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 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.

Articles

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.

The HCPFive: Top News for Healthcare Providers from the Week of 09/06

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 (FDA) approval of an autoinjector formulation of lerodalcibep-liga (Lerochol) and an updated indication statement for MACE reduction, topline phase 3 data for avexitide in adults with post-bariatric 

 following Roux-en-Y gastric bypass surgery, the FDA’s acceptance of a New Drug Application (NDA) for ecopipam (EBS-101) in pediatric Tourette syndrome, the accelerated approval of pariglasgene brecaparvovec-opnr (Genglycos) for glycogen storage disease type Ia (GSD1a), and the FDA’s Fast Track designation of LTI-03 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 August 16, 2026 — let's jump in!

Lerodalcibep Autoinjector Receives FDA Approval for Hypercholesterolemia

On August 17, 2026, the FDA approved an autoinjector formulation of LIB Therapeutics’ lerodalcibep-liga (Lerochol), a third-generation PCSK9 inhibitor. The single-use device delivers the existing once-monthly, 300 mg/1.2 mL dose via a pressure-activated, single-motion injection completed in seconds.

The Agency also approved an updated indication statement for lerodalcibep-liga reflecting the established reduction in major adverse cardiovascular events (MACE) achieved through LDL-C lowering in adults with hypercholesterolemia treated with statins or with monoclonal antibody PCSK9 inhibitors added to statin therapy.

Avexitide Reduces Hypoglycemic Events in Phase 3 LUCIDITY Trial for PBH

On August 18, 2026, Amylyx Pharmaceuticals announced positive topline results from the phase 3 LUCIDITY trial evaluating avexitide in adults with post-bariatric hypoglycemia following Roux-en-Y gastric bypass (RYGB) surgery.The trial met its primary endpoint as agreed with the FDA, with the investigational glucagon-like peptide-1 (GLP-1) receptor antagonist reducing the composite rate of Level 2 and Level 3 hypoglycemic events by 55% compared with placebo (

 = .000003). LUCIDITY also met all secondary endpoints.

FDA Accepts NDA for Ecopipam in Pediatric Tourette Syndrome

On August 19, 2026, the FDA accepted Teva Pharmaceuticals' NDA for ecopipam (EBS-101), a first-in-class selective D1 receptor antagonist, and granted Priority Review for the treatment of pediatric patients with Tourette syndrome, with a target action date late in the first quarter of 2027.

"If approved, ecopipam would be the first new therapy for Tourette syndrome in more than 10 years and the first novel mechanism of action in more than 50 years, offering patients and families a long-awaited new treatment option,” Eric Hughes, MD, PhD, executive vice president, Global R&D and chief medical officer, at Teva, said in a statement.

FDA Approves Gene Therapy for Glycogen Storage Disease Type 1a

On August 20, 2026, the FDA granted accelerated approval to pariglasgene brecaparvovec-opnr (Genglycos), a one-time AAV8 gene therapy, to reduce daily cornstarch intake as an adjunct to nutritional management in patients 8 years and older with GSD1a, making it the first approved treatment for the condition.

FDA Fast Tracks LTI-03 for Idiopathic Pulmonary Fibrosis

On August 20, 2026, the FDA granted Fast Track designation to LTI-03, an inhaled peptide therapy from Rein Therapeutics, for IPF. The decision follows a prior Orphan Drug designation already granted to LTI-03 for IPF, whose Caveolin-1-derived mechanism sets it apart from existing antifibrotics by targeting alveolar epithelial repair alongside fibrotic signaling.

Multiple FDA actions and late-stage readouts spanned cardiometabolic, neurologic, rare genetic, and pulmonary disease programs. Lerodalcibep-liga gained an autoinjector option for monthly PCSK9 inhibition and an updated MACE-reduction indication tied to LDL-C lowering. Avexitide achieved a highly significant 55% reduction in clinically meaningful hypoglycemic events in phase 3 post–Roux-en-Y post-bariatric hypoglycemia. Ecopipam’s pediatric Tourette NDA was accepted with Priority Review. AAV8 gene therapy pariglasgene brecaparvovec-opnr received accelerated approval for GSD1a. LTI-03 secured Fast Track for IPF.

Stay updated with the latest healthcare breakthroughs, including a new lerodalcibep FDA approval and phase 3 avexitide data in post-bariatric hypoglycemia.

The HCPFive: Top News for Healthcare Providers from the Week of 08/16


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 phase 3 UP-AA data supporting AbbVie's supplemental NDA for upadacitinib (Rinvoq) in severe 

, new coverage of the phase 3 VALOR trial establishing Priovant's brepocitinib as the first targeted therapy to succeed in a placebo-controlled 

 trial, a phase 3 miss for Tenax Therapeutics' TNX-103 in 

 associated with heart failure with preserved ejection fraction, a one-year check-in on how Insmed's brensocatib (Brinsupri) has transformed 

 care, and HCPLive's preview of the six trials to watch at the European Society of Cardiology Congress 2026 in Munich.
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 August 9, 2026 — let's jump in!

