Pharnext moves production of its pending drug PXT303 to the United States

(AOF) – Pharnext, a biotech company developing new treatments for neurodegenerative diseases without satisfactory therapeutic solutions, today announced that it has successfully moved the manufacture of PXT3003, its drug for Charcot-Marie-Tooth disease type 1A (CMT1A), to Unither Pharmaceuticals’ U.S. plant in Rochester, New York, from Unither’s plant in Colomiers (Haute-Garonne, France).

With increased production capacity for PXT3003 oral solution, Pharnext can now manufacture 3,500-liter batches, which could be compatible with a commercial distribution chain for this product. On the same day, the biotech announced the issue of 100 bonds convertible into shares (the “OCA”) with a nominal value of 10,000 euros each, for a total amount of one million euros.

If the results of the pivotal Phase III clinical study of PXT3003 are positive in the fourth quarter of 2023 and lead to the granting of marketing authorization (MA) in Europe and the United States, the drug would be marketed in the form of a 5 mL single-dose oral solution sachet to be kept in the cold chain.

Production of single-dose sachets of PXT3003 for the PREMIER trial is currently being maintained at the Unither Colomiers production site in France.