Financials
Cash Data
- Monthly Burn
- Burn Trend
- Dilution Risk
- SEC Filing
Key Stats
Upcoming Catalysts
FDA decisions, readouts and PDUFA dates · scored by probability of approval
| Catalyst | Drug / Treatment | Stage | Prob. of Approval | Description | Drug Type | Therapeutic Area | Source |
|---|---|---|---|---|---|---|---|
PDUFA 2026 | Example Drug Treatment for example condition requiring FDA review | Phase 3 | Small Molecule | Oncology | - |
RYTM Catalyst Timeline
Dated clinical, regulatory and corporate events for Rhythm Pharmaceuticals, Inc.
Catalyst Timeline
Dated clinical, regulatory & corporate events for Rhythm Pharmaceuticals, Inc.
Upcoming catalysts 2
Event history 50
Past FDA Catalysts and PDUFA Decisions
How RYTM actually traded into and out of each decision
| Date | Drug | Catalyst | Stage | Reaction | Event Move % | Best Trade % |
|---|---|---|---|---|---|---|
| 2026-09-08 | setmelanotide (IMCIVREE) | Phase 3 data readout | Phase 3 |
Drug Pipeline Intelligence
| Product | Revenue | Prior period | Change |
|---|---|---|---|
| IMCIVREE |
| Drug | Indication | Phase | PTRS | rNPV | Status | Enroll | Velocity | Design | Est. Completion | ML Signal | Last Change |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Setmelanotide Small moleculeMarketedNCT05774756 | Hypothalamic Obesity | Phase 3 | ACTIVE NOT_RECRUITING | 200 | Apr 16, 2027 | ||||||
| Setmelanotide Small moleculeNCT06772597 | Prader-Willi Syndrome | Phase 2 | ACTIVE NOT_RECRUITING | 58 | Oct 31, 2027 | ||||||
| Bivamelagon Small moleculeNCT07156578 | Hypothalamic Obesity | Phase 2 | ENROLLING BY_INVITATION | 25 | Apr 15, 2028 | ||||||
| RM-718 Small moleculeNCT06239116 | Hypothalamic Obesity | Phase 1 | ACTIVE NOT_RECRUITING | 111 | Nov 1, 2028 | ||||||
| Setmelanotide Small moleculeMarketedNCT05093634 | Obesity | Phase 3 | COMPLETED | 296 | Jun 30, 2026 | ||||||
| Setmelanotide Small moleculeMarketedNCT03651765 | Obesity Associated With Defects in Leptin-melanocortin Pathway | Phase 3 | COMPLETED | 233 | Jan 9, 2025 | ||||||
| Setmelanotide Small moleculeMarketedNCT04966741 | Bardet-Biedl Syndrome | Phase 3 | COMPLETED | 83 | Nov 8, 2024 | ||||||
| Setmelanotide Small moleculeMarketedNCT03287960 | Leptin Receptor Deficiency Obesity | Phase 3 | COMPLETED | 15 | Sep 25, 2020 | ||||||
| Setmelanotide Small moleculeMarketedNCT02896192 | Pro-opiomelanocortin (POMC) Deficiency Obesity | Phase 3 | COMPLETED | 15 | May 25, 2020 | ||||||
| Setmelanotide Small moleculeMarketedNCT01749137 | Overweight | Phase 2 | COMPLETED | 74 | Sep 28, 2013 | ||||||
| Setmelanotide Small moleculeMarketedNCT04963231 | Genetic Obesity | Phase 2 | COMPLETED | 377 | Sep 30, 2024 | ||||||
| Setmelanotide Small moleculeMarketedNCT03262610 | Hypertriglyceridemia | Phase 2 | COMPLETED | 1 | Jan 31, 2018 | ||||||
| Setmelanotide Small moleculeMarketedNCT02041195 | Overweight and Obesity | Phase 1 | COMPLETED | 99 | Dec 1, 2014 | ||||||
| Setmelanotide Small moleculeMarketedNCT04348175 | Renal Insufficiency | Phase 1 | COMPLETED | 32 | Apr 17, 2021 | ||||||
| LB54640 Small moleculeCompletedNCT06046443 | Hypothalamic Obesity | Phase 2 | COMPLETED | 28 | Feb 9, 2026 | ||||||
| RM-493 Small moleculeMarketedNCT01867437 | Obesity | Phase 1 | COMPLETED | 15 | Mar 1, 2014 | ||||||
| RM-493 Small moleculeMarketedNCT02431442 | Overweight | Phase 1 | COMPLETED | 57 | Jan 1, 2014 |
Clinical Trial Results
Readouts, endpoints and source filings for every RYTM program
| Drug Name | Indication | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
