Rhythm Pharma (NASDAQ: RYTM) sees 50% 2025 IMCIVREE revenue jump

Rhea-AI Filing Summary

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.

Positive

• Strong growth in IMCIVREE sales: Preliminary unaudited net product revenues reached approximately $57 million in Q4 2025 (up 11% sequentially) and about $194 million for 2025 versus $130 million in 2024, an increase of roughly 50% year over year.
• Multiple late-stage clinical and regulatory milestones: Upcoming 2026 events include a PDUFA goal date of March 20, 2026 for acquired hypothalamic obesity, several Phase 3 topline readouts for setmelanotide, additional Phase 2 data in Prader-Willi syndrome, and advancement of bivamelagon and RM-718 in acquired HO.

Negative

• None.

Insights

Biopharma equity analyst

Rhythm posts strong IMCIVREE revenue growth with multiple late-stage obesity milestones ahead.

Rhythm Pharmaceuticals estimates IMCIVREE net product revenues of about $57 million in Q4 2025, an 11% sequential increase, and approximately $194 million for full-year 2025 versus $130 million in 2024, implying roughly 50% year-over-year growth. U.S. sales contributed about 68% of Q4 and 69% of 2025 preliminary revenues, underscoring continued reliance on the domestic market.

The pipeline update centers on setmelanotide expansion into acquired hypothalamic obesity, congenital HO, genetically caused MC4R pathway diseases, and Prader-Willi syndrome, with multiple catalysts in 2026. Key events include the FDA’s PDUFA goal date of March 20, 2026 for acquired HO, several Phase 3 topline readouts in the first quarter of 2026, and six-month Phase 2 data in PWS in the first half of 2026. Additional programs, bivamelagon and RM-718, are progressing toward pivotal and later-stage development in acquired HO.

The company emphasizes that these revenue numbers are preliminary, unaudited estimates subject to change after closing and audit procedures. Actual impact on future performance will depend on final audited results, regulatory decisions on setmelanotide, and the outcomes and timing of the Phase 2 and Phase 3 trials described for 2026.

8-K Event Classification

4 items: 2.02, 7.01, 8.01, 9.01

4 items

Item 2.02 Results of Operations and Financial Condition Financial

Disclosure of earnings results, typically an earnings press release or preliminary financials.

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

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, and exhibit attachments filed with this report.

Understanding 8-K Material Events →

0001649904false00016499042026-01-092026-01-09

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): January 9, 2026

RHYTHM PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

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

222 Berkeley Street

12th Floor

Boston, MA 02116

(Address of principal executive offices) (Zip Code)

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

N/A

(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, $0.001 par value per share	RYTM	The Nasdaq Stock Market LLC (Nasdaq Global Market)

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 2.02. Results of Operations and Financial Condition.

On January 9, 2026, Rhythm Pharmaceuticals, Inc. (the “Company”) issued a press release announcing, among other

things, the Company’s preliminary unaudited net product revenues for the fourth quarter of 2025 and the fiscal year ended

December 31, 2025. The full text of the press release issued by the Company is furnished as Exhibit 99.1 to this Current

Report on Form 8-K.

The information contained in Item 2.02 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.

Item 7.01. Regulation FD Disclosure.

On January 9, 2026, in connection with its participation in the J.P. Morgan Healthcare Conference, the Company posted a

corporate slide presentation in the “Investors” portion of its website at www.rhythmtx.com. A copy of the presentation is

furnished as Exhibit 99.2 to this Current Report on Form 8-K. The Company undertakes no obligation to update,

supplement or amend the materials attached hereto as Exhibit 99.2.

The information contained in Item 7.01 of this Current Report on Form 8-K (including Exhibit 99.2) shall not be deemed

“filed” for purposes of Section 18 of 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, or the Exchange Act, except as expressly provided

by specific reference in such a filing.

Item 8.01. 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 contributed approximately 68% of fourth quarter preliminary unaudited net product revenues and

approximately 69% of full-year 2025 preliminary unaudited net product revenues.

The Company also provided an update on anticipated upcoming milestones:

Setmelanotide

Acquired Hypothalamic Obesity (HO)

•Launch IMCIVREE in the United States for the treatment of acquired hypothalamic obesity pending FDA

approval; the FDA’s assigned PDUFA goal date is March 20, 2026;

•Announce topline data in the 12-patient Japanese cohort of the setmelanotide Phase 3 trial in acquired HO in the

first quarter of 2026.

Congenital HO

•Complete enrollment in the setmelanotide Phase 3 trial substudy in congenital HO in the first half of 2026.

Genetically Caused MC4R Pathway Diseases

•Announce topline data in the Phase 3 EMANATE trial evaluating setmelanotide in genetically caused MC4R

pathway diseases in the first quarter of 2026.

Prader-Willi Syndrome (PWS)

•In December 2025, Rhythm announced positive preliminary data for the exploratory phase 2 trial of setmelanotide

in patients with PWS that showed BMI and hyperphagia reductions at month 3 and month 6, as well as safety and

tolerability consistent with setmelanotide’s well-established clinical profile. Rhythm anticipates announcing six-

month results from 18 patients from the ongoing Phase 2 trial in the first half of 2026.

Bivamelagon

•Pending further feedback from U.S. and European regulatory agencies, initiate a pivotal Phase 3 trial evaluating

bivamelagon in acquired HO in 2026.

RM-718

•Complete enrollment in the Phase 1, Part C trial evaluating the weekly, MC4R agonist RM-718 in patients with

acquired HO in the first quarter of 2026.

