Every 8-K that Rhythm Pharmaceuticals, Inc. (RYTM) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow RYTM and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full RYTM filings page.
Rhythm Pharmaceuticals, Inc. reported second‑quarter 2026 results highlighted by uptake of IMCIVREE for acquired hypothalamic obesity. Net product revenue from global IMCIVREE sales was $71.3 million, a 19% sequential increase, with U.S. revenue of $51.0 million (72% of the total) and ex‑U.S. revenue of $20.3 million, which included a $3.8 million French Contribution M charge. Net loss attributable to common stockholders was $(50.4) million, or $(0.73) per share. Cash, cash equivalents and short‑term investments were $330.9 million as of June 30, 2026, which the company expects will fund operations for at least 24 months.
Since FDA approval in March 2026, the acquired HO launch generated more than 400 patient start forms from approximately 300 prescribers and increased reimbursed patients by greater than 20% quarter over quarter. Preliminary Phase 2 data for weekly injectable RM‑718 in acquired HO showed a −11.6% mean BMI reduction at 16 weeks (n=7), comparable to prior results with setmelanotide and bivamelagon, with only mild, localized hyperpigmentation noted. Rhythm reiterated 2026 Non‑GAAP operating expense guidance of $363–$397 million and outlined milestones including a Japan IMCIVREE HO launch decision by year‑end 2026, European launches beginning in 2027, and initiation of a pivotal Phase 3 bivamelagon trial.
Rhythm Pharmaceuticals reported the results of its Annual Meeting of Stockholders held on June 24, 2026. Shareholders representing 64,146,146 votes, about 92% of the 69,675,938 eligible votes as of the April 27, 2026 record date, participated online or by proxy.
Two Class III directors were elected to terms running until the 2029 annual meeting. David W. J. McGirr received 53,167,971 votes for and 8,704,527 withheld, while David P. Meeker, MD received 59,961,848 votes for and 1,910,650 withheld, with 2,273,648 broker non-votes for each.
Shareholders also ratified Ernst & Young LLP as independent registered public accounting firm for the year ending December 31, 2026, with 63,924,852 votes for and 197,701 against. On an advisory basis, compensation of named executive officers was approved with 50,368,659 votes for, 11,467,157 against and 36,682 abstentions, plus 2,273,648 broker non-votes.
Rhythm Pharmaceuticals used this 8-K to highlight new clinical and real‑world data for its MC4R agonist portfolio, led by IMCIVREE (setmelanotide), in Prader‑Willi syndrome (PWS), acquired hypothalamic obesity (HO) and Bardet‑Biedl syndrome (BBS).
Interim six‑month results from an exploratory Phase 2 trial in 18 PWS patients showed a −3.06% mean BMI reduction at Month 6 among 17 treated patients, with adult and pediatric subgroups each around −3% and pediatric patients achieving a −0.35 mean BMI z‑score reduction. DEXA data in 16 patients showed a −4.19% mean fat‑mass loss with a +0.74% lean‑mass gain, while most patients with moderate to severe hyperphagia and elevated anxiety scores achieved clinically meaningful improvements. Safety and tolerability were consistent with the known setmelanotide profile.
Rhythm also updated its PWS epidemiology work, estimating 12,500–16,000 patients in each of the U.S. and Europe and 8,500–12,750 with both hyperphagia and obesity in each region. Additional ENDO 2026 presentations described an −18.9% mean BMI reduction over up to 2.5 years in acquired HO, one‑year oral bivamelagon BMI reductions of −6.7% to −16.6% across dose cohorts, and real‑world BBS data in 286 U.S. patients, where 62% of adults achieved at least 10% body‑weight loss and obesity‑related outpatient visits declined after treatment.
Rhythm Pharmaceuticals reported strong commercial momentum in the first quarter of 2026 as it launched IMCIVREE for acquired hypothalamic obesity in the U.S. and secured European Commission Marketing Authorization for the same indication. More than 150 patient start forms were received in the first six weeks after U.S. FDA approval on March 19, 2026.
Net product revenue from global IMCIVREE sales reached $60.1 million for the quarter, up from $37.7 million a year earlier. Revenue of $36.9 million came from the U.S. and $23.2 million from outside the U.S. The company recorded a net loss attributable to common stockholders of $56.7 million, or $(0.83) per share.
Rhythm ended March 31, 2026 with $340.6 million in cash, cash equivalents and short-term investments and expects this to fund operations for at least 24 months. For full-year 2026, it projects $385–$415 million in Non-GAAP operating expenses as it advances setmelanotide, bivamelagon and RM-718 across multiple late-stage and early-stage trials.
