(News Bulletin 247) – Poxel stock recorded one of the strongest rises in the CAC Mid & Small index on Wednesday after obtaining orphan drug designation from the European Commission for the treatment of adrenoleukodystrophy, a neurodegenerative disease.
Around 11:15 am, the title gained 5.8% while the Mid & Small index fell back at the same time by 0.6%.
In a press release published in the 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 favorable opinion already issued by the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA).
As a reminder, the United States Food and Drug Administration (FDA) had previously granted PXL770 and PXL065 ‘orphan drug’ (ODD) status and a ‘fast track’ accelerated review procedure in the treatment of ALD.
Two phase IIa proof-of-concept (POC) clinical studies 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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