Why Is AGIOS PHARMACEUTICAL (AGIO) Stock Down Today?

Agios Pharmaceuticals stock fell 15.04% to $31.63 as the FDA delayed the review of the company’s mitapivat supplemental new drug application for sickle cell disease. The primary driver was the announcement of a new PDUFA goal date, which pushed the regulatory decision to February 1, 2027.

What Happened

The FDA extended the review period for the mitapivat sNDA, a move that delayed the potential label expansion for the drug. Agios stated that it remains launch-ready and is currently in labeling discussions with the agency. Despite the regulatory delay, H.C. Wainwright assumed coverage of the stock with a Buy rating and a price target of $55. Truist Securities also maintained a Buy rating on the shares but lowered its price target to $37. The company is unprofitable, with a trailing twelve-month EPS of negative $7.01, though revenue has grown 140.6% over the same period.

What The Data Shows

The stock opened at $37.04, a 0.5% gap down from the prior close of $37.23. The session high was $37.06 at 7:10 AM ET, while the session low reached $30.75 at 9:30 AM ET. Volume so far stands at 0.2 million shares, which is 0.1 times the three-month daily average. The company has a market capitalization of $2.3 billion and a beta of 0.63. Over the last 8 sessions, the stock moved down 5.0%, from $34.79 to $33.07. The 52-week range is $22.24 to $46.00. Recent insider activity includes three sells totaling $1.3 million over the last 90 days, with no buys recorded. Sarah Gheuens, the Chief Medical Officer, sold shares on October 26, October 21, and August 4. Congressional trades show two buys in the last 90 days, with no sells.

What To Watch

Investors will monitor the FDA’s labeling discussions and the February 1, 2027, PDUFA goal date for the mitapivat sickle cell disease indication.