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Rhythm Pharmaceuticals, Inc.

RYTMFDA catalysts, PDUFA dates & pipeline intelligence
$89.47
▲ +0.2 · +0.22%

Financials

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Total Assets
Total Liabilities
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52W LOW $74.5052W HIGH $122.20
Volume
289.45 K
Value Traded
85.27 M
Short % Float
16.28%
Days to Cover
14.1
-0.81%Week
-9.22%1 Month
-17.19%3 Month
+6.28%6 Month
+305.73%5 Year
+278.46%All Time

Cash Data

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Key Stats

Market Cap
6.13 B
EPS (TTM)
-2.98
P/E Ratio
-
Ent. Value
5.91 B
Total Shares
68.50 M
Float Shares
66.13 M
Insiders
3.96%
Institutions
110.04%

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 3Small MoleculeOncology-
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Every FDA decision, readout and PDUFA date, with drug type, therapeutic area and a PoA score you can trade on.
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PoA blends historical approval base rates, trial design score and FDA review track record.

RYTM Catalyst Timeline

Dated clinical, regulatory and corporate events for Rhythm Pharmaceuticals, Inc.

Catalyst Timeline

Dated clinical, regulatory & corporate events for Rhythm Pharmaceuticals, Inc.

534Total events
11Upcoming
148Tier-1 (high impact)
2017 to 2027Coverage

Upcoming catalysts 2

T2Enrollment Complete
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SetmelanotideApproved
T2Enrollment Complete
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RM-718

Event history 50

▲Product LaunchSetmelanotideApprovedPost-Market
Commercial launch of IMCIVREE in Japan for acquired hypothalamic obesity
acquired hypothalamic obesitysource ↗
▲FDA ApprovalSetmelanotideApprovedFDA Decision
Health Canada approves IMCIVREE for weight management in acquired hypothalamic obesity
acquired hypothalamic obesitysource ↗
▲Poster PresentationSetmelanotideApprovedPresentation
Poster: Real-world BMI and hunger data for up to 18 months in paediatric acquired HO in France
acquired hypothalamic obesitysource ↗
▲Oral PresentationSetmelanotideApprovedPresentation
Oral: Impact of setmelanotide on metabolic index scores in paediatric acquired HO (Phase 3 post-hoc)
acquired hypothalamic obesitysource ↗
●Long Term DataSetmelanotideApprovedClinical Data
Oral/poster: Weight outcomes at 5-6 years of setmelanotide in paediatric POMC/LEPR deficiency or BBS
POMC or LEPR deficiency or Bardet-Biedl syndrome and obesitysource ↗
●Subgroup AnalysisSetmelanotideApprovedClinical Data
Post hoc analysis: Impact of setmelanotide on metabolic syndrome severity and risk score in acquired HO
acquired hypothalamic obesitysource ↗
●Poster PresentationPresentation
Poster: Association of clinical features of BBS in patients with obesity and biallelic BBS variants
Bardet-Biedl syndrome and obesitysource ↗
●R&D DayPresentation
Rhythm-sponsored expert-led satellite symposium at ESPE 2026
rare MC4R pathway diseasessource ↗
▲Oral PresentationSetmelanotideApprovedPresentation
Oral: Impact of setmelanotide on metabolic index scores in paediatric acquired HO (Phase 3 post-hoc)
acquired hypothalamic obesitysource ↗
▲Poster PresentationSetmelanotideApprovedPresentation
Poster: Real-world BMI and hunger data for up to 18 months in paediatric acquired HO in France
acquired hypothalamic obesitysource ↗
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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 %
2026-09-08setmelanotide (IMCIVREE) Phase 3 data readout Phase 3
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Reaction: 30 trading days around the event · Event Move: close to close on decision day · Best Trade: peak run-up from entry 10 days before the decision

