RHYTHM PHARMACEUTICALS, INC. 8-K

What Happened

• On January 9, 2026, Rhythm Pharmaceuticals (RYTM) filed an 8‑K reporting preliminary, unaudited net product revenues for IMCIVREE® (setmelanotide): approximately $57 million for Q4 2025 (an 11% sequential increase) and approximately $194 million for the full year 2025 (vs. $130 million in 2024, ≈50% increase). The company also posted a corporate slide presentation in connection with the J.P. Morgan Healthcare Conference.
• Rhythm cautioned these figures are preliminary and unaudited — final results may change as year‑end close and audit procedures are completed. The 8‑K also summarizes upcoming regulatory and clinical milestones for setmelanotide, bivamelagon (LB54640) and RM‑718.

Key Details

• Q4 2025 preliminary net product revenues: ~$57 million (up 11% vs Q3 2025).
• Full‑year 2025 preliminary net product revenues: ~$194 million vs $130 million in 2024 (≈50% YoY growth).
• U.S. sales accounted for ~68% of Q4 2025 and ~69% of full‑year 2025 preliminary net revenues.
• Near‑term milestones: FDA PDUFA date for IMCIVREE in acquired hypothalamic obesity on March 20, 2026; topline Phase 3 cohort readouts (Japanese cohort and EMANATE trial) expected Q1 2026; several enrollment and readout targets across congenital HO, PWS, bivamelagon and RM‑718 scheduled through 2026.

Why It Matters

• For investors, the preliminary revenue figures show continued commercial growth and stronger sales traction for IMCIVREE in 2025, with meaningful YoY and sequential gains.
• The March 20, 2026 PDUFA date and multiple near‑term trial readouts create upcoming regulatory and clinical catalysts that could affect the company’s outlook.
• Because the numbers are preliminary and unaudited, investors should await the company’s final audited results and monitor clinical/regulatory updates for confirmed impact on future revenue and valuation.