London-based Ark Therapeutics' efforts to pioneer a gene-based brain cancer therapy in Europe hit a new hurdle today as European regulators demanded a new trial of Cerepro ahead of any approval. Ark pulled its marketing application, which had been rejected last December, and says it's considering selling the company.
An expert advisory panel for the European Medicines Agency decided at the end of last year that Cerepro failed to measure up to its efficacy standards. The therapy is Ark's lead program, and this new setback drove its shares down 15 percent, leaving the developer studying its options.
"Ark has initiated a full review of its substantial portfolio of assets, their potential and alternative strategies and options to optimise shareholder value," the company says in a statement. A number of approaches have been made to the company, it added, but there's no guarantee of an offer.
- here's the press release
- here's the story from Reuters