HCPLive Editorial Staff

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 final 24-month phase 3 VISIONARY data showing Otsuka’s sibeprenlimab (Voyxact) stabilizes eGFR decline in 

, the FDA approval of BioCryst’s berotralstat (Orladeyo) 150 mg oral pellets for 

prophylaxis in patients aged ≥12 years, the FDA accelerated approval of AstraZeneca’s ravulizumab (Ultomiris) as the first C5 complement inhibitor indicated in IgA nephropathy, the FDA approval of AbbVie’s subcutaneous induction regimen for risankizumab (Skyrizi) in adults with moderately to severely active 

, and the FDA approval of GSK’s bepirovirsen (Hibsago) as the first antisense oligonucleotide approved for 

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 October 18, 2026 — let’s jump in!

Sibeprenlimab Stabilizes eGFR Over 24 Months in IgA Nephropathy: VISIONARY

Final 24-month data from the phase 3 VISIONARY trial showed Otsuka’s sibeprenlimab (Voyxact), a selective APRIL inhibitor, produced an annualized eGFR slope of +0.3 mL/min/1.73 m² per year versus a placebo decline of 4.2 — a treatment difference of 4.5 mL/min/1.73 m² per year (P<.0001). The least-squares mean eGFR change from baseline favored sibeprenlimab by 9.2 mL/min/1.73 m² at 2 years, and 24-hour uPCR fell 61.3% from baseline versus 1.3% with placebo. Benefit was consistent across prespecified subgroups defined by proteinuria level, baseline eGFR, and SGLT2 inhibitor use, and Otsuka has initiated a rolling sBLA seeking traditional approval based on the 24-month eGFR endpoint.

FDA Approves Berotralstat Oral Pellets for Adults, Adolescents With HAE

On October 21, 2026, the FDA approved BioCryst’s berotralstat (Orladeyo) 150 mg oral pellet formulation for prophylaxis of hereditary angioedema attacks in patients aged ≥12 years, adding a pellet alternative to the existing capsule for adults and adolescents. The pellet formulation had previously been approved for children aged 2 to <12 years in December 2025; the new 150 mg strength is intended to allow those patients to remain on pellets as they age into adolescence, and to serve adults who have difficulty swallowing capsules. Berotralstat remains the first and only targeted oral prophylactic therapy covering the full HAE population from age 2 and older.

Ravulizumab Receives FDA Accelerated Approval for IgA Nephropathy

On October 21, 2026, the FDA granted accelerated approval to AstraZeneca’s ravulizumab (Ultomiris) to reduce proteinuria in adults with primary IgA nephropathy at risk for disease progression, making it the first and only C5 complement inhibitor indicated in IgAN and the drug’s fifth approved indication. The approval was based on a prespecified interim analysis of the phase 3 I CAN trial, in which ravulizumab reduced 24-hour UPCR by 43.4% versus placebo at week 34 (P<.0001), with reductions observed as early as week 10. Continued approval is contingent on the trial’s second primary endpoint — eGFR change at week 106 — with those late-breaking results presented at ASN Kidney Week on October 23, 2026.

FDA Approves Subcutaneous Risankizumab Induction for Crohn’s Disease

On October 23, 2026, the FDA approved a subcutaneous induction regimen for AbbVie’s risankizumab (Skyrizi) in adults with moderately to severely active Crohn’s disease, based on the phase 3 AFFIRM trial, in which 56% of patients achieved clinical remission at week 12 versus 30% with placebo. The approval allows patients to initiate therapy at home via on-body injector at weeks 0, 2, 4, and 8, rather than requiring intravenous infusion — though IV induction remains an option. Approximately 65% of AFFIRM participants had previously failed advanced therapy, supporting the new regimen’s use even in a refractory population.

FDA Approves Bepirovirsen for Chronic Hepatitis B

On October 20, 2026, the FDA approved bepirovirsen (Hibsago; GSK/Ionis), the first antisense oligonucleotide approved for chronic hepatitis B virus (HBV) infection, for use alongside existing nucleos(t)ide analogue therapy in adults without cirrhosis with suppressed HBV DNA and HBsAg ≤3,000 IU/mL. The approval was supported by two replicate phase 3 B-Well trials showing a 19% functional cure rate in eligible patients — compared to less than 1% with standard of care alone — with 24% of bepirovirsen-treated patients meeting criteria to discontinue all hepatitis B therapy. The FDA granted the drug Fast Track, Breakthrough Therapy, and Priority Review designations; a companion diagnostic to identify eligible patients was also authorized.

