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
Euclid space telescope sees gorgeous cosmic cloud | Space photo of the day for Nov. 18, 2025 - 2As world leaders enter climate talks, people in poverty have the most at stake
- 3Presenting Nintendo's New Pastel Satisfaction Con Tones for Switch Gamers: 3 Upscale Choices
- 4Israel kidnaps PIJ terrorist in covert op. in Hamas-controlled Gaza in pursuit of Ran Gvili
- 5Dental, Vision, and Hearing Inclusion in Senior Protection.
- Cruising Solo All over the Planet: An Excursion of Self-Disclosure
- Manual for Famous Beverages 2024
- Why home maintenance deserves a spot in the annual health and budget plans
- Most loved Amusement Park for Small children: Which One Do You Suggest?
- I was about to film a movie with Glen Powell when my hair started falling out in clumps. Alopecia has made me unrecognizable as an actor.
- Ukraine's naval drones are gunning for Russia's 'shadow fleet.' A security source says a tanker just suffered a critical hit.
- Choosing Moving Styles for Your Restroom Redesign
- Ukraine Now Using Drone Boats To Attack Russian Riverine Targets
- Check out the exclusive pitch deck Valerie Health used to raise $30 million from Redpoint Ventures to automate healthcare faxes
