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PresentationLadies and gentlemen, thank you for standing by. Welcome to Rhythm Pharmaceuticals Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. I would like now to turn the conference over to Dave Connolly, Head of Investor Relations. Please go ahead.David ConnollyHead of Investor Relations & Corporate Communications Thank you, Michelle. Good morning, everyone, and welcome. This morning, we issued a press release announcing that the preliminary data from ...

Rhythm Pharmaceuticals Inc. (NASDAQ:RYTM) stock is higher on Thursday, after the company shared preliminary results from its exploratory Phase 2 trial of setmelanotide in patients with Prader-Willi syndrome (PWS).PWS is a rare genetic disorder characterized by muscle weakness and feeding difficulties in infancy. An insatiable hunger and tendency toward severe obesity starting in childhood could follow.PWS also involves delayed development, intellectual disability, behavioral issues, and physical traits, suc ...

U.S. stocks were mixed, with the Dow Jones gaining more than 600 points on Thursday.Shares of Diamond Hill Investment Group Inc (NASDAQ:DHIL) rose sharply during Thursday's session after First Eagle agreed to acquire the company for $175 per share in a $473 million all-cash deal.Diamond Hill Investment Group shares jumped 45.3% to $170.74 on Thursday.Here are some other big stocks recording gains in today’s session.Planet Labs PBC (NYSE:PL) gained 29.7% to $16.79 after the company reported better-than-expec ...

Rhythm Pharmaceuticals Conference Call Summary Company Overview - **Company**: Rhythm Pharmaceuticals (NasdaqGM:RYTM) - **Focus**: Development of treatments for rare diseases, specifically targeting Prader-Willi syndrome (PWS) Key Points from the Conference Call Industry and Product Development - **Exploratory Phase Two Trial**: Preliminary data indicates that setmelanotide shows a positive efficacy signal in treating PWS [2][4] - **Trial Details**: Conducted as a single-center study at the University of Florida, led by Dr. Jennifer Miller [4] - **Next Steps**: Based on early data, the company plans to proceed to a Phase 3 program in PWS [4][30] Clinical Trial Results - **Patient Enrollment**: 18 patients enrolled, with a mean BMI of 39.1 [11] - **BMI Changes**: Six out of eight patients showed a decrease in BMI at three months, with reductions ranging from -1.3% to -4.8% [12] - **Long-term Goals**: Aiming for a 5% reduction in BMI at one year as a key endpoint for the Phase 3 study [5][30] Efficacy and Safety - **Positive Outcomes**: Significant changes in BMI and HQCT scores observed at three and six months [4][12] - **Patient Compliance**: High compliance noted, with most patients tolerating doses of 4 to 5 mg [17][48] - **Adverse Events**: Setmelanotide was well tolerated, with common side effects including hyperpigmentation and injection site reactions [17] Market Need and Patient Population - **Unmet Medical Need**: PWS is characterized by severe obesity and hyperphagia, with limited therapeutic options available [8] - **Prevalence**: Estimated at approximately 20,000 patients in the U.S. [8] Future Plans - **Phase 3 Trial Proposal**: Plans to submit a proposal to the FDA after completing the current trial and gathering six-month data from all patients [31] - **RM-718 Development**: Initiated a part D arm in the Phase 1 study of RM-718, a weekly MC4R agonist, to be tested in up to 20 PWS patients [5][32] Insights from Experts - **Dr. Jennifer Miller's Commentary**: Emphasized the complexity of PWS and the importance of understanding individual patient responses [18][19] - **Patient Experience**: Patients reported feeling better overall, with improved diabetes control and reduced hyperphagia [21][24] Regulatory Considerations - **FDA Expectations**: The primary endpoint for the Phase 3 trial is likely to be a change in mean BMI, with a focus on achieving a 5% reduction [34] - **Responder Analysis**: Important for regulatory approval, assessing how many patients achieve significant weight loss [34] Conclusion - **Overall Sentiment**: The early data from the trial is promising, supporting the move to Phase 3 with confidence in achieving positive outcomes [30][31] - **Next Data Release**: Full six-month data expected to be disclosed in the first half of 2026 [32] This summary encapsulates the key points discussed during the Rhythm Pharmaceuticals conference call, highlighting the company's focus on PWS, the promising trial results, and future plans for product development and regulatory submissions.

-- BMI and hyperphagia reductions have been observed in patients with PWS treated with setmelanotide at Month 3 (n=8) and Month 6 (n=5); 17 of 18 enrolled patients remain on therapy -- -- Promising results supportive of Phase 3, registrational trial of setmelanotide in PWS -- -- Company initiated Phase 1, Part D study to evaluate weekly MC4R agonist RM-718 in patients with PWS -- -- Company to hold conference call on Thursday, December 11 at 8:00 a.m. -- BOSTON, Dec. 11, 2025 (GLOBE NEWSWIRE) -- Rhythm P ...

BOSTON, Dec. 10, 2025 (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 Thursday, December 11 at 8:00 a.m. ET to disclose preliminary data from its exploratory Phase 2 trial of setmelanotide in patients with Prader-Willi syndrome (PWS). Conference Call Information Rhythm Pharmaceutica ...

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Core Insights - The article discusses Rhythm Pharmaceuticals, Inc. (RYTM) and its recent developments in the context of a late-stage study win related to a rare obesity disorder [2]. Company Overview - Rhythm Pharmaceuticals operates in the biotech sector, focusing on developing treatments for rare obesity disorders [2]. - The company has a model portfolio that includes over 10 small and mid-cap stocks, providing deep analysis for each [2]. Market Position - The Biotech Analysis Central service offers extensive resources, including a library of over 600 biotech investing articles, aimed at helping healthcare investors make informed decisions [2]. Analyst Background - The author, Terry Chrisomalis, has a background in Applied Science and years of experience in the biotech sector, contributing to long-term value generation in healthcare investments [2].

Core Insights - The article discusses Rhythm Pharmaceuticals, Inc. (RYTM) and highlights a recent late-stage study win that could impact the company's position in the rare obesity disorder market [2]. Company Overview - Rhythm Pharmaceuticals operates in the biotech sector, focusing on developing treatments for rare obesity disorders [2]. - The company has a model portfolio that includes over 10 small and mid-cap stocks, providing deep analysis for each [2]. Market Analysis - The article emphasizes the importance of informed decision-making for healthcare investors, suggesting that Rhythm's recent study win may create new investment opportunities [2].