Praxis Precision Medicines Announces the FDA Has Granted Breakthrough Therapy Designation for Ulixacaltamide HCl in Essential Tremor [Yahoo! Finance]
Praxis Precision Medicines, Inc. (PRAX)
Company Research
Source: Yahoo! Finance
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 to address the substantial unmet need in patients with ET. We recently completed a series of positive interactions with the FDA, that, together
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News
- Praxis Precision Medicines Announces the FDA Has Granted Breakthrough Therapy Designation for Ulixacaltamide HCl in Essential TremorGlobeNewswire
- 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