NEW YORK, December 30, 2025, 05:21 ET — Premarket
- PRAX closed up 13.25% at $304.58 on Monday after a new FDA designation; the stock was down about 1% in late trade.
- The FDA granted Breakthrough Therapy Designation for ulixacaltamide in essential tremor; Praxis reiterated plans to file an NDA in early 2026.
- BTIG raised its price target on PRAX to $843 from $507, according to The Fly.
Praxis Precision Medicines Inc shares rose 13.25% on Monday to close at $304.58, after the U.S. Food and Drug Administration granted Breakthrough Therapy Designation for its essential tremor candidate ulixacaltamide, a filing showed. The stock opened at $317.72 and traded between $298 and $317.72, and was down about 1% in after-hours trading.
Breakthrough Therapy Designation is an FDA pathway meant to speed development and review for drugs aimed at serious conditions when early clinical evidence suggests a meaningful step up over available therapies. For traders, it often serves as a signal that a program is moving from “data” toward an actual approval filing. U.S. Food and Drug Administration
Praxis said the designation keeps it on track to file a New Drug Application, or NDA — the marketing application needed to seek U.S. approval — in early 2026. “We are diligently preparing for the filing of the ulixacaltamide NDA, which we expect in early 2026,” Chief Executive Officer Marcio Souza said. The company said essential tremor affects about 7 million people in the United States and that propranolol is the only approved drug therapy, with many patients going untreated due to limits in current options. GlobeNewswire
In its SEC filing, Praxis said the FDA’s decision was based on positive topline results from its Essential3 program, which included two Phase 3 studies — late-stage trials typically required before a company seeks approval. Phase 3 results and the timing of an NDA submission are the two datapoints investors tend to trade hardest in development-stage biotech.
BTIG raised its price target on Praxis to $843 from $507 and reiterated a buy rating, The Fly reported on Monday.
The move came even as biotech was soft early Tuesday, with the SPDR S&P Biotech ETF down about 1.2% and the iShares Nasdaq Biotechnology ETF down about 0.7% in premarket indications.
The next catalyst investors are watching is straightforward: the NDA filing itself and any color on timing once the company turns in its application. After that, traders typically focus on whether the FDA accepts the filing for review and what kind of review track the agency assigns.
Investors are also watching whether the stock can hold recent gains after Monday’s gap-up move, with technical traders paying attention to whether momentum carries the shares back toward the session high.
Praxis last raised significant capital in October, when it announced an offering expected to generate about $567 million in net proceeds and said it believed the proceeds and existing cash would fund operations into 2028.
