FDA clears Prelude Therapeutics (NASDAQ: PRLD) to start Phase 1 trial of PRT12396

Rhea-AI Filing Summary

Prelude Therapeutics reported that the U.S. Food and Drug Administration has cleared it to begin a Phase 1 study of PRT12396. This drug is described as a mutant-selective JAK2V617F inhibitor being developed to treat patients with certain myeloproliferative neoplasms, a group of blood cancers. The update was shared via a press release furnished as an exhibit to the report.

Insights

Biotech regulatory and pipeline analyst

Prelude gained FDA clearance to start a first-in-human trial for PRT12396.

Prelude Therapeutics disclosed that the U.S. Food and Drug Administration cleared a Phase 1 study under its Investigational New Drug Application for PRT12396. The compound is described as a mutant-selective JAK2V617F inhibitor targeting certain myeloproliferative neoplasms.

This clearance moves PRT12396 into clinical development, a key milestone for any preclinical asset. It signals that regulators reviewed the preclinical and manufacturing data and found it acceptable to proceed with initial human testing, which typically focuses on safety and dosing.

The company furnished the news through a press release dated February 3, 2026, attached as Exhibit 99.1. Future updates in company filings can provide details such as initial dosing, sites, and early safety observations as the Phase 1 study progresses.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of The Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): January 29, 2026

Prelude Therapeutics Incorporated

(Exact Name of Registrant as Specified in its Charter)

Delaware		001-39527				81-1384762
(State or other jurisdiction of incorporation or organization)		(Commission File Number)				(I.R.S. Employer Identification No.)
175 Innovation Boulevard Wilmington, Delaware				19805
(Address of principal executive offices)				(Zip Code)

Registrant’s telephone number, including area code: (302) 467-1280

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, $0.0001 par value per share		PRLD		Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 7.01 Regulation FD Disclosure.

On February 3, 2026 Prelude Therapeutics Incorporated (the "Company") issued a press release announcing that the U.S. Food and Drug Administration cleared the Company to proceed with a Phase 1 study under its Investigational New Drug Application for PRT12396, a mutant-selective JAK2V617F inhibitor being developed for the treatment of patients with certain myeloproliferative neoplasms.

The information in this Current Report on Form 8-K and in Exhibit 99.1 attached hereto is being furnished, but shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (“Exchange Act”), and is not incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit Number		Description
99.1		Press Release dated February 3, 2026
104		Cover Page Interactive Data File (embedded within the Inline XBRL Document)

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	PRELUDE THERAPEUTICS INCORPORATED
Date: February 3, 2026	By:	/s/ Bryant Lim
		Bryant Lim
		Chief Financial Officer and Chief Legal Officer

FAQ

What did Prelude Therapeutics (PRLD) announce regarding PRT12396?

Prelude Therapeutics announced that the U.S. Food and Drug Administration cleared it to proceed with a Phase 1 study of PRT12396. This candidate is a mutant-selective JAK2V617F inhibitor intended for patients with certain myeloproliferative neoplasms, moving the program into initial clinical testing.

What is PRT12396 in the Prelude Therapeutics (PRLD) pipeline?

PRT12396 is described as a mutant-selective JAK2V617F inhibitor being developed by Prelude Therapeutics. It targets patients with certain myeloproliferative neoplasms, a type of blood cancer. The FDA has cleared an Investigational New Drug Application to start a Phase 1 clinical study of this compound.

What regulatory milestone did Prelude Therapeutics (PRLD) achieve with the FDA?

Prelude Therapeutics achieved U.S. Food and Drug Administration clearance to proceed with a Phase 1 study under its Investigational New Drug Application for PRT12396. This allows the company to begin first-in-human testing focused on safety and dosing in certain myeloproliferative neoplasm patients.

For which condition is Prelude Therapeutics (PRLD) developing PRT12396?

Prelude Therapeutics is developing PRT12396 for patients with certain myeloproliferative neoplasms. These are blood cancers, and PRT12396 is described as a mutant-selective JAK2V617F inhibitor, aiming at a specific disease-driving mutation identified in this patient population.

How did Prelude Therapeutics (PRLD) communicate the FDA clearance for PRT12396?

Prelude Therapeutics communicated the FDA clearance through a press release dated February 3, 2026, which is attached as Exhibit 99.1. The company furnished this information in a current report, noting that the press release is not deemed filed for liability purposes under the Exchange Act.