Rhythm Pharmaceuticals generated $51.3 million in product revenue during Q3 2025, primarily from U.S. IMCIVREE sales, but reported a net loss of $54.3 million due to higher R&D and SG&A expenses.
Rhythm Pharmaceuticals delivered strong second-quarter results, with global IMCIVREE sales reaching $48.5 million, a 29% sequential increase. The company also strengthened its financial position with a $189.2 million public offering and reported positive clinical data for bivamelagon and setmelanotide in acquired hypothalamic obesity.
Rhythm Pharmaceuticals reported strong first quarter 2025 results with net product revenue from global sales of IMCIVREE reaching $37.7 million. The company achieved significant progress in its clinical trials, with the pivotal Phase 3 TRANSCEND trial for setmelanotide in acquired hypothalamic obesity meeting its primary endpoint, and regulatory submissions on track for Q3 2025. Additionally, the company's cash on-hand is expected to support operations into 2027.
Rhythm Pharmaceuticals reported solid growth in global sales of IMCIVREE during Q4 2024, driven by treatment of Bardet-Biedl syndrome. The company also raised $75 million in gross proceeds under its ATM equity offering program, extending its cash runway into 2027.
Rhythm Pharmaceuticals reported Q3 2024 net revenue of $33.3 million from global sales of IMCIVREE. The company's cash position is expected to support operations into 2026.
Rhythm Pharmaceuticals reported strong Q2 2024 results with $29.1 million in net revenue from global IMCIVREE sales. The company is progressing with clinical trials and regulatory submissions, including expanding IMCIVREE's label to treat pediatric patients as young as 2 years old. Existing cash is expected to fund operations into 2026.
Rhythm Pharmaceuticals reported Q4 2023 net revenue from global sales of IMCIVREE® (setmelanotide) of $24.2 million. Enrollment was completed in the 120-patient, pivotal cohort of the Phase 3 setmelanotide trial in hypothalamic obesity, with top-line data expected in 1H2025. The company also announced Phase 3 development plans for setmelanotide in hypothalamic obesity in Japan and acquired global rights to oral MC4R agonist LB54640 from LG Chem.
Rhythm Pharmaceuticals reported net revenue from global sales of IMCIVREE® (setmelanotide) of $22.5 million for the third quarter of 2023. The company's cash on-hand of $299.3 million is expected to be sufficient to fund planned operations into 2026.
Rhythm Pharmaceuticals reported strong revenue performance in Q2 2023, driven by robust patient demand for IMCIVREE® in the U.S. The company achieved a commercial sales milestone, making them eligible for an additional $25 million investment. Enrollment in the pivotal Phase 3 trial for setmelanotide in hypothalamic obesity is expected to be completed by the end of 2023.
Rhythm Pharmaceuticals reported financial results for the first quarter ended March 31, 2023. The company saw strong commercial progress with IMCIVREE in the U.S. and launched it in Germany. They also dosed the first patients in their pivotal Phase 3 trial for hypothalamic obesity and expect to complete enrollment in Q1 2024.
Rhythm Pharmaceuticals reported a strong 2022, highlighted by the successful U.S. launch of IMCIVREE for Bardet-Biedl syndrome (BBS) following FDA approval in June and its expansion into eight international markets. The company also initiated a pivotal Phase 3 trial for setmelanotide in hypothalamic obesity and acquired Xinvento B.V. to broaden its pipeline into congenital hyperinsulinism (CHI).
Rhythm Pharmaceuticals reported its Q3 2022 financial results and business update, highlighting the U.S. launch of IMCIVREE® for Bardet-Biedl Syndrome with strong demand and the EC authorization expansion for IMCIVREE. The company also completed a $140 million public offering, extending its cash runway into 2025.
Rhythm Pharmaceuticals reported a strong start to the U.S. launch of IMCIVREE® for Bardet-Biedl syndrome (BBS) with over 50 prescriptions written in the first six weeks. The EMA's CHMP recommended expanding IMCIVREE's marketing authorization to include the treatment of obesity and control of hunger in patients with genetically confirmed BBS. Positive interim results from the Phase 2 trial in hypothalamic obesity were announced, with plans to initiate a Phase 3 trial in early 2023.
Rhythm Pharmaceuticals reported its Q1 2022 financial results, highlighting progress towards transforming the care of individuals living with rare genetic diseases of obesity. The company achieved its first European sales in France and is advancing patient identification efforts to support a successful U.S. launch for setmelanotide in Bardet-Biedl and Alström syndromes in June, pending FDA approval.
Rhythm Pharmaceuticals reported their Q4 2021 financial results, highlighting the commercial availability of IMCIVREE and progress in clinical development and regulatory efforts.
Rhythm Pharmaceuticals reported their Q3 2021 financial results, highlighting the submission of regulatory filings in the U.S. and EU for IMCIVREE for the treatment of Bardet-Biedl and Alström syndromes and the ongoing launch preparations.
Rhythm Pharmaceuticals' Q2 2021 earnings showed revenue growth driven by increasing IMCIVREE sales. The company continues to focus on commercialization and expansion efforts, while still reporting a net loss for the quarter. Forward guidance was provided, outlining expectations for continued growth and development.
Rhythm Pharmaceuticals reported its Q1 2021 financial results, marking the first commercial sales of IMCIVREE™ in the U.S. The company also achieved proof-of-concept data from Phase 2 Basket Study and closed a $172.5 million public offering and sold Priority Review Voucher for $100 million.
Rhythm Pharmaceuticals reported its Q4 and full-year 2020 financial results, highlighting the FDA approval of IMCIVREE™ and positive topline data from a Phase 3 trial. The company is well-funded to advance setmelanotide's development and commercialization.
Rhythm Pharmaceuticals reported their Q3 2020 financial results, highlighting progress towards potential approval of setmelanotide and upcoming clinical milestones.
Rhythm Pharmaceuticals reported tremendous regulatory and clinical progress with setmelanotide. FDA granted rare pediatric disease designations for setmelanotide to treat POMC and LEPR deficiency obesities. The company also submitted MAA to EMA and received FDA acceptance of NDA for setmelanotide in POMC and LEPR deficiency obesities.
Rhythm Pharmaceuticals reported its Q4 and full year 2019 financial results, highlighting progress in developing therapies for rare genetic disorders of obesity and preparing for the potential launch of setmelanotide.