Core Insights - Rhythm Pharmaceuticals, Inc. (RYTM) is expected to report a year-over-year increase in earnings driven by higher revenues for the quarter ended September 2025, with a consensus outlook indicating a quarterly loss of $0.72 per share, reflecting a +1.4% change from the previous year, and revenues projected at $50.24 million, up 51.1% from the year-ago quarter [1][3] Earnings Expectations - The earnings report is anticipated to be released on November 4, and if the actual results exceed expectations, the stock may experience upward movement; conversely, a miss could lead to a decline [2] - The consensus EPS estimate has remained unchanged over the last 30 days, indicating stability in analyst expectations [4] Earnings Surprise Prediction - The Zacks Earnings ESP model suggests that the Most Accurate Estimate for Rhythm Pharmaceuticals is higher than the Zacks Consensus Estimate, resulting in an Earnings ESP of +9.24%, indicating a bullish sentiment among analysts [11] - A positive Earnings ESP is a strong predictor of an earnings beat, especially when combined with a Zacks Rank of 1 (Strong Buy), 2 (Buy), or 3 (Hold) [9] Historical Performance - In the last reported quarter, Rhythm Pharmaceuticals was expected to post a loss of $0.66 per share but actually reported a loss of -$0.75, resulting in a surprise of -13.64% [12] - Over the past four quarters, the company has only beaten consensus EPS estimates once [13] Conclusion - Rhythm Pharmaceuticals is viewed as a compelling candidate for an earnings beat, but investors should consider other factors influencing stock performance beyond just earnings results [16]

Core Viewpoint - Rhythm Pharmaceuticals, Inc. is set to report its third quarter 2025 financial results and provide a corporate update on November 4, 2025, at 8:00 a.m. ET [1] Company Overview - Rhythm Pharmaceuticals is a commercial-stage biopharmaceutical company focused on rare neuroendocrine diseases [3] - The company's lead product, IMCIVREE® (setmelanotide), is an MC4R agonist approved by the FDA for treating obesity related to specific genetic conditions [3][4] - Setmelanotide is indicated for patients aged 2 years and older with syndromic or monogenic obesity due to Bardet-Biedl syndrome (BBS) or deficiencies in POMC, PCSK1, or LEPR [4][5] Upcoming Events - Rhythm will host a live conference call and webcast for its financial results on November 4, 2025 [1] - The company will also participate in two fireside chats on November 12, 2025, at the Guggenheim Healthcare Innovation Conference and the Stifel Healthcare Conference [7] Product Indications - In the U.S., setmelanotide is indicated for long-term weight reduction in patients with specific genetic obesity conditions [4] - In the EU and UK, it is indicated for obesity treatment and hunger control associated with genetically confirmed BBS or related deficiencies [5] Limitations and Contraindications - Setmelanotide is not indicated for obesity due to benign variants of POMC, PCSK1, or LEPR [6][8] - Serious hypersensitivity reactions have been reported, contraindicating its use in patients with prior serious hypersensitivity to the drug [9] Warnings and Precautions - Patients may experience disturbances in sexual arousal, depression, and hypersensitivity reactions [10][11][12] - Skin hyperpigmentation and the development of new melanocytic nevi have been observed, necessitating regular skin examinations [13] Adverse Reactions - Common adverse reactions (≥20% incidence) include skin hyperpigmentation, injection site reactions, nausea, headache, and depression [15]

Core Insights - ClearBridge Investments reported a modest underperformance of its "ClearBridge Small Cap Growth Strategy" compared to the Russell 2000 Growth Index in Q2 2025, as the market rally favored lower market capitalization and riskier stocks [1] - Rhythm Pharmaceuticals, Inc. (NASDAQ:RYTM) showed a one-month return of -4.79% but a significant 95.91% increase over the last 52 weeks, with a market capitalization of $6.458 billion as of October 2, 2025 [2][3] Company Overview - Rhythm Pharmaceuticals, Inc. focuses on metabolic conditions related to genetic and injury-related obesity, with its main product launched in several rare indications and potential for broader market approval soon [3] - The company has a pipeline of candidates aimed at enhancing lifecycle management and addressing related illnesses, indicating robust growth potential [3] Hedge Fund Interest - Rhythm Pharmaceuticals, Inc. was held by 40 hedge fund portfolios at the end of Q2 2025, a decrease from 47 in the previous quarter, suggesting a decline in popularity among hedge funds [4] - Despite acknowledging the potential of Rhythm Pharmaceuticals, the company is viewed as having less upside compared to certain AI stocks, which are considered to carry less downside risk [4]

Core Insights - Rhythm Pharmaceuticals (NASDAQ: RYTM) has experienced a significant price increase of approximately 52% since the previous article, indicating strong market performance and investor interest [1]. Company Overview - Rhythm Pharmaceuticals is recognized as a pioneer in the field of rare genetic obesity, suggesting a unique market position and potential for growth in a specialized healthcare niche [1]. Investment Perspective - The author expresses a long-term beneficial position in Rhythm Pharmaceuticals, indicating confidence in the company's future performance and potential for continued investment success [2].

Group 1 - The article does not provide any specific content related to a company or industry [1]

ConversationDavid ConnollyHead of Investor Relations & Corporate Communications Good morning, everybody. Thank you for joining us today. I'm Dave Connolly, IR here at Rhythm Pharmaceuticals. Before we begin the speaking program, I'll just remind you that this event may include remarks concerning future expectations, plans and prospects, which constitute forward-looking statements. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important f ...

