ARK fails to get MAA for Cerepro
Today Ark released the negative opinion of EMEA for it's crucial Cerepro- drug.
cerepro
Ark Therapeutics gets approval for named patients use in Finland
Ark Therapeutics, an Anglo-Finnish company announced that its was granted a permission to supply it's gene therapy drug Cerepro to named patients in Finland. Previously the company had obtained a similar approval for named patients in France after a submission by a local neurosurgeon.
Ark is expected to receive MAA decision from EMEA later this year and possibly become a first company to market gene therapy drugs in EU:
France Gives First Approval For Named Patient Supply Of Cerepro(R)
Ark Therapeutics Group plc ("Ark" or the "Company") (AKT:LSE) today announces that the first Named Patient Supply (NPS) for Cerepro® has been approved by the French Medicines Control Agency (AFSSAPS) following a 'nominative' ATU application (Autorisation Temporaire d'Utilisation) made by a neuro-surgeon in France. Cerepro® (sitimagene ceradenovec), Ark's novel gene-based medicine, is being developed as an Orphan Drug for the treatment of operable malignant glioma.
