Moleculin Biotech, Inc., (Nasdaq: MBRX) surged 43.59% in the pre-market session after, a clinical-stage pharmaceutical corporation with a wide pipeline of drug candidates targeting highly resistant tumors and viruses, recently confirmed that its drug candidate WP1066 has been licensed by the US Food and Drug Administration (FDA) to qualify for a ‘Rare Pediatric Disorder’ designation.
The classification authorises Moleculin to obtain a New Drug Approval (NDA) transferable Priority Review Voucher (PRV) for any of the three indications, including diffuse intrinsic pontine glioma (DIPG), medulloblastoma, and atypical rhabdoid teratoid tumor.
The company also revealed on November 19 2020 that recent animal results demonstrated a strongly improved performance against acute myeloid leukaemia (‘AML’) when used in conjunction with the widely used antileukemic agent Ara-C against the single agent. The results will be discussed under the title: “High Efficacy of Liposomal Annamycin in Combination with Cytarabine in Syngeneic p53-null AML Mouse Model.” at the 62nd Annual Meeting & Exhibition of the American Society for Hematology.
