Shares of UK-based NuCana (NASDAQ: NCNA) are rallying Wednesday after it said that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Acelarin (NUC-1031).
Acelarin is currently being evaluated in a Phase 3 study for the treatment of patients with advanced biliary tract cancer, which is part of a group of cancers originating in the biliary tract.
Fast Track is designed to facilitate the development and hasten the review of drugs to treat severe conditions and address an unmet medical need. Once a drug is given Fast Track designation, the FDA frequently engages with the company throughout the development and review process.
“We are very pleased that the FDA recognizes the potential of Acelarin to address the significant unmet need of patients with biliary tract cancer,” said Hugh Griffith, NuCana’s Founder and CEO.
NuCana recently announced the enrollment of 418 patients in its Phase 3 study, which will enable the first interim analysis in the first half of 2022.
“With both Fast Track and Orphan Drug designations in place, we look forward to working closely with the FDA in our efforts to gain approval for Acelarin as the first approved front-line treatment option for patients with biliary tract cancer,” Griffith added.
The news has resulted in the company's shares surging over 21% to $2.87. Earlier in the session, its shares reached a high of $3.21.
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