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
Check out the exclusive pitch deck Valerie Health used to raise $30 million from Redpoint Ventures to automate healthcare faxes - 2Careful Nurturing: Techniques for Bringing up Tough Children
- 3Many European nations want Israel to cancel 19 new settlement plans
- 4Top 15 Supportable Design Brands Coming out on top
- 5'Inflaming tensions': Bedouin mayor slams Ben-Gvir's unauthorized visit after meeting cancellation
- Malaysian broadcaster rejects altered graphic about electricity rate hike
- 5 Eating routine Well disposed Snacks to Keep You Fulfilled
- This Canadian crater looks like marbled meat | Space photo of the day for Jan. 6, 2026
- German gas price bill signed into law, but consumers not impressed
- IDF strikes Hamas terror cell operating near Israeli troops in northern Gaza
- Arctic sea ice hits lowest winter level as unprecedented heat hits smashes records all over Earth
- Why Tourists May Want To Reconsider Traveling To This Popular Spot In Italy In 2026
- Manual for Instructive Application for Youngsters
- Black Friday Paramount+ deal: Save 50% and stream these buzzy Taylor Sheridan shows
