Pharnext planning U.S, EU submissions for Charcot-Marie-Tooth therapy on Phase III data

Pharnext S.A. (Euronext:ALPHA) plans to submit regulatory applications to FDA and EMA in 2H19 for PXT3003 to treat mild to moderate Charcot-Marie-Tooth 1A (CMT1A) disease after a high dose of the compound met the primary endpoint of improving patient disability in the Phase III PLEO-CMT trial in the indication.

In June, China's National Medical Products Administration (NMPA) granted Priority Review to an NDA for PXT3003 to treat CMT1A. The product is an oral solution of baclofen, naltrexone and sorbitol (see "Priority Review in China for Pharnext's PXT3003")...