Rhythm Pharmaceuticals to Announce Interim Six-Month Phase 2 Results Evaluating Setmelanotide in Patients with Prader-Willi Syndrome

Rhea-AI Summary

Rhythm Pharmaceuticals (Nasdaq: RYTM) will host a live conference call and webcast on Saturday, June 13 at 9:00 a.m. ET/8:00 a.m. CT to discuss interim six-month Phase 2 results evaluating setmelanotide in patients with Prader-Willi syndrome (PWS).

The webcast and 30-day replay will be available in the Investor Relations section under Events and Presentations on the Rhythm Pharmaceuticals website.

News Market Reaction – RYTM

+1.49%

+1.49% Session close to close

In the Jun 15 session, RYTM gained 1.49%, reflecting a mild positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement highlights an interim six‑month readout from a Phase 2 trial of setmelanotide in P...

Analysis

This announcement highlights an interim six‑month readout from a Phase 2 trial of setmelanotide in Prader‑Willi syndrome, continuing Rhythm’s strategy of regular data updates in rare neuroendocrine diseases. Recent filings show quarterly net product revenue of $60.1M but a net loss of $55.6M, supported by $340.6M in cash and an effective shelf with up to $200,000,000 in at‑the‑market capacity. Investors may watch the PWS efficacy and safety data, subsequent development plans, and any financing actions following the update.

Key Figures

Net product revenue: $60.1M Prior-year revenue: $37.7M Net loss: $55.6M +5 more

8 metrics

Net product revenue $60.1M Quarter ended March 31, 2026 (IMCIVREE sales)

Prior-year revenue $37.7M Net product revenue previous-year quarter

Net loss $55.6M Quarter ended March 31, 2026

Cash & investments $340.6M Cash, cash equivalents and short-term investments at March 31, 2026

Deferred royalty obligation $108.5M Royalty financing liability at March 31, 2026

2026 Non-GAAP opex $385–$415M Projected full-year 2026 operating expenses

ATM capacity $200,000,000 Common stock offering limit under at-the-market agreement

Registered conversion shares 2,395,831 shares Common shares issuable from Series A Convertible Preferred Stock under shelf

Historical Context

5 past events · Latest: May 29 (Positive)

Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
May 29	Scientific abstracts	Positive	-5.0%	Seven ENDO 2026 abstracts on setmelanotide and bivamelagon, including PWS and BBS.
May 28	Clinical publication	Positive	+1.7%	Publication of new evidence-based Bardet-Biedl syndrome diagnostic algorithm.
May 26	Investor conferences	Positive	+2.3%	Management participation in Jefferies and Goldman Sachs healthcare conferences.
May 12	Data presentations	Positive	+4.5%	Six posters, including new setmelanotide data at a major endocrinology congress.
May 06	Investor conference	Positive	+4.7%	CEO fireside chat at Bank of America Global Healthcare Conference with webcast access.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Recent Rhythm headlines have mostly been positive scientific or conference updates, with share reactions typically positive but with one notable negative reaction to abstract-related news.

Recent Company History

Over the past six weeks, Rhythm has highlighted expanding clinical and commercial momentum. Updates included new data presentations on setmelanotide at the European Congress of Endocrinology (May 12), multiple investor conference appearances, and diagnostic and abstract acceptances in Bardet‑Biedl and Prader‑Willi syndromes. Share reactions to these largely positive items were usually favorable, though the ENDO 2026 abstracts on May 29 coincided with a -5.01% move. Today’s upcoming PWS Phase 2 interim results fit this pattern of frequent data‑driven communication.

Key Terms

phase 2, prader-willi syndrome, schedule 13g, series a convertible preferred stock, +4 more

8 terms

phase 2 medical

"interim six-month results from the Company’s Phase 2 trial evaluating setmelanotide"

Phase 2 is the mid-stage clinical trial where a new drug or treatment is tested in a larger group of patients to see if it works and to keep checking safety after initial human testing. Think of it as a field test that proves whether a product actually delivers its promised benefit. Investors watch Phase 2 closely because its results strongly influence a medicine’s chances of reaching the market, the size of its potential sales, and the company’s valuation.

prader-willi syndrome medical

"Phase 2 trial evaluating setmelanotide in patients with Prader-Willi syndrome (PWS)"