Rhythm Pharmaceuticals reported changes to its Board of Directors. On April 1, 2026, the Board elected industry veteran Kimberly J. Popovits as a non-employee Class II director, with her term running until the 2028 annual meeting of stockholders. She will receive compensation under the existing non-employee director policy and enter the company’s standard indemnification agreement.
On the same date, long-serving director Edward T. Mathers resigned from the Board, with the company stating his resignation was not due to any disagreement over operations, policies or practices. Rhythm highlights its commercial-stage rare disease focus built around IMCIVREE (setmelanotide), an MC4R agonist approved for specific rare obesity indications in the United States, European Union and United Kingdom.
Rhythm Pharmaceuticals reported that a key European regulatory committee has issued a positive opinion supporting an expansion of the current marketing authorization for IMCIVREE (setmelanotide). The recommendation covers treatment of obesity and control of hunger in adults and children 4 years and older with acquired hypothalamic obesity caused by hypothalamic injury or impairment.
The opinion from the EMA’s Committee for Medicinal Products for Human Use will now be reviewed by the European Commission, which decides on marketing authorizations in the European Union. A final decision on the proposed label expansion is anticipated in the second quarter of 2026.
Rhythm Pharmaceuticals reports that the U.S. Food and Drug Administration has approved an expanded indication for IMCIVREE (setmelanotide) to treat adults and children aged 4 years and older living with acquired hypothalamic obesity. IMCIVREE is now described as the first and only FDA‑approved therapy for this rare condition.
The approval is based on the pivotal Phase 3 TRANSCEND trial in 142 patients, where setmelanotide achieved a placebo‑adjusted -18.4% reduction in BMI. Patients on setmelanotide (n=94) saw a -15.8% BMI change versus a +2.6% increase on placebo (n=48) at 52 weeks (p<0.0001). Setmelanotide was generally well tolerated; common adverse events included skin hyperpigmentation, nausea, vomiting and headache. Rhythm estimates about 10,000 people in the U.S. are living with acquired hypothalamic obesity, highlighting a meaningful new commercial and clinical opportunity for its lead asset.
Rhythm Pharmaceuticals reported topline results from its global Phase 3 EMANATE trial of setmelanotide in four MC4R-pathway genetic obesity substudies. Using the predefined analysis of mean percent BMI change at Week 52 in the modified intent-to-treat population with multiple imputation, none of the substudies met their primary endpoint, with placebo‑adjusted BMI reductions of –4.3% in POMC/PCSK1 heterozygotes, –3.6% in LEPR heterozygotes, –4.0% in SRC1 (NCOA1) and –1.7% in SH2B1, all with non‑significant p‑values.
Post hoc analyses using last observation carried forward showed statistically significant, larger BMI reductions in the POMC/PCSK1 and SRC1 groups, including least‑squares mean differences of –5.5% and –6.2%, and placebo‑adjusted reductions of –9.7% and –8.0% in genetically confirmed completers. No new safety signals emerged; adverse events were consistent with prior experience, mainly skin hyperpigmentation, injection‑site reactions, nausea, vomiting and headache. Rhythm plans further analysis of EMANATE and to advance next‑generation MC4R agonists bivamelagon and RM‑718 in selected genetic indications.
Rhythm Pharmaceuticals, Inc. reported additional positive 52-week data from its global Phase 3 TRANSCEND trial of setmelanotide in acquired hypothalamic obesity. Across all 142 patients, including 12 from a Japanese cohort and 10 supplemental patients, treatment achieved a -18.8% placebo-adjusted difference in BMI reduction.
The company’s supplemental New Drug Application for setmelanotide in acquired hypothalamic obesity is under U.S. FDA review with a March 20, 2026 PDUFA goal date, and Rhythm will submit the final data package on March 2, 2026. In Europe, a Type II variation to the Marketing Authorization Application is under EMA review, with an expected CHMP opinion in the second quarter of 2026 and potential marketing authorization in the second half of 2026.
Rhythm also plans to submit the full data package to Japan’s PMDA to seek marketing authorization. The company estimates about 10,000 patients with acquired hypothalamic obesity in the United States, approximately 10,000 in Europe and 5,000 to 8,000 in Japan, highlighting a meaningful rare-disease population for this potential new indication.
Rhythm Pharmaceuticals reported strong growth for the fourth quarter and full year 2025 while remaining loss-making. Net product revenue from global sales of IMCIVREE® was $57.3 million in the fourth quarter and $194.8 million for 2025, up from $41.8 million and $130.1 million in 2024. Cash, cash equivalents and short-term investments were $388.9 million as of December 31, 2025, compared with $320.6 million a year earlier, giving the company at least 24 months of operating runway based on current plans.
