Pharnext to conduct additional late-stage study

The FDA has recommended Pharnext SA (OTCPK:PNEXF) to conduct an additional Phase 3 study to evaluate PXT3003 in Charcot-Marie-Tooth Disease Type 1A (“CMT1A”).

In U.S., Pharnext completed its discussions with the FDA concerning the positive results of its Phase 3 PLEO-CMT study, in which the high dose arm was prematurely stopped due to an unexpected intercurrent formulation event.

Because of this event, the FDA advised that Pharnext run an additional Phase 3 study to ultimately support a NDA for PXT3003 in CMT1A.

The expected calendar of the filing of the dossier for a marketing authorization will be updated accordingly.

Pharnext’s PXT3003 is a novel oral fixed-dose combination of baclofen, naltrexone and sorbitol.

https://seekingalpha.com/news/3495953-pharnext-conduct-additional-late-stage-study-pxt3003-cmt1a