Cerepro sitimagene ceradenovec regulatory update

EMEA's CHMP issued a negative opinion on an MAA from Ark Therapeutics for Cerepro sitimagene to treat operable malignant glioma. The committee said the results of the Phase III trial included in the MAA did not show that Cerepro was effective. The committee also said Cerepro was associated with an increased risk of hemiparesis and seizures. Thus, CHMP concluded that the benefits of Cerepro did not outweigh its risks. Ark said it intends to appeal. ...