A rare genetic disorder caused by missing or altered instructions on a specific chromosome that leads to constant hunger, low muscle tone, learning challenges, and hormonal problems; think of it as a faulty instruction manual that affects growth, appetite control, and development. Investors care because the condition creates a defined patient population, special regulatory incentives, and long-term medical needs that shape demand for therapies, diagnostics, and care services, influencing market size and risk for drug developers.

schedule 13g regulatory

"Rhythm Pharmaceuticals amended a Schedule 13G to report beneficial ownership stakes"

A Schedule 13G is a formal document that investors file with the government when they acquire a large ownership stake in a company, usually for investment purposes rather than control. It helps keep the public informed about who owns significant parts of a company's shares, which can influence how the company is managed and how investors make decisions. Filing this schedule is important for transparency and understanding the ownership landscape of publicly traded companies.

series a convertible preferred stock financial

"shares issuable on conversion of Series A Convertible Preferred Stock"

Series A convertible preferred stock is a class of shares sold in an early funding round that gives investors a mix of protection and upside: it pays a priority claim over common shares if the company is sold or closes, but can be converted into ordinary shares to share in future growth. Think of it like a hybrid between a safer stake and a ticket to ownership; it matters to investors because it affects who controls the company, how future gains are split, and how much their investment is protected from downside.

at-the-market style arrangement financial

"offer up to $200,000,000 of common stock under an at‑the‑market style arrangement"

An at-the-market style arrangement is a way for a company to raise money by selling newly issued shares directly into the open market at the current trading price, typically through a broker who places the shares gradually over time. It matters to investors because it provides flexible, often quicker capital with less upfront marketing than a big share sale, but can dilute existing holdings and affect the stock’s supply and short-term price — like quietly adding more slices to a pizza being sold by the slice at whatever the register currently shows.

restricted stock units financial

"granted 6,808 Restricted Stock Units, each representing a right to receive one share"

Restricted stock units are a type of company reward where employees are promised shares of stock, but they only fully own these shares after meeting certain conditions, like staying with the company for a set time. They matter because they can become valuable assets and are often used to motivate employees to help the company succeed.

stock options financial

"10,257 stock options with an exercise price of $88.12 per share"

Stock options are agreements that give a person the right to buy or sell a company's stock at a specific price within a certain time frame. They are often used as a reward or incentive, similar to a coupon that can be used later if the stock price rises, allowing the holder to make a profit.

non-gaap operating expenses financial

"projects $385–$415 million in Non-GAAP operating expenses as it advances setmelanotide"

Non-GAAP operating expenses are the costs a company reports that exclude certain items typically considered unusual or non-recurring, such as restructuring charges or asset write-downs. They are used to give investors a clearer view of the company's regular, ongoing expenses by filtering out one-time or non-core costs, helping them better assess the company's true operational performance.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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BOSTON, June 12, 2026 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global commercial-stage biopharmaceutical company focused on transforming the lives of patients living with rare neuroendocrine diseases, today announced that it will host a live conference call and webcast on Saturday, June 13 at 9:00 a.m. ET/8:00 a.m. CT to discuss interim six-month results from the Company’s Phase 2 trial evaluating setmelanotide in patients with Prader-Willi syndrome (PWS).

David Meeker, M.D., Chairman, President and Chief Executive Officer will be joined by Jennifer Miller, M.D., Pediatric Endocrinology, University of Florida College of Medicine to discuss the data.

Conference Call Information

Rhythm Pharmaceuticals will host a live conference call and webcast at 9:00 a.m. ET/8:00 a.m. CT on Saturday, June 13 to discuss this update. Participants may register for the conference call here. It is recommended that participants join the call ten minutes prior to the scheduled start.

A webcast of the call will also be available under "Events and Presentations" in the Investor Relations section of the Rhythm Pharmaceuticals website at https://ir.rhythmtx.com/. The archived webcast will be available on Rhythm Pharmaceuticals’ website approximately two hours after the conference call and will be available for 30 days following the call.

