Syndax FDA approval: Revuforj for NPM1‑mutant R/R AML

Accepted by SEC EDGAR 10/24/2025 - 04:40 PM EDT Learn about SEC filing dates

Rhea-AI Filing Summary

Syndax Pharmaceuticals (SNDX) announced FDA approval of Revuforj (revumenib) for the treatment of relapsed or refractory acute myeloid leukemia with a susceptible NPM1 mutation in adult and pediatric patients one year and older who have no satisfactory alternative treatment options. The company disclosed the news via a press release and held a conference call on October 24, 2025.

The filing notes forward-looking statements regarding plans to make Revuforj commercially available for this indication. A copy of the press release is furnished as Exhibit 99.1.

Positive

• FDA approval of Revuforj (revumenib) for R/R AML with susceptible NPM1 mutation in patients ≥1 year lacking satisfactory alternatives

Negative

• None.

Insights

Biopharma regulatory analyst

FDA approval grants U.S. marketing for Revuforj in a defined AML niche.

Syndax reports that the FDA approved Revuforj (revumenib) to treat R/R AML with a susceptible NPM1 mutation in adults and pediatric patients one year and older who lack satisfactory alternatives. Approval allows U.S. promotion and distribution strictly within this labeled population.

The company states plans to make Revuforj commercially available for this indication. The filing does not provide financial terms, pricing, or timelines, so commercial impact cannot be gauged here.

The exhibit (press release) anchors the approval and indication. Subsequent disclosures may detail launch specifics, but this excerpt focuses on the regulatory outcome and the stated plan to commercialize.

8-K Event Classification

2 items: 8.01, 9.01

2 items

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, or exhibit attachments filed with this report.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Syndax Pharmaceuticals (SNDX) announce?

Syndax announced that the FDA approved Revuforj (revumenib) to treat R/R AML with a susceptible NPM1 mutation in eligible adults and pediatric patients one year and older.

Which patients are covered by the Revuforj approval?

Adults and pediatric patients one year and older with relapsed or refractory AML and a susceptible NPM1 mutation who have no satisfactory alternative treatment options.

Did Syndax discuss commercialization plans for Revuforj?

Yes. The filing includes forward-looking statements about plans to make Revuforj commercially available for the approved indication.

Where can I find the detailed announcement?

The press release is furnished as Exhibit 99.1 to the report.

Did Syndax host an event about this news?

Yes. The company held a conference call regarding the announcement on October 24, 2025.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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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): October 24, 2025

SYNDAX PHARMACEUTICALS, INC.

(Exact name of Registrant as Specified in Its Charter)

Delaware			001-37708	32-0162505
(State or Other Jurisdiction of Incorporation)			(Commission File Number)	(IRS Employer Identification No.)
730 THIRD AVENUE FLOOR 9
NEW YORK, New York				10017
(Address of Principal Executive Offices)				(Zip Code)

Registrant’s Telephone Number, Including Area Code: (781) 419-1400

(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		SNDX		The Nasdaq Stock Market LLC

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 8.01 Other Events.

On October 24, 2025, Syndax Pharmaceuticals, Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration has approved Revuforj® (revumenib) for the treatment of relapsed or refractory (“R/R”) acute myeloid leukemia (“AML”) with a susceptible nucleophosmin 1 (“NPM1”) mutation in adult and pediatric patients one year and older who have no satisfactory alternative treatment options. A copy of the press release is filed herewith as Exhibit 99.1. The Company held a conference call regarding the announcement on October 24, 2025. The information contained in the press release is incorporated by reference into this Current Report on Form 8-K.

Forward Looking Statements

This Current Report on Form 8-K contains “forward-looking statements,” including, but not limited to, statements regarding the Company’s plans to make Revuforj commercially available for patients with R/R AML with a susceptible NPM1 mutation. These statements relate to future events and involve known and unknown risks, uncertainties and other factors which may cause the Company’s actual results, performance, or achievements to be materially different from any future results, performances, or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “could,” “plans,” “anticipates,” “believes,” and similar expressions intended to identify forward-looking statements. These statements reflect the Company’s current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Any forward-looking statements set forth in this Current Report speak only as of the date of this Current Report. The Company does not intend to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof other than as required by law. You are cautioned not to place undue reliance on any forward-looking statements.

Item 9.01 Financial Statements and Exhibits.

Exhibit No.	Description
99.1	Press Release, dated October 24, 2025
104	Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

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.

			SYNDAX PHARMACEUTICALS, INC.
Date:	October 24, 2025	By:	/s/ Michael A. Metzger
			Michael A. Metzger Chief Executive Officer