Rhythm Pharmaceuticals Reveals FDA Extension for IMCIVREE® (setmelanotide) Review for Acquired Hypothalamic Obesity Patients
FDA Review Extension: The FDA has extended the review period for Rhythm Pharmaceuticals' supplemental New Drug Application for IMCIVREE® (setmelanotide) by three months, moving the PDUFA goal date from December 20, 2025, to March 20, 2026, due to a request for additional sensitivity analyses of clinical efficacy data.
Company Confidence: Rhythm Pharmaceuticals' CEO expressed confidence in the product's potential benefits for patients with acquired hypothalamic obesity, emphasizing collaboration with the FDA and ongoing preparations for market delivery.
Conference Call Announcement: Rhythm Pharmaceuticals will hold a conference call and webcast at 8:00 a.m. ET to discuss the FDA update, with registration recommended ten minutes prior to the start.
About IMCIVREE®: IMCIVREE® is approved for treating obesity related to specific genetic conditions and is part of Rhythm's broader clinical development program for rare neuroendocrine diseases, with ongoing research into additional treatment options.
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Rhythm Pharmaceuticals Stock Soars with Significant Growth Potential
- Significant Market Potential: Rhythm Pharmaceuticals, with a market cap of only $6.8 billion, has seen its stock price soar over the past 12 months, surpassing both Alphabet and Nvidia, indicating strong market performance and growing investor interest.
- Notable Sales Growth: The company's sole approved drug, Imcivree, achieved sales of $194 million in 2025, reflecting a year-over-year increase of approximately 50%, highlighting the rapid growth in demand for treatments in the rare disease sector.
- Clinical Trial Advancements: Rhythm plans to advance its oral MC4R agonist, bivamelagon, into Phase 3 clinical testing in 2026, while also conducting Phase 1 testing for another MC4R agonist, RM-718, showcasing the diversity and potential of its R&D pipeline.
- FDA Approval Catalyst: The FDA is expected to make a decision on Imcivree's application for treating acquired hypothalamic obesity on March 20, 2026, which could significantly enhance Rhythm's market opportunities, impacting treatment options for approximately 20,000 patients in the U.S.
Rhythm Pharmaceuticals: A Hidden Growth Stock Soaring
- Significant Market Potential: Rhythm Pharmaceuticals has a market cap of $6.8 billion, and despite its relatively small size, its stock has outperformed both Alphabet and Nvidia over the past 12 months, indicating strong market performance and investor confidence.
- Notable Sales Growth: The company's sole approved drug, Imcivree, achieved sales of $194 million in 2025, reflecting a year-over-year increase of approximately 50%, highlighting the growing market demand in the rare genetic obesity treatment sector.
- Promising Clinical Trials: Rhythm expects to advance its oral MC4R agonist, bivamelagon, into Phase 3 clinical testing in 2026, alongside another candidate, RM-718, in Phase 1 testing, showcasing the diversity of its pipeline and potential for market expansion.
- FDA Approval Catalyst: The anticipated FDA approval for Imcivree in treating acquired hypothalamic obesity on March 20, 2026, could potentially benefit over 36,000 patients across the U.S., Europe, and Japan, significantly enhancing the company's market outlook and profitability prospects.
Rhythm Pharmaceuticals Reports $194M in 2025 IMCIVREE Sales
- Significant Sales Growth: Rhythm Pharmaceuticals anticipates approximately $194 million in net product revenues from global sales of IMCIVREE® in 2025, representing a 50% increase from 2024, indicating strong market demand in the rare neuroendocrine disease sector.
- Quarterly Performance Boost: The estimated sales for Q4 2025 are around $57 million, reflecting an 11% increase from Q3 2025, showcasing sustained demand and patient acceptance for IMCIVREE in both U.S. and international markets.
- FDA Approval Progress: The company plans to submit a supplemental NDA for IMCIVREE for acquired hypothalamic obesity to the FDA by March 20, 2026, which, if approved, will further expand its market reach and address patient needs.
- Clinical Trial Data Release: Topline data from a 12-patient Japanese cohort in the Phase 3 trial is expected to be announced in Q1 2026, providing crucial support for the global promotion of IMCIVREE.
