Shots:
Telix has entered into a strategic agreement to lead a merger with ITM Isotope Technologies Munich, with Telix shareholders expected to own ~76.3% & ITM shareholders ~23.7% of Telix shares upon completion
As per the deal, Telix will acquire 100% of ITM for $1.65B upfront, comprising $1.25B in the form of 105.8M Telix shares,…
Shots:
The US FDA has approved Bexlutry (lutetium Lu 177 dotatate injection) for the treatment of adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), covering foregut, midgut, & hindgut NETs
Bexlutry is a radioligand equivalent developed through the 505(b)(2) regulatory pathway, targeting Lutathera. The approval is supported by published evidence & targeted bridging data demonstrating…
Shots:
The US FDA has approved Tauklarify (florquinitau F 18 injection/ MK-6240) for PET of the brain in adults with cognitive impairment who are being evaluated for Alzheimer’s disease to identify pts with tau neurofibrillary tangle (NFT) pathology
Approval was supported by Study 1 & 2 assessing Tauklarify (IV, 185 MBq) PET images from >500…
Shots:
Telix has dosed the first patient with TLX250-Tx (lutetium-177 (177Lu) girentuximab tetraxetan) in the P-III (LUTEON) study to identify eligible pts with CAIX-positive tumors in r/r clear cell renal cell carcinoma (ccRCC)
LUTEON trial in Australia is part of Telix’s global development program for TLX250-Tx, alongside the P-IIa (LUTEON ATLAS) study in the US…
Shots:
SOFIE Biosciences has dosed the first patient with [18F]FAPI-74, a fluorine-18 labeled radiopharmaceutical, in the P-III (FAPI-GO) trial for the diagnosis of GI cancers
The trial will assess the clinical utility of [¹⁸F]FAPI-74 PET/CT over 24mos. in the detection of metastatic disease in 200 adults with gastroesophageal cancer across 18 sites
Another P-III (FAPI-PRO)…
Shots:
Sanofi has reported data from the ongoing P-II (ALPHAMEDIX-02) trial assessing AlphaMedix (67.6μCi/kg, Q8W, ~4 cycles) in pts, incl. PRRT-naïve (n=35) & exposed (n=26) pts with histologically confirmed unresectable or metastatic SSTR+ GEP-NETs & ≥1 site of measurable disease
Trial met all 1EPs with improved ORR & prolonged benefit, plus showed improvement across 2EPs…

