ALLR - Allarity sinks after regulatory setbacks in U.S. for cancer drug

Allarity Therapeutics (ALLR -31.0%), a clinical-stage biopharmaceutical company, is trading sharply lower in morning hours on Tuesday after announcing a regulatory setback in the U.S. for its experimental therapy dovitinib and DRP-Dovitinib companion diagnostic. The U.S. Food and Drug Administration (FDA) issued Refusal to File (“RTF”) letters as regards the company’s new drug application (“NDA”) for dovitinib and the pre-market approval (“PMA”) application for the DRP-Dovitinib companion diagnostic, the company disclosed Friday. While the FDA indicated that a conclusion on NDA could not be based on the data in the application, the RTFs also apply to the companion diagnostic as both were filed as related submissions targeted as a third-line option for metastatic renal cell carcinoma. While Allarity (NASDAQ:ALLR) thinks that a new prospective clinical trial would be enough to resolve the issues, the company plans to seek further regulatory guidance to respond to the outstanding objections, including a potential

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Allarity sinks after regulatory setbacks in U.S. for cancer drug