Rhythm Pharmaceuticals, Inc. RYTM
Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM) is an endocrine/women's health drug developer. Its lead program, IMCIVREE (setmelanotide), is in Phase 3 for obesity/hyperphagia due to POMC/PCSK1/LEPR deficiency, Bardet-Biedl syndrome, and acquired hypothalamic obesity. Its next catalyst on record is bivamelagon: initiate pivotal Phase 3 trial in acquired HO (2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: bivamelagon — initiate pivotal Phase 3 trial in acquired HO (2026). 2 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| IMCIVREE (setmelanotide) | POMC/PCSK1/LEPR deficiency, BBS, acquired hypothalamic obesity | protein/peptide | Approved |
| setmelanotide (JNDA, acquired HO, Japan) | acquired hypothalamic obesity | protein/peptide | Phase 3 |
| setmelanotide (congenital HO substudy) | congenital hypothalamic obesity (substudy of Phase 3 TRANSCEND) | protein/peptide | Phase 3 |
| bivamelagon | acquired hypothalamic obesity (Phase 2 complete; pivotal Phase 3 planned) | small molecule | Phase 2 |
| setmelanotide | Prader-Willi syndrome (Phase 2) | protein/peptide | Phase 2 |
| RM-718 | acquired hypothalamic obesity (Phase 1/2 Part C); Prader-Willi syndrome (Phase 2 Part D) | protein/peptide | Phase 2 |
| congenital hyperinsulinism candidate | congenital hyperinsulinism (CHI) | unclear | Pre-clinical |
Recent results and decisions
- Aug 4, 2026positive Preliminary open-label RM-718 data in acquired HO: -11.6% mean BMI reduction at 16 weeks (n=7) of 11 enrolled; two discontinuations due to AEs.
-11.6% reduction in mean BMI from baseline (n=7) at 16 weeks of RM-718;
Filing - Mar 19, 2026approval FDA approved IMCIVREE label expansion for acquired hypothalamic obesity in patients aged 4 and older, based on -18.4% placebo-adjusted BMI reduction in Phase 3 TRANSCEND.
the U.S. Food and Drug Administration (FDA) has approved an expanded indication for IMCIVREE® (setmelanotide) to treat patients living with acquired hypothalamic obesity (HO).
Filing - Mar 16, 2026missed All four EMANATE substudies missed the primary BMI endpoint (placebo-adjusted: POMC/PCSK1 Hets -4.3% p=0.15; LEPR Hets -3.6% p=0.94; SRC1 -4.0% p=0.12; SH2B1 -1.7% p=0.43); post hoc LOCF analyses significant in POMC/PCSK1 Hets and SRC1.
The four substudies of this global, Phase 3 trial evaluating setmelanotide did not meet primary endpoints.
Filing
2 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 endocrine/women's health companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.