Shares of PaxMedica (NASDAQ:PXMD) shot up 110% in early trading after the biotech company said that it now expects to file its New Drug Application for PAX-101 in the second half of 2024.
The biotech company said it received constructive feedback at a recent type-B meeting with the FDA that will help it complete the application. It added that most of the work required for the NDA will focus on completing the production of commercial lots of PAX-101 under CMC regulatory guidelines, which it expects to complete in the first half of 2024.
PaxMedic is seeking to get the drug approved as a treatment for African Sleeping Sickness. The company is also developing it as a potential treatment for autism spectrum disorder, according to its website.
The sudden surged was later on accompanied by a consolidated move. With the Trend heading towards the bears zone
The biotech company said it received constructive feedback at a recent type-B meeting with the FDA that will help it complete the application. It added that most of the work required for the NDA will focus on completing the production of commercial lots of PAX-101 under CMC regulatory guidelines, which it expects to complete in the first half of 2024.
PaxMedic is seeking to get the drug approved as a treatment for African Sleeping Sickness. The company is also developing it as a potential treatment for autism spectrum disorder, according to its website.
The sudden surged was later on accompanied by a consolidated move. With the Trend heading towards the bears zone
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