secwatch.observer — SEC 8-K summary
======================================

Issuer:     RHYTHM PHARMACEUTICALS, INC. (RYTM)
CIK:        0001649904
Form:       8-K
Filed at:   2026-03-02T23:59:59+00:00
Accession:  0001104659-26-021801
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Rhythm reports additional positive Phase 3 TRANSCEND data for setmelanotide in hypothalamic obesity
--------------------------------------------------------------------------------

- Placebo-adjusted BMI reduction of 18.8% (N=142); primary endpoint met with -16.4% BMI change on setmelanotide vs +2.4% on placebo (p<0.0001).
- In patients aged 12+ (n=98), setmelanotide group showed 2.5-point reduction in weekly average most hunger score vs 1.3-point for placebo (p=0.0015).
- sNDA under FDA review with PDUFA goal date of March 20, 2026; company submits final data package on March 2, 2026.
- EMA reviewing Type II variation; CHMP opinion expected Q2 2026, potential EU marketing auth in H2 2026.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1649904/000110465926021801/0001104659-26-021801-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1649904/000110465926021801/tm267699d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-26-021801

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer