Agios Pharmaceuticals (NASDAQ:AGIO) Shares Gap Down – Here’s What Happened

Agios Pharmaceuticals, Inc. (NASDAQ:AGIO)’s share price gapped down prior to trading on Friday. The stock had previously closed at $37.23, but opened at $31.43. Agios Pharmaceuticals shares last traded at $31.5940, with a volume of 528,339 shares trading hands.

More Agios Pharmaceuticals News

Here are the key news stories impacting Agios Pharmaceuticals this week:

• Positive Sentiment: Mitapivat’s application received Priority Review and was submitted under the FDA’s accelerated approval pathway, reflecting the significant unmet need in sickle cell disease. Agios said it remains launch-ready and is continuing labeling discussions with the FDA. Agios FDA update
• Positive Sentiment: Agios reported that approximately nine months of additional safety data showed no cases of hepatocellular injury in sickle cell disease patients with a pattern and severity similar to prior liver injuries observed in thalassemia trials. The company said the drug’s benefit-risk profile remains unchanged. Agios mitapivat safety update
• Neutral Sentiment: The FDA’s new PDUFA goal date is February 1, 2027, compared with the original November 1, 2026 target. The decision will determine whether Agios can expand mitapivat into a potentially large sickle cell disease market of roughly 100,000 U.S. patients.
• Negative Sentiment: The FDA requested additional information to assess whether a Risk Evaluation and Mitigation Strategy (REMS) is needed. It classified Agios’ response as a major amendment, triggering a three-month review extension and delaying a potential approval, launch and related revenue opportunity. FDA extends Agios review
• Negative Sentiment: The potential REMS signals that liver-safety considerations remain part of the regulatory review and could add monitoring requirements or commercial friction if mitapivat is approved for sickle cell disease.
• Negative Sentiment: Recent insider activity showed Chief Medical Officer Sarah Gheuens selling 7,866 shares for approximately $296,470 under a pre-arranged Rule 10b5-1 plan. While scheduled sales do not necessarily indicate a change in outlook, the transaction adds a modest negative sentiment signal. Agios insider sale

Wall Street Analyst Weigh In

A number of research firms recently issued reports on AGIO. JPMorgan Chase & Co. upped their price objective on shares of Agios Pharmaceuticals from $31.00 to $34.00 and gave the stock a “neutral” rating in a research report on Friday, August 7th. Truist Financial cut their price objective on Agios Pharmaceuticals from $39.00 to $37.00 and set a “buy” rating on the stock in a report on Wednesday, October 7th. HC Wainwright initiated coverage on Agios Pharmaceuticals in a research report on Thursday. They issued a “buy” rating and a $55.00 target price for the company. Royal Bank Of Canada boosted their price target on Agios Pharmaceuticals from $28.00 to $32.00 and gave the stock a “sector perform” rating in a report on Tuesday, July 7th. Finally, Bank of America raised their target price on Agios Pharmaceuticals from $46.00 to $50.00 and gave the stock a “buy” rating in a research report on Monday, September 21st. One investment analyst has rated the stock with a Strong Buy rating, five have given a Buy rating, four have issued a Hold rating and one has assigned a Sell rating to the company’s stock. Based on data from MarketBeat, the stock has an average rating of “Moderate Buy” and an average price target of $41.50.

Agios Pharmaceuticals Stock Performance

The business has a fifty day moving average of $33.69 and a 200-day moving average of $31.69. The company has a market capitalization of $1.83 billion, a P/E ratio of -4.36 and a beta of 0.63.

Agios Pharmaceuticals (NASDAQ:AGIO) last released its quarterly earnings data on Thursday, July 30th. The biopharmaceutical company reported ($1.69) earnings per share for the quarter, missing the consensus estimate of ($1.65) by ($0.04). Agios Pharmaceuticals had a negative return on equity of 35.67% and a negative net margin of 418.24%. The business had revenue of $44.75 million for the quarter, compared to analyst estimates of $26.39 million. Sell-side analysts anticipate that Agios Pharmaceuticals, Inc. will post -5.83 EPS for the current year.

Insider Activity at Agios Pharmaceuticals

In other news, insider Sarah Gheuens sold 7,866 shares of the firm’s stock in a transaction that occurred on Monday, October 26th. The stock was sold at an average price of $37.69, for a total value of $296,469.54. Following the transaction, the insider owned 54,645 shares in the company, valued at $2,059,570.05. This trade represents a 12.58% decrease in their ownership of the stock. The transaction was disclosed in a document filed with the Securities & Exchange Commission, which is available through this hyperlink. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Insiders sold 39,855 shares of company stock valued at $1,285,512 over the last three months. Corporate insiders own 5.40% of the company’s stock.

Institutional Investors Weigh In On Agios Pharmaceuticals

Several institutional investors have recently bought and sold shares of AGIO. Nykredit A S purchased a new stake in Agios Pharmaceuticals in the 2nd quarter valued at $26,000. Quantinno Capital Management LP boosted its holdings in Agios Pharmaceuticals by 2.7% during the 1st quarter. Quantinno Capital Management LP now owns 27,591 shares of the biopharmaceutical company’s stock worth $933,000 after acquiring an additional 736 shares during the last quarter. AlphaCentric Advisors LLC boosted its holdings in Agios Pharmaceuticals by 6.3% during the 1st quarter. AlphaCentric Advisors LLC now owns 13,971 shares of the biopharmaceutical company’s stock worth $473,000 after acquiring an additional 830 shares during the last quarter. Inspire Investing LLC boosted its holdings in Agios Pharmaceuticals by 4.7% during the 3rd quarter. Inspire Investing LLC now owns 19,130 shares of the biopharmaceutical company’s stock worth $636,000 after acquiring an additional 861 shares during the last quarter. Finally, VIRGINIA RETIREMENT SYSTEMS ET Al grew its stake in shares of Agios Pharmaceuticals by 4.0% in the 3rd quarter. VIRGINIA RETIREMENT SYSTEMS ET Al now owns 28,861 shares of the biopharmaceutical company’s stock worth $960,000 after acquiring an additional 1,100 shares in the last quarter.

Agios Pharmaceuticals Company Profile

Agios Pharmaceuticals, Inc is a biopharmaceutical company focused on discovering and developing medicines for rare diseases involving cellular metabolism. The company’s research is centered on metabolic pathways that influence red blood cell production and function, with the goal of addressing conditions that have limited treatment options.

Agios’ principal commercial product is Pyrukynd (mitapivat), an oral activator of pyruvate kinase. Pyrukynd is approved in the United States and other markets for the treatment of hemolytic anemia in adults with pyruvate kinase deficiency, a rare inherited blood disorder.