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Regulatorynovo nordiskcagrisemasomapacitanemadenecimig

CHMP backs Novo Nordisk's denecimig and Sogroya as CagriSema posts 21% weight loss

The EMA committee recommended FREHEMGO for hemophilia A and once-weekly somapacitan for children with idiopathic short stature, pending European Commission sign-off.

DO
By Daniel Okafor · Regulatory Correspondent
Sep 28 03:10 ETSource: AD HOC NEWS

The wire

  1. 01Novo Nordisk received two positive CHMP opinions and reported CagriSema cut weight 12.4% on average in diabetes patients and 21% versus placebo in obesity at the 1.0 mg dose.
  2. 02Sogroya's somapacitan extension and the CagriSema data bear directly on peptide prescribing in growth disorders and obesity, where tirzepatide is the comparator.
  3. 03European Commission approval is still required for Sogroya; first-country launch of FREHEMGO is expected in Q4 2026, with broader EU rollout in early 2027.

From the source

Novo Nordisk Wins European Backing for Two Specialty Drugs as CagriSema Outperforms Eli Lilly Rival

Novo Nordisk has secured a pair of favorable regulatory opinions in Europe while simultaneously posting late-stage data that strengthens its hand against Eli Lilly in the race for the metabolic-therapy market. The twin developments, alongside a widening artificial-intelligence partnership and a fresh philanthropic commitment, sketch a company working to diversify well beyond its flagship diabetes

Read at ad-hoc-news.de
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