Phase 3 EMANATE missed primary endpoint in all four substudies
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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- Company
- Rhythm Pharmaceuticals, Inc. RYTM
- Drug
- IMCIVREE (setmelanotide)
- For
- MC4R pathway genetic obesity disorders
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- Mar 16, 2026
- Source note
- All four independent substudies of the global Phase 3 EMANATE trial of setmelanotide in genetically caused MC4R pathway diseases failed their pre-specified primary endpoints. Post-hoc analyses showed significant 52-week BMI reductions in heterozygous POMC/PCSK1 and SRC1 (NCOA1) patients.
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- Source: ir.rhythmtx.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- RYTM headlines on this site
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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- Entry
- Setmelanotide congenital HO substudy enrollment completion · Company milestone
- Drug
- setmelanotide (IMCIVREE)
- For
- congenital hypothalamic obesity
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- H2 2026 · the company gave a window, not a day
- Source note
- Q2 2026 PR (Aug 4, 2026) anticipated-milestones section.
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- Source: biospace.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- RYTM headlines on this site
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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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- Entry
- RM-718 Phase 1/2 Part D enrollment completion in Prader-Willi syndrome · Company milestone
- Drug
- RM-718
- For
- Prader-Willi syndrome
- Stage
- Phase 1/2 · an early study that checks safety and takes a first look at effect
- When
- H2 2026 · the company gave a window, not a day
- Source note
- Q2 2026 PR (Aug 4, 2026); RM-718 weekly MC4R agonist also showed 11.6% mean BMI reduction at 16 weeks in acquired HO (n=7).
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- Source: biospace.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- RYTM headlines on this site
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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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- Entry
- UPDATE: Japan MHLW decision on IMCIVREE for acquired HO guided by year-end 2026 · Regulatory approval
- Drug
- IMCIVREE (setmelanotide)
- For
- Acquired hypothalamic obesity
- Stage
- Registration (Japan)
- When
- Q4 2026 · the company gave a window, not a day
- Source note
- existing item RYTM|approval|2026-H2 Japan IMCIVREE aHO; Q2 2026 PR (Aug 4, 2026) now frames the MHLW decision as 'by year-end 2026' (mapped to Q4 per convention).
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- Source: biospace.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- Drugs@FDA ↗ — search the drug name for approval letters
- RYTM headlines on this site
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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.
More details
- Entry
- UPDATE: Bivamelagon pivotal Phase 3 in acquired HO to start by year-end 2026 · Company milestone
- Drug
- Bivamelagon (LB54640)
- For
- Acquired hypothalamic obesity
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- Q4 2026 · the company gave a window, not a day
- Source note
- existing item RYTM|other|2026-H2 Bivamelagon Ph3 start; Q2 2026 PR (Aug 4, 2026) guides 'by year-end 2026' (mapped to Q4).
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- Source: biospace.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- RYTM headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page