The HCPFive: Top News for Healthcare Providers from the Week of 03/08

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 positive data from a pre-specified week 36 interim analysis of the ongoing phase 3 RAINIER trial of povetacicept in IgA nephropathy (IgAN), the US Food and Drug Administration (FDA) acceptance of a New Drug Application (NDA) for lorundrostat in hypertension, new data on weight regain after GLP-1 RA discontinuation, the FDA approval of GSK’s leucovorin calcium (Wellcovorin) tablets as the first treatment for cerebral folate deficiency, and data from the phase 3 INTEGUMENT-OLE study of once-daily roflumilast (Zoryve) cream 0.05% in children 2 to 5 years of age with mild-to-moderate 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 March 08, 2026—let’s jump in!

RAINIER: Povetacicept Reduces Proteinuria By 52.0%

On March 9, Vertex Pharmaceuticals announced positive data from a pre-specified week 36 interim analysis of the ongoing phase 3 RAINIER trial of povetacicept, an engineered fusion protein and dual inhibitor of the BAFF and APRIL cytokines, in IgAN. Results showed patients treated with povetacicept achieved a 52% reduction from baseline in proteinuria as measured by 24-hour urine protein to creatinine ratio (UPCR) and achieved a statistically significant and clinically meaningful 49.8% reduction in UPCR versus placebo (P <.0001).

Lorundrostat Secures FDA NDA Acceptance for Hypertension, Falls Short in Phase 2 OSA Trial

On March 9, 2026, the FDA accepted Mineralys Therapeutics’ NDA for lorundrostat for the treatment of adult patients with hypertension in combination with other antihypertensive drugs. The NDA was based on positive data from the phase 3 Launch-HTN and phase 2 Advance-HTN trials demonstrating favorable safety and blood pressure reduction in adults with hypertension. With the acceptance, the FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 22, 2026.

Discontinuing GLP-1 Treatment Associated With Up to 60% Weight Regain, With Brajan Budini

Findings from a recent study suggest GLP-1RA cessation is associated with a predictable and decelerating pattern of weight regain, reaching 60% at 1 year, that plateaus below pre-treatment levels, suggesting that partial weight-loss benefit may persist long-term but is substantially attenuated.

FDA Approves Leucovorin Calcium (Wellcovorin) Tablets as First Cerebral Folate Deficiency Treatment

On March 10, 2026, the FDA approved GSK’s leucovorin calcium (Wellcovorin) tablets for the treatment of cerebral folate deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (CFD-FOLR1), making it the first treatment for the rare genetic condition of cerebral folate deficiency. The approval was based on a systematic review of the published literature on the topic, including published case reports with patient-level information, as well as mechanistic data.

New Long-Term Data Announced on Roflumilast Cream for Atopic Dermatitis in Children

On March 10, 2026, Arcutis Biotherapeutics announced that Pediatric Dermatology published data from the phase 3 open-label extension (INTEGUMENT-OLE) study evaluating once-daily roflumilast (Zoryve) cream 0.05% in children 2 to 5 years of age with mild-to-moderate atopic dermatitis. Data from the INTEGUMENT-OLE trial, which supported the FDA approval of roflumilast cream 0.05% in October 2025, demonstrated that roflumilast cream 0.05% is safe and well-tolerated, and efficacy was not only maintained but continued to improve with up to 56 weeks of treatment.