Shares of AVEO Pharmaceuticals, Inc. (AVEO - Free Report) have plummeted 57.4% against the industry’s growth of 6.5% in the year so far.
AVEO faced a major setback when it had to delay the submission of a new drug application (NDA) for its vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI), Fotivda (tivozanib), for the first-line treatment of advanced renal cell carcinoma (RCC) in January. The company decided not to file an NDA in the United States after the FDA informed that it was not satisfied with the preliminary overall survival (OS) data reported along with the top-line results from the TIVO-3 study announced last November.
The phase III TIVO-3 program evaluated Fotivda in highly refractory advanced or metastatic RCC patients compared with Bayer AG’s (BAYRY - Free Report) Nexavar (sorafenib).
AVEO has planned for an additional interim OS analysis in August 2019, results of which are expected in the fourth quarter of 2019. Based on these mature OS results, the company will decide on the NDA filing following the FDA’s recommendation. Investors are keen to know the outcome of the same as a positive news might be able to pull the stock up, which has been down for a while now.
Notably, in August 2017, AVEO and its partner EUSA Pharma received approval from the European Commission for Fotivda for the first-line treatment of advanced RCC. The drug is already available in Germany, Spain, Austria and the United Kingdom. The company is focused on launching the medicine across various European countries as it receives royalties from Fotivda sales in the region.
Meanwhile, AVEO is evaluating Fotivda combined with Bristol-Myers’ (BMY - Free Report) Opdivo (an immune checkpoint PD-1 inhibitor) in a phase II study for the treatment of advanced RCC. The company is also examining the drug in a phase I/II probe coupled with AstraZeneca’s (AZN - Free Report) Imfinzi for treating first-line hepatocellular carcinoma.
Apart from Fotivda, AVEO has a promising candidate, ficlatuzumab, in its pipeline. The candidate is currently being evaluated in early-mid/stage studies for various oncological indications. In April, the company along with partner Biodesix, Inc. announced positive results from the phase Ib expansion cohort of ficlatuzumab combined with cytarabine in patients with relapsed and refractory acute myeloid leukemia (AML).
The company is also developing ficlatuzumab in combination with Lilly’s Erbitux in a phase II probe for treating metastatic head and neck squamous cell carcinoma. The candidate is also being evaluated in combination with nab-paclitaxel and gemcitabine for treating pancreatic cancer.
We believe the timely approval of Fotivda in the United States would have provided a huge boost to AVEO as the RCC market holds great potential. However, the string of setbacks the company is facing of late is a woe.
Moreover, the company is heavily dependent on its partners for the development and commercialization of its pipeline candidates. Failure to receive regulatory approvals or the termination of a deal from any of the partners would severely dent the company’s future prospects.
AVEO Pharmaceuticals, Inc. Price
AVEO currently carries a Zacks Rank #4 (Sell). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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