Why Did IMMP Stock Surge 150% In Pre-Market Today?

• The FDA issues ODD to therapies showing encouraging results for treating diseases affecting fewer than 200,000 people.
• This comes after a successful trial of the company’s Eftilagimod Alfa, tested with radiotherapy and the immunotherapy drug Keytruda in patients before surgery.
• Last month, a trial for Efti in first-line non-small cell lung cancer was stopped, leading to an 82% intraday plunge in IMMP stock.

Shares of Immutep Ltd (IMMP) surged around 150% in pre-market trading on Wednesday, on track for their biggest intraday gains since Dec. 10, 2020, after the biotech firm announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for its drug to treat soft tissue sarcoma.

The decision is supported by encouraging results from the Phase II EFTISARC-NEO trial, in which Eftilagimod Alfa (Efti) was tested with radiotherapy and the immunotherapy drug Keytruda in patients before surgery. In 38 patients, the study met its primary endpoint, showing a median tumor hyalinization/fibrosis of 51.5%, well above the 35% target. This essentially means that half of the tumor tissue showed signs of being replaced by scar-like tissue.

The FDA issues ODD to therapies showing encouraging results for treating diseases affecting fewer than 200,000 people. The designation comes with additional benefits, including regulatory assistance, tax credits, fee waivers, and 7 years of market exclusivity upon approval.

Silver Lining After Phase III TACTI-004 Trial Was Abandoned

In March, Immutep announced that its Phase III TACTI-004 trial of Efti in first-line non-small cell lung cancer will be stopped following an interim review by the Independent Data Monitoring Committee (IDMC), which found that the study was unlikely to meet its goals. Following this decision, Immutep expects its cash runway to extend beyond its earlier guidance of the second quarter (Q2) of 2027.

The stock plunged 82% after the March 13 update, dropping below $1 and failing to recover since then. Prior to the update, IMMP shares were placed under a trading halt for five sessions.

How Did Retail Traders React?

Retail sentiment on IMMP stock flipped to ‘extremely bullish’ from ‘bearish’ a day earlier.

One user expects the latest news to lead to new partnerships or even an acquisition.

 https://stocktwits.com/joe77w/message/650314490

However, another user said that the Phase III TACTI-004 failure “still defines the long-term trend.”

The stock has crashed around 80% so far in 2026.

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