Articles

Five late-September 2026 regulatory and late-stage clinical updates span infectious disease, PAH, immunology, diabetes, and nephrology. The FDA granted Priority Review for an Arikayce sNDA that could move inhaled liposomal amikacin into frontline combination therapy for newly diagnosed or recurrent MAC lung disease. Sotatercept’s label now incorporates phase 3 HYPERION data in adults with PAH diagnosed within 12 months. Barzolvolimab met week-12 UAS7 endpoints in two phase 3 CSU trials. FDA approvals also include once-weekly insulin efsitora for type 2 diabetes and obinutuzumab to prevent relapse in frequently relapsing or steroid-dependent childhood-onset idiopathic nephrotic syndrome.

Stay updated with the latest healthcare breakthroughs, including Otsuka’s sibeprenlimab 24-month eGFR data in IgA nephropathy.

The HCPFive: Top News for Healthcare Providers from the Week of 10/18

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.

 Priority Review of Insmed's supplemental new drug application (sNDA) for amikacin liposome inhalation suspension (Arikayce) for Mycobacterium avium complex (MAC) lung disease, the approval of a sotatercept-csrk (Winrevair) label update to include efficacy and safety data from the phase 3 HYPERION trial in adults with pulmonary arterial hypertension (PAH) diagnosed within the previous 12 months, phase 3 EMBARQ-CSU1 and EMBARQ-CSU2 data for barzolvolimab in antihistamine-refractory 

, and the FDA approvals of insulin efsitora alfa-gobe (Onswik) to improve glycemic control in adults with 

 as well as obinutuzumab (Gazyva) for adult and pediatric patients ≥ 2 years of age with frequently relapsing or steroid dependent childhood-onset idiopathic nephrotic syndrome.

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 September 20, 2026 — let's jump in!

FDA Grants Priority Review for Insmed's ARIKAYCE sNDA for MAC Lung Disease

On September 21, 2026, the FDA granted Priority Review to Insmed's supplemental new drug application (sNDA) for amikacin liposome inhalation suspension (ALIS; Arikayce) seeking full approval for newly diagnosed and recurrently infected MAC lung disease.

Amikacin liposome inhalation suspension is currently approved only under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) for refractory MAC lung disease in patients who have failed ≥ 6 months of multidrug therapy without achieving negative sputum culture conversion. If approved, the sNDA would expand the label to frontline use as part of combination antibacterial therapy, moving amikacin liposome inhalation suspension from a refractory-disease option to a treatment-naive one.

FDA Updates Sotatercept Label with HYPERION Data in Early PAH

On September 22, 2026, the FDA approved a label update for sotatercept-csrk (Winrevair) to include efficacy and safety data from the phase 3 HYPERION trial in adults with PAH diagnosed within the previous 12 months.

The activin signaling inhibitor already carries approval for adults with PAH (WHO Group 1) to improve exercise capacity and WHO functional class and to reduce clinical worsening events, including hospitalization, lung transplantation, and death. The HYPERION update extends label evidence to patients earlier in their disease course, adding to prior data from the STELLAR and ZENITH trials.

EMBARQ-CSU: Barzolvolimab Meets Primary, Secondary Endpoints in CSU Trials

On September 22, 2026, Celldex Therapeutics reported topline results from the phase 3 EMBARQ-CSU1 and EMBARQ-CSU2 trials of barzolvolimab (CDX-0159), showing the anti-KIT monoclonal antibody met the primary endpoint of mean change from baseline in weekly urticaria activity score (UAS7) at week 12 in patients with antihistamine-refractory CSU. The studies represent the largest program conducted in antihistamine refractory CSU, including patients with advanced therapy experienced/refractory CSU.

Weekly Insulin Efsitora Alfa (Onswik) Gains FDA approval for Type 2 Diabetes

On September 24, 2026, the FDA approved insulin efsitora alfa-gobe (Onswik), a once-weekly basal insulin, to improve glycemic control in adults with type 2 diabetes, based on 4 phase 3 QWINT trials. According to parent company Eli Lilly, efsitora is designed to maintain steady basal insulin levels across a full 7-day dosing interval, reducing basal injections from approximately 365 to 52 per year vs once-daily basal insulin. The US decision is the fourth global approval for efsitora in type 2 diabetes, following actions in the European Union, Mexico, and Japan.

FDA Approves Obinutuzumab (Gazyva) for Idiopathic Nephrotic Syndrome

On September 25, 2026, the FDA approved obinutuzumab (Gazyva) to reduce the risk of relapse in adult and pediatric patients 2 years of age and older with frequently relapsing or steroid dependent childhood-onset idiopathic nephrotic syndrome who are in complete remission. The decision makes obinutuzumab the first FDA-approved treatment option for idiopathic nephrotic syndrome in 70 years and was supported by data from the phase 3 INShore study showing a greater proportion of people experienced no relapses after week 8 and were in complete remission at one year with obinutuzumab (95%) compared with mycophenolate mofetil (73%).

