Ark pulls Cerepro MAA, seeks alternatives

Ark Therapeutics Group plc (LSE:AKT) withdrew an MAA for Cerepro sitimagene ceradenovec to treat operable malignant glioma and said it will review strategic alternatives. Ark said it is in discussions with "a number of parties" who have approached the company.

Ark said that during a re-examination procedure concerning the MAA, the European Medicines Agency (EMA) requested an additional clinical trial of Cerepro. The company had been appealing a negative opinion from EMA's CHMP (See BioCentury, Feb. 08, 2010). ...