NuCana (NASDAQ:NCNA) stock is surging higher on Wednesday after the company revealed fast track designation from the U.S. Food and Drug Administration (FDA) for Acelarin.
Acelarin is a treatment in development by NuCana for patients suffering from advanced biliary tract cancer. There’s currently a Phase III study underway that covers using it as a first-line treatment for this use.
So what does that mean for NCNA stock? Fast track designation is handed out by the FDA to treatments aiming at serious conditions or unmet medical needs. With it, the review process of a drug can go much fast, which means getting to market sooner.
Hugh Griffith, founder and CEO of NuCana, said this in the press release boosting NCNA stock higher today.
“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 the United States. 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.”
NCNA stock is seeing heavy trading on today’s FDA news. As of this writing, some 78 million shares have changed hands. For perspective, the company’s daily average trading volume is around 357,000 shares.
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On the date of publication, William White did not have (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.
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