[FDA headquarters in Washington DC.]
JHVEPhoto
* The U.S. FDA has granted Orphan Drug designation to Keros Therapeutics' (NASDAQ:KROS [https://seekingalpha.com/symbol/KROS]) KER-065 for Duchenne muscular dystrophy.
* The candidate [https://seekingalpha.com/pr/20206766-keros-announces-u-s-fda-orphan-drug-designation-granted-to-kerminus-065-for-the-treatment-of] is considered a novel ligand trap designed to "inhibit the biological effects of myostatin and activin A, two ligands that signal through activin receptors, to increase skeletal muscle regeneration, increase muscle size and strength, reduce body fat, reduce fibrosis of the skeletal muscle and increase bone strength."
* In March, topline phase 1 results [https://seekingalpha.com/pr/20050309-keros-therapeutics-announces-initial-topline-results-from-the-phase-1-clinical-trial-of] on KER-065 showed it was well tolerated with no major safety signals, and there was evidence for activin inhibition across tissues.
MORE ON KEROS THERAPEUTICS
* Keros falls after discontinuation of mid-stage trial for PAH therapy [https://seekingalpha.com/news/4453425-keros-falls-after-discontinuation-of-hypertension-treatment-trial]
* Seeking Alpha’s Quant Rating on Keros Therapeutics [https://seekingalpha.com/symbol/KROS/ratings/quant-ratings]
* Historical earnings data for Keros Therapeutics [https://seekingalpha.com/symbol/KROS/earnings]
* Financial information for Keros Therapeutics [https://seekingalpha.com/symbol/KROS/income-statement]
Keros gains Orphan Drug designation for Duchenne muscular dystrophy asset
Published 2 months ago
Aug 20, 2025 at 2:03 PM
Neutral
Auto