Agios Pharmaceuticals faces securities fraud investigation over delayed FDA approval.

Pomerantz LLP is investigating Agios Pharmaceuticals for potential securities fraud and unlawful business practices. The investigation concerns Agios' announcement of a delayed FDA approval for its drug PYRUKYND for treating alpha- or beta-thalassemia. Investors who have suffered losses are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980.

NEW YORK, Sept. 12, 2025 — Pomerantz LLP, a renowned law firm specializing in corporate, securities, and antitrust class litigation, has announced that it is investigating claims on behalf of investors of Agios Pharmaceuticals, Inc. (NASDAQ: AGIO). The investigation centers on whether Agios and its officers or directors have engaged in securities fraud or other unlawful business practices Pomerantz Law Firm Investigates Claims On Behalf of Investors of Agios Pharmaceuticals, Inc. - AGIO^[1].

The investigation was prompted by Agios' recent announcement regarding the delayed FDA approval of its drug PYRUKYND® (mitapivat), an oral pyruvate kinase (PK) activator for the treatment of adult patients with non-transfusion-dependent (NTD) and transfusion-dependent (TD) alpha- or beta-thalassemia. On September 4, 2025, Agios revealed that the FDA had extended the Prescription Drug User Fee Act (PDUFA) goal date for the supplemental New Drug Application (sNDA) of PYRUKYND by three months to December 7, 2025 Pomerantz Law Firm Investigates Claims On Behalf of Investors of Agios Pharmaceuticals, Inc. - AGIO^[1].

Following this announcement, Agios' stock price fell by $4.48 per share, or 11.03%, closing at $36.13 per share on September 4, 2025 Pomerantz Law Firm Investigates Claims On Behalf of Investors of Agios Pharmaceuticals, Inc. - AGIO^[1]. Investors who have suffered losses are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980 Pomerantz Law Firm Investigates Claims On Behalf of Investors of Agios Pharmaceuticals, Inc. - AGIO^[1].

Pomerantz LLP, known for its pioneering work in securities class actions, is urging investors to come forward with any information that could assist in the investigation. The firm has a history of recovering multimillion-dollar damages on behalf of class members Pomerantz Law Firm Investigates Claims On Behalf of Investors of Agios Pharmaceuticals, Inc. - AGIO^[1].