Immutep Limited (NASDAQ:IMMP) shares plunged roughly 80% on Friday after the biotechnology company announced it would discontinue its Phase III TACTI-004 clinical trial following a futility review.
The Independent Data Monitoring Committee (IDMC) recommended ending the study, which was evaluating eftilagimod alfa (“efti”) as a treatment for patients with first-line non-small cell lung cancer. After assessing the available safety and efficacy data, the committee concluded the trial was unlikely to achieve its intended objectives and advised stopping it for futility.
Immutep said it will immediately cease patient enrollment and begin a structured wind-down of the trial. This process will include continued patient monitoring and the closure of clinical sites in accordance with regulatory and ethical requirements.
Chief Executive Officer Marc Voigt said the company was both disappointed and surprised by the decision, particularly given the performance of efti in other clinical programs. Immutep is now conducting a full review of the available trial data to evaluate possible next steps for the therapy.
Following the trial’s termination, the company indicated its existing cash resources are now expected to last well beyond the previously projected runway of the second quarter of 2027. An updated financial outlook will be provided once operational adjustments are completed and the trial data has been fully analyzed.
Analysts quickly revised their views on the stock. Baird analyst Colleen Kusy downgraded Immutep from Outperform to Neutral, cutting the price target to $1.00 from $7.00. Citizens analyst Reni Benjamin also lowered the rating from Market Outperform to Market Perform, removing previously projected revenues tied to the non-small cell lung cancer indication.
Although the company continues to run clinical studies in other disease areas, analysts believe the shares may trade largely in line with the broader market until new randomized trial results provide clearer signals on the pipeline’s prospects.