Allarity Therapeutics announced Monday that the Securities and Exchange Commission has made a preliminary determination recommending an enforcement action against the company for alleged violations of federal securities laws.
The U.S. Securities and Exchange Commission has slapped Allarity Therapeutics with a Wells Notice over alleged violations of federal securities law, the Boston-based biotech announced in a business update on Monday.
The Wells Notice—a document that the Securities and Exchange Commission (SEC) issues informing companies and people of an upcoming enforcement action—is related to certain “disclosures” in connection with FDA meetings for Allarity’s investigational drug dovitinib or dovitinib-DRP, being developed for cancer indications.
Allarity did not reveal the exact nature of its alleged infringements. However, the company indicated in its business update that the conduct flagged by the Wells Notice occurred during or prior to fiscal year 2022.
“A Wells Notice is neither a formal charge of wrongdoing nor a final determination that the recipient has violated any law,” Allarity emphasized in its announcement. The company stated that the notice only lets the biotech know that staff of the SEC have made a “preliminary determination” of an infringement and will recommend that the SEC take enforcement action.
Three former officers of Allarity were also served Wells Notices in relation to the same issue.
Allarity “is continuing to cooperate with the SEC and maintains that its actions were appropriate,” the company announced, and “intends to pursue the Wells Notice process, including submitting a formal response to the SEC.”
Dovitinib is an investigational small molecule pan-tyrosine kinase inhibitor that Allarity in-licensed from Novartis. In December 2021, the biotech filed a New Drug Application for dovitinib, proposing it as a third-line treatment for metastatic renal cell carcinoma (mRCC). However, in February 2022, the FDA responded with a Refusal to File Letter, stating that Allarity’s application was “not sufficiently complete to permit substantive reviews.”
Allarity sought a meeting with the FDA to discuss the regulator’s decision and announced the results in August 2022. According to the regulator, Allarity would need to run another dosing study before conducting another Phase III trial that, in turn, would open the path for a resubmission.
These FDA requirements would “increase the cost, time, and market risks of advancing dovitinib as a monotherapy in the increasingly competitive indication of third-line mRCC,” Allarity said at the time. As a result, the company pivoted its development strategy to test dovitinib as part of combination regimens, particularly with its new PARP inhibitor stenoparib.
In March 2024, Allarity announced that it would eliminate the combination treatments and instead solely focus on stenoparib in advanced recurrent ovarian cancer.
