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Investing.com -- Innate Pharma SA (EPA:IPH) (NASDAQ:IPHA) stock surged 23% on Monday after the company announced that the U.S. Food and Drug Administration (FDA) completed its review of the confirmatory Phase 3 protocol for lacutamab in cutaneous T-cell lymphomas (CTCL) with no further comments.
The regulatory clearance allows the company to proceed with TELLOMAK 3, an open-label, randomized study 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.
The trial will include two independent cohorts with progression-free survival as the primary endpoint. Innate Pharma plans to initiate the Phase 3 trial in the first half of 2026.
According to the company, the FDA provided encouraging initial feedback on Innate’s proposed regulatory pathway, which could potentially include Accelerated Approval for Sézary syndrome once the Phase 3 trial is underway.
"This important regulatory milestone with the FDA marks a key step forward for the lacutamab program," said Jonathan Dickinson, Chief Executive Officer of Innate Pharma. "Building on robust Phase 2 data from TELLOMAK, 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."
The company reported that data from the Phase 2 TELLOMAK trial demonstrated durable activity, a favorable safety profile, and improvements in patients’ quality of life. Lacutamab is being developed to treat CTCL, which the company describes as an orphan disease with high unmet medical need.
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