FDA Grants Breakthrough Device Designation to Orchestra BioMed's AVIM Therapy for Hypertension
• Orchestra BioMed received FDA Breakthrough Device Designation for its atrioventricular interval modulation therapy, designed to reduce blood pressure in high-risk patients with uncontrolled hypertension.
• The designation provides accelerated FDA review and potential pathways for higher reimbursement for AVIM-enabled pacemakers, benefiting an estimated 7.7 million eligible patients in the U.S.
• The therapy is currently being evaluated in the BACKBEAT pivotal study in partnership with Medtronic, with Orchestra BioMed's stock surging over 25% following the announcement.
Rhythm Pharmaceuticals Announces Positive IMCIVREE® Sales and Pipeline Advancements
• Rhythm Pharmaceuticals reports preliminary unaudited net revenues of approximately $42 million for Q4 2024 and $130 million for full year 2024 from global IMCIVREE® sales.
• Topline data from the Phase 3 trial of setmelanotide in acquired hypothalamic obesity (HO) is expected in the first half of 2025.
• A new Phase 2 trial exploring setmelanotide in Prader-Willi syndrome (PWS) is planned to commence in the first quarter of 2025.
• Enrollment is completed in the Phase 3 EMANATE trial substudies for genetically-caused MC4R pathway diseases, with topline data anticipated in H1 2026.
Phase III LEAP-012 Study Shows Promising Results for Intermediate-Stage HCC Treatment
The LEAP-012 phase III trial demonstrates that combining lenvatinib, pembrolizumab, and TACE significantly improves progression-free survival in patients with intermediate-stage hepatocellular carcinoma, compared to placebo plus TACE.
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