Peptide News Digest

#Tlx

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Industry · View digest

Telix Agrees to Merge with ITM Isotope Technologies Munich for $1.65B Upfront Plus Up to $700M in ITM-11 Milestones, Adding Lu-177, Ac-225, and Tb-161 Production

Telix Pharmaceuticals announced late on September 20, 2026 U.S. Eastern time (September 21 in Australia) an agreement to merge with Germany's ITM Isotope Technologies Munich for $1.65 billion upfront on a cash-free, debt-free basis, including 105.8 million Telix shares, plus up to $700 million tied to regulatory approvals and sales milestones. The milestones are linked to ITM-11 (177Lu-edotreotide), a somatostatin receptor-targeted treatment for gastroenteropancreatic neuroendocrine tumors that completed the Phase 3 COMPETE trial and has fully enrolled a second Phase 3 study, COMPOSE. Telix describes ITM as the world's leading supplier of therapeutic radioisotopes and the only producer of globally scaled commercial-grade lutetium-177, with actinium-225 and terbium-161 production as well. The deal needs Telix shareholder and regulatory approvals and is expected to close by the end of fiscal 2026.

Regulatory · View digest

Telix Pharmaceuticals Pixclara (Floretyrosine F 18) FDA PDUFA Action Date Arrives Friday September 11 for PET Imaging of Recurrent or Progressive Glioma

Telix Pharmaceuticals Limited (NASDAQ: TLX) reached its FDA Prescription Drug User Fee Act (PDUFA) action date of Friday September 11, 2026 for TLX101-Px (Pixclara, floretyrosine F 18, also called 18F-FET), an investigational positron emission tomography (PET) imaging agent designed to help distinguish recurrent or progressive glioma from treatment-related changes in adult and pediatric patients with previously treated glioma. The FDA had accepted the resubmitted NDA in April 2026 following an earlier complete response letter. Pixclara carries FDA Fast Track and Orphan Drug designations. Standard MRI post-treatment surveillance struggles to differentiate true tumor progression from pseudoprogression or radiation necrosis; a PET imaging agent that binds selectively to actively metabolizing tumor cells addresses a substantial diagnostic gap. If approved, Pixclara would be one of the first tumor-specific glioma PET agents to enter the U.S. market. The company had not confirmed the FDA action outcome as of end of Friday U.S. business hours; investors were watching for a Monday morning announcement.