[8-K] RHYTHM PHARMACEUTICALS, INC. Reports Material Event

Rhea-AI Filing Summary

Rhythm Pharmaceuticals reported a regulatory timing update. The U.S. Food and Drug Administration extended the Prescription Drug User Fee Act (PDUFA) goal date for the supplemental New Drug Application for IMCIVREE (setmelanotide) to treat acquired hypothalamic obesity by three months, moving it from December 20, 2025 to March 20, 2026.

The company also furnished a press release and an investor presentation as exhibits to provide additional context. Information furnished under Regulation FD is not deemed filed for liability purposes.

Insights

Regulatory affairs analyst

FDA extended the PDUFA goal date by three months.

The update centers on timing: the FDA moved the PDUFA goal date for Rhythm’s sNDA for IMCIVREE in acquired hypothalamic obesity from December 20, 2025 to March 20, 2026. A PDUFA goal date is the agency’s target for completing its review.

This change affects the review calendar but does not signal an approval outcome. The company furnished a press release and presentation for context, with no additional financial terms or proceeds discussed in the excerpt.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

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FORM 8-K

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CURRENT REPORT

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Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

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Date of Report (Date of earliest event reported): November 6, 2025

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RHYTHM PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

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Delaware		001-38223		46-2159271
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification Number)

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222 Berkeley Street

12th Floor

Boston, MA 02116

(Address of principal executive offices) (Zip Code)

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Registrant’s telephone number, including area code: (857) 264-4280

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N/A

(Former name or former address, if changed since last report)

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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:

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☐ 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))

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

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Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, $0.001 par value per share	RYTM	The Nasdaq Stock Market LLC (Nasdaq Global Market)

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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).

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Emerging growth company ☐

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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. ☐

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Item 7.01. Regulation FD Disclosure.

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On November 7, 2025, Rhythm Pharmaceuticals, Inc. (the “Company”) issued a press release and published a presentation in connection with the matters disclosed in Item 8.01 of this Current Report on Form 8-K. A copy of the related press release and presentation is furnished as Exhibit 99.1 and Exhibit 99.2, respectively, to this Current Report on Form 8-K.

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The information contained in Item 7.01 of this Current Report on Form 8-K (including Exhibits 99.1 and 99.2 attached hereto) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as expressly provided by specific reference in such a filing.

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Item 8.01. Other Events.

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On November 6, 2025, the U.S. Food and Drug Administration notified the Company that the Prescription Drug User Fee Act (“PDUFA”) goal date for the supplemental New Drug Application for IMCIVREE® (setmelanotide) for the treatment of acquired hypothalamic obesity has been extended by three months from December 20, 2025 to March 20, 2026.

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Item 9.01. Financial Statements and Exhibits.

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(d) Exhibits

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The following Exhibits 99.1 and 99.2 shall be deemed to be furnished and not filed.

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Exhibit	​	​
No.	​	Description
99.1	​	Press release dated November 7, 2025
99.2	​	Presentation dated November 7, 2025
104	​	Cover Page Interactive Data File (embedded within the inline XBRL document)

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SIGNATURES

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

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	RHYTHM PHARMACEUTICALS, INC.
Date: November 7, 2025	By:	/s/ Hunter Smith
		Hunter Smith
		Chief Financial Officer

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FAQ

What did Rhythm Pharmaceuticals (RYTM) announce?

The FDA extended the PDUFA goal date for the sNDA for IMCIVREE in acquired hypothalamic obesity by three months to March 20, 2026.

What was the original PDUFA goal date for RYTM’s IMCIVREE sNDA?

The original date was December 20, 2025.

Which indication is covered by the IMCIVREE sNDA?

Treatment of acquired hypothalamic obesity.

Did Rhythm provide additional materials with this update?

Yes. A press release (Ex. 99.1) and presentation (Ex. 99.2) were furnished.

Does this filing indicate an FDA approval or denial for IMCIVREE?

No. It reports a goal date extension and does not state an approval outcome.