NEW YORK – Allarity Therapeutics on Friday said it received a notice from the US Securities and Exchange Commission warning of SEC enforcement action based on Allarity's alleged violations of federal securities laws.
In an 8-K form filed with the SEC July 19, Allarity said it had received a Wells Notice — which is not a formal charge or final determination — from SEC staff about this recommended enforcement action, which relates to disclosures Allarity made about its meetings with the US Food and Drug Administration regarding its drug candidate dovitinib and companion diagnostic Dovitinib-DRP.
Allarity, once called Oncology Venture, filed a new drug application with the FDA in 2021, in which it sought approval for the once-failed tyrosine kinase inhibitor dovitinib as treatment for advanced renal cell carcinoma patients selected using the Dovitinib-DRP test, which is based on gene expression, microarray, and cell-line data. The firm had also filed for premarket approval for the companion diagnostic earlier in 2021.
Several months later, the company announced that it received a Refusal to File letter from the FDA stating that both the new-drug and premarket approval applications were incomplete, and that it would need additional data to accept the applications. Allarity then scrapped its plans to seek approval for the drug in that indication altogether, and refocused its pipeline away from dovitinib.
Allarity said in its 8-K form that all of the conduct that the SEC takes issue with in the Wells Notice occurred before or during 2022. It also said that three former officers at Allarity received Wells Notices about the same conduct.
"The company is continuing to cooperate with the SEC and maintains that its actions were appropriate," Allarity said in the filing. The firm plans to submit a formal response to the SEC.