Earnings summaries and quarterly performance for RHYTHM PHARMACEUTICALS.
Executive leadership at RHYTHM PHARMACEUTICALS.
David Meeker
Detailed
President and Chief Executive Officer
CEO
AG
Alastair Garfield
Detailed
Chief Scientific Officer
HS
Hunter Smith
Detailed
Chief Financial Officer and Treasurer
JL
Jennifer Lee
Detailed
Executive Vice President, Head of North America
JS
Joseph Shulman
Detailed
Chief Technical Officer
PC
Pamela Cramer
Detailed
Chief Human Resources Officer
YM
Yann Mazabraud
Detailed
Executive Vice President, Head of International
Board of directors at RHYTHM PHARMACEUTICALS.
Research analysts who have asked questions during RHYTHM PHARMACEUTICALS earnings calls.
Derek Archila
Wells Fargo
6 questions for RYTM
Also covers: APLS, ARGX, ARVN +9 more
RS
Raghuram Selvaraju
H.C. Wainwright & Co.
6 questions for RYTM
Also covers: ABEO, ACOG, AQST +20 more
SF
Seamus Fernandez
Guggenheim Partners
6 questions for RYTM
Also covers: AMLX, ARCT, ARQT +9 more
Paul Matteis
Stifel
4 questions for RYTM
Also covers: ABOS, ACAD, ALKS +11 more
PN
Philip Nadeau
TD Cowen
4 questions for RYTM
Also covers: ADVM, APLS, ATRA +13 more
TA
Tazeen Ahmad
Bank of America
4 questions for RYTM
Also covers: ACAD, ALNY, APLS +20 more
CJ
Corinne Johnson
Goldman Sachs
3 questions for RYTM
Also covers: ALT, AMLX, GERN +5 more
DD
Dennis Ding
Jefferies Financial Group Inc.
3 questions for RYTM
Also covers: ARDX, CARA, FOLD +5 more
Joseph Stringer
Needham & Company
3 questions for RYTM
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WI
Whitney Ijem
Canaccord Genuity Inc.
3 questions for RYTM
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FK
Faisal Khashid
Leary Partners
2 questions for RYTM
Also covers: KYTX
JW
John Woolburn
Citizens
2 questions for RYTM
JW
Jonathan Wolleben
JMP Securities, a Citizens Company
2 questions for RYTM
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LG
Leland Gershell
Oppenheimer & Co. Inc.
2 questions for RYTM
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MU
Michael Ulz
Morgan Stanley
2 questions for RYTM
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Mike Owles
Morgan Stanley
2 questions for RYTM
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Phil Nadal
TD Cowen
2 questions for RYTM
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Whitney Lem
Citi
2 questions for RYTM
Corinne Jenkins
Goldman Sachs
1 question for RYTM
Also covers: ACRS, ALEC, ATHA +5 more
DG
Dae Gon Ha
Stifel
1 question for RYTM
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JH
Jeff Hung
Morgan Stanley
1 question for RYTM
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JW
Jon Wolleben
Citizen JMP
1 question for RYTM
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YD
Yuchen Ding
H.C. Wainwright & Co.
1 question for RYTM
Also covers: ABUS, ARDX, CRNX
Recent press releases and 8-K filings for RYTM.
Rhythm Pharmaceuticals Announces Preliminary Q4 and Full Year 2025 Net Product Revenues and Upcoming Milestones
RYTM
Earnings
Guidance Update
Product Launch
- Rhythm Pharmaceuticals announced preliminary, unaudited net product revenues from global sales of IMCIVREE® (setmelanotide) of approximately $57 million for the fourth quarter of 2025, an 11% increase over Q3 2025, and approximately $194 million for the full year of 2025, a 50% increase from FY 2024.
- 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 has a March 20, 2026 PDUFA goal date for its sNDA for setmelanotide in acquired hypothalamic obesity, pending FDA approval for a U.S. launch.
- Rhythm Pharmaceuticals is on track to report topline data in the first quarter of 2026 from the 12-patient Japanese cohort of the setmelanotide Phase 3 trial in acquired hypothalamic obesity and from the Phase 3 EMANATE trial evaluating setmelanotide in genetically caused MC4R pathway diseases.
