NuCana Receives Fast Track Designation from the U.S. Food and Drug Administration for Acelarin® (NUC-1031) for the Treatment of Biliary Tract Cancer
NuCana plc - American Depositary Shares (NCNA)
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Source: GlobeNewswire
EDINBURGH, United Kingdom, Sept. 29, 2021 (GLOBE NEWSWIRE) -- NuCana plc (NASDAQ: NCNA) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Acelarin (NUC-1031), currently being evaluated in a Phase III study (NuTide:121) for the first-line treatment of patients with advanced biliary tract cancer. Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and address an unmet medical need. “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 S. Griffith, NuCana’s Founder and Chief Executive Officer. “We recently announced enrollment of 418 evaluable patients in our Phase III study, which is expected to enable the first interim analysis in the first half of 2022. This has the potential to allow for an accelerated approval of a new drug application (NDA) for Acelarin in th
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NCNA
Sec Filings
- 5/1/24 - Form 6-K
- 4/9/24 - Form 6-K
- 3/27/24 - Form F-6
- NCNA's page on the SEC website