Oncology focused AI company Lantern Pharma Inc (NASDAQ: LTRN) announced on Monday that it has been granted three rare paediatric disease designations (RPDD) by the U.S. FDA for its drug candidate LP-184.
These designations cover malignant rhabdoid tumours (MRT), rhabdomyosarcoma (RMS) and hepatoblastoma, adding to a prior RPDD for Atypical Teratoid Rhabdoid Tumours (ATRT).
LP-184 has demonstrated efficacy in preclinical studies, showing tumour regression and extended event-free survival in specialised models. The drug is currently in a Phase 1A clinical trial across multiple solid tumours.
The RPDD status allows Lantern the potential to earn a Priority Review Voucher (PRV) upon FDA approval, which can expedite future drug reviews or be sold, with recent PRVs fetching over USD100m.
Lantern aims to leverage its AI-driven RADR platform to further develop targeted therapies in paediatric oncology.
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