UP-AA: Upadacitinib Attains Primary Endpoint in New Alopecia Areata Data

Pooled data from the two replicate phase 3 UP-AA trials showed AbbVie's upadacitinib (Rinvoq) 15 mg and 30 mg once daily both met the primary endpoint of SALT score ≤20 at week 24 versus placebo (P<.001 in both studies), with the 30 mg dose achieving SALT ≤20 in 54–55% of patients compared with 1.5–3.4% on placebo. Upadacitinib also became the first JAK inhibitor to meet the ranked secondary endpoint of complete scalp hair regrowth (SALT=0) at week 24 in a phase 3 program, reaching that threshold in up to 22.5% of treated patients. AbbVie submitted a supplemental NDA to the FDA in April 2026; if approved, upadacitinib would join baricitinib as the second JAK inhibitor available for severe alopecia areata in the United States.

Phase 3 Dermatomyositis Trial Sees Brepocitinib Meet Primary Endpoint

In the phase 3 VALOR trial, Priovant's brepocitinib 30 mg — a first-in-class oral TYK2-JAK1 inhibitor — met the primary endpoint of Total Improvement Score at week 52 versus placebo (LS mean difference 15.3 points; P<.001), while the 15 mg dose failed to separate from placebo. The 30 mg dose was superior across all nine key secondary endpoints, including skin disease activity, glucocorticoid tapering, and physical function, with cutaneous improvements observed as early as week 4; serious infections were higher with 30 mg than placebo (10% vs 1%). The FDA accepted Priovant's NDA with Priority Review and a PDUFA target action date in Q3 2026, representing the first positive registrational trial for a targeted therapy in dermatomyositis.

TNX-103 Misses Primary Endpoint in Phase 3 LEVEL PH-HFpEF Trial

On August 10, 2026, Tenax Therapeutics and license partner Orion Corporation announced that the phase 3 LEVEL trial of TNX-103 (oral levosimendan) failed to meet its primary endpoint of improved 6-minute walk distance versus placebo in patients with pulmonary hypertension associated with heart failure with preserved ejection fraction (LSM difference 3.5 meters; P=.63), and the key secondary endpoint of KCCQ total symptom score also failed to separate. A prespecified subgroup with baseline 6MWD below 333 meters showed a 26.3-meter improvement, and exploratory analyses showed a 49% greater NT-proBNP reduction with TNX-103 versus placebo; Tenax plans to request a Type C meeting with the FDA to refine the registrational path around an enriched population. Full LEVEL data are slated for presentation at ESC Congress 2026 in Munich later this month.

One Year of Brensocatib: How Bronchiectasis Care Has Changed

One year after Insmed's brensocatib (Brinsupri) became the first FDA-approved therapy for non-cystic fibrosis bronchiectasis in August 2025, HCPLive spoke with two pulmonologists about real-world experience with the first-in-class DPP-1 inhibitor — which reduced annualized exacerbation rates by 20% versus placebo in the phase 3 ASPEN trial. Prescribers described a field transformed, now anchored by a first national North American clinical practice guideline from CHEST 2026 that includes 13 conditional recommendations and formally integrates brensocatib for patients with frequent exacerbations. Key open questions remain around patient selection in those with co-prevalent NTM infection — affecting roughly half of US bronchiectasis patients — and the drug's long-term safety and tolerability profile in routine clinical use.

European Society of Cardiology 2026 Preview: 6 Trials to Know

ESC Congress 2026 opens August 28 in Munich, Germany, featuring a record 59 late-breaking trials across 12 Hot Line sessions spanning heart failure, acute coronary syndromes, atrial fibrillation, structural heart disease, and preventive cardiology. HCPLive's preview spotlights six trials to watch, including data for aficamten in obstructive hypertrophic cardiomyopathy, pacibekitug in heart failure, and results from the terminated LIBREXIA ACS and CARDIO-TTRansform programs that may still shape future research directions. The HCPLive editorial team will be on-site in Munich for the duration of the conference providing written coverage and clinician interviews.

Pooled phase 3 UP-AA data showed upadacitinib 15/30 mg significantly improved week-24 SALT ≤20, with 30 mg achieving responses in ~54–55% and ranked secondary SALT=0 in up to 22.5%, supporting an FDA sNDA. In dermatomyositis, VALOR met its week-52 primary endpoint with brepocitinib 30 mg, though serious infections increased. TNX-103 failed in PH-HFpEF, prompting an enrichment strategy. Brensocatib’s first-year real-world uptake is reshaping bronchiectasis practice alongside new CHEST guidance. ESC 2026 will feature 59 late-breakers.

