The HCPFive: Top News for Healthcare Providers from the Week of 07/12

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 FDA granting full traditional approval to iptacopan (Fabhalta) for adults with primary IgA nephropathy (IgAN), the FDA approval of enlicitide (Lipfendra) as the first oral PCSK9 inhibitor for hypercholesterolemia, phase 2a data from the SIGNAL-AA trial showing bempikibart effective for alopecia areata at 36 weeks, 12-month open-label extension data for treprostinil palmitil inhalation powder (TPIP) in pulmonary arterial hypertension (PAH), and phase 3 topline results for soficitinib in moderate-to-severe 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 July 12, 2026 — let's jump in!

FDA Grants Full Approval to Iptacopan (Fabhalta) in IgAN

On July 17, 2026, Novartis announced the FDA granted traditional approval to iptacopan (Fabhalta) to slow kidney function decline in adults with primary IgAN at risk of disease progression. The decision converts the therapy's August 2024 accelerated approval into a full approval based on 2-year results from the phase 3 APPLAUSE-IgAN trial, in which iptacopan demonstrated an annualized mean eGFR change of −3.0 mL/min/1.73 m²/yr vs −5.7 mL/min/1.73 m²/yr for placebo — representing a 48% slowing of eGFR decline. Iptacopan is the first and only complement inhibitor approved to significantly slow kidney function decline in adults with primary IgAN. The drug is available only through a Risk Evaluation and Mitigation Strategy (REMS) program due to risk of serious infections caused by encapsulated bacteria.

FDA Approves Enlicitide (Lipfendra) for LDL-C Lowering in Adults With Hypercholesterolemia

On July 16, 2026, Merck announced the FDA approved enlicitide (Lipfendra) as an adjunct to diet and exercise for the reduction of LDL-C in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). Enlicitide is the first FDA-approved oral PCSK9 inhibitor — a once-daily 20 mg macrocyclic peptide tablet. The approval was supported by two phase 3 CORALreef trials: CORALreef Lipids (n=2,904) showed a placebo-adjusted 56% LDL-C reduction at week 24, and CORALreef HeFH (n=303) showed a 59% reduction. An ongoing cardiovascular outcomes trial, CORALreef Outcomes, is assessing whether enlicitide reduces cardiovascular morbidity and mortality.

SIGNAL-AA: Bempikibart Effective for Alopecia Areata at 36 Weeks

On July 13, 2026, Q32 Bio announced positive 36-week topline results from Part B of the phase 2a SIGNAL-AA trial evaluating bempikibart, an investigational fully human anti-IL-7Rα monoclonal antibody, in 33 adults with severe or very severe alopecia areata. Bempikibart met its primary endpoint, with a 35.3% mean reduction in SALT score and 40.0% of patients achieving SALT-20 at week 36. No treatment-related serious or grade ≥3 adverse events were reported. The trial population included patients with prior JAK inhibitor experience (36.4%), and several patients maintained or improved hair regrowth after stopping treatment. Q32 Bio plans to advance a registration-directed program in the first half of 2027.

Daily Inhaled TPIP Improved PAH Measures at 12 Months in OLE

On July 16, 2026, Insmed announced 12-month data from the open-label extension (OLE) of the phase 2b TPIP PAH program, showing treprostinil palmitil inhalation powder (TPIP) — an investigational once-daily dry powder prostanoid prodrug — produced sustained improvements across all secondary efficacy endpoints in patients with PAH. Both the TPIP-continued group and patients who crossed over from placebo showed approximately 55-meter improvements in 6-minute walk distance and approximately 60% reductions in NT-proBNP from baseline at month 12. Approximately 80% of patients in both groups achieved WHO Functional Class I or II at month 12. The phase 3 PALM-PAH trial is now enrolling, with change in 6-minute walk distance as the primary endpoint.

Soficitinib Meets Primary Endpoint in New Phase 3 Atopic Dermatitis Data

On July 15, 2026, InnoCare Pharma announced positive topline results from a registrational phase 3 trial of soficitinib (ICP-332), an investigational selective oral TYK2 inhibitor, in approximately 579 adults with moderate-to-severe atopic dermatitis. The trial met its primary endpoint with statistical significance and demonstrated clinically meaningful improvements across multiple secondary endpoints. No new safety signals were identified compared with prior clinical experience. Soficitinib is also being evaluated in vitiligo, psoriasis, prurigo nodularis, and chronic spontaneous urticaria, with regulatory filing intentions for AD.