By Sam Boughedda
Investing.com — Allarity Therapeutics Inc (NASDAQ:ALLR) closed its second day listed on the Nasdaq up 23% after submitting a New Drug Application (NDA) to the FDA for marketing approval of dovitinib — a third-line treatment of renal cell carcinoma, a type of cancer.
The Cambridge, Massachusetts-based company said the NDA is supported by its prior premarket approval submission for the use of Dovitinib-DRP.
“This NDA submission for dovitinib, in connection with the Dovitinib-DRP® companion diagnostic, is a historic milestone for our Company and an important step for late-stage renal cell carcinoma patients awaiting new treatment options," Allarity’s CEO Steve Carchedi said.
Allarity added that the drug has previously shown clinical activity in several other similar areas, including RCC, gastrointestinal stromal tumors, endometrial cancer, metastatic breast cancer, and hepatocellular carcinoma, and it expects to further assess the benefits of dovitinib in them.
"Over the past decade, we have worked diligently to advance our novel oncology therapeutics pipeline together with our unique DRP diagnostic technology to realize the promise of personalized cancer care for patients," added Carchedi.
Allarity closed up 6% on its first day of trading on the Nasdaq, after listing shares via a recapitalization share exchange with PIPE financing. It had previously traded in Stockholm.