Rhythm Pharma Hits the Right Note with Promising Early Results from PWS Trial
Stock Performance: Rhythm Pharmaceuticals Inc. (RYTM) shares rose 14.24% to $119.69 following positive preliminary results from its Phase 2 trial of setmelanotide for Prader-Willi syndrome (PWS).
Trial Results: In the ongoing 52-week trial, setmelanotide showed potential benefits, with 6 of 8 patients achieving BMI reductions at Month 3 and 3 of 5 patients at Month 6, alongside significant reductions in hyperphagia.
Future Plans: The company plans to advance setmelanotide into a Phase 3 registrational trial for PWS, contingent on the successful completion of the current Phase 2 trial.
Additional Research: Rhythm has initiated a Part D arm in a Phase 1 trial for MC4R agonist RM-718, aiming to enroll up to 20 PWS patients, with the first screening expected in December 2025.
Rhythm Pharma to Share Initial Phase 2 Results of Setmelanotide for Prader-Willi Syndrome Today
Upcoming Data Release: Rhythm Pharmaceuticals will present preliminary data from its Phase 2 trial of Setmelanotide for Prader-Willi syndrome on December 11, 2025, addressing a rare genetic disorder with limited treatment options.
Setmelanotide Overview: The drug, already approved for obesity treatment in certain genetic conditions, is also under review for acquired hypothalamic obesity, with an FDA decision expected on March 20, 2025.
Pipeline Development: Rhythm is advancing additional MC4R agonists, including Bivamelagon and RM-718, with ongoing trials and plans for a pivotal phase III trial for Bivamelagon in 2026.
Financial Performance: The company reported third-quarter 2025 net product revenue of $51.3 million, with strong growth in U.S. sales, and ended September 30 with $416.1 million in cash and investments, supporting its development programs.
Rhythm Pharmaceuticals to Disclose Preliminary Data from PWS Trial on December 11
- Clinical Trial Update: Rhythm Pharmaceuticals will host a conference call on 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, which is expected to provide significant support for the company's market positioning in rare neuroendocrine diseases.
- Investor Engagement: The conference will be available via webcast, requiring participants to register ten minutes in advance, demonstrating the company's commitment to transparency and investor communication aimed at boosting market confidence.
- Product Background: Setmelanotide is Rhythm's lead asset, already FDA-approved for obesity treatment associated with Bardet-Biedl syndrome, and the upcoming data is anticipated to further propel its application in other rare diseases.
- Future Outlook: Rhythm is advancing the clinical development of setmelanotide in other rare diseases, and the data release is expected to lay the groundwork for future regulatory submissions and market expansion.
Rhythm Pharmaceuticals Stock Soars with Significant Growth Potential
- Significant Market Potential: Rhythm Pharmaceuticals, with a market cap of only $6.8 billion, has seen its stock price soar over the past 12 months, surpassing both Alphabet and Nvidia, indicating strong market performance and growing investor interest.
- Notable Sales Growth: The company's sole approved drug, Imcivree, achieved sales of $194 million in 2025, reflecting a year-over-year increase of approximately 50%, highlighting the rapid growth in demand for treatments in the rare disease sector.
- Clinical Trial Advancements: Rhythm plans to advance its oral MC4R agonist, bivamelagon, into Phase 3 clinical testing in 2026, while also conducting Phase 1 testing for another MC4R agonist, RM-718, showcasing the diversity and potential of its R&D pipeline.
- FDA Approval Catalyst: The FDA is expected to make a decision on Imcivree's application for treating acquired hypothalamic obesity on March 20, 2026, which could significantly enhance Rhythm's market opportunities, impacting treatment options for approximately 20,000 patients in the U.S.
Rhythm Pharmaceuticals: A Hidden Growth Stock Soaring
- Significant Market Potential: Rhythm Pharmaceuticals has a market cap of $6.8 billion, and despite its relatively small size, its stock has outperformed both Alphabet and Nvidia over the past 12 months, indicating strong market performance and investor confidence.
- Notable Sales Growth: The company's sole approved drug, Imcivree, achieved sales of $194 million in 2025, reflecting a year-over-year increase of approximately 50%, highlighting the growing market demand in the rare genetic obesity treatment sector.
