AVEO Pharmaceuticals, Inc. (AVEO - Free Report) reported earnings of 10 cents per share in the third quarter of 2019, surpassing the Zacks Consensus Estimate of 1 cent. It also rebounded from the year-ago loss of 18 cents.
The company’s top line comprises collaboration and licensing revenues plus partnership royalties. Total revenues in the reported quarter were $25.7 million, up from $2.5 million in the year-ago period. Revenues also comprehensively beat the Zacks Consensus Estimate of $13 million.
Shares of AVEO were up 8.8% following the company’s earnings release on Nov 12. However, the stock has plunged 65% so far this year against the industry’s increase of 1.2%.
In August 2017, AVEO and partner EUSA Pharma received an approval from the European Commission of its VEGF tyrosine kinase inhibitor Fotivda (tivozanib) for the first-line treatment of advanced renal cell carcinoma (RCC). It is the first approved drug in the company’s portfolio. AVEO is focused on launching the medicine across Europe and other countries.
Research & development expenses were down 23.1% year over year to $4 million. However, general and administrative expenses increased 7.4% year over year to $2.9 million.
AVEO had around $57.7 million worth of cash, cash equivalents and marketable securities as of Sep 30, 2019 compared with $40.2 million on June 30, 2019. The company believes that this will help fund its planned operations through the second quarter of 2021.
In September 2019, AVEO announced updated data from the second prespecified analysis of overall survival (OS) in a late-stage TIVO-3 study on Fotivda. This randomized, open-label phase III study evaluated Fotivda for the treatment of patients with highly refractory metastatic renal cell carcinoma (RCC) compared with Bayer AG’s (BAYRY - Free Report) Nexavar (sorafenib).
These results include an OS hazard ratio of less than one that favors Fotivda.
Earlier this month, AVEO provided a regulatory update after a meeting with the FDA authorities to discuss OS results from the phase III TIVO-3 study to proceed with a New Drug Application (NDA) for Fotivda. The company plans to file an NDA for Fotivda in the first quarter of 2020 and expects to report results from the final OS analysis in June 2020.
However, during the review, if the final analysis yields an OS hazard ratio of more than 1, AVEO will withdraw its NDA for Fotivda.
Meanwhile, in September 2019, AVEO initiated enrollment in the Ib/II DEDUCTIVE study evaluating Fotivda in combination with AstraZeneca’s (AZN - Free Report) PD-L1 inhibitor Imfinzi (durvalumab) for the first-line treatment of patients with advanced unresectable hepatocellular carcinoma, who have not received prior systemic therapy.
AVEO is also evaluating Fotivda in combination with Bristol-Myers’ (BMY - Free Report) PD-1 inhibitor, Opdivo (nivolumab) in the Ib/II TiNivo study for the treatment of advanced or metastatic RCC.
Apart from Fotivda, AVEO has a promising candidate, ficlatuzumab, in its pipeline. It is currently being evaluated in early-mid/stage studies for various oncological indications. Last week, AVEO along with partner Biodesix, Inc initiated the phase II CyFi-2 study, which evaluated ficlatuzumab in combination with high-dose cytarabine versus high-dose cytarabine alone in patients with relapsed/refractory acute myeloid leukemia (AML).
AVEO Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
AVEO currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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