Rhythm Pharmaceuticals, Inc. RYTM
Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM) is a rare genetic drug developer. Its lead program, bivamelagon, is in Phase 3 for acquired hypothalamic obesity. Its next catalyst on record is RM-718: Complete enrollment in Phase 1/2 Part D trial in PWS (H2 2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: RM-718 — Complete enrollment in Phase 1/2 Part D trial in PWS (H2 2026). 5 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| IMCIVREE (setmelanotide) | acquired hypothalamic obesity, BBS, POMC/PCSK1/LEPR deficiency | protein/peptide | Approved |
| bivamelagon | acquired hypothalamic obesity | small molecule | Phase 3 |
| setmelanotide | congenital hypothalamic obesity | protein/peptide | Phase 3 |
| setmelanotide | Prader-Willi syndrome | protein/peptide | Phase 2 |
| RM-718 | acquired hypothalamic obesity | protein/peptide | Phase 1 |
| RM-718 | Prader-Willi syndrome | protein/peptide | Phase 1 |
| bivamelagon | Prader-Willi syndrome | small molecule | Pre-clinical |
| CHI program | congenital hyperinsulinism | unclear | Pre-clinical |
Recent results and decisions
- Nov 3, 2026started Bivamelagon to advance to Phase 3 trials for Prader-Willi syndrome with 26-week placebo-controlled trial measuring hyperphagia reduction.
Prader-Willi syndrome • Global, phase 3 placebo-controlled trial • 26 weeks • Primary endpoint: Hyperphagia reduction (HQ-CT)
Filing - 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
3 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 rare genetic 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.