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Material updates from SEC filings (8-K, 10-Q, 10-K) ranked by impact, with no firehose noise.
Other Events. On June 13, 2026, Rhythm announced interim six-month data from its exploratory Phase 2 trial of setmelanotide in patients with PWS, which are summarized below. Rhythm enrolled 18 patients with PWS aged 6-23 years old with a BMI ≥30 kg/m 2 for patients ≥18 years of age or BMI ≥95th percentile for age and sex for patients younger than 18 in this Phase 2 trial. The 52-week trial remains ongoing, and 17 patients remain on active therapy as of June 12, 2026. Results from the six-mont…
and shall be deemed to be furnished, and not filed: Exhibit No. Description 99.1 Press release dated May 5, 2026 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. Date: May 5, 2026 By: /s/ Hunter C. Smith Hunter C. Smith Chief Fina…
Departure of Directors or Principal Officers; Election of Directors; Appointment of Principal Officers; Compensatory Arrangements of Certain Officers On April 1, 2026, the Board of Directors (the “Board”) of Rhythm Pharmaceuticals, Inc. (the “Company”) elected Kimberly J. Popovits as a non-employee director of the Company, effective on the same date. Ms. Popovits will serve as a Class II director to hold office until the Company’s 2028 annual meeting of stockholders and until her successor is…
Other Events. On March 26, 2026, Rhythm announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending to expand the current marketing authorization for IMCIVREE ® (setmelanotide) to include the treatment of obesity and the control of hunger in adults and children 4 years of age and above with acquired hypothalamic obesity (HO) due to hypothalamic injury or impairment. The CHMP opinion will now be reviewed…
Regulation FD Disclosure. On March 26, 2026, Rhythm Pharmaceuticals, Inc. (“Rhythm”) issued a press release announcing that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending to expand the current marketing authorization for IMCIVREE ® (setmelanotide) to include the treatment of obesity and the control of hunger in adults and children 4 years of age and above with acquired hypothalamic obesity (HO) due to hyp…
Other Events. On March 19, 2026, Rhythm announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for IMCIVREE® (setmelanotide) to treat patients living with acquired hypothalamic obesity (HO). With this expansion, IMCIVREE is indicated to reduce excess body weight and maintain reduction long term in adults and pediatric patients aged 4 years and older with acquired HO. The approval is supported by the positive pivotal Phase 3 TRANSCEND trial of setmelanot…
Other Events. On March 1, 2026, Rhythm announced additional data from its global Phase 3 TRANSCEND trial of setmelanotide in patients with acquired hypothalamic obesity, which are summarized below. This new data set includes 12 patients from a Japanese cohort and 10 supplemental patients who were enrolled in addition to the primary 120-patient pivotal cohort. Highlights from these 52-week data include: - -18.8% placebo-adjusted difference 1 in BMI reduction (N=142); - Primary endpoint of mean…
and shall be deemed to be furnished, and not filed: Exhibit No. Description 99.1 Press release dated February 26, 2026 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. Date: February 26, 2026 By: /s/ Hunter C. Smith Hunter C. Smit…
Other Events On January 9, 2026, the Company announced preliminary unaudited net revenues from global sales of IMCIVREE® (setmelanotide) of approximately $57 million for the fourth quarter of 2025, an increase of 11% percent on a sequential basis from the third quarter of 2025. Net product revenues for the full year of 2025 are expected to be approximately $194 million, compared to $130 million for the full year of 2024, an increase of approximately 50% year over year. U.S. sales of IMCIVREE…
of this Current Report on Form 8-K (including Exhibit 99.1 ) 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.
Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers. On December 16, 2025, Camille L. Bedrosian, M.D. notified the Board of Directors (the “Board”) of Rhythm Pharmaceuticals, Inc. (the “Company”) of her decision to resign from the Board, effective immediately. Dr. Bedrosian currently serves on the Compensation & Management Development Committee, and the Governance and Nominating Committee. Dr. Bedr…
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.
and shall be deemed to be furnished, and not filed: Exhibit No. Description 99.1 Press release dated November 4, 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, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. RHYTHM PHARMACEUTICALS, INC. Date: November 4, 2025 By: /s/ Hunter C. Smith Hunt…
and shall be deemed to be furnished, and not filed: Exhibit No. Description 99.1 Press release dated August 5, 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, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. RHYTHM PHARMACEUTICALS, INC. Date: August 5, 2025 By: /s/ Hunter C. Smith Hunter S…
Other Events. On July 9, 2025, Rhythm Pharmaceuticals, Inc. (the “Company”) entered into an underwriting agreement (the “Underwriting Agreement”) with Morgan Stanley & Co. LLC and BofA Securities, Inc., as the representatives of the several underwriters named in Schedule I thereto (collectively, the “Underwriters”), in connection with the offering, issuance and sale (the “Offering”) by the Company of 2,058,824 shares of the Company’s common stock, $0.001 par value per share (the “Common Stock…
Other Events. On July 9, 2025, Rhythm announced topline results from its Phase 2 clinical trial evaluating bivamelagon (formerly LB54640), an investigational oral MC4R agonist, in patients with acquired hypothalamic obesity, which are summarized below. Bivamelagon achieved statistically significant and clinically meaningful reductions in body mass index (“BMI”) at 14 weeks of treatment, consistent with BMI reductions achieved with setmelanotide therapy in similar patient populations in past t…
and shall be deemed to be furnished, and not filed: Exhibit No. Description 99.1 Press release dated May 7, 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, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. RHYTHM PHARMACEUTICALS, INC. Date: May 7, 2025 By: /s/ Hunter Smith Hunter Smith Chie…
Other Events On April 7, 2025, Rhythm announced topline results from its Phase 3 TRANSCEND clinical trial evaluating setmelanotide in patients with acquired hypothalamic obesity, which are summarized below. The global trial met its primary endpoint with a highly statistically significant and clinically meaningful reduction in body mass index (BMI) with setmelanotide in both adult and pediatric patients versus placebo. Highlights from the top-line data include: • -19.8% placebo-adjusted…
and shall be deemed to be furnished, and not filed: Exhibit No. Description 99.1 Press release dated February 26, 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, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. RHYTHM PHARMACEUTICALS, INC. Date: February 26, 2025 By: /s/ Hunter Smith Hunte…
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