Praxis Precision Medicines Announces Positive Pre-NDA Meeting with FDA for Ulixacaltamide in Essential Tremor
Praxis Precision Medicines, Inc. (PRAX)
Company Research
Source: GlobeNewswire
BOSTON, Dec. 04, 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 the successful completion of its pre-NDA (New Drug Application) meeting with the FDA, including receipt of written feedback and an in-person meeting. Praxis has gained alignment from the agency on the content of the NDA and expects to complete its NDA submission in early 2026. “We are very pleased with the collaborative discussions we recently had with the FDA and remain on track to submit Praxis’ first NDA in early 2026. Building on the strong momentum from the positive Essential3 program, where ulixacaltamide demonstrated statistically significant and clinically meaningful improvements in daily functioning, the FDA feedback moves us closer to delivering a much-needed the
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- How EMBOLD Efficacy Stop And Ulixacaltamide FDA Pathway At Praxis Precision Medicines (PRAX) Has Changed Its Investment Story [Yahoo! Finance]Yahoo! Finance
- Praxis Precision Medicines: Latest Study Wins Sets Up 2 CNS Drug Approvals In 2026 [Seeking Alpha]Seeking Alpha
- Top Midday Gainers [Yahoo! Finance]Yahoo! Finance
- Praxis Precision Medicines (NASDAQ:PRAX) was given a new $304.00 price target on by analysts at Needham & Company LLC.MarketBeat
- Praxis Precision Medicines (NASDAQ:PRAX) had its "overweight" rating reaffirmed by analysts at Piper Sandler.MarketBeat
PRAX
Earnings
- 11/5/25 - Beat
PRAX
Sec Filings
- 11/21/25 - Form 4
- 11/21/25 - Form 4
- 11/21/25 - Form 4
- PRAX's page on the SEC website