| setmelanotide BreakthroughPriorityOrphan | acquired hypothalamic obesity | Phase 3 | 2026-09-10 | -11.5% reduction in mean BMI from baseline (p <0.0001) in patients who reached 6 months (n=17); -13.4% reduction in mean BMI from baseline (p <0.001) in patients who reached 9 months (n=14); -10.5% reduction in mean BMI from baseline (p <0.01) in patients who reached 12 months (n=13); -9.0% reduction in BMI from baseline (p<0.13) in patients who reached 18 months (n=5); More than 88% of patients achieved a ≥0.2-point reduction in BMI z-score after 6, 9, or 12, and 18 months of treatment; 100% of patients achieving ≥0.2-point reduction in BMI z-score at 12 months (n=13) and 18 months (n=5); Metabolic syndrome z-BMI score mean change was -0.8 vs -0.2 for the placebo group (p=0.006) (n=35 vs n=19); The mean change in Lipid Accumulation Product (LAP) (n=41 vs n=22) from baseline was -25.6 compared with +3.6 for the placebo group (p<0.0001); The mean change in Triglyceride-Glucose Waist Circumference Index (TyG-WC) (n=38 vs n=22) was -116.8 vs +34.0 for the placebo group (p<0.0001)Read More | Rhythm Pharmaceuticals Announces New Data Presentations at the European Society for Paediatric Endocrinology MeetingRead More |
Inside Trades
| Insider | Side | Shares | Price | Value | Date |
|---|---|---|---|---|---|
| Meeker David PDirector, Officer (President and CEO) | Option | 50,000 289,258 held | $6.05 | 09/14/2026 |
Hedge Fund 13F Activity
Hedge Funds invested in RYTM
| Fund | % of Portfolio | Current MV | Shares Owned | Activity |
|---|---|---|---|---|
| RA CAPITAL MANAGEMENT, L.P. | 6.4 % (4.9 %) | 740.22 M | 6.67 M |
RYTM Institutional Ownership Trends
RYTM Short Interest
Shares sold short, counted twice a month.
Options Data
Option Volume
Option Chain Statistics
| Expiry | Call Vol | Put Vol | Vol P/C | Call OI | Put OI | OI P/C | IV Call | IV Call OI-Wtd | IV Call Vol-Wtd | IV Put | IV Put OI-Wtd | IV Put Vol-Wtd |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2026-11-20 | ||||||||||||
Real-Time Option Chain
| Calls | Strike | Puts | ||||
|---|---|---|---|---|---|---|
| Last | Vol | OI | Last | Vol | OI | |
| No data available | ||||||
Calls vs Puts by Expiry
Competitive positioning
How RYTM ranks across every disease it competes in
RYTM News
Rhythm Pharmaceuticals to Report Third Quarter 2026 Financial Results on Tuesday, November 3, 2026
Rhythm Pharmaceuticals will host a conference call on November 3, 2026, to discuss its Q3 financial results. The company will also participate in investor conferences on November 9 and 11, 2026. Rhythm's lead product, setmelanotide, is approved for treating rare neuroendocrine diseases and obesity-related conditions.
Read more →Rhythm Pharmaceuticals Announces Commercial Launch of IMCIVREE® (setmelanotide) in Japan for Patients with Acquired Hypothalamic Obesity
Rhythm Pharmaceuticals has launched IMCIVREE (setmelanotide) in Japan for acquired hypothalamic obesity, following its approval by the Ministry of Health, Labour and Welfare. This marks the first approved treatment for this condition in Japan. The launch is supported by data from a pivotal Phase 3 trial demonstrating significant efficacy in reducing body mass index.
Read more →Rhythm Pharmaceuticals Announces Health Canada Approval of IMCIVREE® (setmelanotide) for Weight Management in Adult and Pediatric Patients 4 years of Age and Older with Acquired Hypothalamic Obesity
Rhythm Pharmaceuticals has received Health Canada approval for IMCIVREE (setmelanotide) to manage weight in patients aged 4 and older with acquired hypothalamic obesity. This approval follows the drug's initial approval for obesity due to Bardet-Biedl syndrome. The decision is based on positive results from the Phase 3 TRANSCEND trial, which demonstrated significant weight loss in participants.
