Pharnext unscrews on the stock exchange after the cold shower of the Fda (Photo credits: Adobe Stock -)
(CercleFinance.com) – Pharnext unscrews 24% after announcement that the US FDA has recommended the biopharmaceutical company to conduct an additional Phase 3 clinical trial for PXT3003 in Charcot-Marie-Tooth's disease. type 1A (CMT1A).
The FDA has acknowledged that this disease has a significant medical need, having granted the 'Fast Track' designation to PXT3003 in February 2019. The prospective schedule for filing the registration dossier in the United States will subsequently be adapted accordingly.
In parallel, Pharnext continues its PXT3003 development program in CMT1A in Europe and China. It is actively pursuing its efforts to make progress in the registration process in Europe.