Stay updated with the latest healthcare breakthroughs, including the FDA approval of insulin efsitora alfa-gobe (Onswik).

The HCPFive: Top News for Healthcare Providers from the Week of 09/20

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 recap of six late-breaking trials from ERS Congress 2026 in Barcelona spanning 

, the FDA acceptance of Takeda's zasocitinib NDA under Priority Review for moderate-to-severe 

, a Q&A on what the first FDA-approved photodynamic therapy for a skin cancer means for superficial basal cell carcinoma care, new ASH guidelines raising ferritin thresholds for 

 diagnosis across key populations, and the FDA approval of Bayer's finerenone (Kerendia) as the first new treatment in more than 30 years for adults with 

 associated with type 1 diabetes.
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 September 13, 2026 — let's jump in!

ERS Congress 2026: 6 Late-Breaking Trials to Know

ERS Congress 2026, held September 5–9 in Barcelona, delivered a late-breaking program spanning COPD, asthma, IPF, and alpha-1 antitrypsin deficiency. Top highlights included replicate phase 3 data from the OBERON and TITANIA trials showing tozorakimab, an IL-33 receptor antagonist, reduced moderate and severe COPD exacerbations by 29–34% in former smokers — the first phase 3 IL-33 antagonist success in this indication — alongside eosinophil-guided ICS strategy data, nerandomilast long-term tolerability results from the FIBRONEER-ON extension, and early clinical findings from a genetic correction program in AATD.

Zasocitinib NDA Acceptance: What It Means for Psoriasis Treatment

On September 14, 2026, the FDA accepted Takeda's NDA for zasocitinib, an investigational once-daily oral TYK2 inhibitor, under Priority Review for adults with moderate-to-severe plaque psoriasis, with a PDUFA target action date in Q1 2027. The filing is supported by the phase 3 LATITUDE PsO 3001 and 3002 trials, in which zasocitinib met co-primary and all 44 ranked secondary endpoints, achieving sPGA 0/1 in roughly 70% of patients at week 16 versus 11–13% on placebo and 30–32% on apremilast. Dermatologist Raj Chovatiya, MD, PhD, told HCPLive that the drug's oral route and high clearance rates could broaden access for patients hesitant about biologics and for those with limited but burdensome disease.

Q&A: What the First FDA-Approved PDT for Skin Cancer Means for sBCC Care

On September 14, 2026, the FDA approved Biofrontera's Ameluz (aminolevulinic acid hydrochloride) topical gel, 10%, used with the BF-RhodoLED lamp series, for superficial basal cell carcinoma in adults — making it the first FDA-approved photodynamic therapy for any skin cancer. The approval was supported by phase 3 ALA-BCC-CT013 data (n=187) showing a 66% composite clinical and histological complete response rate at 12 weeks versus 5% with vehicle-PDT. Neal Bhatia, MD, told HCPLive the treatment may be particularly useful in cosmetically sensitive areas and could be used alongside imiquimod rather than in direct competition with Mohs surgery.

ASH Issues New Ferritin Thresholds for Iron Deficiency Diagnosis

The American Society of Hematology published new evidence-based clinical practice guidelines raising serum ferritin thresholds for the diagnosis of iron deficiency across multiple populations: ≤20 ng/mL for children aged 9 months to 4 years, ≤30 ng/mL for adults and menstruating or pregnant individuals, and ≤50 ng/mL for those with heavy menstrual bleeding or pregnancy with anemia. For patients with inflammation — including those with cancer, IBD, or infectious disease — the guidelines recommend using ferritin <100 ng/mL or transferrin saturation <20% to account for ferritin's behavior as an acute-phase reactant. The five GRADE-based recommendations are intended to support earlier and more accurate diagnosis, and treatment-focused guidance is expected in 2027.

FDA Approves Finerenone (Kerendia) for CKD and Type 1 Diabetes

On September 17, 2026, Bayer announced the FDA approved finerenone (Kerendia) to reduce UACR — and thereby lower the risk of sustained eGFR decline and end-stage kidney disease — in adults with CKD associated with type 1 diabetes, marking the first new treatment for this population in more than 30 years. The approval was supported by the phase 3 FINE-ONE trial (n=242), which showed a 25% UACR reduction over 6 months versus placebo (P=.0001), with results published concurrently in the New England Journal of Medicine. This is finerenone's third US indication, following approvals for CKD with type 2 diabetes and for heart failure with LVEF ≥40%, and makes it the only MRA approved for CKD associated with both T1D and T2D.