Read more →Rhythm Pharmaceuticals Announces New Data Presentations at the European Society for Paediatric Endocrinology Meeting
Rhythm Pharmaceuticals presented new data at the European Society for Paediatric Endocrinology Meeting, highlighting the efficacy of setmelanotide in treating acquired hypothalamic obesity in pediatric patients. Real-world data showed significant reductions in BMI and hunger scores over 18 months. Additionally, Phase 3 analyses indicated improvements in various cardiometabolic risk indices, supporting the treatment's potential benefits.
Read more →Rhythm Pharmaceuticals Announces MHLW Approval of IMCIVREE® (setmelanotide) for Patients with Acquired Hypothalamic Obesity (HO) in Japan
Rhythm Pharmaceuticals has received marketing authorization from Japan's MHLW for IMCIVREE (setmelanotide) to treat acquired hypothalamic obesity (HO). This approval marks the first therapy for this condition in Japan, with a commercial launch expected by the end of 2026, pending pricing. The decision is supported by positive results from the Phase 3 TRANSCEND trial.
Read more →Rhythm Pharmaceuticals Announces Appointment of Manher (AJ) Joshi as Chief Medical Officer
Rhythm Pharmaceuticals has appointed Dr. Manher 'AJ' Joshi as Chief Medical Officer, effective August 17, 2026. Dr. Joshi brings over two decades of experience in biopharmaceutical development, which will aid Rhythm's growth and focus on rare neuroendocrine diseases. The company aims to enhance its leadership in this field and advance its clinical pipeline.
Read more →Rhythm Pharmaceuticals Announces IMCIVREE® (setmelanotide) Receives Expanded Marketing Authorization in the United Kingdom for Treatment of Obesity and Control of Hunger in Patients with Acquired Hypothalamic Obesity due to Hypothalamic Injury or Impairment
Rhythm Pharmaceuticals has announced that its drug IMCIVREE® (setmelanotide) has received expanded marketing authorization from the MHRA in the United Kingdom. This authorization is specifically for the treatment of obesity and control of hunger in patients aged 4 years and older who suffer from acquired hypothalamic obesity due to hypothalamic injury or impairment. This marks a significant advancement in addressing this rare condition.
Read more →Rhythm Pharmaceuticals Announces Participation in Upcoming Investor Conferences
Rhythm Pharmaceuticals announced that its CEO David Meeker and CFO Hunter Smith will participate in fireside chats at three upcoming investor conferences. These events include the Canaccord Genuity 46th Annual Growth Conference, the Wells Fargo 21st Annual Healthcare Conference, and the Morgan Stanley 24th Annual Global Healthcare Conference. The discussions will be webcasted, allowing wider access to the company's updates.
Read more →Rhythm Pharmaceuticals Reports Second Quarter 2026 Financial Results and Business Update
Rhythm Pharmaceuticals reported strong financial results for Q2 2026, with net product revenue from IMCIVREE reaching $71.3 million. The U.S. launch of IMCIVREE for acquired hypothalamic obesity has seen over 400 patient start forms since FDA approval. Positive clinical trial results and upcoming launches in Japan and Europe are expected to drive further growth.
Read more →Rhythm Pharmaceuticals Announces Preliminary Data from Phase 2 Trial that Showed RM-718 Demonstrated Positive Efficacy Signal in Acquired Hypothalamic Obesity
Rhythm Pharmaceuticals announced preliminary data from its Phase 2 trial of RM-718, an MC4R agonist for acquired hypothalamic obesity. The trial showed a significant mean BMI reduction of 11.6% after 16 weeks. The results are comparable to existing treatments, with limited adverse effects reported. Management will discuss these findings in a conference call.
Read more →Rhythm Pharmaceuticals to Report Second Quarter 2026 Financial Results on Tuesday, August 4, 2026
Rhythm Pharmaceuticals will host a live conference call on August 4, 2026, to report its second quarter financial results and provide a corporate update. The company focuses on rare neuroendocrine diseases and has received FDA and European Commission approvals for its lead product, setmelanotide. The call will be accessible via their website, with an archived version available for 30 days.
