Moleculin Announces FDA Approves 3 Rare Pediatric Disease Designations for WP1066
HOUSTON, Dec. 1, 2020 /PRNewswire/ -- Moleculin Biotech, Inc., (Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, today announced that the US Food and Drug Administration (FDA) has approved its request for a "Rare Pediatric Disease" designation for its drug candidate WP1066. The designation entitles Moleculin to receive a transferrable Priority Review Voucher (PRV) upon New Drug Approval (NDA) for each of three indications, including diffuse intrinsic pontine glioma (DIPG), medulloblastoma and atypical teratoid rhabdoid tumor.
"The early activity we are seeing in WP1066 is both unexpected and encouraging," commented Walter Klemp, Chairman and CEO of Moleculin. "The approval of these three Rare Pediatric Disease designations is a reminder of just how important our efforts are to potentially help children with brain tumors."
Mr. Klemp concluded: "It is also important for investors to understand the implications of the PRVs or Priority Review Vouchers. These vouchers are issued upon drug approval of the rare disease indication from the FDA and, once issued, can be transferred to other drug developers. These PRVs have historically had tremendous value and have been recently sold for up to $100 million or more. For Moleculin to have the potential for three of them is noteworthy indeed."
About Moleculin Biotech, Inc.
Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors and viruses. The Company's clinical stage drugs are: Annamycin, a Next Generation Anthracycline, designed to avoid multidrug resistance mechanisms with little to no cardiotoxicity being studied for the treatment of relapsed or refractory acute myeloid leukemia, more commonly referred to as AML, WP1066, an Immune/Transcription Modulator capable of inhibiting p-STAT3 and other oncogenic transcription factors while also stimulating a natural immune response, targeting brain tumors, pancreatic cancer and hematologic malignancies, and WP1220, an analog to WP1066, for the topical treatment of cutaneous T-cell lymphoma. Moleculin is also engaged in preclinical development of additional drug candidates, including other Immune/Transcription Modulators, as well as WP1122 and related compounds capable of Metabolism/Glycosylation Inhibition.
For more information about the Company, please visit http://www.moleculin.com.
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SOURCE Moleculin Biotech, Inc.
Company Codes: NASDAQ-SMALL:MBRX