Prelude Therapeutics Wins FDA Nod for Incyte-Partnered Cancer Study

The biotech's stock rose after the agency cleared an early-stage trial for its blood cancer candidate PRT12396.

Feb. 3, 2026 at 11:07am

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Prelude Therapeutics (PRLD), a biotech company based in Wilmington, Delaware, saw its stock rise after the FDA cleared an early-stage clinical trial for its blood cancer candidate PRT12396, which is being developed in partnership with Incyte (INCY).

Why it matters

This is an important milestone for Prelude as it advances its pipeline of oncology treatments. The FDA clearance allows the company to move forward with testing its novel blood cancer drug, which could potentially lead to new treatment options for patients.

The details

Prelude said the FDA has greenlighted its Investigational New Drug (IND) application for PRT12396, paving the way for the company to initiate a Phase 1 clinical trial of the experimental therapy. PRT12396 is being developed through a collaboration with Incyte, a major biopharmaceutical firm.

  • The FDA clearance was announced on February 3, 2026.

The players

Prelude Therapeutics

A biotech company based in Wilmington, Delaware that is developing novel oncology treatments.

Incyte

A major biopharmaceutical company that is partnering with Prelude Therapeutics on the development of PRT12396.

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What’s next

With the FDA clearance, Prelude can now initiate a Phase 1 clinical trial to evaluate the safety and efficacy of PRT12396 in patients with blood cancers.

The takeaway

This FDA clearance represents an important advancement for Prelude's pipeline and its partnership with Incyte, as the companies work to bring new treatment options to blood cancer patients.