Abliva - IND approved by the FDA, preparing for Ph II/III
With the investigational new drug (IND) application approved by the FDA, Abliva is getting ready for the pivotal Phase II/III trial for its lead drug candidate KL1333, NAD+ modulator expected to increase cellular energy production in primary mitochondrial disorder (PMD) patients. Phase Ia/b data with first findings from treating patients were published in 2021. Abliva is now focused on finalising the regulatory approvals in other countries. Another major focus for the management is to establish funding for the Phase II/III study, which should start sometime in 2022. The recently announced planned convertible loan should provide bridge funding until then. Our valuation is little changed at SEK1.25bn or SEK3.11/share.NeuroVive Pharmaceutical is engaged in the conducting research and development into pharmaceuticals that protect the mitochondria and pharmaceuticals to promote more effective mitochondrial function. The drug development technology platform is cyclosporine A, versions of cyclosporine, and molecules with a similar structure, which together, constitute a new class of pharmaceutical called cyclophilin inhibitors. The project portfolio also includes drug candidates for cellular energy regulation.
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