On Friday, Praxis Precision Medicines, Inc. (NASDAQ:PRAX) released interim data from Study 1 of the Essential3 program of ulixacaltamide in essential tremor (ET).
The Independent Data Monitoring Committee (IDMC) recommended stopping the study for futility. The results are unlikely to meet the primary efficacy endpoint.
The committee also indicated that some underlying statistical model assumptions might have influenced this outcome and encouraged Praxis to explore alternative analysis methods.
Also Read: Praxis Precision Medicines Touts Encouraging Data For Mid-Stage Epilepsy Drug
Given the advanced enrollment status for both Study 1 and Study 2 in the Essential3 program and advice received by the IDMC, Praxis has decided to complete both studies, with topline results expected in the third quarter of 2025.
The decision about whether the data supports the submission of an NDA will be made after analyzing the final results for Study 1 and Study 2.
As of December 31, 2024, Praxis had $469.5 million in cash, cash equivalents and marketable securities, which is expected to fund operations into 2028.
Praxis incurred a net loss of $58.7 million for the fourth quarter of 2024 compared to $26.9 million for the fourth quarter of 2023.
Analyst Reactions:
- HC Wainwright analyst maintains Praxis Precision Medicine with a Buy, lowering the price target from $120 to $105.
- Needham analyst maintains Praxis Precision Medicine with a Buy, lowering the price target from $150 to $85.
- Baird analyst maintains Praxis Precision Medicine with an Outperform, lowering the price target from $117 to $73.
- Truist Securities analyst maintains Praxis Precision with a Buy, lowering the price target from $175 to $85.
Price Action: PRAX stock is down 4.09% at $37.02 at the last check Monday.
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