The HCPFive: Top News for Healthcare Providers from the Week of 05/31

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 expert insight on the expanded FDA approval of linaclotide (Linzess) for children aged 2–5 years with functional constipation, pulmonology updates from the 2026 American Thoracic Society International Conference featuring late-breaking data on AD109, ralinepag, amikacin liposome inhalation suspension (ALIS), and itepekimab, an FDA complete response letter (CRL) for CTx-1301 (dexmethylphenidate HCl) for ADHD, phase 3 post hoc data for lorundrostat in patients with hypertension and chronic kidney disease (CKD), and the first pediatric-specific evidence-based guidelines for atopic dermatitis.

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 31, 2026 — let's jump in!

FDA Issues CRL for CTx-1301 for Daily Dexmethylphenidate in ADHD

On June 2, 2026, Cingulate announced the FDA issued a complete response letter (CRL) for CTx-1301 (dexmethylphenidate HCl), an investigational once-daily ADHD treatment, citing Chemistry, Manufacturing, and Controls (CMC) information requests. The FDA did not raise any concerns regarding the clinical safety or efficacy of CTx-1301. Two pivotal phase 3 studies — one in adults and one in children and adolescents aged 6–17 years — had previously demonstrated meaningful improvements on validated ADHD symptom scales. The CRL came proximate to the assigned PDUFA target action date of May 31, 2026. Cingulate said CMC work is already underway and resubmission is its immediate priority.

Lorundrostat Lowers BP, Albuminuria in Phase 3 CKD Hypertension Analysis

On June 2, 2026, post hoc data from the phase 3 Launch-HTN trial — presented at the 35th European Meeting on Hypertension and Cardiovascular Protection in Gdańsk, Poland — showed lorundrostat, an investigational oral aldosterone synthase inhibitor, was associated with a −9.6 mm Hg reduction in systolic blood pressure (SBP) vs placebo at week 12 in participants with hypertension and CKD. Lorundrostat also significantly reduced albuminuria in this subgroup. The FDA is currently reviewing lorundrostat for uncontrolled or resistant hypertension, with a PDUFA target action date of December 22, 2026.

FDA Expansion of Linaclotide for Children 2–5 Years With Functional Constipation

On June 3, 2026, Julie Khlevner, MD, AGAF, a pediatric gastroenterologist at Columbia University Vagelos College of Physicians and Surgeons, discussed the expanded FDA approval of linaclotide (Linzess) for children aged ≥2 years with functional constipation (FC). Previously approved for FC in patients aged ≥6 years, the expanded indication now covers children aged 2–5 years. The approval was supported by data from a 12-week phase 3 randomized, placebo-controlled trial in which linaclotide 72 mcg demonstrated improvement in spontaneous bowel movement frequency compared with placebo. Linaclotide remains the only FDA-approved prescription therapy for pediatric FC.

HCPLive Five: Pulmonology Updates at ATS 2026

The recap features 5 expert interviews from the 2026 American Thoracic Society International Conference, covering late-breaking data across sleep apnea, tuberculosis, pulmonary arterial hypertension (PAH), MAC lung disease, and COPD. Key highlights include pooled phase 3 data for AD109 (aroxybutynin + atomoxetine) showing a 39.3% reduction in apnea-hypopnea index vs 12.6% with placebo in CPAP-intolerant adults; a 55% clinical worsening risk reduction (HR 0.45; P <.0001) with ralinepag in PAH; an 88% culture conversion rate at 6 months with ALIS for MAC lung disease; and a 27.1% reduction in COPD exacerbations with itepekimab in former smokers in the AERIFY-1 trial.

Why Pediatric Eczema Finally Has Its Own Guidelines

Pediatric dermatologists Andrew C. Krakowski, MD, and Carla Torres-Zegarra, MD, discussed the first pediatric-specific evidence-based guidelines for the prevention and treatment of atopic dermatitis (AD), published in the Journal of the American Academy of Dermatology in April 2026. The guidelines address a long-standing gap in which clinicians managing AD in children had to rely primarily on data extrapolated from adult populations. Atopic dermatitis affects up to 25% of pediatric patients and is among the most frequent reasons for referral to pediatric dermatology.