Agios: pre-sNDA FDA meeting para sa mitapivat sa sickle cell disease itinakda sa Q1 2026

The press release states that Agios will hold a pre-sNDA meeting with the FDA in Q1 2026 for mitapivat in sickle cell disease, after which the company plans to submit a U.S. marketing application. This sets the next regulatory milestone for the sickle cell indication following the November 2025 topline readout.

Mahahalagang fact

Na-file: Ene 12, 2026, 12:11 PM
Kaganapan: Naitakda ang petsa ng PDUFA
Direksyon: Neutral
Kumpanya: AGIOAgios
Asset: mitapivat
Pinagmulan: SEC 8-K
Kumpiyansa: May source
Kalendaryo: Desisyon ng FDA (PDUFA) · Nob 1, 2026 · Inaprubahan

Sipi mula sa source

EX-99.1 2 agio-011226xprxex991.htm EX-99.1 Document Exhibit 99.1 Agios Outlines 2026 Strategic Priorities and Key Milestones to Accelerate Rare Disease Portfolio Growth • AQVESME™ (mitapivat) U.S. commercial launch in thalassemia underway following December 2025 FDA approval • Pre-sNDA meeting with FDA for mitapivat in sickle cell disease anticipated in first quarter of 2026, with planned U.S. regulatory submission to follow • Company progressing early- and mid-stage pipeline in multiple high-value indications • Clear path to profitability through the company’s existing commercial presence in thalassemia and PK deficiency, with potential to achieve over $1 billion in peak global sales CAMBRIDGE, Mass. , Jan. 12, 2026 – Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biop

SEC 8-K