8/105 sources · 4 publishersUpdated Oct 8, 18:04 UTC
FDA grants Fast Track designation to Perspective Therapeutics' PSV359 for FAP‑positive solitary fibrous tumors
Perspective Therapeutics announced that the U.S. Food and Drug Administration granted Fast Track designation for its investigational radiopharmaceutical PSV359. The designation applies to adult patients with locally advanced, unresectable or metastatic fibroblast activation protein‑positive solitary fibrous tumors. PSV359 is currently being evaluated in a multi‑center Phase 1/2a study. The announcement was made on October 8 2026.
Why it matters
Perspective says the Fast Track status will allow more frequent interactions with the FDA and could enable accelerated review pathways, potentially shortening the time to market for PSV359.
Key facts
- 1The FDA granted Fast Track Designation for PSV359 on October 8 2026. globenewswire.com
- 2PSV359 is an investigational FAP‑targeted alpha‑particle therapy using the isotope 212Pb. globenewswire.com
- 3The drug is being studied in an ongoing Phase 1/2a multi‑center, open‑label dose‑finding and dose‑expansion trial (NCT06710756). globenewswire.com
- 4The company’s Chief Medical Officer and CEO both highlighted the lack of approved FAP‑α therapies and the potential of Fast Track to accelerate development. globenewswire.com
- 5Perspective’s stock rose 4.24% to $2.46 following the announcement. rttnews.com
Summary written by AlphAI from 5 of 5 sources. Not investment advice. Figures are as stated by the linked sources.