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Roche Advances Obesity Drug Trial and Receives FDA Decision Date for Breast Cancer Therapy

Mar 06, 2026

Roche announced positive phase II results for obesity drug petrelintide showing 10.7% weight reduction, while the FDA set a December 18 decision date for breast cancer drug giredestrant.

FDA Accepts Roche's Giredestrant Filing for ESR1-Mutated Breast Cancer

Feb 20, 2026

The FDA has accepted Roche's new drug application for oral SERD giredestrant in ESR1-mutated, ER-positive advanced breast cancer, with a decision expected by December 18, 2026. The filing is restricted to the ESR1-mutant population despite phase 3 trial benefits in broader patients.