Now that Aveo's share price has been badly mauled in the aftershock of an FDA panel vote rejecting its kidney cancer drug tivozanib, the class action suits are starting to pile up at the front door.
The committee voted 13 to 1 against Aveo, deciding that the biotech had not produced the needed efficacy data in a single pivotal study. And given the harsh assessment of Aveo from top FDA officials, this is one vote that is not likely to be overturned inside the agency.
Regulators at the FDA have weighed the data for Aveo's tivozanib, raising a simple question that could prove vexing for the biotech: Should another clinical trial be required before the agency delivers its verdict on the cancer drug, given that alternative treatments are available?
The company's CEO says that 45 staffers are being pink slipped--17% of the workforce--while another 30 open positions will not be filled. The move should save some $100 million over three years.
Aveo Oncology gave investors the jitters Thursday, revealing an issue in survival data from a pivotal trial for its lead cancer drug tivozanib. The experimental treatment fared worse than Onyx Pharmaceuticals ($ONXX) and Bayer's Nexavar in an early assessment of overall survival (OS), and Aveo has decided to probe the issue before it asks the FDA for approval of tivozanib.
Bayer looks to secure blockbuster status for regorafenib; J&J demonstrated impressive results among pre-chemo prostate cancer patients; Aveo raises the flag for tivozanib; Seattle Genetics plans to look at new indications for Adcetris.
The avalanche of ASCO abstracts last night triggered a flurry of news reports about the most notable new data on experimental therapies to be revealed ahead of next month's big meeting in Chicago.
Aveo's share price slid a modest 30 cents, or 2.53%, to $11.77, as of 10:30 a.m. ET Wednesday.
Thousands of experimental meds are winding their way through various stages of clinical trials today, and the largest category among the contenders is cancer drugs.
The fast-growing developer tells The Boston Globe that it plans to hire 120 new staffers this year in preparation for the likely upcoming launch of tivozanib.