSINESS WIRE)-- #biopharma--Avanzanite's Partner Agios Pharmaceuticals Announces Regulatory Update.

Agios today announced that the CHMP has adopted a positive opinion for the new indication for PYRUKYND in adults for anemia associated with thalassemia

Agios today announced the company will host a conference call and live webcast on Thursday, October 30, 2025, at 8:00 a.m. ET to report its third quarter

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...