COGT - Cogent Biosciences nabs FDA's Orphan Drug Designation for cancer therapy

syahrir maulana/iStock via Getty Images Cogent Biosciences ([[COGT]] +0.5%) has received the FDA’s Orphan Drug Designation for a treatment targeted at gastrointestinal stromal tumors ((GIST)). GISTs making up less than 1% of all gastrointestinal tumors affect about 4K – 6K adults in the U.S. each year. FDA’s orphan drug designation is aimed at giving financial incentives to developers of therapies for rare diseases and conditions. In addition to tax credits for clinical trial costs and a waiver of the user fee for marketing applications, the developers can also claim seven years of marketing exclusivity for the orphan drugs after the regulatory approval. Cogent’s most advanced candidate, CGT9486, targets mutations in the exon 17 gene found in patients with advanced GIST. The company expects to start three clinical trials for CGT9486 this year.

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Cogent Biosciences nabs FDA’s Orphan Drug Designation for cancer therapy