Calico receives EMA PRIME designation for VWM treatment fosigotifator
The designation follows US FDA Breakthrough Therapy status for the eIF2B activator targeting vanishing white matter, a rare disease with no approved therapies.
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Biotechnology company studying aging and developing potential therapies
calicolabs.comLast updated
In short: Calico received EMA PRIME designation for fosigotifator, its vanishing white matter treatment, after FDA Breakthrough Therapy status.
The designation follows US FDA Breakthrough Therapy status for the eIF2B activator targeting vanishing white matter, a rare disease with no approved therapies.
The designation is for treating Vanishing White Matter disease, based on early clinical evidence.
The designation was granted for ABBV-CLS-628, an anti-PAPP-A antibody developed with AbbVie, which also has Fast Track status and is in Phase 2.
ABBV-CLS-628, an anti-PAPP-A monoclonal antibody developed with AbbVie, is in Phase 2 trials for ADPKD.
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