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RedHill Biopharma's Opaganib Gains FDA Rare Pediatric Disease Status for Neuroblastoma

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RedHill Biopharma (RDHL) said Tuesday the US Food and Drug Administration has granted rare pediatric disease designation to opaganib for neuroblastoma, in addition to its existing orphan drug designation.

The designation could qualify the drug for a priority review voucher and provide benefits such as faster review, fee waivers, tax credits and potential seven-year market exclusivity if approved, the company added.

RedHill said the neuroblastoma market could reach $3.5 billion by 2032 and noted preclinical data supporting opaganib's potential in neuroblastoma and other cancers, including triple-negative breast cancer.

Shares of the company were down more that 12% in premarket trading Tuesday.

Price: $0.90, Change: $-0.12, Percent Change: -12.75%

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