Telix Shares Up 6.7% After FDA Acceptance

Telix Pharmaceuticals ADR (NASDAQ:TLX) surged 6.7% after FDA accepted its resubmitted NDA for TLX101-Px, a glioma PET imaging agent.
The FDA set a PDUFA goal date of September 11, 2026, and granted Orphan Drug and Fast Track designations to TLX101-Px.
CEO Kevin Richardson said 2026 guidance excludes TLX101-Px revenue; analyst Robert Burns keeps Buy rating with $20 target.
Experts from UCSF and Mass General highlighted the unmet need for imaging residual glioma after treatment.