HCW ups AVEO Pharma PT to $9 from $6.50

H.C. Wainwright raised its price target for AVEO Pharmaceuticals (NASDAQ:AVEO) to $9 from $6.50 after the company reported positive top line results from its Phase 3 TIVO-3 study, evaluating tivozanib for the treatment of refractory renal cell carcinoma (RCC). The stock closed at $2.54 on Nov. 5.

According to management, patients treated with tivozanib achieved a median progression free survival (PFS) of 5.6 months, compared with 3.9 months for patients treated with Bayer’s Nexavar (sorafenib), which represents a 44% improvement.

Patients treated with tivozanib also achieved an 18% objective response rate (ORR), compared with 8% for sorafenib. A preliminary analysis has failed to show differences in overall survival (OS), as only 46% of potential OS events having been reported.

“In our view, the positive PFS and ORR results from TIVO-3, combined with the results of the previous TIVO-1 study, should be sufficient to convince the FDA to approve tivozanib for the treatment of both first-line and third-line RCC,” writes analyst Swayampakula Ramakanth.

He said that according to management, the company has been working on a NDA since January and is prepared to submit it for FDA approval within the next six months.

The company also plans to build out a commercial team, including 70 direct sales agents, to independently market tivozanib in the U.S., with an expected launch in the second quarter of 2020, he added.

Sign up for the BioTuesdays weekly newsletter

Get the latest news on the healthcare industry’s corporate and clinical developments, executive moves, and market updates. Every Tuesday, in your inbox.