ConversationDavid ConnollyHead of Investor Relations & Corporate Communications Good morning, everybody. Thank you for joining us today. I'm Dave Connolly, IR here at Rhythm Pharmaceuticals. Before we begin the speaking program, I'll just remind you that this event may include remarks concerning future expectations, plans and prospects, which constitute forward-looking statements. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important ...

Rhythm Pharmaceuticals Conference Call Summary Company Overview - **Company**: Rhythm Pharmaceuticals (NasdaqGM:RYTM) - **Focus**: Development of treatments for rare diseases, specifically targeting acquired hypothalamic obesity (HO) [1][2] Industry Context - **Condition**: Acquired hypothalamic obesity (HO) is characterized by significant weight gain due to injury to the hypothalamus, often following surgeries for benign tumors like craniopharyngiomas [18][19] - **Market Need**: There are currently no approved therapies for HO, representing a significant unmet medical need [20][31] Key Points from the Call Commercial Readiness - Rhythm Pharmaceuticals is preparing for the launch of its drug, setmelanotide, with a PDUFA date set for December 20, 2023 [3][17] - The company has a solid global foundation with over 350 employees across 15 countries and availability in more than 25 countries [18] Clinical Data and Efficacy - **Phase 2 and Phase 3 Trials**: Setmelanotide has shown promising results, with a 19.8% placebo-adjusted BMI reduction in the phase 3 trial [14][24] - **Patient Response**: Nearly all patients in the trials exhibited some level of response, with 80% losing 5% or more of their body weight [25][26] - **Safety Profile**: The drug's side effects are consistent with MC4R agonist-related effects, primarily nausea and vomiting [29][30] Patient Experience and Challenges - Patients with HO face multiple medical issues, including neuroendocrine dysfunction and obesity, leading to a complex treatment landscape [20][54] - The average patient experiences significant weight gain post-injury, with some doubling their body weight within two years [60][61] - The psychological impact of HO is profound, as patients often mourn their previous active lifestyles [57][58] Regulatory and Market Strategy - Rhythm Pharmaceuticals is actively engaging with regulatory bodies to ensure timely access to treatments for patients [17][62] - The company is also conducting claims analysis and engaging with healthcare providers to better understand the epidemiology of HO, adjusting patient estimates to around 10,000 in the U.S. [32] Future Directions - The company is exploring additional therapeutic options, including oral formulations and combination therapies with GLP-1 agonists, to enhance treatment efficacy [15][28][66] - There is a strong emphasis on early diagnosis and intervention to improve patient outcomes [11][12] Additional Insights - The complexity of HO requires a multifaceted approach to treatment, including behavioral modifications and environmental restrictions [66] - The need for better diagnostic criteria for HO is highlighted, as current methods may overlook patients who gain weight rapidly post-injury [73][74] This summary encapsulates the critical aspects of the conference call, focusing on Rhythm Pharmaceuticals' strategic positioning, clinical advancements, and the broader implications for the treatment of acquired hypothalamic obesity.

Clinical Trial Results & Regulatory - Setmelanotide achieved a 19.8% placebo-adjusted difference in BMI reduction from baseline in the Phase 3 acquired hypothalamic obesity (HO) trial (P<0.0001)[33] - In the setmelanotide arm of the Phase 3 trial, patients experienced a -16.5% change in BMI from baseline[32] - A statistically significant reduction in Most Hunger Score was observed with setmelanotide vs placebo in participants aged ≥12 years (P=0.0086)[40] - Setmelanotide was generally well-tolerated in the Phase 3 trial, with most common adverse events including skin hyperpigmentation (55.6%), nausea (50.6%), and headache (38.3%)[45] Market Opportunity & Commercial Strategy - The estimated U S prevalence of acquired HO is approximately 10,000 individuals[48] - The estimated prevalence in Europe is also around 10,000 individuals[48] - The estimated prevalence in Japan is between 5,000 and 8,000 individuals[48] - Rhythm anticipates strong commercial and Medicaid coverage for setmelanotide in HO, similar to or better than coverage for Bardet-Biedl syndrome (BBS)[82] Company Readiness - Rhythm has established a solid global foundation with IMCIVREE available in >25 countries and >350 employees in 15 different countries[23] - The company has an experienced rare disease team in place to support ongoing growth in BBS[72]

Company Overview - Terns Pharmaceuticals is a small-cap, clinical-stage biotech company focused on developing therapies for metabolic dysfunction and obesity-related conditions, with key candidates including TERN-601 and TERN-501 [3][4][6] - TERN-601 is an oral GLP-1 candidate currently in mid-stage studies, with a 12-week phase 2 clinical trial initiated for weight loss, expecting data in the fourth quarter [3][6] Pipeline and Development - Terns Pharmaceuticals is also developing TERN-501 for metabolic dysfunction-associated steatohepatitis and as a potential combination therapy to enhance GLP-1 medicines [1] - TERN-701 is another candidate in a phase 1 study for cancer therapy, with data readout anticipated in the fourth quarter [1] Market Context - The anti-obesity market is rapidly growing, attracting significant attention from both large and small pharmaceutical companies, with the potential for substantial financial returns [5] - Oral medications like TERN-601 could address patient preferences and lower manufacturing costs compared to subcutaneous injections, which may enhance market competitiveness [2][3] Competitive Landscape - Terns Pharmaceuticals faces competition from other biotech firms developing oral GLP-1 medicines, making it crucial to deliver strong results for TERN-601 to impress the market [2][6] - The success of Terns Pharmaceuticals is heavily reliant on the progress of TERN-601, with potential stock volatility if mid-stage studies do not yield positive results [6]