Aveo Oncology (AVEO) announced that the U.S. Food and Drug Administration approved the New Drug Application (NDA) for its tivozanib used for the treatment of kidney cancer.
Tivozanib is the company’s next-generation vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI) targeted for the treatment of relapsed or refractory renal cell carcinoma (RCC). The FDA has assigned the application standard review and a Prescription Drug User Fee Act target deadline date of March 31, 2021.
“The acceptance of our NDA filing marks yet another important milestone for AVEO, as we pursue our goal of providing RCC patients whose disease has relapsed or become refractory to multiple lines of therapy with a meaningful new treatment option,” said Aveo President and CEO Michael Bailey. “In parallel, we continue to focus on commercial-readiness to ensure we are well positioned to support the potential launch of tivozanib, subject to approval.”
In a separate statement, Aveo disclosed that the TIVO-3 trial met the primary endpoint of progression free survival and the secondary endpoint of overall response rate and was generally found to be well tolerated. Tivozanib has been tested in several tumor types, including colorectal, ovarian and breast cancers.
However, the company said that the FDA indicated that it did not currently plan on convening an Oncologic Drug Advisory Committee (ODAC) to discuss the application.
Commenting on the news, Swayampakula Ramakanth, an analyst at H.C. Wainwright said he expects the FDA to review the application, and if accepted, then a positive opinion would be an “inflection point for the stock”.
Shares in Aveo, which plunged to a multi-year low in March have since seen their value almost triple. The stock fell 6% to $7.67 as of the close on Monday.
Aveo’s announcement prompted Ramakanth to raise his price target on the stock to $12 from $10, and maintain a Buy rating, saying that he is encouraged by the overall results, which have removed the last hurdle for the NDA filing for tivozanib as a treatment for relapsed or refractory (r/r) RCC.
“Given that TIVO-3 study met both the primary endpoint of progression free survival (PFS) and the secondary endpoint of overall response rate (ORR), we anticipate an acceptance of tivozanib’s NDA, which is expected imminently at the end of the 60-day regulatory clock,” Ramakanth wrote in a note to investors. “As a result, we are increasing the probability of launch of tivozanib for treatment of r/r RCC to reflect the reduced regulatory risk.”
Looking at the rest of Wall Street ratings, the stock scores only Buy recommendations leading up to a Strong Buy consensus. The bullish $20.67 average price target indicates a stellar 169% upside potential in the shares in the coming 12 months. (See Aveo stock analysis on TipRanks).
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