The HCPFive: Top News for Healthcare Providers from the Week of 07/26

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 a post hoc analysis of pooled FIBRONEER trial data suggesting Boehringer Ingelheim's nerandomilast (Jascayd) reduces mortality risk in pulmonary fibrosis, the July 31 market exit of Stallergenes Greer's Palforzia — the only United States Food and Drug Administration (FDA)-approved prescription peanut oral immunotherapy — and what it means for patients and clinicians, the FDA De Novo authorization of Caristo Diagnostics' CaRi-Heart as the first technology to quantify coronary inflammation from routine CT angiography, the FDA approval of Otsuka's centanafadine (SIMTRIYO) as the first-in-class norepinephrine, dopamine, and serotonin reuptake inhibitor for ADHD in adults and children aged ≥6 years, and the FDA approval of Freenome's SimpleScreen™ CRC as a blood-based screening test for colorectal cancer in average-risk adults aged ≥45 years, with Abbott set to commercialize the test this fall.

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 26, 2026 — let's jump in!

1. Nerandomilast Reduces Mortality Risk in Pulmonary Fibrosis Analysis

On July 31, 2026, HCPLive reported on a post hoc pooled analysis of the FIBRONEER-IPF and FIBRONEER-ILD trials showing nerandomilast (Jascayd; Boehringer Ingelheim), an oral preferential PDE4B inhibitor, reduced the risk of death by up to 43% versus placebo. In the pooled dataset, deaths occurred in 13.5% of placebo-treated patients compared with 9.2% (HR 0.67; P=.009) and 7.7% (HR 0.57; P<.001) in patients receiving nerandomilast 9 mg and 18 mg twice daily, respectively. The mortality reduction reached nominal significance in FIBRONEER-ILD, where both doses reduced the hazard ratio to 0.51, but not in FIBRONEER-IPF as a standalone trial. Because this was a post hoc analysis, the findings are exploratory; nerandomilast is FDA-approved for IPF and PPF based on FVC decline data from the FIBRONEER program.

2. Palforzia Discontinued, Ending the Only FDA-Approved Peanut OIT Option

On July 31, 2026, peanut allergen powder-dnfp (Palforzia; Stallergenes Greer), the first and only FDA-approved oral immunotherapy (OIT) for peanut allergy in children ages 1–17, was voluntarily discontinued by its manufacturer. The decision, which the company stated is not related to product safety, quality, or efficacy, ends six years of commercial availability since Palforzia's original 2020 FDA approval under Aimmune Therapeutics. HCPLive spoke with allergists Robert Wood, MD, and Jacqueline Ross, MD, about the practical implications for patients currently in treatment and what transition options remain available.

3. CaRi-Heart Receives FDA De Novo Authorization for Coronary Inflammation

On July 29, 2026, Caristo Diagnostics announced the FDA granted De Novo authorization for CaRi-Heart, the first and only technology authorized in the United States to quantify coronary inflammation from routine coronary CT angiography (CCTA). Developed from more than a decade of research at the University of Oxford, CaRi-Heart uses AI to generate a coronary inflammation score and assess cardiovascular mortality risk — addressing a gap in risk stratification, given that nearly half of first heart attacks occur in patients classified as low-risk by traditional tools. The technology is supported by validation data from large independent patient populations, with results published in The Lancet, and by the ORFAN registry, which aims to incorporate outcomes data from up to 250,000 patients. CPT codes 0992T and 0993T for CaRi-Heart have been effective since January 1, 2026, and commercial launch in the US is planned for Q4 2026.

4. FDA Approves Centanafadine (SIMTRIYO) for ADHD in Adults and Children Aged ≥6 Years

On July 24, 2026, Otsuka Pharmaceutical announced the FDA approved centanafadine (SIMTRIYO), a once-daily extended-release capsule, for the treatment of ADHD in adults and pediatric patients aged ≥6 years weighing ≥20 kg. Centanafadine is the first and only FDA-approved norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI), introducing a mechanism distinct from both stimulant and existing nonstimulant ADHD therapies. The approval was supported by four randomized, double-blind, placebo-controlled phase 3 trials spanning children, adolescents, and adults; in pediatric and adolescent trials, the high-dose group showed statistically significant ADHD-RS-5 improvements versus placebo, with benefit emerging by week 1. Commercial availability is pending DEA scheduling.

5. FDA Approves Freenome Blood Test for Colorectal Cancer Screening

On July 27, 2026, the FDA approved Freenome's SimpleScreen™ CRC, a blood-based colorectal cancer (CRC) screening test for average-risk adults aged ≥45 years, providing clinicians with a second FDA-approved blood-based CRC screening option alongside Guardant Health's Shield. The approval was supported by findings from the PREEMPT CRC study (n>48,000), the largest prospective clinical validation study for a blood-based CRC test, in which SimpleScreen detected approximately 8 in 10 colorectal cancers and correctly returned negative results in 9 of 10 patients without CRC or advanced precancerous lesions. Abbott will exclusively commercialize the test in the United States beginning this fall; the approval meets Medicare coverage criteria, and the American Cancer Society is expected to incorporate SimpleScreen CRC into its screening guidelines by name.