- Promising Clinical Trials: Rhythm expects to advance its oral MC4R agonist, bivamelagon, into Phase 3 clinical testing in 2026, alongside another candidate, RM-718, in Phase 1 testing, showcasing the diversity of its pipeline and potential for market expansion.
- FDA Approval Catalyst: The anticipated FDA approval for Imcivree in treating acquired hypothalamic obesity on March 20, 2026, could potentially benefit over 36,000 patients across the U.S., Europe, and Japan, significantly enhancing the company's market outlook and profitability prospects.
Rhythm Pharmaceuticals Reports $194M in 2025 IMCIVREE Sales
- Significant Sales Growth: Rhythm Pharmaceuticals anticipates approximately $194 million in net product revenues from global sales of IMCIVREE® in 2025, representing a 50% increase from 2024, indicating strong market demand in the rare neuroendocrine disease sector.
- Quarterly Performance Boost: The estimated sales for Q4 2025 are around $57 million, reflecting an 11% increase from Q3 2025, showcasing sustained demand and patient acceptance for IMCIVREE in both U.S. and international markets.
- FDA Approval Progress: The company plans to submit a supplemental NDA for IMCIVREE for acquired hypothalamic obesity to the FDA by March 20, 2026, which, if approved, will further expand its market reach and address patient needs.
- Clinical Trial Data Release: Topline data from a 12-patient Japanese cohort in the Phase 3 trial is expected to be announced in Q1 2026, providing crucial support for the global promotion of IMCIVREE.
Rhythm Pharma Hits the Right Note with Promising Early Results from PWS Trial
Stock Performance: Rhythm Pharmaceuticals Inc. (RYTM) shares rose 14.24% to $119.69 following positive preliminary results from its Phase 2 trial of setmelanotide for Prader-Willi syndrome (PWS).
Trial Results: In the ongoing 52-week trial, setmelanotide showed potential benefits, with 6 of 8 patients achieving BMI reductions at Month 3 and 3 of 5 patients at Month 6, alongside significant reductions in hyperphagia.
Future Plans: The company plans to advance setmelanotide into a Phase 3 registrational trial for PWS, contingent on the successful completion of the current Phase 2 trial.
Additional Research: Rhythm has initiated a Part D arm in a Phase 1 trial for MC4R agonist RM-718, aiming to enroll up to 20 PWS patients, with the first screening expected in December 2025.
Rhythm Pharma to Share Initial Phase 2 Results of Setmelanotide for Prader-Willi Syndrome Today
Upcoming Data Release: Rhythm Pharmaceuticals will present preliminary data from its Phase 2 trial of Setmelanotide for Prader-Willi syndrome on December 11, 2025, addressing a rare genetic disorder with limited treatment options.
Setmelanotide Overview: The drug, already approved for obesity treatment in certain genetic conditions, is also under review for acquired hypothalamic obesity, with an FDA decision expected on March 20, 2025.
Pipeline Development: Rhythm is advancing additional MC4R agonists, including Bivamelagon and RM-718, with ongoing trials and plans for a pivotal phase III trial for Bivamelagon in 2026.
Financial Performance: The company reported third-quarter 2025 net product revenue of $51.3 million, with strong growth in U.S. sales, and ended September 30 with $416.1 million in cash and investments, supporting its development programs.
Rhythm Pharmaceuticals to Disclose Preliminary Data from PWS Trial on December 11
- Clinical Trial Update: Rhythm Pharmaceuticals will host a conference call on 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, which is expected to provide significant support for the company's market positioning in rare neuroendocrine diseases.
- Investor Engagement: The conference will be available via webcast, requiring participants to register ten minutes in advance, demonstrating the company's commitment to transparency and investor communication aimed at boosting market confidence.
- Product Background: Setmelanotide is Rhythm's lead asset, already FDA-approved for obesity treatment associated with Bardet-Biedl syndrome, and the upcoming data is anticipated to further propel its application in other rare diseases.
- Future Outlook: Rhythm is advancing the clinical development of setmelanotide in other rare diseases, and the data release is expected to lay the groundwork for future regulatory submissions and market expansion.
