The HCPFive: Top News for Healthcare Providers from the Week of 05/24

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 interim phase 1b data for VERVE-102, the US Food and Drug Administration approval of linaclotide (Linzess) for pediatric patients ≥ 2 years of age with functional constipation (FC), the Priority Review of Zydus Therapeutics’ new drug application (NDA) for saroglitazar in adults with primary biliary cholangitis (PBC), new phase 3 data for bepirovirsen in adults with chronic hepatitis B, and the FDA approval of insulin human (Afrezza) Inhalation Powder for use in children and adolescents aged 6 and older living with type 1 and type 2 diabetes.

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 May 24, 2026 — let's jump in!

VERVE-102 Lowers PCSK9, LDL-C in Interim Phase 1b Hypercholesterolemia Data

On May 25, 2026, Eli Lilly reported interim phase 1b data for VERVE-102, an investigational in vivo base-editing therapy targeting PCSK9, with dose-dependent reductions in circulating PCSK9 and low-density lipoprotein cholesterol (LDL-C) after a single intravenous infusion. The results were presented as a late-breaking oral presentation at the European Atherosclerosis Society Congress (EASC). The FDA has also granted Fast Track designation for VERVE-102 for LDL-C reduction in participants with hyperlipidemia and high lifetime cardiovascular risk.

FDA Approves Linaclotide (Linzess) for Functional Constipation in Patients 2 Years And Older

On May 27, 2026, the FDA approved Ironwood Pharmaceuticals’ linaclotide (Linzess) for pediatric patients ≥ 2 years of age with FC, expanding its previous approval for patients ≥ 6 years of age with FC. With this decision, linaclotide is now available for children ages 2-5 years with FC and remains the only FDA-approved prescription therapy for pediatric FC.

FDA Grants Priority Review to Saroglitazar NDA for Primary Biliary Cholangitis

On May 28, 2026, the FDA granted Priority Review to Zydus Therapeutics’ new drug application (NDA) for saroglitazar in adults with PBC. The application seeks approval for use with ursodeoxycholic acid (UDCA) in adults with inadequate response to UDCA, or as monotherapy in those unable to tolerate UDCA. The FDA has also assigned a Prescription Drug User Fee Act target action date of November 27, 2026. Zydus said it plans a US launch by March 2027 if the agent is approved.

Bepirovirsen Achieves 19% Functional Cure in Chronic Hepatitis B

On May 28, 2026, GSK announced pivotal phase 3 data for bepirovirsen, an investigational antisense oligonucleotide, showing a statistically significant functional cure rate of 19% in adults with chronic hepatitis B (CHB). Results were simultaneously published in the New England Journal of Medicine and presented at the European Association for the Study of the Liver (EASL) congress on May 28, 2026.

FDA Approves Inhaled Insulin Afrezza for Pediatric Patients With Diabetes

On May 29, 2026, the FDA approved insulin human (Afrezza) Inhalation Powder for use in children and adolescents aged 6 and older living with type 1 and type 2 diabetes. It is the only ultra rapid-acting inhaled insulin approved by the FDA to improve glycemic control in children, adolescent, and adult patients with diabetes mellitus. The decision was based on results from the pivotal INHALE‑1 clinical trial, along with additional safety, efficacy, and long‑term exposure data from studies evaluating inhaled insulin over the past 2 decades of development.