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.
WELCOME BONUS - Free Share Bundle When You Invest £50!
Open a UK Investment Account: Shares, ISAs, Managed Portfolio
Invest in 15,000+ shares and ETFs. Open an account now, invest at least £50, and you’ll get a free share bundle worth between £40 and £200. T&Cs apply.
IG
View Offers
Empfohlener Broker
Multi Asset Platform
“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.
Should You Invest in NuCana Shares?
One of the most frequently asked questions we receive is, “what stocks are best to buy right now?” It’s a wide-ranging question, but one that we have answered… Our AskTraders stock analysts regularly review the market and compile a list of which companies you should be adding to your portfolio, including short and longer-term positions. Here are the best stocks to buy right now