Financial Performance - Rhythm Pharmaceuticals reported preliminary unaudited net revenues of approximately $57 million for Q4 2025, an 11% increase sequentially from Q3 2025[7]. - Full-year 2025 net product revenues are expected to be around $194 million, a 50% increase compared to $130 million in 2024[7]. - U.S. sales of IMCIVREE accounted for approximately 68% of Q4 2025 net product revenues and about 69% of full-year 2025 revenues[7]. - The financial results presented are preliminary and subject to change pending the completion of financial closing and audit procedures[13]. Clinical Trials and Research - The company plans to complete enrollment in the Phase 3 trial substudy for congenital hypothalamic obesity in the first half of 2026[8]. - Topline data from the Phase 3 EMANATE trial for genetically caused MC4R pathway diseases is expected to be announced in Q1 2026[9]. - Positive preliminary data for the exploratory Phase 2 trial of setmelanotide in Prader-Willi Syndrome showed BMI and hyperphagia reductions at months 3 and 6[10]. - A pivotal Phase 3 trial for bivamelagon in acquired hypothalamic obesity is planned for 2026, pending regulatory feedback[11]. - Enrollment in the Phase 1 trial for RM-718 is expected to be completed in Q1 2026[12]. Product Launch and Approvals - The company anticipates launching IMCIVREE in the U.S. for acquired hypothalamic obesity pending FDA approval, with a PDUFA goal date of March 20, 2026[14].

-- Q4 2025 preliminary net product revenues from global sales of IMCIVREE® (setmelanotide) of approximately $57 million for the fourth quarter of 2025, an 11% increase over Q3 2025 -- -- FY 2025 preliminary net product revenue of approximately $194 million, approximately 50% increase from FY2024 -- -- March 20, 2026 PDUFA goal date for sNDA for setmelanotide in acquired hypothalamic obesity -- -- On track to report topline data from 12-patient Japanese cohort of setmelanotide Phase 3 trial in acquired hypo ...

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Core Viewpoint - Rhythm Pharmaceuticals announced positive preliminary data from an exploratory Phase II trial of setmelanotide for Prader-Willi syndrome, indicating a potential efficacy signal [2]. Group 1: Company Overview - Rhythm Pharmaceuticals is conducting research on setmelanotide, which is being evaluated for its effectiveness in treating Prader-Willi syndrome [2][3]. - The company held a conference call to discuss the trial results, with key presentations from its leadership and external experts [1][3]. Group 2: Trial Details - The Phase II trial is exploratory in nature and aims to assess the efficacy of setmelanotide in patients with Prader-Willi syndrome [2][3]. - Dr. Jennifer Miller from the University of Florida is the principal investigator for this Phase II trial, highlighting the collaboration with academic institutions [3].

Core Insights - Rhythm Pharmaceuticals Inc. has reported positive preliminary results from its exploratory Phase 2 trial of setmelanotide for patients with Prader-Willi syndrome (PWS) [1][3] - The company plans to advance setmelanotide into a Phase 3 registrational trial, contingent on the successful completion of the current Phase 2 trial [3] Trial Details - The Phase 2 trial enrolled 18 patients and is ongoing, with a focus on assessing the effects of setmelanotide on BMI and hyperphagia [2][6] - Preliminary results indicate that 6 of 8 patients achieved BMI reductions at Month 3, and 3 of 5 patients achieved reductions at Month 6, with some showing deeper reductions [6] Safety and Tolerability - Safety and tolerability results for setmelanotide have been consistent with its established clinical profile, with 17 of the 18 enrolled patients remaining on active therapy [6] Stock Performance - Following the announcement of the trial results, Rhythm Pharmaceuticals' stock increased by 14.24%, closing at $119.69 [5] Additional Developments - Rhythm has initiated a Part D arm in the Phase 1 trial of MC4R agonist RM-718, planning to enroll up to 20 patients, with the first patient expected to be screened in December 2025 [4]

Group 1 - U.S. stocks showed mixed performance, with the Dow Jones increasing by over 600 points on Thursday [1] - Diamond Hill Investment Group Inc's shares surged 45.3% to $170.74 after First Eagle announced an acquisition for $175 per share in a $473 million all-cash deal [1] Group 2 - Planet Labs PBC's stock rose 29.7% to $16.79 following better-than-expected third-quarter sales results and an optimistic fourth-quarter sales guidance [2] - Nextdoor Holdings Inc experienced a gain of 22.9% to $3.11 [2] - Gemini Space Station Inc's shares jumped 19.2% to $13.54 after regulatory approval for its subsidiary to offer prediction markets to U.S. customers [2] - Rhythm Pharmaceuticals Inc's stock increased by 13.5% to $119.00 after announcing preliminary results from a Phase 2 trial for setmelanotide in Prader-Willi syndrome patients [2] - Candel Therapeutics Inc gained 12.4% to $6.52 [2] - VersaBank's shares rose 12.34% to $14.52 [2] - Perpetua Resources Corp's stock increased by 10.4% to $28.37 [2] - iHeartMedia Inc jumped 10.1% to $5.19 [2] - NovaBay Pharmaceuticals Inc gained 9.5% to $2.65 [2] - Idaho Strategic Resources Inc's shares rose 9.3% to $43.62 [2] - Immunovant Inc's stock increased by 8.5% to $25.57 after pricing a $550 million common stock offering [2] - Vail Resorts Inc gained 8.3% to $153.30 following first-quarter results [2] - Mosaic Co's shares surged 7.2% to $25.47 amid higher fertilizer stock prices after reports of Ukraine attacking Russian fertilizer plants [2] - Wayfair Inc's stock rose 6.9% to $99.76 [2] - Centene Corp gained 5.3% to $40.72 [2]

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 ...