The U.S. FDA has accepted for review Telix Pharmaceuticals Ltd’s resubmitted NDA for TLX101-Px (Pixclara, 18F-floretyrosine, 18F-FET), its radiolabeled glioma imaging product for characterizing progressive or recurrent glioma in adult and pediatric patients. The FDA assigned a Sept. 11, 2026, PDUFA date.
The U.S. FDA has accepted for review Telix Pharmaceuticals Ltd’s resubmitted NDA for TLX101-Px (Pixclara, 18F-floretyrosine, 18F-FET), its radiolabeled glioma imaging product for characterizing progressive or recurrent glioma in adult and pediatric patients. The FDA assigned a Sept. 11, 2026, PDUFA date.
What Cowen analyst Tara Bancroft called an “exciting” year ahead for Day One Biopharmaceuticals Inc. will be shared by Servier SAS, after the French firm agreed to pay $21.50 per share to acquire Day One in a deal that notched an equity value of about $2.5 billion.
Siren Biotechnology Inc. has obtained IND approval from the FDA enabling the initiation of its first-in-human trial for its lead investigational program SRN-101 in adult patients with recurrent high-grade glioma.
Ehrlich Biotechnology Co. Ltd. has described antibody-drug conjugates comprising an antibody targeting EGFR (HER1; erbB1) covalently linked to a camptothecin derivative through a linker reported to be useful for the treatment of cancer.
High-grade gliomas, including glioblastomas, are aggressive cancers of the brain that usually recur despite standard treatment, including radiation therapy. These mechanisms conferring persistence to tumor cells may be explained by DNA damage response pathways, especially those relying on ataxia-telangiectasia mutated (ATM) and DNA-dependent protein kinase (DNA-PK), which induce the repair of radiation-induced DNA damage. The effects of the ATM/DNA-PK inhibitor XRD-0394 were evaluated in in vitro models of glioma.
In glioblastoma multiforme, MTAP loss leads to MTA accumulation, which partially inhibits PRMT5, making the cells reliant on residual PRMT5 activity for survival. Targeting this remaining PRMT5 with MTA-cooperative inhibitors induces synthetic lethality, representing a promising targeted approach for MTAP-deleted gliomas. Researchers from Ryvu Therapeutics SA reported the preclinical profile of RVU-305, a PRMT5 inhibitor, in MTAP-deleted cancer models.
Shanghai Institute of Materia Medica of the Chinese Academy of Sciences has described isocitrate dehydrogenase (NADP) cytoplasmic (IDH1; PICD; IDP) (mutant) inhibitors reported to be useful for the treatment of glioma.
Mutations in the isocitrate dehydrogenase enzymes IDH1 and IDH2 have been associated with oncogenic transformation in several malignancies, including gliomas, acute myeloid leukemia (AML), cholangiocarcinoma and chondrosarcomas. Despite the approval of several mIDH1 inhibitors, suboptimal blood-brain barrier penetration and the development of acquired resistance limit their use.
Malignant gliomas, which include glioblastomas, are the most frequent primary brain cancer and are associated with extremely poor prognosis. They nearly always recur after treatment, rapidly leading to death.
