Poxel: share price rises following orphan drug designation
At around 11:15 a.m., the stock was up 5.8%, while the Mid & Small index was down 0.6% at the same time.
In a press release issued this morning, the biopharmaceutical company announced that Brussels had granted orphan drug designation (ODD) to PXL770 and PXL065 for the treatment of adrenoleukodystrophy (ALD).
This decision follows a positive opinion already given by the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA).
For the record, the US Food and Drug Administration (FDA) had previously granted PXL770 and PXL065 'orphan drug' (ODD) status and a 'fast track' review procedure in the treatment of ALD.
Two Phase IIa proof-of-concept (POC) clinical trials for PXL770 and PXL065 are ready to be launched in ALD patients with adrenomyeloneuropathy (AMN), but Poxel specifies that their launch is conditional on additional funding.
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