Telix Pharmaceuticals stock jumps on trial completion, FDA path

Telix Pharmaceuticals (TLX) stock rose 5.2% in pre-market trading after completing patient enrollment in its Phase 3 BiPASS study for prostate cancer detection. The FDA aligned on an NDA pathway, and H.C. Wainwright reiterated a Buy rating with a $20.00 price target. The company reported strong H1 2026 financials, including 22% revenue growth and 146% EBITDA increase.

Universe Pharmaceuticals (UPC) rose 34.89% after-hours due to multiple Schedule 13G filings. BioAffinity (BIAF) explores new uses for its CyPath Lung test, up 3%. Modular Medical (MODD) gained 7% after announcing a product launch. MAIA (MAIA) rose 6% following an insider purchase. Telix (TLX) completed a Phase 3 study, up 2.21%. aTyr Pharma (ATYR) awaits FDA response, up 4%.

Telix Pharmaceuticals has completed patient enrollment in its Phase 3 BiPASS study for prostate cancer imaging agents Illuccix and Gozellix. The company has aligned with the FDA on an NDA pathway, which, if approved, could support reimbursement and broaden patient access. The study aims to evaluate the diagnostic performance of 68Ga-PSMA-PET combined with MRI for detecting prostate cancer prior to biopsy, potentially reducing unnecessary procedures.

Telix Pharmaceuticals reported a $38M profit after tax for H1 2026, including a $40M payment from Regeneron. Revenue rose 22% YoY to $477M, with adjusted EBITDA up 146% to $52M. R&D spending increased to $124M. The company expects 2026 revenue to exceed $1B, including the Regeneron payment.

Telix Pharmaceuticals reported H1 earnings, with precision medicine EBITDA up 26% YoY to AUD 132M. Telix Manufacturing Solutions revenue rose 10% YoY to AUD 89M, while internal revenue via RLS increased 70% to AUD 57M. The company's PSMA imaging portfolio revenue grew 9% sequentially to $202M. Telix is investing in manufacturing and distribution capacity and has regulatory updates for Pixclara and Zircaix. The BiPASS study is nearing enrollment completion, potentially doubling the PSMA imaging m

Telix Pharmaceuticals reaffirmed its FY26 guidance, projecting revenue of $950M-$970M and total income exceeding $1B, including $40M from Regeneron. H1 2026 revenue rose 22% YoY to $477M, with adjusted EBITDA up 146% to $52M. The company's strong performance is partly driven by a one-time payment from Regeneron.