Qualigen Therapeutics slumps on FDA setback for covid candidate

US biotech Qualigen Therapeutics’ (Nasdaq: QLGN) shares tumbled more than 22% to $1.30 yesterday, after it announced its intention to prioritize its focus to its oncology pipeline that includes QN-247 and RAS-F.

These plans follow feedback the company received from the US Food and Drug Administration regarding Qualigen’s investigational new drug (IND) application for one of its other compounds, QN-165, for the treatment of COVID-19 in hospitalized patients.

“Although the FDA requested that we perform additional pre-clinical toxicity and safety pharmacology studies before proceeding with clinical trials in COVID-19 patients, we believe that, given the time horizon which these suggested studies would require, coupled with the already very crowded COVID-19 vaccine and therapeutic landscape, the best and most prudent strategy for us at this time is to pivot to focusing primarily on our oncology pipeline that includes QN-247 and RAS-F assets for which we have already seen encouraging pre-clinical data,” commented Michael Poirier, Qualigen’s chairman and chief executive.