NuCana Inc. (NASDAQ: NCNA) stock gains by 19.20% in the current market trading session. NuCana is a clinical-stage pharmaceutical business focusing on improving cancer treatment results by using their ProTide technology to convert nucleoside analogues, one of the most often prescribed chemotherapy drugs, into more effective and safer medications.
NCNA stock’ Current Development
NuCana reported that Acelarin (NUC-1031), which is presently being studied in a Phase III trial (NuTide:121) for the first-line management of patients with severe biliary tract cancer, has been awarded Fast Track designation by the US Food and Drug Administration (FDA).
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Fast track is a procedure that speeds up the development and review of medicines that cure severe illnesses or meet an unmet medical need. The goal is to deliver critical new medicines to patients sooner. Filling an unmet medical need is described as delivering a therapy where none exists or offering a therapy that might be better than what is now provided. Once a medication is designated as Fast Track, the FDA and the drug firm are urged to communicate early and frequently throughout the drug development and review process.
Hugh S. Griffith, NuCana’s Founder and CEO commented,
They are delighted that the FDA sees Acelarin as having the potential to meet a substantial unmet need among patients with biliary tract cancer. In their Phase III project, they just revealed the inclusion of 418 evaluable patients, with the first interim analysis due in the first half of 2022. This might also pave the way for a fast approval of Acelarin’s new drug application (NDA) in the United States. They hope to work together with the FDA in their efforts to achieve approval for Acelarin which will be the first authorised front-line therapy option for patients with biliary tract cancer, now that they have both Fast Track and Orphan Drug designations.