Baird reiterates Outperform rating on AVEO Pharmaceuticals as European regulators seeking TIVO-3 OS update

Analysts at Baird remained optimistic about AVEO Pharmaceuticals Inc (NASDAQ:AVEO) Wednesday after the company disclosed the European Medicines Agency (EMA) wanted to see topline data results from the Phase 3 TIVO-3 trial of its cancer drug tivozanib, which is sold under the brand name Fotivda.  

Baird senior analyst Madhu S Kumar wrote in a note to clients that the EMA request is “entirely reasonable” and “expected” as part of the regulator’s post-marketing authorization requirements following Fotivda’s approval as a treatment for advanced renal cell carcinoma, or kidney cancer in Europe.

“We have greater optimism than Street consensus around TIVO-3′s potential to have an improvement in the 4Q19 interim analysis of overall survival based upon a series of proprietary statistical analyses performed on the results to date,” wrote Kumar in a note to clients.

READ: AVEO Pharmaceuticals’ Phase 3 trial of tivozanib in renal cell carcinoma meets primary endpoint

“Taken as a whole, we reiterate our AVEO Outperform rating and $2 price target ahead of the 4Q19 interim OS analysis in TIVO-3.”

In August 2017, the European Commission granted marketing authorization for tivozanib to AVEO Pharmaceuticals’ licensee EUSA Pharma (UK) Limited.

Tivozanib or Fotivda, is an oral, once-daily, tyrosine kinase inhibitor approved for the treatment of adult patients with advanced renal cell carcinoma in the European Union plus Norway and Iceland.

The sticking point right now pertains to post-market data requested by a committee belonging to the EMA from the Phase 3 TIVO-3 study which was the primary data source supporting drug approval.

Specifically, the committee wants to see an analysis to explain the discordance between the final progression-free survival (PFS) results and preliminary overall survival (OS) results.

It wants to see more rounded OS data before drawing a conclusion and has agreed to an additional interim analysis in August.

AVEO stock fell 14.6% to $1.35 in afternoon trading.

READ: AVEO Pharmaceuticals stock rockets on positive results on leukemia drug

“Similar to the Food and Drug Administration (FDA), the Committee for Medicinal Products for Human Use accepted the proposal to conduct an additional interim overall survival analysis in August 2019,” the company disclosed in a Form 8-K filing.

“The CHMP further provided that regulatory action should be considered if the August 2019 interim OS analysis confirms a negative trend in OS,” it added in the filing.

Cambridge, Massachusetts-based AVEO is a biotech dedicated to advancing a broad portfolio of targeted medicines for oncology and other areas of unmet medical need.

The company’s strategy is to retain North American rights to its oncology portfolio while securing partners in development and commercialization outside of North America.

Contact Uttara Choudhury at [email protected]

Follow her on Twitter: @UttaraProactive 

Story by ProactiveInvestors