On November 20, 2025, a short‑seller research firm, Culper Research, released a report accusing Praxis Precision Medicines Inc. (NASDAQ: PRAX) of manipulating data from its Phase 3 essential tremor trial for ulixacaltamide.
The report alleges that Praxis altered the primary endpoint of the study at the last minute, used optimistic assumptions to impute outcomes for 36 % of patients who discontinued the trial, and otherwise applied questionable statistical methods that could undermine the integrity of the data set.
If the allegations are substantiated, the company could face regulatory rejection of ulixacaltamide, the drug that drives nearly all of Praxis’s valuation. Analysts had previously assigned an 80 % probability of approval and a $3 billion valuation to the asset, which underpins the company’s $4.5 billion market capitalization.
Praxis reported Q3 2025 earnings on November 5, 2025, with an earnings per share of –$3.36 versus an expected –$3.45, a modest beat of $0.09. The narrow margin likely reflects continued cost discipline amid modest revenue growth.
In response to the allegations, Praxis scheduled an expert fireside chat for November 24, 2025, featuring CEO Marcio Souza, an HC Wainwright analyst, and a statistician, to discuss the clinical data and address investor concerns.
Investors reacted negatively to the report, citing the data manipulation allegations, the unapproved endpoint change, and the use of imputed data as key concerns that could jeopardize the drug’s regulatory approval and the company’s valuation.
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