In addition to a flurry of investor lawsuits spawned by the FDA's slap-down of its marketing application for the kidney cancer drug tivozanib, Aveo Pharmaceuticals now has an SEC inquiry on its hands. The biotech revealed on Thursday that it had received a subpoena from the SEC 8 days ago demanding "documents and information" on the drug.
Days after the Cambridge, MA-based biotech whacked close to two thirds of its staff as it scrambled to stay afloat in the wake of a scathing regulatory assessment of its lead drug, the developer says that the FDA has handed over the expected rejection notice for tivozanib as a treatment for kidney cancer.
After starting to gut most of its staff this week, Aveo Oncology has started down a longer path to potential approval of its top drug candidate tivozanib, for which the company no longer plans to develop for kidney cancer.
Staring straight at an almost certain FDA rejection for its kidney cancer drug tivozanib, Cambridge, MA-based Aveo Oncology today grabbed the budget ax and hacked deep into its staff. A total of 140 workers are being laid off--62% of its workforce--and the biotech's COO is joining the exodus in July.
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.