Drug Pipeline Intelligence

Pipeline Score
Pipeline Value
Commercial Value
Valuation Signal
4
Drugs Scored
rNPV / MCap
Top Drug
Top 38%
Small Cap
(rank 250 of 657)
Percentile Rank
Commercial products (revenue basis: trailing 4 quarters of total revenue (10-K and 10-Q), to Jun 2026; product lines: last four quarters to Jun 2026 (10-K and 10-Q))
ProductRevenuePrior periodChange
IMCIVREE
Showing 17 of 23 assets
DrugIndicationPhasePTRSrNPVStatusEnrollVelocityDesignEst. CompletionML SignalLast Change
Setmelanotide Small moleculeMarketedNCT05774756Hypothalamic ObesityPhase 3 ACTIVE NOT_RECRUITING 200Apr 16, 2027
Setmelanotide Small moleculeNCT06772597Prader-Willi SyndromePhase 2 ACTIVE NOT_RECRUITING 58Oct 31, 2027
Bivamelagon Small moleculeNCT07156578Hypothalamic ObesityPhase 2 ENROLLING BY_INVITATION 25Apr 15, 2028
RM-718 Small moleculeNCT06239116Hypothalamic ObesityPhase 1 ACTIVE NOT_RECRUITING 111Nov 1, 2028
Setmelanotide Small moleculeMarketedNCT05093634ObesityPhase 3 COMPLETED 296Jun 30, 2026
Setmelanotide Small moleculeMarketedNCT03651765Obesity Associated With Defects in Leptin-melanocortin PathwayPhase 3 COMPLETED 233Jan 9, 2025
Setmelanotide Small moleculeMarketedNCT04966741Bardet-Biedl SyndromePhase 3 COMPLETED 83Nov 8, 2024
Setmelanotide Small moleculeMarketedNCT03287960Leptin Receptor Deficiency ObesityPhase 3 COMPLETED 15Sep 25, 2020
Setmelanotide Small moleculeMarketedNCT02896192Pro-opiomelanocortin (POMC) Deficiency ObesityPhase 3 COMPLETED 15May 25, 2020
Setmelanotide Small moleculeMarketedNCT01749137OverweightPhase 2 COMPLETED 74Sep 28, 2013
Setmelanotide Small moleculeMarketedNCT04963231Genetic ObesityPhase 2 COMPLETED 377Sep 30, 2024
Setmelanotide Small moleculeMarketedNCT03262610HypertriglyceridemiaPhase 2 COMPLETED 1Jan 31, 2018
Setmelanotide Small moleculeMarketedNCT02041195Overweight and ObesityPhase 1 COMPLETED 99Dec 1, 2014
Setmelanotide Small moleculeMarketedNCT04348175Renal InsufficiencyPhase 1 COMPLETED 32Apr 17, 2021
LB54640 Small moleculeCompletedNCT06046443Hypothalamic ObesityPhase 2 COMPLETED 28Feb 9, 2026
RM-493 Small moleculeMarketedNCT01867437ObesityPhase 1 COMPLETED 15Mar 1, 2014
RM-493 Small moleculeMarketedNCT02431442OverweightPhase 1 COMPLETED 57Jan 1, 2014
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Clinical Trial Results

Readouts, endpoints and source filings for every RYTM program

Drug Name Indication Phase Date Trial Results SummaryTitleSource
setmelanotide
BreakthroughPriorityOrphan
acquired hypothalamic obesityPhase 32026-09-10-11.5% 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 MoreRhythm Pharmaceuticals Announces New Data Presentations at the European Society for Paediatric Endocrinology MeetingRead More
Scroll for more · summaries link to the source press release
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Inside Trades

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InsiderSideSharesPriceValueDate
Meeker David PDirector, Officer (President and CEO)Option 50,000 289,258 held$6.05 09/14/2026
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Hedge Fund 13F Activity

Fund % of Portfolio Current MV Shares Owned Activity
RA CAPITAL MANAGEMENT, L.P. 6.4 % (4.9 %) 740.22 M 6.67 M
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RYTM Institutional Ownership Trends

RYTM Short Interest

Shares sold short, counted twice a month.

16.28%
Short % of Float
of tradable shares sold short
10.8M
Shares Sold Short
+4.7% vs prior count
14.1 Very high
Days to Cover
trading days of normal volume to buy every short share back
761.7K
Avg Daily Volume
the average used for days to cover
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Options Data

Option Volume

Open Interest
Call OI
Put OI
Put-Call Ratio
OI 30-day avg
Today vs avg
Option Volume
Call Vol
Put Vol
Put-Call Ratio
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Today vs avg

Option Chain Statistics

ExpiryCall VolPut VolVol P/CCall OIPut OIOI P/CIV CallIV Call OI-WtdIV Call Vol-WtdIV PutIV Put OI-WtdIV Put Vol-Wtd
2026-11-20
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Real-Time Option Chain

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Calls vs Puts by Expiry

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Competitive positioning

How RYTM ranks across every disease it competes in

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See how RYTM ranks against every competitor across each disease it develops in: phase, best drug, trials and likelihood of approval.
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RYTM News

RYTM
Oct 21, 2026
RYTMConferences/Events

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 →
RYTM
Oct 13, 2026
RYTMFDA Updates

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 →
RYTM
Sep 22, 2026
RYTMFDA Updates

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.

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RYTM
Sep 10, 2026
RYTMConferences/Events

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 →
RYTM
Aug 24, 2026
RYTMFDA Updates

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.

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RYTM
Aug 17, 2026
RYTMGeneral

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.

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RYTM
Aug 11, 2026
RYTMFDA Updates

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 →
RYTM
Aug 4, 2026
RYTMConferences/Events

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.

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RYTM
Aug 4, 2026
RYTMGeneral

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.

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RYTM
Aug 4, 2026
RYTMPhases

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.

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RYTM
Jul 21, 2026
RYTMConferences/Events

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 →
RYTM
Jul 8, 2026
RYTMPhases

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 →
RYTM
Jun 15, 2026
RYTMConferences/Events

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 →
RYTM
Jun 13, 2026
RYTMPhases

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.

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RYTM
Jun 12, 2026
RYTMPhases

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 →
RYTM
May 29, 2026
RYTMConferences/Events
▼ -5%on this news

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.

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RYTM
May 28, 2026
RYTMGeneral

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.

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RYTM
May 26, 2026
RYTMConferences/Events

rhythm pharmaceuticals announces participation in upcoming investor conferences

rhythm pharmaceuticals announces participation in upcoming investor conferences

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RYTM
May 12, 2026
RYTMConferences/Events

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 →
RYTM
May 6, 2026
RYTMConferences/Events

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 →

About Rhythm Pharmaceuticals, Inc.

Boston, MA 414 employees rhythmtx.com
Headquarters222 BERKELEY STREET, BOSTON, MA, 02116
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