The U.S. Securities and Exchange Commission has issued Boston based Allarity Therapeuticswith a Wells Notice over alleged violations of federal securities law, the Boston-based biotech announced in a business update on Monday. A Wells Notice says 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. It is not a formal charge of wrongdoing

Dovitinib is an investigational small molecule pan-tyrosine kinase inhibitor that Allarity licensed from Novartis. In December 2021, it filed for dovitinib, proposing it as a treatment for metastatic renal cell carcinoma (mRCC). However, in February 2022, the FDA  said that Allarity’s application was “not sufficiently complete to permit substantive reviews.”

Allarity met the FDA to discuss the regulator’s decision. 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 it decided to test dovitinib as part of combination regimens, particularly with its new PARP inhibitor stenoparib. In 2024 Allarity announced that it wouldeliminate combiuntion treatments and instead solely focus on stenoparib in advanced recurrent ovarian cancer.

Jeff Newman represents whistleblowers nationwide relating to Medicare and Medicaid fraud, under the state and federal False Claims Act (Qui Tam) laws. He also represents whistleblowers in major claims under the SEC, CFTC and FINCEN whistleblower programs and can be reached at Jeff@JeffNewmanLaw.com or at 617-823-3217