FDA Grants Breakthrough Therapy Designation to Praxis Precision Medicines' Ulixacaltamide for Essential Tremor

Reuters12-29 21:00

FDA Grants Breakthrough Therapy Designation to <a href="https://laohu8.com/S/PRAX">Praxis Precision Medicines</a>' Ulixacaltamide for Essential Tremor

Praxis Precision Medicines Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to ulixacaltamide, its selective small molecule inhibitor of T-type calcium channels, for the treatment of essential tremor. The designation was based on positive topline results from the Essential3 Phase 3 program. Following a successful pre-NDA meeting and alignment with the FDA on the New Drug Application (NDA) content, Praxis expects to submit the NDA for ulixacaltamide in early 2026. The Breakthrough Therapy Designation is intended to expedite the development and review of drugs that may offer substantial improvement over existing therapies for serious conditions.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Praxis Precision Medicines Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9617591-en) on December 29, 2025, and is solely responsible for the information contained therein.

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The designation was based on positive topline results from the Essential3 Phase 3 program. Following a successful pre-NDA meeting and alignment with the FDA on the New Drug Application (NDA) content, Praxis expects to submit the NDA for ulixacaltamide in early 2026. The Breakthrough Therapy Designation is intended to expedite the development and review of drugs that may offer substantial improvement over existing therapies for serious conditions.\n      \n\n\nDisclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Praxis Precision Medicines Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. 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