Aveo’s Tivozanib Gets FDA Approval for New Drug Application to Treat Kidney Cancer

Aveo Oncology (AVEO) announced that the United States Food and Drug Administration has 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 (VEGFR-TKI) tyrosine kinase inhibitor for the treatment of relapsed or refractory renal cell carcinoma (CRC). The FDA has assigned the standard review of the application and a target deadline for the Prescription Drug User Fee Act of March 31, 2021.

“The acceptance of our NDA dossier marks another important milestone for AVEO, as we continue our goal of providing RCC patients whose disease has relapsed or has become refractory to multiple lines of treatment with a meaningful new treatment option. Said Michael, President and CEO of Aveo. Bailey. “At the same time, we continue to focus on market readiness to ensure we are well positioned to support the potential launch of tivozanib, subject to approval. “

In a separate statement, Aveo revealed that the TIVO-3 trial met the primary endpoint of progression-free survival and the secondary endpoint of overall response rate and was generally well tolerated. Tivozanib has been tested in several types of tumors, including colorectal, ovarian and breast cancers.

However, the company said the FDA has indicated that it does not currently have plans to convene an Oncology Drug Advisory Committee (ODAC) to discuss the request.

Commenting on the news, Swayampakula Ramakanth, an analyst with HC Wainwright said he expects the FDA to consider the request, and if it is granted, a positive opinion would be a “inflection point for the stock.”

Shares of Aveo, which plunged to a multi-year low in March, have since seen their value nearly triple. The stock fell 6% to $ 7.67 at Monday’s close.

Aveo’s announcement prompted Ramakanth to raise his share price target to $ 12 from $ 10, and maintain a buy rating, saying he was encouraged by the overall results, which removed the final hurdle for NDA deposition for tivozanib as treatment of relapse or refractory (r / r) RCC.

“Since the TIVO-3 study met both the primary endpoint of progression-free survival (PFS) and the secondary endpoint of overall response rate (ORR), we anticipate acceptance of the tivozanib NDA, which is imminently expected in the late 1960s – regulatory clock of the day, ”Ramakanth wrote in a note to investors. “As a result, we are increasing the likelihood of initiating tivozanib for the treatment of r / r RCC to reflect the reduced regulatory risk. “

Looking at the rest of Wall Street ratings, the stock only notes buy recommendations leading to strong buy consensus. The bullish average of $ 20.67 price target indicates a stellar 169% upside potential in stocks over the next 12 months. (See the analysis of Aveo shares on TipRanks).

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