7 days ago
Rhythm Pharmaceuticals Announces Preliminary Q4 and Full Year 2025 Net Product Revenues and Upcoming Milestones
RYTM
Earnings
Guidance Update
New Projects/Investments
- Rhythm Pharmaceuticals announced preliminary unaudited net product revenues of approximately $57 million for Q4 2025, an 11% increase over Q3 2025, and $194 million for FY 2025, representing a 50% increase from FY 2024.
- U.S. sales contributed approximately 68% of Q4 2025 and 69% of FY 2025 preliminary net product revenues.
- Key upcoming milestones include a March 20, 2026 PDUFA goal date for setmelanotide in acquired hypothalamic obesity, and topline data readouts in the first quarter of 2026 for the Japanese cohort of the setmelanotide Phase 3 trial in acquired HO and the Phase 3 EMANATE trial.
- The company also anticipates announcing six-month results from the Phase 2 trial of setmelanotide in Prader-Willi syndrome in the first half of 2026 and initiating a pivotal Phase 3 trial for bivamelagon in acquired HO in 2026.
7 days ago
Rhythm Pharmaceuticals Announces Preliminary 2025 Revenues and Key Pipeline Milestones
RYTM
Earnings
Guidance Update
New Projects/Investments
- Rhythm Pharmaceuticals reported preliminary, unaudited Q4 2025 net revenues of approximately $57 million from global sales of IMCIVREE (setmelanotide), representing an 11% sequential increase from Q3 2025, and full-year 2025 net revenues of approximately $194 million.
- As of September 30, 2025, the company held $416.1 million in cash, cash equivalents, and short-term investments, which is projected to fund planned operations for at least 24 months.
- A PDUFA goal date of March 20, 2026, is set for setmelanotide in conditions associated with acquired hypothalamic obesity.
- Setmelanotide achieved a -19.8% placebo-adjusted difference in BMI reduction from baseline (P<0.0001) in the Phase 3 acquired hypothalamic obesity trial.
- Upcoming milestones include Q1 2026 topline data from the Japanese cohort of the Phase 3 acquired hypothalamic obesity trial and the Phase 3 EMANATE trial.
7 days ago
Rhythm Pharmaceuticals Announces Positive Preliminary Phase 2 Results for Setmelanotide in Prader-Willi Syndrome
RYTM
New Projects/Investments
Guidance Update
- Rhythm Pharmaceuticals reported positive preliminary results from its Phase 2 trial evaluating setmelanotide in patients with Prader-Willi Syndrome (PWS).
- The trial observed reductions in BMI and hyperphagia in patients treated with setmelanotide at Month 3 (n=8) and Month 6 (n=5).
- These promising preliminary results are supportive of advancing setmelanotide into a Phase 3 registrational trial for PWS.
- The study indicated a favorable safety profile, with no deaths, serious adverse events, or drug withdrawals reported among the 18 patients.
- Rhythm Pharmaceuticals has also initiated a Phase 1 study (Part D) to evaluate RM-718 in PWS, with the first patient screening anticipated in December 2025.
Dec 11, 2025, 1:00 PM
Rhythm Pharmaceuticals Reports Positive Preliminary Phase 2 Data for Setmelanotide in PWS and Plans Phase 3
RYTM
New Projects/Investments
- Rhythm Pharmaceuticals shared preliminary positive data from its open-label phase 2 study of setmelanotide in patients with Prader-Willi Syndrome (PWS), showing positive changes in BMI and HQCT at three and six months.
- The company plans to proceed to a phase 3 program for setmelanotide in PWS, with a target of achieving a 5% reduction in BMI at one year.
- Enrollment for the phase 2 study is complete with 18 patients treated, and data from the first eight patients at three months and five patients at six months were presented.
- A new Part D arm has been initiated in the phase 1 study of their weekly MC4R agonist, RM718, to test it in up to 20 PWS patients.
- Full six-month data from the setmelanotide PWS trial is expected to be disclosed in the first half of 2026.
Dec 11, 2025, 1:00 PM
Rhythm Pharmaceuticals Reports Positive Preliminary Phase II Data for Setmelanotide in PWS and Advances RM-718
RYTM
- Rhythm Pharmaceuticals announced preliminary positive data from its open-label Phase II study of setmelanotide in patients with Prader-Willi Syndrome (PWS), showing positive changes in BMI and HQ-CT scores at three and six months.
- The company plans to proceed to a Phase III program in PWS, with a goal of achieving a 5% reduction in BMI at one year.
