Also known as: Menarini
NewAmsterdam Pharma said regulatory decisions on obicetrapib in Europe, the UK and Switzerland remain expected in 2H26. PREVAIL interim analysis is planned for 4Q2026, with a result expected in 1Q2027.
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.
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.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07753954 |
Medical Imaging to Re-evaluate Elacestrant Clinical Usage |
NOT_YET_RECRUITING | PHASE2 |
| NCT07222215 |
PhII Randomized CAPecitabine + ELAcestrant vs. Capecitabine Alone in ER+ Breast Cancer (CAPELA) |
RECRUITING | PHASE2 |
| NCT06828848 |
A Study to Assess How Vaborem® is Taking up in the Body and Tolerated in Paediatric Patients With Gram Negative Infections, Including But Not Restricted to Complicated Urinary Tract Infections |
RECRUITING | PHASE2 |
| NCT05512364 |
Elacestrant for Treating ER+/HER2- Breast Cancer Patients With ctDNA Relapse (TREAT ctDNA) |
RECRUITING | PHASE3 |
