IPHA Stock Soars Pre-Market After FDA Clears Late-Stage Trial For Lacutamab In Rare Skin Cancers

• The company said that the planned confirmation late-stage trial is designed to demonstrate the efficacy of Lacutamab in certain patients with Sézary syndrome and Mycosis fungoides.
• The primary goal of the study is to gauge progression-free survival. 
• The FDA reviewed the protocol of the trial with no further comments, the company further noted. 
   

Shares of Innate Pharma SA (IPHA) soared 13% in the premarket session on Monday after the company said that the U.S. Food and Drug Administration had cleared a confirmatory late-stage trial of Lacutamab in cutaneous T-cell lymphomas to proceed.

Cutaneous T-cell lymphoma (CTCL) is a rare type of non-Hodgkin lymphoma that affects the skin. Symptoms include patches, plaques, or tumors on the skin that can be itchy and may resemble eczema or psoriasis.

About the Late-Stage Confirmatory Trial

The company said that the planned confirmation late-stage trial is designed to demonstrate the efficacy of Lacutamab in patients with Sézary syndrome and Mycosis fungoides, who failed at least one prior line of systemic therapy. Both Sézary syndrome and Mycosis fungoides are types of cutaneous T-cell lymphomas.

The primary goal of the study is to gauge progression-free survival or the length of time a patient lives with a disease, such as cancer, without it getting worse, which can include time when the cancer is stable or cured.

The company now intends to initiate the confirmatory trial in the first half of 2026. The FDA reviewed the protocol of the trial with no further comments, the company further noted.

In a mid-stage trial, Lacutamab demonstrated durable activity, a favorable safety profile, and improvements in patients’ quality of life.

“...this milestone brings us one step closer to our next goal, submitting for accelerated approval in Sézary syndrome once the Phase 3 trial is underway,” CEO Jonathan Dickinson said.

How Did Stocktwits Users React?

On Stocktwits, retail sentiment around IPHA stock jumped from ‘neutral’ to ‘extremely bullish’ territory over the past 24 hours while message volume rose from ‘normal’ to ‘extremely high’ levels.

A Stocktwits user recommended buying the stock under $3.

Another cheered the news as significant and positive.

IPHA stock is down by 4% this year and over the past 12 months. 

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