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Gedatolisib Demonstrates Promising Efficacy in Phase 3 VIKTORIA-1 Trial for HR+/HER2- Advanced Breast Cancer: NDA Submission Initiated
Posted inOncology

Gedatolisib Demonstrates Promising Efficacy in Phase 3 VIKTORIA-1 Trial for HR+/HER2- Advanced Breast Cancer: NDA Submission Initiated

Posted by MedXY By MedXY 10/24/2025
Celcuity's phase 3 VIKTORIA-1 trial reveals that gedatolisib, a broad-spectrum PI3K/mTORC1/2 inhibitor, significantly improves progression-free survival in hormone receptor-positive, HER2-negative advanced breast cancer patients post CDK4/6 inhibitor therapy, prompting NDA rolling submission.
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Oral Iptacopan Monotherapy in Paroxysmal Nocturnal Haemoglobinuria: 48-Week Outcomes from APPLY-PNH and APPOINT-PNH Phase 3 Trials
Posted inClinical Updates Internal Medicine news Pediatrics Specialties

Oral Iptacopan Monotherapy in Paroxysmal Nocturnal Haemoglobinuria: 48-Week Outcomes from APPLY-PNH and APPOINT-PNH Phase 3 Trials

Posted by MedXY By MedXY 08/03/2025
Oral iptacopan provides sustained haemolysis control and improved haemoglobin in PNH patients over 48 weeks, with a favorable safety profile, supporting its role as a new therapeutic option.
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