The HCPFive: Top News for Healthcare Providers from the Week of 07/13

Welcome to The HCPFive, your go-to roundup for the latest healthcare news and breakthroughs, curated specifically for busy healthcare professionals.

Each week, we highlight 5 key developments or headlines from healthcare that you need to know—whether it's a cutting-edge treatment, regulatory updates, or innovations shaping the future of medicine. This week's top stories include the US Food and Drug Administration approvals of finerenone (Kerendia) for adults with heart failure with a left ventricular ejection fraction (LVEF) of 40% or greater and an update to the VARIPULSE Platform’s irrigation flow rate as well as Orphan Drug Designation for Endeavor Biosciences’ taladegib (ENV-101) for the treatment of idiopathic pulmonary fibrosis (IPF) and phase 3 data for baxdrostat in difficult-to-control hypertension and palopegteriparatide (TransCon PTH) in hypoparathyroidism.

With The HCPFive, you'll get the essential takeaways to stay informed and ahead of the curve. Here’s your quick dive into the top stories for the week of July 13, 2025—let’s jump in!

FDA Approves Finerenone (Kerendia) for Heart Failure with Ejection Fraction of 40% or More

On July 14, 2025, the FDA approved Bayer’s finerenone (Kerendia) for adults with heart failure with a LVEF of 40% or greater. The decision was supported by data from the FINEARTS-HF trial and indicates finerenone for reducing the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults with heart failure with mildly reduced ejection fraction (HFmrEF) and preserved ejection fraction (HFpEF).

Baxdrostat Meets Efficacy Endpoint in Phase 3 Trial for Resistant Hypertension

Baxdrostat, a potential first-in-class aldosterone synthase inhibitor (ASI) for the treatment of difficult-to-control hypertension, achieved the primary endpoint of statistically significant systolic blood pressure (SBP) reduction in its phase 3 BaxHTN trial.

Announced by parent company AstraZeneca on July 14, 2025, the results of BaxHTN indicate baxdrostat’s potential to lower aldosterone content, preventing dysregulation, which has been cited as a leading cause of hypertension.

FDA Approves Updated VARIPULSE Platform Irrigation Flow Rate for Heart Disease

On July 14, the FDA also approved an update to Johnson & Johnson MedTech’s VARIPULSE Platform’s irrigation flow rate, which is designed to optimize irrigation and support consistent successful operations with low adverse event rates. At the time of the approval, >10,000 VARIPULSE procedures had been performed across all approved countries, and the platform has maintained a neurovascular adverse event rate of <.5% based on internal customer reported data/complaints.

Palopegteriparatide Provides Sustained Response in Adults with Hypoparathyroidism

Results from the randomized, double-blind, placebo-controlled, phase 3 PaTHway trial demonstrate a sustained response to Ascendis Pharma’s palopegteriparatide therapy in adults with hypoparathyroidism. In the 3-year trial, palopegteriparatide continued to provide durable responses in adults with hypoparathyroidism, regardless of whether it was post-surgical, autoimmune, genetic, or idiopathic. Biochemistries, kidney function, and quality of life were all significantly improved.

FDA Grants Orphan Drug Designation to Taladegib, Potential Idiopathic Pulmonary Fibrosis Treatment

On July 16, 2025, the FDA granted Orphan Drug Designation to Endeavor Biosciences’ taladegib for the treatment of IPF. The investigational Hedgehog signaling pathway inhibitor is currently being evaluated in the phase 2b Wound-remodeling Hedgehog-Inhibitor ILD Study Testing Lung Function Endpoints-PF (WHISTLE-PF) clinical trial.