About Rhythm Pharmaceuticals

Rhythm is a commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. Rhythm’s lead asset, IMCIVREE^® (setmelanotide), an MC4R agonist designed to treat hyperphagia and severe obesity, is approved by the U.S. Food and Drug Administration (FDA) to reduce excess body weight and maintain weight reduction long term in adult and pediatric patients aged 4 years and older with acquired hypothalamic obesity, adult and pediatric patients 2 years of age and older with syndromic or monogenic obesity due to Bardet-Biedl syndrome (BBS) or genetically confirmed pro-opiomelanocortin (POMC), including proprotein convertase subtilisin/kexin type 1 (PCSK1), deficiency or leptin receptor (LEPR) deficiency. The European Commission (EC) has authorized setmelanotide for the treatment of obesity and control of hunger in patients 4 years of age and above with acquired hypothalamic obesity; and both the EC and the UK’s Medicines & Healthcare Products Regulatory Agency (MHRA) have authorized setmelanotide for the treatment of obesity and the control of hunger associated with genetically confirmed BBS or genetically confirmed loss-of-function biallelic POMC, including PCSK1, deficiency or biallelic LEPR deficiency in adults and children 2 years of age and above. Additionally, Rhythm is advancing a broad clinical development program for setmelanotide in other rare diseases, as well as investigational MC4R agonists bivamelagon and RM-718, and a preclinical suite of small molecules for the treatment of congenital hyperinsulinism. Rhythm’s headquarters is in Boston, MA.

Setmelanotide Indication

In the United States, setmelanotide is indicated to reduce excess body weight and maintain weight reduction long term in adults and pediatric patients aged 4 years and older with acquired hypothalamic obesity, in adult and pediatric patients aged 2 years and older with syndromic or monogenic obesity due to Bardet-Biedl syndrome (BBS) or Pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency confirmed by genetic testing demonstrating variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS).

In the European Union and the United Kingdom, setmelanotide is indicated for the treatment of obesity and the control of hunger associated with genetically confirmed BBS or loss-of-function biallelic POMC, including PCSK1, deficiency or biallelic LEPR deficiency in adults and children 2 years of age and above. In the European Union and the United Kingdom, setmelanotide should be prescribed and supervised by a physician with expertise in obesity with underlying genetic etiology.

Limitations of Use

Setmelanotide is not indicated for the treatment of patients with the following conditions as setmelanotide would not be expected to be effective:

• Obesity due to suspected POMC, PCSK1, or LEPR deficiency with POMC, PCSK1, or LEPR variants classified as benign or likely benign
• Other types of obesity not related to acquired HO, BBS, or POMC, PCSK1 or LEPR deficiency, including obesity associated with other genetic syndromes and general (polygenic) obesity.

Important Safety Information

CONTRAINDICATIONS

Prior serious hypersensitivity to setmelanotide or any of the excipients in IMCIVREE. Serious hypersensitivity reactions (e.g., anaphylaxis) have been reported.

WARNINGS AND PRECAUTIONS

Disturbance in Sexual Arousal: Spontaneous penile erections and increased frequency of penile erections in males have occurred. Inform patients that these events may occur and instruct patients who have an erection lasting longer than 4 hours to seek emergency medical attention.

Depression and Suicidal Ideation: Depression and suicidal ideation have occurred. Monitor patients for new onset or worsening depression or suicidal thoughts or behaviors. Consider discontinuing IMCIVREE if patients experience suicidal thoughts or behaviors, or clinically significant or persistent depression symptoms occur.

Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis) have been reported. If suspected, advise patients to promptly seek medical attention and discontinue IMCIVREE.

Skin Hyperpigmentation, Darkening of Pre-existing Nevi, and Development of New Melanocytic Nevi: Generalized or focal increases in skin pigmentation occurred in the majority of IMCIVREE-treated patients. IMCIVREE may also cause development of new melanocytic nevi or darkening of pre-existing nevi. Perform a full body skin examination prior to initiation and periodically during treatment to monitor pre-existing and new pigmented lesions.

Acute Adrenal Insufficiency with Acquired HO: Patients with acquired HO and secondary adrenal insufficiency reported serious adverse reactions related to acute adrenal insufficiency in 5% of IMCIVREE-treated patients and no placebo-treated patients. In patients with secondary adrenal insufficiency, monitor for clinical signs of acute adrenal insufficiency.

Sodium Imbalance in Patients with Acquired HO and Central Diabetes Insipidus: Patients with acquired HO and concomitant central diabetes insipidus (DI)/arginine vasopressin (AVP) deficiency reported hyponatremia in 6% of IMCIVREE-treated patients and 2% of placebo-treated patients and hypernatremia in 5% of IMCIVREE-treated patients and 4% of placebo-treated patients. Monitor serum sodium levels with changes in fluid intake and hydration status. Adjust the doses of concomitant therapies for DI/AVP deficiency as needed.

