The U.S. Food and Drug Administration (FDA) has accepted Agios Pharmaceuticals Inc.’s (NASDAQ:AGIO) supplemental New Drug Application (sNDA) for mitapivat, an oral pyruvate kinase (PK) activator, in sickle cell disease with a Priority Review.
Following the announcement, the stock jumped by more than 15%.
FDA Sets November Decision Date For Agios Sickle Cell Disease Drug
The Prescription Drug User Fee Act (PDUFA) goal date for this sNDA, submitted under the FDA’s accelerated approval pathway, is November 1.
The FDA’s Priority Review designation is granted to applications for medicines that may offer significant improvements in safety or efficacy for serious conditions, shortening the target review timeline from the standard 10 months to six months.
RISE UP Data Supports Mitapivat Filing
The mitapivat sNDA is based on data from the RISE UP Phase 2 and Phase 3 trials in patients aged 16 years or older with sickle cell disease.
Mitapivat is currently approved in the U.S. for adult patients in two hemolytic anemias: PK deficiency (2022) and thalassemia (2025).
Analysts Lift Price Forecasts
Following the FDA milestone, several Wall Street firms raised their price forecasts for Agios. Truist Securities increased its price forecast to $41 from $36 while maintaining its Buy rating.
Analyst Gregory Renza said investor attention has remained focused on Agios’ efforts to secure accelerated approval for mitapivat in sickle cell disease using hemoglobin as a surrogate endpoint.
Renza added that the FDA’s ongoing review of the sNDA, combined with new RISE UP transfusion-burden data presented at the European Hematology Association Congress, reduces risk for the confirmatory REIGNITE study.
Bank of America Securities also raised its price forecast to $46 from $40 and reiterated its Buy rating. Meanwhile, RBC Capital maintained its Sector Perform rating and increased its price forecast to $32 from $28.
Agios Pharma Technical Analysis
AGIO is trading well above its major moving averages. The stock sits 25.4% above its 20-day simple moving average of $34.24 and 35.1% above its 200-day simple moving average of $31.77.
The 20-day moving average remains above the 50-day moving average, signaling a bullish short-term trend. However, the 50-day average is still below the 200-day average following a death cross formed in December 2025.
The Relative Strength Index stands at 84, placing the stock in overbought territory. That reading suggests momentum remains strong but also increases the risk of a short-term pullback or consolidation.
Key resistance is near $44, just below the 52-week high of $46. Initial support is around $39.
Earnings Outlook
Investors are also looking ahead to the company’s second-quarter earnings report, scheduled for July 30.
Analysts expect a loss of $1.71 per share on revenue of $25.64 million. In the same quarter last year, Agios reported a loss of $1.93 per share on revenue of $12.46 million.
Wall Street maintains a Buy consensus rating on the stock, with an average price forecast of $39.71 based on 12 analysts. Forecasts range from $31 to $50.
AGIO Stock Price Activity: Agios Pharmaceuticals shares were up 15.49% at $43.18 at the time of publication on Tuesday, according to Benzinga Pro data.
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