The FDA added three months to its review after requesting information on possible safety measures for Agios' sickle cell drug.

Agios Pharmaceuticals (AGIO) fell 18% after the FDA delayed its decision on mitapivat for sickle cell disease to 2027. The FDA is considering if a REMS safety program is required. Agios has $964.8M in cash and sells mitapivat for thalassemia under a REMS. Novo Nordisk (NVO) also faces REMS questions for its similar drug, etavopivat, planned for filing in 2026.

Agios Pharmaceuticals (AGIO) reported a three-month extension in the FDA's review of mitapivat for sickle cell disease, with a new PDUFA date of February 1, 2027. The extension follows additional information requested by the FDA, including updated safety data. AGIO shares are down 17.55% to $30.69.

Agios Pharmaceuticals announced the FDA extended the PDUFA goal date for mitapivat in sickle cell disease to February 2027, a 3-month delay. The extension follows a major amendment to the sNDA, which was submitted under accelerated approval. Agios maintains confidence in mitapivat's potential, citing positive RISE UP trial results. The company expects mitapivat to be a significant growth driver.

Agios Pharmaceuticals (AGIO) received a new FDA goal date of February 1, 2027, for mitapivat in sickle cell disease, extended by three months due to additional safety information. The company submitted updated safety data and is launch-ready. AGIO stock is currently trading at $31.26, down 15.97%.

Agios Pharmaceuticals (AGIO) shares dropped 12% after the FDA extended its review of Pyrukynd's marketing application by three months. The FDA had previously granted priority review in July.

Agios Pharmaceuticals (NASDAQ:AGIO) announced the FDA extended its review of mitapivat for sickle cell disease to February 1, 2027, due to a major amendment request. The extension follows additional safety data submission. Mitapivat is approved for other conditions. Agios continues discussions with the FDA.