ADVERSE REACTIONS

Most common adverse reactions (incidence ≥20% in at least 1 indication) included skin hyperpigmentation, injection site reactions, nausea, headache, diarrhea, abdominal pain, vomiting, depression, and spontaneous penile erection.

USE IN SPECIFIC POPULATIONS

Treatment with IMCIVREE is not recommended when breastfeeding. Discontinue IMCIVREE when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus.

To report SUSPECTED ADVERSE REACTIONS, contact Rhythm Pharmaceuticals at +1 (833) 789-6337 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch. See section 4.8 of the Summary of Product Characteristics for information on reporting suspected adverse reactions in Europe.

Please see the full Prescribing Information for additional Important Safety Information.

Forward-looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the safety, efficacy, potential benefits of, and clinical design or progress, potential regulatory submissions, approvals and timing thereof for any of our products or product candidates at any dosage or in any indication; the presentation of clinical data and results from our trials, including the ongoing Phase 2 trial of setmelanotide in patients with PWS, including at The Endocrine Society’s Annual Meeting taking place June 13-16, 2026 in Chicago, and the content, date and timing of any of the foregoing. Statements using words such as “expect”, “anticipate”, “believe”, “may”, “will” and similar terms are also forward-looking statements. Such statements are subject to numerous risks and uncertainties, including, but not limited to, our ability to enroll patients in clinical trials, the design and outcome of clinical trials, the impact of competition, the ability to achieve or obtain necessary regulatory approvals, risks associated with data analysis and reporting, 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, our ability to successfully commercialize setmelanotide, our liquidity and expenses, our ability to retain our key employees and consultants, and to attract, retain and motivate qualified personnel, and general economic conditions, and other important factors, including those discussed under the caption “Risk Factors” in Rhythm’s Quarterly Report on Form 10-Q for the three months ended March 31, 2026, 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 release or to update them to reflect events or circumstances occurring after the date of this release, whether as a result of new information, future developments or otherwise.

Corporate Contacts:
David Connolly
Head of Investor Relations and Corporate Communications
Rhythm Pharmaceuticals, Inc.
857-264-4280
dconnolly@rhythmtx.com  

Kate Walsh
Director, Corporate Communications
Rhythm Pharmaceuticals, Inc.
857-264-4280
kwalsh@rhythmtx.com

FAQ

When will Rhythm Pharmaceuticals (RYTM) discuss interim Phase 2 Prader-Willi syndrome data?

Rhythm Pharmaceuticals will discuss interim six-month Phase 2 Prader-Willi syndrome data on a live conference call Saturday, June 13 at 9:00 a.m. ET/8:00 a.m. CT. According to Rhythm, a webcast and 30-day replay will be available on its investor relations website.

How can investors access the Rhythm Pharmaceuticals (RYTM) webcast on setmelanotide Phase 2 interim results?

Investors can access the Rhythm Pharmaceuticals webcast through the Investor Relations section of its website under “Events and Presentations.” According to Rhythm, the live webcast and an archived replay will be posted approximately two hours after the call and remain available for 30 days.

Who will present Rhythm Pharmaceuticals’ interim Phase 2 Prader-Willi syndrome results on June 13?

David Meeker, M.D., Chairman, President and CEO of Rhythm Pharmaceuticals, and Jennifer Miller, M.D., Pediatric Endocrinology, University of Florida College of Medicine, will present. According to Rhythm, they will discuss interim six-month Phase 2 data for setmelanotide in Prader-Willi syndrome.

What is the focus of Rhythm Pharmaceuticals’ June 13, 9:00 a.m. ET investor call for RYTM shareholders?

The June 13 investor call will focus on interim six-month Phase 2 results evaluating setmelanotide in patients with Prader-Willi syndrome. According to Rhythm, the call is accessible via registration for the teleconference and through a simultaneous webcast on its investor relations website.

How can I register for the Rhythm Pharmaceuticals (RYTM) conference call on Prader-Willi syndrome data?

Participants can register for the Rhythm Pharmaceuticals conference call using the provided registration link referenced by the company. According to Rhythm, investors should join about ten minutes before the 9:00 a.m. ET start and can alternatively listen via the live webcast on its website.