- Among the first eight patients reaching three months, six experienced a BMI decrease (ranging from -1.3% to -4.8%), and two of the five patients reaching six months achieved a 5% BMI reduction.
- Additionally, Rhythm Pharmaceuticals initiated a Part D arm in the Phase I study of its weekly MC4R agonist, RM-718, to evaluate it in up to 20 PWS patients, with the first patient screening anticipated this month.
- Setmelanotide demonstrated good tolerability in the study, with hyperpigmentation and injection site reactions being the most common adverse events.
Dec 11, 2025, 1:00 PM
Rhythm Pharmaceuticals Announces Positive Preliminary Phase 2 Data for Setmelanotide in Prader-Willi Syndrome
RYTM
New Projects/Investments
- On December 11, 2025, Rhythm Pharmaceuticals announced positive preliminary results from its exploratory Phase 2 trial of setmelanotide in patients with Prader-Willi syndrome (PWS).
- The trial demonstrated BMI and hyperphagia reductions in patients treated with setmelanotide, with 6 of 8 patients achieving BMI reductions at Month 3 and 6 of 7 evaluable patients showing meaningful reductions in Hyperphagia Questionnaire for Clinical Trials (HQ-CT) scores at Month 3.
- Rhythm Pharmaceuticals plans to advance setmelanotide into a Phase 3 registrational trial for PWS and has initiated a Part D arm in a Phase 1 trial to evaluate RM-718, a weekly MC4R agonist, in PWS patients, with the first patient screening for RM-718 anticipated in December 2025.
- Seventeen of the 18 patients enrolled in the Phase 2 trial remain on active setmelanotide therapy, and safety and tolerability results have been consistent with the drug's established clinical profile.
Dec 11, 2025, 12:50 PM
Rhythm Pharmaceuticals Announces Positive Preliminary Phase 2 Results for Setmelanotide in Prader-Willi Syndrome
RYTM
New Projects/Investments
- Rhythm Pharmaceuticals announced positive preliminary results from its exploratory Phase 2 trial of setmelanotide in patients with Prader-Willi syndrome (PWS), showing reductions in BMI and hyperphagia at Month 3 (n=8) and Month 6 (n=5).
- The company plans to advance setmelanotide into a Phase 3 registrational trial for PWS, pending successful completion of the Phase 2 trial.
- Additionally, Rhythm initiated a Phase 1, Part D study to evaluate its weekly MC4R agonist RM-718 in PWS patients, with the first patient screening anticipated in December 2025.
- 17 of the 18 enrolled patients remain on active setmelanotide therapy, with safety and tolerability consistent with its established clinical profile.
Dec 11, 2025, 12:30 PM
Rhythm Pharmaceuticals to Announce Preliminary Setmelanotide Phase 2 Data for Prader-Willi Syndrome
RYTM
New Projects/Investments
- Rhythm Pharmaceuticals will host a conference call and webcast on Thursday, December 11 at 8:00 a.m. ET to disclose preliminary data.
- This data is from its exploratory Phase 2 trial of setmelanotide in patients with Prader-Willi syndrome (PWS).
- Setmelanotide (IMCIVREE), the company's lead asset and an MC4R agonist, is already approved for other rare neuroendocrine diseases in the U.S., EU, and UK.
Dec 10, 2025, 9:01 PM
Rhythm Pharmaceuticals Discusses PDUFA Extension, Commercial Strategy, and Pipeline Updates
RYTM
Product Launch
Guidance Update
New Projects/Investments
- Rhythm Pharmaceuticals received a three-month PDUFA extension for setmelanotide in Hypothalamic Obesity (HO) due to a major amendment request from the FDA, pushing the potential approval date to March 2026.
- The company views the extended time as advantageous for commercial preparation, particularly for a rare disease launch like HO, which has an estimated 7,000 to 10,000 patients in the U.S..
- Rhythm Pharmaceuticals expects to release data for setmelanotide in Prader-Willi Syndrome (PWS) before the Christmas break, with the CEO assigning a 50-50 probability of success due to the disease's complexity.
- The company is also developing next-generation assets, including 718, a more potent and specific MC4R agonist, with enrollment for the open-label first part expected to complete in Q1 2026 and data readout by mid-year 2026.
Nov 12, 2025, 2:30 PM
Quarterly earnings call transcripts for RHYTHM PHARMACEUTICALS.
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