By Chris Wack
Allarity Therapeutics Inc. shares fell 33% to $4.43 after the company said late Friday the U.S. Food and Drug Administration provided it with Refusal to File letters regarding a new drug application for dovitinib for third-line treatment of metastatic renal cell carcinoma.
The refusal also covers an accompanying pre-market approval application for the DRP-Dovitinib companion diagnostic, the company said.
Allarity said that the FDA determined that the NDA, submitted Dec. 22, 2021, and the PMA application, submitted April 2, 2021, weren't sufficiently complete to permit substantive reviews.
The FDA's refusal to file decision primarily involves submitted clinical trial data that don't enable a conclusion of efficacy based on non-inferiority data set, Allarity said. Because the PMA and NDA were filed as related applications, the RTFs also apply to the DRP-Dovitinib companion diagnostic, the company said.
Allarity said it intends to seek immediate guidance from the FDA, which may include requesting a Type A meeting with the agency to clarify and respond to the issues identified in the RTF letters, and seek additional guidance concerning information, data, and specific deliverables that the agency would require for a resubmitted NDA and PMA to be deemed complete.
The company said it expects a new prospective clinical trial would be required to overcome the FDA's outstanding objections.
Write to Chris Wack at email@example.com
(END) Dow Jones Newswires
February 22, 2022 10:42 ET (15:42 GMT)Copyright (c) 2022 Dow Jones & Company, Inc.