The HCPFive: Top News for Healthcare Providers from the Week of 09/06

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 (FDA) approval of Abbott's TactiFlex Duo Ablation Catheter, Sensor Enabled, for patients with atrial fibrillation, the acceptance of Intellia Therapeutics’ Biologics License Application (BLA) for lonvoguran ziclumeran (lonvo-z) for hereditary angioedema (HAE), Breakthrough Therapy designation for DT120 (lysergide) orally disintegrating tablet for major depressive disorder, positive 12-week induction results from Part A of the phase 2 SKYLINE trial evaluating SPY003 for ulcerative colitis (UC), and positive topline results from the phase 3 CHAPTER-3 study of deucrictibant extended-release (XR) tablet for HAE.

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 September 06, 2026 — let's jump in!

TactiFlex Duo Ablation Catheter Receives FDA Approval for AFib

On September 8, 2026, the FDA approved Abbott's TactiFlex Duo Ablation Catheter, Sensor Enabled, for treating patients with atrial fibrillation, including complex cases. The approval rests on 12-month results from the FlexPulse investigational device exemption (IDE) study, presented as late-breaking data at the European Society of Cardiology (ESC) Congress 2026 and published simultaneously in EP Europace.

Lonvo-z BLA Accepted by FDA With Priority Review for HAE

On September 8, 2026, the FDA accepted Intellia Therapeutics’ BLA for lonvoguran ziclumeran (lonvo-z) and granted it priority review for HAE in patients aged ≥ 16 years, setting a Prescription Drug User Fee Act (PDUFA) target action date of March 10, 2027. If approved, lonvo-z would become the first in vivo CRISPR-based therapy to reach the HAE market and the only one-time treatment option available to patients who currently manage the disease with chronic intravenous or subcutaneous prophylaxis.

DT120 ODT Receives Second FDA Breakthrough Therapy Designation in MDD

On September 8, 2026, Definium Therapeutics received a second Breakthrough Therapy designation from the FDA for DT120 (lysergide) orally disintegrating tablet, this time for major depressive disorder. The designation follows an initial Breakthrough Therapy designation for DT120 in generalized anxiety disorder, positioning the ergoline-derived 5-HT2A partial agonist across 2 psychiatric indications with FDA-recognized potential for substantial improvement over available therapy.

SPY003 Meets Primary Endpoint in Phase 2 Trial for Ulcerative Colitis

On September 8, 2026, Spyre Therapeutics reported positive 12-week induction results from Part A of the phase 2 SKYLINE trial evaluating SPY003, an investigational anti-IL-23 antibody, in patients with moderately-to-severely active UC. According to the Company, this readout completes proof-of-concept for all 3 components of Spyre's inflammatory bowel disease (IBD) combination pipeline, following earlier positive Part A results for SPY001 (anti-α4β7) and SPY002 (anti-TL1A).

Deucrictibant XR Meets Primary Endpoint in HAE Prophylaxis

On September 8, 2026, Pharvaris reported positive topline results from the phase 3 CHAPTER-3 study of deucrictibant extended-release (XR) tablet, showing an 83% reduction in mean monthly HAE attack rate versus placebo (P <.0001) across all 3 HAE types in adolescents and adults. The study is the first and only prophylaxis phase 3 program to evaluate all 3 HAE types, including HAE with normal C1 inhibitor, a population without a dedicated oral prophylactic option in this analysis.