News & Events zu Praxis Precision Medicines Inc (PRAX)PRAXPraxis Precision Medicines Inc

Marcio Souza: Company Makes Significant Progress Towards Multi-Product Commercialization

"This quarter reflected meaningful progress toward becoming a multi-product commercial company, with both ulixacaltamide and relutrigine advancing closer to patients through ongoing constructive dialogue with the FDA with positive mid-cycle meetings and BIMO sponsor inspections completed for both programs. We have also taken significant steps in launch preparations: our commercial leadership is in place, we are standing up our state-of-the-art commercial systems, and the momentum is tangible with field force hiring well under way," said Marcio Souza, president and chief executive officer. "Across the rest of our portfolio, the Breakthrough Therapy Designation for elsunersen, our third in twelve months, further validates our position as a leader in CNS disease, our Solidus ASO platform for treating devastating CNS disorders and the depth of our CNS therapeutic development engine. Lastly, we're excited to be continuing the POWER2 study with renewed conviction, informed by what we learned in POWER1, as we work to transform care for patients with focal epilepsy with vormatrigine."

Praxis Collaborates with Remagine Labs to Develop Drug Patch

Praxis Precision and Remagine Labs announced a research collaboration and license agreement to develop an iontophoretic transdermal patch for the delivery of ulixacaltamide, Praxis's highly selective T-type calcium channel inhibitor in development for essential tremor. Under the agreement, Praxis and Remagine will collaborate to apply Remagine's platform, designed for precise, multi-day active transdermal dosing, to ulixacaltamide, complementing Praxis's oral program. Praxis has also made an equity investment in Remagine Labs.

Praxis Precision Receives FDA BTD for elsunersen

Praxis Precision announced that the FDA has granted BTD for elsunersen, an antisense oligonucleotide for the treatment of seizures associated with SCN2A Developmental and Epileptic Encephalopathy caused by Gain of Function variants in SCN2A.