Praxis Precision Medicines Announces FDA Acceptance of New Drug Application for Ulixacaltamide HCl in Patients with Essential Tremor
Praxis Precision Medicines, Inc. (PRAX)
Company Research
Source: GlobeNewswire
FDA assigned PDUFA target action date of January 29, 2027 No advisory committee meeting expected BOSTON, April 14, 2026 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a fully integrated, leading central nervous system (CNS) precision neuroscience biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for ulixacaltamide HCl for the treatment of essential tremor (ET) in adults. The FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of January 29, 2027 and is not planning to hold an advisory committee meeting. “Today’s announcement brings us one step closer to delivering something patients living with essential tremor have been waiting for, a therapy developed specifically for their condition,” said Marcio Souza, president and chief executive officer. “We look forward to continuing to work with the FDA through the review process while we pr
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PRAX
News
- Praxis Precision Medicines (PRAX) had its "buy" rating reaffirmed by Deutsche Bank Aktiengesellschaft.MarketBeat
- Praxis Precision Medicines (PRAX) had its "buy" rating reaffirmed by Needham & Company LLC. They now have a $510.00 price target on the stock.MarketBeat
- Praxis to Showcase Essential3, the First Positive Phase 3 Program in Essential Tremor, at AAN 2026GlobeNewswire
- Praxis Precision Medicines (PRAX) was upgraded by Raymond James Financial, Inc. to "strong-buy".MarketBeat
- Praxis Precision Medicines (PRAX) is now covered by Raymond James Financial, Inc.. They set a "strong-buy" rating and a $815.00 price target on the stock.MarketBeat
PRAX
Earnings
- 2/19/26 - Miss
PRAX
Sec Filings
- 4/14/26 - Form 8-K
- 4/6/26 - Form 8-K
- 3/27/26 - Form SCHEDULE
- PRAX's page on the SEC website