AVEO Oncology (AVEO - Free Report) received a major setback as it had to delay its submission of a new drug application (“NDA”) seeking approval for its kidney cancer drug, Fotivda (tivozanib). The company decided not to submit a NDA in the United States after the FDA informed the company that it was not satisfied with the preliminary overall survival (“OS”) data reported along with the topline TIVO-3 study data on progression-free-survival in November 2018.
Shares of AVEO plunged 60.5% following the unfavorable news on Jan 31. The company’s shares have declined 66.5% in the past six months compared with the industry’s decline of 15.3%.
The phase III TIVO-3 study is evaluating Fotivda in highly refractory advanced or metastatic renal cell carcinoma (“RCC”) patients compared to Bayer AG’s (BAYRY - Free Report) Nexavar (sorafenib).
The FDA informed the company that the preliminary OS data was not sufficient to alleviate the concerns related to potential detriment in OS raised in the complete response issued earlier in 2013 for similar application. The FDA’s recommendation indicates that it required additional data for approving the drug.
Previously, the company intended to submit the NDA in the first half of 2019. The company did not provide an update on timeline for submission and stated that a filling will follow the availability of more mature OS results.
Earlier, AVEO had planned a final analysis of OS in August 2019. However, a longer-than-expected median OS and discussion with the FDA led the company to designate the analysis in August as interim. Data from this interim analysis will be available in the fourth quarter of 2019.
Moreover, the company stated that a group of patients were not included during preliminary OS analysis in November. However, including data from the group increased the hazard ratio or failure rate for OS analysis for the candidate by more than 5%.
We remind investors that Fotivda is approved for first-line treatment of advanced RCC in Europe. Moreover, AVEO is developing the candidate in combination with Bristol-Myers’ (BMY - Free Report) Opdivo for treating advanced RCC.
Zacks Rank & Stock to Consider
AVEO carries a Zacks Rank #3 (Hold). Galectin Therapeutics Inc. (GALT - Free Report) is a better-ranked stock in the healthcare space, sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Galectin’s loss estimates have narrowed from 44 cents to 38 cents for 2018 and from $1.12 to 98 cents for 2019 over the past 60 days. The company delivered a positive earnings surprise in all the last four quarters, with the average beat being 18.65%. Share price of the company has risen 24% in the past year.
More Stock News: This Is Bigger than the iPhone!
It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 27 billion devices in just 3 years, creating a $1.7 trillion market.
Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 6 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2020.
Click here for the 6 trades >>