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Immutep's FDA Orphan Drug Designation for Rare Cancer Treatment Sends Shares Soaring Premarket
Immutep (IMMP) said early Wednesday that the United States Food and Drug Administration has granted orphan drug designation to eftilagimod alfa for the treatment of soft tissue sarcoma, a rare cancer.Shares of the company surged more than 58% in recent premarket activity.The move follows clinical data from a phase 2 trial that evaluated efti in combination with radiotherapy and Keytruda (pembrolizumab). In 38 patients, the study met its primary endpoint, demonstrating a median tumor hyalinization/fibrosis of almost 52%, exceeding the pre-specified target of 35% and historical benchmarks of about 15% with radiotherapy alone. Tumor hyalinization/fibrosis refers to healing.The company said the results were observed across multiple sarcoma subtypes and showed immune activation consistent with efti, with a favourable safety profile and no delays to planned surgery.Price: $0.495, Change: $+0.1838, Percent Change: +58.80%
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