Immutep Limited ( IMMP ) shares are tumbling on Friday following the company’s update for the TACTI-004 Phase 3 trial.

The Australia-based biotech announced that the Independent Data Monitoring Committee has recommended the discontinuation of the TACTI-004 Phase 3 trial due to a planned interim futility analysis.

Immutep Halts TACTI-004 Phase 3 Trial

The TACTI-004 trial was evaluating the company’s lead drug, eftilagimod alfa, in combination with Merck & Co. Inc.’s Keytruda (pembrolizumab) and chemotherapy as first-line therapy for advanced/metastatic non-small cell lung cancer (NSCLC).

The committee’s recommendation to halt the trial was based on a review of safety and efficacy data, leading to an orderly wind-down of the study and a reassessment of capital allocation priorities.

In a statement, CEO Marc Voigt expressed disappointment over the outcome, highlighting the unexpected nature of the results given the drug’s performance in other trials.

The company is now focused on advancing its pipeline of therapies, including eftilagimod alfa, and anticipates that its cash runway will extend beyond the previous guidance of the second quarter of calendar year 2027.

Other Studies With Lead Drug

Efti is under evaluation for a variety of solid tumors, including NSCLC, as well as head and neck squamous cell carcinoma (HNSCC), soft tissue sarcoma, and breast cancer.

In May 2025, Immutep ( IMMP ) shared additional data from the investigator-initiated INSIGHT-003 trial of triple combination therapy in front-line NSCLC consisting of efti administered in conjunction with Keytruda and chemotherapy (carboplatin and pemetrexed).

The company said it achieved a 60.8% response rate and 90.2% disease control rate as of the data cut-off date of May 6, 2025.

Analyst Consensus & Recent Actions: The stock carries a Buy Rating. Recent analyst moves include:

Citizens: Downgraded to Market Perform (Mar. 13)

Baird: Downgraded to Neutral (Lowers Target to $1.00) (Mar. 13)

Citizens: Initiated with Market Outperform (Target $10.00) (Feb. 23)

IMMP Slides to 52-Week Low

IMMP Price Action: Immutep ( IMMP ) shares were down 80.62% at $0.53 at the time of publication on Friday. The stock is trading at a new 52-week low, according to Benzinga Pro data.

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