Dec 24 (Reuters) - Shares of Agios Pharmaceuticals (AGIO) jumped 18% on Wednesday after the U.S. Food and Drug Administration approved the expanded use of its drug for the treatment of a type of blood disorder.
The drug mitapivat is now approved as a treatment for patients with anemia in both non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia, the company said late on Tuesday.
Thalassemia is an inherited blood disorder affecting the body's ability to produce hemoglobin and healthy red blood cells.
The drug, under the brand name Aqvesme, is expected to be available in late January next year, following the implementation of the required safety program.
Mitapivat was already approved by the U.S. FDA in 2022 to treat low red blood cell counts in adults with pyruvate kinase deficiency, under the brand name of Pyrukynd.
"The approval unlocks an additional $320 million in peak revenue opportunity layered atop the existing mitapivat franchise," Truist analyst Gregory Renza said.
The latest approval is based on a late-stage study in which patients receiving mitapivat showed a statistically significant increase in hemoglobin response compared to those on placebo.
Aqvesme will carry a boxed warning for liver function tests every four weeks during the first 24 weeks of treatment and advises against use in patients with cirrhosis, Renza added.
(Reporting by Siddhi Mahatole in Bengaluru; Editing by Vijay Kishore)
latest_posts
- 1
American tourists left stranded in the Caribbean following flight cancellations after airspace closed for Maduro operation - 2NASA satellite gazes into Medusa Pool | Space photo of the day for Dec. 24, 2025
- 3The Best Cell phone Brands for Tech Aficionados
- 4Manual for Vegetarian Protein Powder
- 5The Hybrid Volkswagen ID. ERA 9X Will Become the Brand’s New Flagship in China
- Hezbollah rockets hit 165 UNIFIL positions in Lebanon while targeting Israel, IDF reveals
- The Best 10 Innovation Advancements of the Year
- Watch Rocket Lab launch Japanese technology-demonstrating satellite to orbit tonight
- 5 Worldwide Road Food varieties You Should Attempt
- Syrian army says recent drone attacks targeted its bases near Iraq, most shot down
- Italy fertility rate fell to new low of 1.14 in 2025
- Nvidia Share Price Could Be Hit Hard By Iran War
- Who plays Moana in the live-action remake? What to know about Catherine Lagaʻaia.
- Top 10 Books That Will Have an impact on Your Viewpoint
