Rhythm Pharmaceuticals Inc. filed SEC Form 8-K: Regulation FD Disclosure, Other Events, Financial Statements and Exhibits
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Item 7.01. Regulation FD Disclosure.
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.
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.
Item 8.01. Other Events.
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.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
The following Exhibits 99.1 and 99.2 shall be deemed to be furnished and not filed.
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No. | Description | |
99.1 | ||
99.2 | ||
104 | Cover Page Interactive Data File (embedded within the inline XBRL document) |
SIGNATURES
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.
| RHYTHM PHARMACEUTICALS, INC. | |
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Date: November 7, 2025 | By: | /s/ Hunter Smith |
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| Hunter Smith |
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| Chief Financial Officer |