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
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Raghuram Selvaraju
H.C. Wainwright & Co.
6 questions for RYTM
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SF
Seamus Fernandez
Guggenheim Partners
6 questions for RYTM
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Paul Matteis
Stifel
4 questions for RYTM
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Philip Nadeau
TD Cowen
4 questions for RYTM
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TA
Tazeen Ahmad
Bank of America
4 questions for RYTM
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Corinne Johnson
Goldman Sachs
3 questions for RYTM
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Dennis Ding
Jefferies Financial Group Inc.
3 questions for RYTM
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Joseph Stringer
Needham & Company
3 questions for RYTM
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Whitney Ijem
Canaccord Genuity Inc.
3 questions for RYTM
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Faisal Khashid
Leary Partners
2 questions for RYTM
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John Woolburn
Citizens
2 questions for RYTM
JW
Jonathan Wolleben
JMP Securities, a Citizens Company
2 questions for RYTM
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Leland Gershell
Oppenheimer & Co. Inc.
2 questions for RYTM
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Michael Ulz
Morgan Stanley
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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
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Dae Gon Ha
Stifel
1 question for RYTM
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Jeff Hung
Morgan Stanley
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Jon Wolleben
Citizen JMP
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Yuchen Ding
H.C. Wainwright & Co.
1 question for RYTM
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Recent press releases and 8-K filings for RYTM.
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
Rhythm Pharmaceuticals Provides Update on AHO Approval Timeline and Pipeline
RYTM
Product Launch
New Projects/Investments
Guidance Update
- Rhythm Pharmaceuticals' CEO discussed the MC4 axis biology and its benefits in genetic and hypothalamic obesity (AHO), noting that the number of conditions affecting this pathway is larger than initially thought.
- The PDUFA date for AHO approval was extended to March 2025 due to an FDA request for a sensitivity analysis, which showed no difference in results. The commercial team is fully hired and the additional three months are considered advantageous for the rare disease launch.
- The estimated patient population for AHO in the U.S. is now 7,000-10,000, with growing confidence based on claims analyses. Setmelanotide has demonstrated better efficacy in AHO patients compared to GLP-1s, even in those who previously did not respond to GLP-1s.
- The company plans to release Prader-Willi Syndrome (PWS) data before Christmas break and aims to complete enrollment for the open-label part of its next-generation asset, 718, in Q1 2026, with results expected by mid-year.
Nov 12, 2025, 2:30 PM
Rhythm Pharmaceuticals Discusses PDUFA Extension and Pipeline Updates
RYTM
Guidance Update
New Projects/Investments
- Rhythm Pharmaceuticals received a three-month PDUFA date extension for its AHO application, pushing the decision to March 20, 2026, due to a major amendment request from the FDA. The company views the additional time as advantageous for preparing the commercial organization for launch.
- The company estimates the hypothalamic obesity (HO) patient population in the U.S. to be between 7,000 and 10,000, with increasing confidence driven by claims analyses.
- Management emphasized the differentiation of setmelanotide from GLP-1s in treating HO, noting that setmelanotide corrects the underlying hormonal deficiency, leading to significant weight loss where GLP-1s often show modest or no response.
- Rhythm plans to release Prader-Willi syndrome (PWS) data before the Christmas break and expects to complete enrollment for the open-label part of the 718 trial in Q1 2026, with data readout by mid-year.
- The company is also excited about commercial opportunities in Europe and Japan, noting similar epidemiology to the U.S. in Europe and a surprisingly high prevalence in Japan.
Nov 12, 2025, 2:30 PM
Rhythm Pharmaceuticals Presents Positive Setmelanotide Data at ObesityWeek 2025
RYTM
New Projects/Investments
- Rhythm Pharmaceuticals presented four data sets at ObesityWeek® 2025, highlighting positive results for its lead asset, setmelanotide.
- Phase 3 TRANSCEND trial data showed setmelanotide achieved significant BMI reductions in patients with acquired hypothalamic obesity, including a -27.1% mean placebo-adjusted difference when used with GLP-1 therapy and -19.0% without GLP-1 therapy.
- The presentations also indicated that setmelanotide treatment led to meaningful improvements in cardiometabolic health and patient-reported outcomes, such as hunger, weight, energy levels, and physical activity.
- Setmelanotide (IMCIVREE®) is currently approved in the U.S., EU, and UK for specific rare neuroendocrine diseases causing obesity, and Rhythm is advancing its clinical development for other rare diseases.
Nov 10, 2025, 12:00 PM
Quarterly earnings call transcripts for RHYTHM PHARMACEUTICALS.
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