NEW YORK, December 30, 2025, 14:54 ET — Regular session
- PRAX shares fell about 3% in afternoon trade after Monday’s surge on FDA news
- FDA granted Breakthrough Therapy Designation for ulixacaltamide in essential tremor
- Analysts lifted price targets as investors focus on the next FDA filing milestone
Shares of Praxis Precision Medicines Inc (NASDAQ: PRAX) slipped about 3% on Tuesday, giving back part of a sharp rally sparked by an FDA regulatory boost for its lead essential tremor program. The stock was down 3% at $295.50 as of 2:39 p.m. ET, after opening at $304.00 and trading between $286.58 and $304.70.
The company said on Monday the U.S. Food and Drug Administration granted Breakthrough Therapy Designation for ulixacaltamide to treat essential tremor, and said the decision was based on positive topline results from the Essential3 program, two Phase 3, or late-stage, studies. Breakthrough Therapy Designation is reserved for drugs that target serious conditions and show early signs they may improve meaningfully over available therapies, a status that can speed development and regulatory review. SEC
For investors, the label adds regulatory momentum ahead of a planned New Drug Application, the filing that asks the FDA to approve a medicine for sale. Praxis said it expects to submit the ulixacaltamide application in early 2026 following a recently completed pre-NDA meeting with the agency, and described ulixacaltamide as a selective inhibitor of T-type calcium channels. The company estimates about seven million people in the United States live with essential tremor and said propranolol is the only approved drug, with limited efficacy and tolerability. GlobeNewswire
Jefferies analyst Andrew Tsai called the breakthrough tag “notable FDA validation” and raised his estimated odds of success for ulixacaltamide to 80%-90% from about 70%, according to TipRanks. Jefferies has a Buy rating and a $450 price target on Praxis shares, the report said. markets.businessinsider.com
BTIG also raised its price target to $843 from $507 and reiterated a Buy rating, Benzinga reported, after Praxis shares closed at $268.95 on Friday. The wide spread in targets underscores how much of the bull case rests on execution and FDA timing. Benzinga
The stock jumped about 14% on Monday as traders priced in the regulatory milestone, TipRanks data published by Markets Insider showed. Tuesday’s pullback pushed the shares below that early-week peak as some investors locked in gains. markets.businessinsider.com
Breakthrough Therapy Designation does not guarantee approval, but it often increases the pace of interaction between drugmakers and regulators as an application comes together. For Praxis, the next major swing factor is the NDA submission itself and whether the FDA accepts it for review.
Investors are watching for signs the filing stays on track, and for any details on manufacturing readiness and the scope of the proposed label. Any request for additional studies or tighter safety monitoring language could move timelines.
The FDA label also re-focuses attention on the treatment gap in essential tremor, where many patients cycle through older medicines or remain untreated. That commercial opportunity is a key part of the upside case that analysts are trying to model.
Trading in Praxis has been driven by regulatory milestones and analyst reassessments rather than near-term revenue, as the company remains in the development stage. That setup can amplify moves in either direction when new information hits the tape.
From here, investors will look for any deeper read-through on the Essential3 data package, and for more color on the agency’s review path once the NDA lands. Until then, the stock is likely to remain headline-sensitive.
