Amsterdam Molecular falls as CHMP rebuffs Glybera
Amsterdam Molecular Therapeutics Holding N.V. (Euronext:AMT) fell EUR 1.32 (67%) to EUR 0.64 on Friday after EMA's CHMP recommended against approval of Glybera to treat lipoprotein lipase (LPL) deficiency. Amsterdam Molecular said it will ask for re-examination after the committee concluded that studies had not shown a consistent long-lasting benefit of the AAV vector encoding the LPL gene. The biotech plans to generate additional data from existing patients for CHMP to review.
The agency also issued a negative opinion for Luveniq voclosporin from Lux Biosciences Inc. (Jersey City, N.J.) to treat non-infectious uveitis in the intermediate or posterior segments of the eye. CHMP was concerned that the one main trial supporting the MAA did not show in a "robust way" that Luveniq was more effective than placebo. Lux has rights for ophthalmic indications from Isotechnika Pharma Inc. (TSX:ISA), which was off C$0.02 (10%) to C$0.18. ...