ClearPoint Neuro (NASDAQ:CLPT) shares fell 24% on Tuesday following updated clinical trial results from partner uniQure N.V. (NASDAQ:QURE) for its experimental Huntington’s disease gene therapy.
uniQure shares declined 55% after the company reported updated data for ifezuntirgene inilparvovec, also known as AMT-130.
The treatment did not achieve statistical significance on a primary clinical measure at 48 months, although the company reported dose-dependent slowing of disease progression.
ClearPoint Provides AMT-130 Delivery Technology
ClearPoint Neuro is involved in the AMT-130 programme through its partnership with uniQure.
The company provides an MRI-guided navigation platform and its SmartFlow cannula system, which are used to deliver the gene therapy directly into the striatum of the brain.
ClearPoint’s technology therefore forms part of the administration process for AMT-130 during the clinical development programme.
AMT-130 Outcome Creates Uncertainty Over Potential Future Revenue
The trial update introduces uncertainty around potential future commercial revenue for ClearPoint Neuro associated with AMT-130.
Any revenue from supplying delivery hardware and software for commercial AMT-130 procedures would depend on the therapy progressing through the regulatory process and reaching the market.
The supplied information does not indicate that the US Food and Drug Administration has made a regulatory decision on AMT-130. The clinical result therefore does not itself represent an FDA rejection.
The potential effect on ClearPoint Neuro’s future revenue remains uncertain and will depend on uniQure’s subsequent clinical and regulatory plans for the programme.
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