Allarity Therapeutics Inc (NASDAQ:ALLR) has submitted a marketing application to the FDA seeking approval for dovitinib for the third-line treatment of renal cell carcinoma (RCC) patients.
- The Company's NDA filing is supported by its prior pre-market approval (PMA) submission with the FDA for using Dovitinib-DRP, the Company's validated companion diagnostic for the drug, to select and treat RCC patients most likely to respond to dovitinib.
- The submission marks Allarity's first regulatory application for marketing approval.
- Related content: Benzinga's Full FDA Calendar.
- Dovitinib is a small molecule, pan-tyrosine kinase inhibitor in-licensed from Novartis AG (NYSE:NVS) and is Allarity's most advanced clinical therapeutic candidate.
- Yesterday, Allarity closed its Recapitalization Share Exchange resulting in its initial public listing of 8.07 million shares and listing on the NASDAQ under the trading symbol "ALLR."
- Simultaneously, the Company closed on a $20 million PIPE investment.
- The Company issued 20,000 shares of preferred stock at $1,000 per share and a common stock purchase warrant to purchase 2.02 million shares to 3i, LP, a Delaware limited partnership.
- Price Action: ALLR shares are up 27.4% at $13.38 during the market session on the last check Wednesday.
