Culper Research announced that it is short Praxis Precision (PRAX) Medicines, which last month announced “positive” results from its Phase 3 trial of ulixacaltamide to treat essential tremor. The firm believe the readout appears severely compromised by an unapproved late endpoint change, optimistic imputation for a high discontinuation rate, and misuse of the cited analytical method, each of which experts believe could independently undermine FDA approval. Taken together, these issues point to significant downside risk ahead of the Q4 pre-NDA meeting as FDA scrutiny intensifies, Culper says in a note to investors.
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