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Rhythm Pharmaceuticals Announces Preliminary, Unaudited Fourth Quarter and Full Year 2025 Net Product Revenues and Upcoming Milestones

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-- Q4 2025 preliminary net product revenues from global sales of IMCIVREE® (setmelanotide) of approx...

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AI Summary

RYTM expects $57 million in Q4 2025 revenues from IMCIVREE sales. FY 2025 revenues are projected at $194 million, a 50% increase. PDUFA goal date for hypothalamic obesity is set for March 20, 2026. Phase 3 trial results from Japan cohort expected in early 2026. Rhythm is launching bivamelagon and continuing RM-718 trials.

Sentiment Rationale

The significant revenue growth and upcoming FDA milestones generally lead to positive stock performance; historical instances show that strong earnings often precede upward price revisions.

Trading Thesis

Upcoming FDA decision on March 20, 2026, will likely affect stock price in the near term based on market expectations.

Market-Moving

  • RYTM's anticipated FDA approval could significantly boost investor confidence.
  • Positive trial data could attract additional investment and increase stock value.
  • Higher than projected revenues may trigger analyst upgrades.
  • Market reaction expected to be bullish ahead of March 2026 PDUFA date.

Key Facts

  • RYTM expects $57 million in Q4 2025 revenues from IMCIVREE sales.
  • FY 2025 revenues are projected at $194 million, a 50% increase.
  • PDUFA goal date for hypothalamic obesity is set for March 20, 2026.
  • Phase 3 trial results from Japan cohort expected in early 2026.
  • Rhythm is launching bivamelagon and continuing RM-718 trials.

Companies Mentioned

  • IMCIVREE (IMCIVREE)

Corporate Developments

The article highlights critical developments that have direct implications for RYTM's market performance, especially with significant Q4 results and important regulatory timelines.

Rhythm Pharmaceuticals Reports Strong Revenue Growth for 2025

BOSTON, Jan. 9, 2026 (GLOBE NEWSWIRE) — Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a biopharmaceutical company dedicated to addressing rare neuroendocrine diseases, has announced preliminary unaudited net product revenues for the fourth quarter (Q4) and full year (FY) 2025. The company reported approximately $57 million in net product revenues for Q4 2025, marking an 11% increase compared to Q3 2025, and a total of approximately $194 million for FY 2025, which is an approximate 50% increase from FY 2024.

Highlights of Fourth Quarter and Full Year 2025 Earnings

Rhythm Pharmaceuticals' growth reflects successful operations in both U.S. and international markets. The increase in revenues is primarily attributed to:

  • Steady rise in patients receiving reimbursed therapy for IMCIVREE® (setmelanotide).
  • Consistent progress in improving access to IMCIVREE globally.
  • U.S. sales accounted for approximately 68% of Q4 revenues and 69% of revenues for the full year.

CEO David Meeker, M.D. highlighted the company's performance, stating, “2025 was a year of strong execution and reflects significant progress toward our mission of transforming the lives of patients with rare neuroendocrine diseases.”

Upcoming Milestones and Strategic Initiatives

Rhythm Pharmaceuticals is actively preparing for significant upcoming events aimed at furthering the reach of IMCIVREE and expanding its portfolio:

  • Launch of IMCIVREE for acquired hypothalamic obesity in the U.S. is pending FDA approval, with a PDUFA goal date set for March 20, 2026.
  • Topline data from the 12-patient Japanese cohort of the Phase 3 trial in acquired hypothalamic obesity is expected in Q1 2026.
  • Results from the Phase 3 EMANATE trial, evaluating setmelanotide in genetically caused MC4R pathway diseases, will also be reported in the first quarter of 2026.

Rhythm plans to complete enrollment in a substudy for congenital hypothalamic obesity in 2026 and aims to initiate further trials involving investigational therapies such as the oral MC4R agonist, bivamelagon, and RM-718.

Financial Disclosure Advisory

The reported preliminary financial results for Q4 and FY 2025 are based on available information and have not been audited. Rhythm emphasizes that actual results may vary and should not be interpreted as complete financial statements. Full fourth quarter and annual financial results are scheduled for release in late February 2026.

About Rhythm Pharmaceuticals

Rhythm Pharmaceuticals operates with a mission to transform the lives of individuals affected by rare neuroendocrine diseases. Its primary product, IMCIVREE® (setmelanotide), is an MC4R agonist approved by the U.S. FDA for weight reduction in specific obesity cases. The company is also advancing various clinical programs aimed at treating congenital hyperinsulinism and other conditions. Rhythm's headquarters is based in Boston, MA.

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