This week's highlight includes phase 3 trial results across dermatology, cardiology, and pulmonology, and a major conference preview.

The HCPFive: Top News for Healthcare Providers from the Week of 08/09

This week's top stories include new 2-year results from the phase 3 VISIONARY trial of sibeprenlimab-szsi (Voyxact) in IgA nephropathy (IgAN), the US Food and Drug Administration (FDA) Fast Track Designation of Aravax's investigational peptide immunotherapy PVX108 for peanut allergy, and the FDA approvals of Mucinex 12HR Cold & Fever Multi-Symptom for fever, cough, chest congestion and body pain in cold/flu, oveporexton (Orzeyful) tablets for narcolepsy type 1 in adults, and mRNA-1010 (mFLUSIVA) as a seasonal influenza vaccine for use in all adults ≥ 50 years of age.

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 August 2, 2026 — let's jump in!

Sibeprenlimab (Voyxact) Stabilizes Kidney Function in IgAN

On August 3, 2026, 2-year results from the phase 3 VISIONARY trial were presented in a late-breaking session at GlomCon Hawaii 2026, with data showing sibeprenlimab-szsi (Voyxact) returned the annualized rate of kidney function decline in IgAN to a near-physiologic level.

The trial met its key secondary endpoint, the annualized estimated glomerular filtration rate (eGFR) slope was +0.3 mL/min/1.73 m²/year (95% Confidence Interval [CI], -0.4 to 0.9) with sibeprenlimab, compared with -4.2 mL/min/1.73 m²/year (95% CI, -4.9 to -3.6) with placebo, a treatment difference of +4.5 mL/min/1.73 m²/year (95% CI, 3.6 to 5.4; 

Aravax's PVX108 Receives FDA Fast Track Designation for Peanut Allergy

On August 3, 2026, The FDA granted Fast Track designation to PVX108, Aravax's investigational peptide immunotherapy for peanut allergy. PVX108 enters this pathway as a peptide-based immunotherapy distinct from oral immunotherapy products such as Palforzia, which was officially discontinued as of July 31, 2026. PVX108 is designed to retrain immune tolerance without the acute allergic reactions associated with existing desensitization approaches.

FDA Approves Mucinex 12HR Cold & Fever Multi-Symptom for OTC Use

On August 5, 2026, Reckitt announced the FDA approval of Mucinex 12HR Cold & Fever Multi-Symptom, making it the first and only FDA-approved OTC cold and flu medication that treats fever, cough, chest congestion and body pain for 12 hours. The fixed-dose product contains guaifenesin, dextromethorphan hydrobromide, and naproxen sodium in a bilayer tablet.

FDA Approves Oveporexton (Orzeyful) for Narcolepsy Type 1

On August 5, 2026, the FDA approved oveporexton (Orzeyful) tablets for narcolepsy type 1 in adults, the first medicine to directly target orexin signaling loss and address the disorder as a complete condition.

Oveporexton is the first agent to activate the OX2R receptor directly, restoring the signal lost when orexin-producing neurons are destroyed. The approval was granted to Takeda Pharmaceuticals America, Inc, following Breakthrough Therapy Designation and Priority Review.

mFLUSIVA Receives FDA Approval for Influenza in Adults 50 and Older

On August 6, 2026, the FDA approved mRNA-1010 (mFLUSIVA), Moderna's mRNA-based seasonal influenza vaccine, for use in all adults ≥ 50 years of age, granting full approval in adults aged 50 to 64 years and accelerated approval in adults aged ≥ 65 years. The decision marks the first mRNA-based influenza vaccine cleared in the United States and follows a unanimous recommendation from the FDA's Vaccines and Related Biological Products Advisory Committee.

Key late-breaking VISIONARY phase 3 data in IgA nephropathy showed sibeprenlimab-szsi achieved near-physiologic renal decline, with a +0.3 mL/min/1.73 m²/year eGFR slope versus -4.2 on placebo (Δ +4.5; P<.0001). The FDA granted Fast Track to Aravax’s PVX108 peptide immunotherapy for peanut allergy, aiming to induce tolerance with fewer acute reactions after Palforzia’s discontinuation. Additional FDA actions included approval of an FDA-approved OTC 12-hour multi-symptom Mucinex product, first-in-class orexin-2 receptor agonist oveporexton for narcolepsy type 1, and Moderna’s first US-cleared mRNA influenza vaccine for adults ≥50.

Stay updated with the latest healthcare breakthroughs, including phase 3 sibeprenlimab data in IgAN and the FDA approval of oveporexton for narcolepsy.