Read more →Rhythm Pharmaceuticals Announces The New England Journal of Medicine Publication of Phase 3 TRANSCEND Trial Results in Acquired Hypothalamic Obesity
Rhythm Pharmaceuticals announced the publication of Phase 3 TRANSCEND trial results in The New England Journal of Medicine. The trial demonstrated significant weight loss and hunger reduction in patients with acquired hypothalamic obesity treated with setmelanotide. The FDA has approved setmelanotide as the first therapy for this condition, highlighting its potential impact on patient care.
Read more →Rhythm Pharmaceuticals Announces Multiple New Data Presentations from MC4R Agonists in Acquired Hypothalamic Obesity (HO), Bardet-Biedl Syndrome (BBS) and Prader-Willi Syndrome (PWS) at ENDO 2026
Rhythm Pharmaceuticals presented new data at ENDO 2026, showcasing the effectiveness of MC4R agonists, particularly setmelanotide and bivamelagon, in treating acquired hypothalamic obesity (HO), Bardet-Biedl syndrome (BBS), and Prader-Willi syndrome (PWS). The data revealed significant weight loss and improvements in hunger measures, with a focus on long-term efficacy and real-world outcomes. However, some adverse events were reported, including nausea and hypersensitivity reactions.
Read more →Rhythm Pharmaceuticals Presents Positive Interim Six-month Data from Phase 2 Trial of Setmelanotide in Patients with Prader-Willi Syndrome (PWS) at ENDO 2026
Rhythm Pharmaceuticals presented positive interim data from a Phase 2 trial of setmelanotide for Prader-Willi syndrome (PWS) at ENDO 2026. The results showed significant reductions in BMI and fat mass, alongside improvements in hyperphagia and anxiety. These findings support the rationale for advancing to Phase 3 trials. The ongoing study includes 17 patients, with promising outcomes noted at the six-month mark.
Read more →Rhythm Pharmaceuticals to Announce Interim Six-Month Phase 2 Results Evaluating Setmelanotide in Patients with Prader-Willi Syndrome
Rhythm Pharmaceuticals will announce interim results from its Phase 2 trial of setmelanotide in patients with Prader-Willi syndrome on June 13, 2026. The conference call will feature insights from company executives and a pediatric endocrinologist. Setmelanotide is already approved for certain obesity-related conditions, highlighting its potential impact on rare diseases.
Read more →Rhythm Pharmaceuticals Announces Seven Abstracts Accepted for Presentation at ENDO 2026
Rhythm Pharmaceuticals announced that seven abstracts, including four late-breaking ones, have been accepted for presentation at ENDO 2026, scheduled for June 13-16, 2026. Key presentations will focus on the efficacy of setmelanotide in treating Prader-Willi syndrome and acquired hypothalamic obesity. The company will also host its inaugural MOMENTUM meeting to discuss advancements in MC4R pathway diseases.
Read more →Rhythm Pharmaceuticals Announces Publication of New Bardet-Biedl Syndrome Diagnostic Algorithm in the American Journal of Medical Genetics
Rhythm Pharmaceuticals announced the publication of a new diagnostic algorithm for Bardet-Biedl syndrome (BBS) in the American Journal of Medical Genetics. This evidence-based algorithm aims to simplify and expedite the diagnosis of BBS, integrating advances in genetic testing and clinical understanding. It is designed to assist healthcare practitioners in making timely diagnoses across various clinical presentations.
Read more →rhythm pharmaceuticals announces participation in upcoming investor conferences
rhythm pharmaceuticals announces participation in upcoming investor conferences
Read more →Rhythm Pharmaceuticals Announces New Data Presentations at the 2026 European Congress of Endocrinology
Rhythm Pharmaceuticals announced the presentation of new data on setmelanotide at the 2026 European Congress of Endocrinology, highlighting its effectiveness for treating acquired hypothalamic obesity. Real-world data showed significant BMI reductions in patients, along with improvements in cardiometabolic risk factors. Additionally, research underscored the issue of underreporting hyperphagia severity in affected individuals. Overall, the findings support setmelanotide's role as a therapeutic option for patients with this rare neuroendocrine condition.
Read more →Rhythm Pharmaceuticals Announces Participation in Upcoming Bank of America Global Healthcare Conference
Rhythm Pharmaceuticals announced that its CEO, Dr. David Meeker, will participate in a fireside chat at the Bank of America Global Healthcare Conference on May 13, 2026. The event will be webcasted, allowing broader access to the discussion. Rhythm is dedicated to addressing rare neuroendocrine diseases and has received FDA and European approvals for its lead product, setmelanotide.
Read more →