Short answer
RHYTHM PHARMACEUTICALS, INC. (RYTM) filed an 8-K current report with the SEC on June 15, 2026 reporting Item 7.01 (Regulation FD Disclosure), Item 8.01 (Other Events), Item EX-99.1 (Exhibit EX-99.1). Interim six-month data from exploratory Phase 2 setmelanotide trial in Prader-Willi syndrome patients.
RHYTHM PHARMACEUTICALS, INC. 8-K event analysis
AI summary of each reported item and its exhibits
Item 7.01 · Regulation FD Disclosure
- Interim six-month data from exploratory Phase 2 setmelanotide trial in Prader-Willi syndrome patients
- Disclosure dated June 13, 2026, via press release and investor presentation
- Potential read-through for setmelanotide’s PWS development strategy and future regulatory positioning
Item 8.01 · Other Events
- PWS Phase 2 data showed −3.06% mean BMI reduction at Month 6 across 17 patients, with 8 of 10 hyperphagic patients improving ≥7 HQ-CT points
- Pediatric PWS results included −0.35 BMI z-score change, with 5 of 7 achieving clinically meaningful reductions
- Acquired hypothalamic obesity data supported setmelanotide durability, showing −18.9% mean BMI reduction through 2.5 years across 11 patients
- Oral bivamelagon produced −6.7% to −16.6% mean BMI changes at Week 52 across dosing cohorts, supporting Rhythm’s pipeline diversification
- Real-world BBS data showed 62% of adults achieving ≥10% weight loss after 12 months, alongside reduced obesity-related outpatient visits
Item EX-99.1 · Exhibit EX-99.1
- Phase 2 interim data support setmelanotide’s potential in PWS, strengthening the case for Phase 3 development
- At Month 6, 17 patients achieved a mean BMI reduction of 3.06%; trial remains ongoing through 52 weeks
- Hyperphagia improved meaningfully in 8 of 10 patients with baseline HQ-CT scores above 13
- Body composition improved across 16 patients, with lean mass up 0.74% and fat mass down 4.19%
- PWS expansion could address an estimated 8,500–12,750 U.S. patients with hyperphagia and obesity
Generated from the filing text and exhibits; verify against the original. What 8-K item codes mean
Other RHYTHM PHARMACEUTICALS, INC. 8-K filings
Get the next RYTM 8-K as it lands
Follow RYTM for push alerts, or ask the research agent what this filing means.