Major late-breaking data from ERS Congress 2026 spanned COPD, asthma, IPF, and alpha-1 antitrypsin deficiency, including phase 3 efficacy for IL-33 pathway blockade and longer-term antifibrotic tolerability. The FDA accepted Takeda’s zasocitinib NDA under Priority Review for moderate-to-severe plaque psoriasis on robust phase 3 outcomes. A first-in-class FDA approval established photodynamic therapy for superficial basal cell carcinoma. ASH updated ferritin thresholds to improve iron deficiency detection, especially amid inflammation. Finerenone gained a new indication for CKD in type 1 diabetes, supported by UACR reduction.

Stay updated with the latest healthcare breakthroughs, including Bayer's finerenone expanding to type 1 diabetes-associated CKD.

The HCPFive: Top News for Healthcare Providers from the Week of 09/13

This week's top stories include the US Food and Drug Administration (FDA) approval of Abbott's TactiFlex Duo Ablation Catheter, Sensor Enabled, for patients with 

, the acceptance of Intellia Therapeutics’ Biologics License Application (BLA) for lonvoguran ziclumeran (lonvo-z) for 

, Breakthrough Therapy designation for DT120 (lysergide) orally disintegrating tablet for 

, positive 12-week induction results from Part A of the phase 2 SKYLINE trial evaluating SPY003 for 

, and positive topline results from the phase 3 CHAPTER-3 study of deucrictibant extended-release (XR) tablet for HAE.

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 September 06, 2026 — let's jump in!

TactiFlex Duo Ablation Catheter Receives FDA Approval for AFib

On September 8, 2026, the FDA approved Abbott's TactiFlex Duo Ablation Catheter, Sensor Enabled, for treating patients with atrial fibrillation, including complex cases. The approval rests on 12-month results from the FlexPulse investigational device exemption (IDE) study, presented as late-breaking data at the European Society of Cardiology (ESC) Congress 2026 and published simultaneously in EP Europace.

Lonvo-z BLA Accepted by FDA With Priority Review for HAE

On September 8, 2026, the FDA accepted Intellia Therapeutics’ BLA for lonvoguran ziclumeran (lonvo-z) and granted it priority review for HAE in patients aged ≥ 16 years, setting a Prescription Drug User Fee Act (PDUFA) target action date of March 10, 2027. If approved, lonvo-z would become the first in vivo CRISPR-based therapy to reach the HAE market and the only one-time treatment option available to patients who currently manage the disease with chronic intravenous or subcutaneous prophylaxis.

DT120 ODT Receives Second FDA Breakthrough Therapy Designation in MDD

On September 8, 2026, Definium Therapeutics received a second Breakthrough Therapy designation from the FDA for DT120 (lysergide) orally disintegrating tablet, this time for major depressive disorder. The designation follows an initial Breakthrough Therapy designation for DT120 in generalized anxiety disorder, positioning the ergoline-derived 5-HT2A partial agonist across 2 psychiatric indications with FDA-recognized potential for substantial improvement over available therapy.

SPY003 Meets Primary Endpoint in Phase 2 Trial for Ulcerative Colitis

On September 8, 2026, Spyre Therapeutics reported positive 12-week induction results from Part A of the phase 2 SKYLINE trial evaluating SPY003, an investigational anti-IL-23 antibody, in patients with moderately-to-severely active UC. According to the Company, this readout completes proof-of-concept for all 3 components of Spyre's inflammatory bowel disease (IBD) combination pipeline, following earlier positive Part A results for SPY001 (anti-α4β7) and SPY002 (anti-TL1A).

Deucrictibant XR Meets Primary Endpoint in HAE Prophylaxis

On September 8, 2026, Pharvaris reported positive topline results from the phase 3 CHAPTER-3 study of deucrictibant extended-release (XR) tablet, showing an 83% reduction in mean monthly HAE attack rate versus placebo (P <.0001) across all 3 HAE types in adolescents and adults. The study is the first and only prophylaxis phase 3 program to evaluate all 3 HAE types, including HAE with normal C1 inhibitor, a population without a dedicated oral prophylactic option in this analysis.

Regulatory and clinical milestones spanned electrophysiology, rare disease, psychiatry, and IBD. FDA cleared Abbott’s TactiFlex Duo sensor-enabled ablation catheter for atrial fibrillation based on 12‑month FlexPulse IDE outcomes. Intellia’s lonvoguran ziclumeran BLA for hereditary angioedema received priority review, targeting a March 2027 action date and offering a potential one-time in vivo CRISPR option. Definium’s DT120 lysergide ODT earned a second Breakthrough Therapy designation for MDD. Spyre’s SPY003 met phase 2 UC induction endpoints. Pharvaris’ deucrictibant XR reduced HAE attacks 83% in phase 3.

Stay updated with the latest healthcare breakthroughs, including a new ablation catheter for AFib and progress in the hereditary angioedema pipeline.