Financial Disclosure Advisory

This Current Report on Form 8-K contains certain estimated preliminary financial results for the fourth quarter and fiscal

year ended December 31, 2025. These estimates are based on the information available to the Company at this time. The

Company’s financial closing procedures for the fourth quarter and full year 2025 are not yet complete and, as a result,

actual results may vary from the estimated preliminary results presented here due to the completion of the Company’s

financial closing and audit procedures. The estimated preliminary financial results have not been audited or reviewed by

the Company’s independent registered public accounting firm. These estimates should not be viewed as a substitute for the

Company’s full interim or annual financial statements. Accordingly, you should not place undue reliance on this

preliminary data.

Forward-Looking Statements

This Current Report on Form 8-K contains forward-looking statements within the meaning of the Private Securities

Litigation Reform Act of 1995. All statements contained in this Current Report that do not relate to matters of historical

fact should be considered forward-looking statements, including without limitation statements regarding the Company’s

anticipated financial performance for any period of time, including preliminary unaudited revenues, for the fourth quarter

and full year ending December 31, 2025; the potential, safety, efficacy, and regulatory and clinical progress, potential

regulatory submissions, approvals and timing thereof of setmelanotide and other product candidates, including

bivamelagon (LB54640) and RM-718; the announcement of data from our clinical trials, including our global Phase 3 trial

evaluating setmelanotide in patients with acquired hypothalamic obesity; the ongoing enrollment of patients in our clinical

trials; our participation in upcoming events and presentations; and the timing of any of the foregoing. Statements using

words such as “expect”, “anticipate”, “believe”, “may”, “will”, “aim” and similar terms are also forward-looking

statements. Such statements are subject to numerous risks and uncertainties, including, but not limited to, our actual

financial results for the fourth quarter and full year 2025 may differ from our preliminary estimates; our ability to enroll

patients in clinical trials, the design and outcome of clinical trials, the ability to achieve necessary regulatory approvals,

risks associated with data analysis and reporting, failure to identify and develop additional product candidates, unfavorable

pricing regulations, third-party reimbursement practices or healthcare reform initiatives, risks associated with the laws and

regulations governing our international operations and the costs of any related compliance programs, the impact of

competition, risks relating to product liability lawsuits, inability to maintain collaborations, or the failure of these

collaborations, our reliance on third parties, risks relating to intellectual property, our ability to hire and retain necessary

personnel, general economic conditions, risks related to internal control over financial reporting, and the other important

factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the quarter ended September

30, 2025 and our other filings with the Securities and Exchange Commission. Except as required by law, we undertake no

obligations to make any revisions to the forward-looking statements contained in this Current Report release or to update

them to reflect events or circumstances occurring after the date of this Current Report, whether as a result of new

information, future developments or otherwise.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

The following Exhibits 99.1 and 99.2 relate to Items 2.02 and 7.01, respectively and shall be deemed to be furnished, and

not filed:

Exhibit No.		Description
99.1		Press release dated January 9, 2026
99.2		Corporate Presentation dated January 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: January 9, 2026	By:	/s/ Hunter C. Smith
		Hunter C. Smith
		Chief Financial Officer

FAQ

What preliminary 2025 revenues did Rhythm Pharmaceuticals (RYTM) report for IMCIVREE?

Rhythm Pharmaceuticals reported preliminary unaudited net product revenues from global sales of IMCIVREE of approximately $57 million for the fourth quarter of 2025 and about $194 million for the full year 2025, compared to $130 million for the full year 2024.

How fast did Rhythm Pharmaceuticals (RYTM) grow IMCIVREE sales in 2025?

The company stated that the approximate $57 million in Q4 2025 IMCIVREE revenue represented an 11% sequential increase over the third quarter of 2025. Full-year 2025 net product revenues of about $194 million were described as an increase of approximately 50% year over year versus $130 million in 2024.

How much of Rhythm Pharmaceuticals’ IMCIVREE revenue came from the U.S. in 2025?

According to the company, U.S. sales of IMCIVREE contributed approximately 68% of preliminary unaudited net product revenues in the fourth quarter of 2025 and about 69% of preliminary unaudited net product revenues for the full year 2025.

What is the key upcoming FDA date for Rhythm Pharmaceuticals’ acquired hypothalamic obesity indication?

Rhythm plans to launch IMCIVREE in the United States for acquired hypothalamic obesity pending FDA approval. The FDA has assigned a PDUFA goal date of March 20, 2026 for this indication.

What clinical milestones did Rhythm Pharmaceuticals outline for setmelanotide in 2026?

The company plans to announce topline data from the 12-patient Japanese cohort of the Phase 3 trial in acquired hypothalamic obesity and from the Phase 3 EMANATE trial in genetically caused MC4R pathway diseases in the first quarter of 2026. It also expects to complete enrollment in the Phase 3 substudy in congenital hypothalamic obesity in the first half of 2026 and to report six-month results from 18 patients in the ongoing Phase 2 Prader-Willi syndrome trial in the first half of 2026.

Are Rhythm Pharmaceuticals’ reported 2025 financial figures final and audited?

No. The company explained that the figures for the fourth quarter and full year ended December 31, 2025 are estimated preliminary financial results based on information currently available. The financial closing procedures and audit are not yet complete, and the estimates have not been audited or reviewed by the independent registered public accounting firm, so actual results may differ.

What other obesity-related programs besides setmelanotide is Rhythm Pharmaceuticals advancing?

In addition to setmelanotide, Rhythm is developing bivamelagon, for which it plans to initiate a pivotal Phase 3 trial in acquired hypothalamic obesity in 2026 pending further regulatory feedback, and RM-718, for which it plans to complete enrollment in a Phase 1, Part C trial in patients with acquired hypothalamic obesity in the first quarter of 2026.