Agios Pharmaceuticals (AGIO) · mitapivat
Wording changed · A neutral label for the two timing statements. It says nothing about the program’s results.
Before
Stated timing: November 1, 2026
The Prescription Drug User Fee Act (PDUFA) goal date for this sNDA, submitted under the FDA’s accelerated approval pathway, is November 1, 2026.
· filed · SEC filing
After
Stated timing: February 1, 2027
The PDUFA goal date for this sNDA, which was submitted under the FDA’s accelerated approval pathway and granted Priority Review, is now February 1, 2027.
Company press release · SEC filing pending · published · Company press release · SEC filing pending
Company explanation
On October 28, 2026, the FDA informed Agios that the company’s response had been classified as a major amendment to the sNDA, resulting in a three-month review extension.
Data as of . The earlier sentence is retained from its SEC filing. The later sentence and explanation are quoted from the company press release linked above.
Source: ORION, orionbiotechai.com/changes/AGIO-mitapivat-2026-10-30, data as of Oct 31, 2026
https://www.orionbiotechai.com/changes/AGIO-mitapivat-2026-10-30
Agios Pharmaceuticals (AGIO) pipeline and stated timing · Calendar · Companies A–Z · Follow by RSS
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