R&D expenses were $167.3 million in 2025, down from $238.0 million mainly due to non-recurring in-process R&D costs in 2024, while SG&A expenses rose to $194.9 million from $144.3 million as the company expanded headcount and commercial operations. Net loss attributable to common stockholders narrowed to $201.9 million in 2025 from $264.6 million in 2024, with loss per share improving to $3.11 from $4.34.
The company highlighted a March 20, 2026 PDUFA goal date for its supplemental application seeking approval of setmelanotide for acquired hypothalamic obesity, positive Phase 2 data for oral MC4R agonist bivamelagon, and multiple upcoming Phase 3 and Phase 2 data readouts in 2026. Rhythm guided to 2026 non-GAAP operating expenses of $385 million to $415 million, excluding stock-based compensation and certain in-licensing costs, reflecting continued investment in commercial expansion and its MC4R pathway pipeline.
Rhythm Pharmaceuticals reported estimated preliminary unaudited net product revenues from global sales of IMCIVREE of approximately $57 million for the fourth quarter of 2025, an 11% sequential increase from the third quarter of 2025. For full-year 2025, net product revenues are expected to be about $194 million, up from $130 million in 2024, an increase of roughly 50% year over year. U.S. sales accounted for about 68% of preliminary fourth quarter revenues and about 69% of preliminary full-year 2025 revenues.
The company highlighted upcoming milestones for setmelanotide, including a planned U.S. launch of IMCIVREE for acquired hypothalamic obesity pending FDA approval, with a PDUFA goal date of March 20, 2026, topline Phase 3 data in acquired HO and genetically caused MC4R pathway diseases in the first quarter of 2026, and additional Phase 2 data in Prader-Willi syndrome in the first half of 2026. Rhythm also plans a pivotal Phase 3 trial of bivamelagon in acquired HO and is advancing RM-718 in a Phase 1 trial. The company stressed that the financial figures are preliminary, unaudited estimates and may change after closing and audit procedures.
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.
Rhythm Pharmaceuticals, Inc. filed a current report stating that on November 4, 2025 it announced financial results for the third quarter ended September 30, 2025. The company released these results through a press release, which is provided as Exhibit 99.1.
The press release is being furnished, not filed, meaning it is not subject to certain liability provisions of the Exchange Act and is not automatically incorporated into other securities law filings unless specifically referenced.
Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM) filed an 8-K announcing that on July 9, 2025 it entered into an underwriting agreement with Morgan Stanley & Co. LLC and BofA Securities, Inc. to issue 2,058,824 common shares at $85.00 per share. The underwriters fully exercised their 30-day option for an additional 308,823 shares, bringing the total to 2,367,647 shares. Closing is expected on July 11, 2025, subject to customary conditions.
Gross proceeds are about $201.3 million; net proceeds, after underwriting discounts and estimated expenses, are expected to be $188.7 million. The transaction was conducted under the company’s effective Form S-3 shelf registration (File No. 333-270233) and is supported by a legal opinion from Latham & Watkins LLP.
Management plans to deploy the funds to:
- Advance clinical development of pipeline product candidates
- Support commercialization of IMCIVREE
- Provide working capital and cover general corporate purposes
Based on current operating plans, Rhythm believes its existing cash, cash equivalents, short-term investments, and the net proceeds from this offering will fund operations for at least the next 24 months. Forward-looking statements in the filing note that actual cash needs could differ due to market or operational factors.
Key exhibits include the Underwriting Agreement (Ex. 1.1) and related legal opinion (Ex. 5.1).
Rhythm Pharmaceuticals (Nasdaq: RYTM) filed an 8-K disclosing the June 24 2025 Annual Meeting results and a governance change.
- Officer exculpation amendment: Stockholders approved a charter change (55.5 M FOR / 3.5 M AGAINST) extending Delaware-permitted liability protection to certain officers; became effective upon June 25 2025 filing.
- Director elections: Jennifer Good re-elected with 55.6 M votes; Edward T. Mathers retained his seat with 35.2 M votes.
- Auditor confirmation: Ernst & Young LLP ratified for FY-2025 with 60.6 M (99.7 %) FOR.
- Say-on-pay: Executive compensation passed (40.9 M FOR, 18.1 M AGAINST).
- Quorum: 60.7 M votes present, representing 92.7 % of eligible votes.
No operational or financial metrics were updated; the lone material item is the officer liability shield, which may dilute shareholder recourse.