Praxis Precision Medicines Announces the FDA Has Granted Breakthrough Therapy Designation for Ulixacaltamide HCl in Essential Tremor
Praxis Precision Medicines, Inc. (PRAX)
Company Research
Source: GlobeNewswire
The Breakthrough Therapy Designation was granted based on the positive topline results from the Essential3 Phase 3 program in essential tremor Praxis remains on track to submit ulixacaltamide NDA in early 2026 based on recently completed pre-NDA meeting with the FDA BOSTON, Dec. 29, 2025 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system (CNS) disorders characterized by neuronal excitation-inhibition imbalance, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for ulixacaltamide, a differentiated and highly selective small molecule inhibitor of T-type calcium channels, for the treatment of patients with essential tremor (ET). “The granting of the Breakthrough Therapy Designation for ulixacaltamide, based on the Essential3 program, further underscores its potential t
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News
- Praxis Precision Medicines Announces the FDA Has Granted Breakthrough Therapy Designation for Ulixacaltamide HCl in Essential Tremor [Yahoo! Finance]Yahoo! Finance
- Stocks making the biggest moves premarket: DigitalBridge, Praxis Precision Medicines, Coupang & more [CNBC]CNBC
- Praxis Precision Medicines (NASDAQ:PRAX) had its "buy" rating reaffirmed by analysts at BTIG Research.MarketBeat
- Has Praxis Precision Medicines Rally Gone Too Far or Is the Market Still Missing Something [Yahoo! Finance]Yahoo! Finance
- Praxis Precision Medicines (NASDAQ:PRAX) was given a new $750.00 price target on by analysts at UBS Group AG.MarketBeat
PRAX
Earnings
- 11/5/25 - Beat
PRAX
Sec Filings
- 12/29/25 - Form 8-K
- 12/11/25 - Form 8-K
- 12/8/25 - Form 8-K
- PRAX's page on the SEC website