The HCPFive: Top News for Healthcare Providers from the Week of 03/01

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 acceptance of a New Drug Application for rusfertide in polycythemia vera, topline data from the phase 3 AFFIRM study of risankizumab (Skyrizi) subcutaneous induction in Crohn’s disease, phase 3 data for ralinepag in pulmonary arterial hypertension, phase 2 SUMMIT trial data on bezuclastinib in nonadvanced systemic mastocytosis, and ACTIVATE trial data on vaginal seeding in cesarean-delivered infants.

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 01, 2026—let’s jump in!

FDA Accepts New Drug Application for Rusfertide, Grants Priority Review In Polycythemia Vera

On March 2, 2026, the FDA accepted and granted Priority Review to an NDA for rusfertide for polycythemia vera based on results from the phase 3 VERIFY, phase 2 REVIEW, and long-term extension THRIVE study. Announced by Takeda and Protagonist, the Prescription Drug User Fee Act (PDUFA) target action date is set for the third quarter of this calendar year.

AFFIRM: Risankizumab (Skyrizi) Subcutaneous Induction Achieves Primary Endpoints in Crohn’s Disease

On March 2, 2026, AbbVie announced positive topline results from the phase 3, randomized, placebo-controlled, double-blind AFFIRM study evaluating the efficacy and safety of risankizumab (Skyrizi) subcutaneous (SC) induction treatment versus placebo in adult patients with moderately to severely active Crohn's disease. Findings showed significantly greater proportions of patients treated with risankizumab SC induction achieved the co-primary endpoints of Crohn's Disease Activity Index clinical remission and endoscopic response at week 12 compared to placebo.

ADVANCE OUTCOMES: Ralinepag Outperforms Placebo in Slowing Disease Progression in PAH

On March 2, 2026, United Therapeutics Corporation announced that its investigative prostacyclin receptor agonist ralinepag met its primary endpoint of reducing worsening clinical events in patients with pulmonary arterial hypertension in the phase 3 ADVANCE OUTCOMES study. The study additionally met several important secondary endpoints, including increasing odds of clinical improvement by 47%, in predominantly pre-treated patients with pulmonary arterial hypertension.

SUMMIT: Bezuclastinib Delivers Durable, Deepening Symptom Relief in NonAdvSM, With Cem Akin, MD

Bezuclastinib, an oral, highly selective type 1 KIT inhibitor, has demonstrated that clinically meaningful symptom improvement not only holds but continues to deepen out to 48 weeks of treatment in patients with nonadvanced systemic mastocytosis (NonAdvSM), with every assessed symptom domain showing progressive gains over the treatment course. Data from the pivotal, multicenter, randomized, double-blind, placebo-controlled phase 2 SUMMIT trial were presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) 2026 Annual Meeting held in Philadelphia, Pennsylvania.

Vaginal Seeding Partially Modifies Infant Microbiome in ACTIVATE, With Jose Clemente, PhD

Vaginal seeding in cesarean-delivered infants was associated with altered early gut microbiome patterns and differences in food sensitization at 12 months, according to late-breaking ACTIVATE trial data presented at the 2026 AAAAI Annual Meeting in Philadelphia. Jose Clemente, PhD, associate professor of Genetics and Genomics and Immunology at the Icahn School of Medicine at Mount Sinai, explains the biologic rationale behind the trial and what the findings may mean for clinicians.