RYTM · Company research
4 upcoming catalysts · 0 phase 2+ trials on file
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Setmelanotide congenital HO substudy enrollment completion, expected in the second half of 2026 (no exact date yet). A company milestone for Rhythm (setmelanotide (IMCIVREE) for congenital hypothalamic obesity): a step in the program rather than a decision or a data readout.
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RM-718 Phase 1/2 Part D enrollment completion in Prader-Willi syndrome, expected in the second half of 2026 (no exact date yet). A company milestone for Rhythm (RM-718 for Prader-Willi syndrome): a step in the program rather than a decision or a data readout.
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Rhythm expects Japanese regulators to decide on IMCIVREE (setmelanotide) for Acquired hypothalamic obesity in Q4 2026 (Oct–Dec) (no exact date yet). An approval lets the company start selling it in that market.
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UPDATE: Bivamelagon pivotal Phase 3 in acquired HO to start by year-end 2026, expected in Q4 2026 (Oct–Dec) (no exact date yet). A company milestone for Rhythm (Bivamelagon (LB54640) for Acquired hypothalamic obesity): a step in the program rather than a decision or a data readout.
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Rhythm presented data on setmelanotide (IMCIVREE) for acquired hypothalamic obesity (pediatric), Bardet-Biedl syndrome at a medical meeting in Sep 2026. The linked source has the details.
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UK regulators approved Rhythm’s IMCIVREE (setmelanotide) for Acquired hypothalamic obesity on Aug 11, 2026. The company can now sell it in that market.
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Rhythm reported results from its Phase 2 study of RM-718 for Acquired hypothalamic obesity on Aug 4, 2026. The study met its main goal.
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Rhythm presented data on IMCIVREE (setmelanotide) for Prader-Willi syndrome at a medical meeting on Jun 13, 2026. The linked source has the details.
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Positive CHMP opinion for IMCIVREE in acquired hypothalamic obesity, on Mar 26, 2026. A company milestone for Rhythm (IMCIVREE (setmelanotide) for Acquired hypothalamic obesity): a step in the program rather than a decision or a data readout.
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The FDA approved Rhythm’s IMCIVREE (setmelanotide) for Acquired hypothalamic obesity on Mar 19, 2026. The company can now sell it in that market.
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Rhythm reported results from its Phase 3 study of IMCIVREE (setmelanotide) for MC4R pathway genetic obesity disorders on Mar 16, 2026. The study missed its main goal.
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