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Onco-Summaries: Daily Oncology Updates at a Glance


08/04/2026











FDA Grants Orphan Drug Status to Plus Therapeutics’ REYOBIQ™ for Pediatric Malignant Gliomas (Ref)


Plus Therapeutics’ REYOBIQ™ (rhenium Re186 obisbemeda) has been granted orphan drug status for pediatric malignant gliomas, with scope expanded to include pediatric ependymoma

Regulatory & Clinical Progress:


  • The ODD for pediatric malignant gliomas builds on recent regulatory and clinical progress for REYOBIQ, including completion of a Type B meeting with the FDA supporting development plans in leptomeningeal metastases (LM), encouraging clinical data from the ReSPECT-LM trial, and ongoing advancement of Phase 1 and Phase 2 studies


  • FDA clearance of an IND to evaluate REYOBIQ in pediatric high‑grade glioma and ependymoma
























FDA Grants Orphan Drug Designation to Compass Therapeutic’s Tovecimig for Biliary Tract Cancer (Ref)


Compass Therapeutics, ABL Bio’s partner, received Orphan Drug Designation (ODD) from the U.S. FDA for tovecimig (ABL001; DLL4 x VEGF-A BsAb), a treatment for biliary tract cancer

Clinical Development:


  • Currently in Phase 2/3 COMPANION-002 trial for second-line biliary tract cancer patients, combined with paclitaxel


  • Key efficacy data (Overall Survival and Progression-Free Survival) expected this month


  • Compass previously received Fast Track Designation in Apr 2024, now leveraging both Fast Track and Orphan Drug benefit



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