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 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.

Articles

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.

The HCPFive: Top News for Healthcare Providers from the Week of 08/02

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 post hoc analysis of pooled FIBRONEER trial data suggesting Boehringer Ingelheim's nerandomilast (Jascayd) reduces mortality risk in 

, the July 31 market exit of Stallergenes Greer's Palforzia — the only United States Food and Drug Administration (FDA)-approved prescription peanut oral immunotherapy — and what it means for patients and clinicians, the FDA De Novo authorization of Caristo Diagnostics' CaRi-Heart as the first technology to quantify 

 from routine CT angiography, the FDA approval of Otsuka's centanafadine (SIMTRIYO) as the first-in-class norepinephrine, dopamine, and serotonin reuptake inhibitor for ADHD in adults and children aged ≥6 years, and the FDA approval of Freenome's SimpleScreen™ CRC as a blood-based screening test for colorectal cancer in average-risk adults aged ≥45 years, with Abbott set to commercialize the test this fall.

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 26, 2026 — let's jump in!

Nerandomilast Reduces Mortality Risk in Pulmonary Fibrosis Analysis

On July 31, 2026, HCPLive reported on a post hoc pooled analysis of the FIBRONEER-IPF and FIBRONEER-ILD trials showing nerandomilast (Jascayd; Boehringer Ingelheim), an oral preferential PDE4B inhibitor, reduced the risk of death by up to 43% versus placebo. In the pooled dataset, deaths occurred in 13.5% of placebo-treated patients compared with 9.2% (HR 0.67; P=.009) and 7.7% (HR 0.57; P<.001) in patients receiving nerandomilast 9 mg and 18 mg twice daily, respectively. The mortality reduction reached nominal significance in FIBRONEER-ILD, where both doses reduced the hazard ratio to 0.51, but not in FIBRONEER-IPF as a standalone trial. Because this was a post hoc analysis, the findings are exploratory; nerandomilast is FDA-approved for IPF and PPF based on FVC decline data from the FIBRONEER program.

Palforzia Discontinued, Ending the Only FDA-Approved Peanut OIT Option

On July 31, 2026, peanut allergen powder-dnfp (Palforzia; Stallergenes Greer), the first and only FDA-approved oral immunotherapy (OIT) for peanut allergy in children ages 1–17, was voluntarily discontinued by its manufacturer. The decision, which the company stated is not related to product safety, quality, or efficacy, ends six years of commercial availability since Palforzia's original 2020 FDA approval under Aimmune Therapeutics. 

 spoke with allergists Robert Wood, MD, and Jacqueline Ross, MD, about the practical implications for patients currently in treatment and what transition options remain available.

CaRi-Heart Receives FDA De Novo Authorization for Coronary Inflammation

On July 29, 2026, Caristo Diagnostics announced the FDA granted De Novo authorization for CaRi-Heart, the first and only technology authorized in the United States to quantify coronary inflammation from routine coronary CT angiography (CCTA). Developed from more than a decade of research at the University of Oxford, CaRi-Heart uses AI to generate a coronary inflammation score and assess cardiovascular mortality risk — addressing a gap in risk stratification, given that nearly half of first heart attacks occur in patients classified as low-risk by traditional tools. The technology is supported by validation data from large independent patient populations, with results published in The Lancet, and by the ORFAN registry, which aims to incorporate outcomes data from up to 250,000 patients. CPT codes 0992T and 0993T for CaRi-Heart have been effective since January 1, 2026, and commercial launch in the US is planned for Q4 2026.

FDA Approves Centanafadine (SIMTRIYO) for ADHD in Adults and Children Aged ≥6 Years

On July 24, 2026, Otsuka Pharmaceutical announced the FDA approved centanafadine (SIMTRIYO), a once-daily extended-release capsule, for the treatment of ADHD in adults and pediatric patients aged ≥6 years weighing ≥20 kg. Centanafadine is the first and only FDA-approved norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI), introducing a mechanism distinct from both stimulant and existing nonstimulant ADHD therapies. The approval was supported by four randomized, double-blind, placebo-controlled phase 3 trials spanning children, adolescents, and adults; in pediatric and adolescent trials, the high-dose group showed statistically significant ADHD-RS-5 improvements versus placebo, with benefit emerging by week 1. Commercial availability is pending DEA scheduling.

FDA Approves Freenome Blood Test for Colorectal Cancer Screening

On July 27, 2026, the FDA approved Freenome's SimpleScreen™ CRC, a blood-based colorectal cancer (CRC) screening test for average-risk adults aged ≥45 years, providing clinicians with a second FDA-approved blood-based CRC screening option alongside Guardant Health's Shield. The approval was supported by findings from the PREEMPT CRC study (n>48,000), the largest prospective clinical validation study for a blood-based CRC test, in which SimpleScreen detected approximately 8 in 10 colorectal cancers and correctly returned negative results in 9 of 10 patients without CRC or advanced precancerous lesions. Abbott will exclusively commercialize the test in the United States beginning this fall; the approval meets Medicare coverage criteria, and the American Cancer Society is expected to incorporate SimpleScreen CRC into its screening guidelines by name.

Five late-July 2026 developments span fibrotic lung disease, allergy therapeutics, cardiometabolic imaging, neuropsychiatry, and oncology screening. Post hoc pooled FIBRONEER data suggest nerandomilast may reduce mortality in pulmonary fibrosis, complementing prior FVC-based approvals. Palforzia’s voluntary market exit removes the only FDA-approved peanut oral immunotherapy, forcing treatment continuity planning. FDA De Novo authorization clears CaRi-Heart to quantify coronary inflammation from standard CCTA. Centanafadine becomes a first-in-class NDSRI for ADHD ages ≥6. SimpleScreen CRC adds a second FDA-approved blood-based colorectal screening option.

Stay updated with the latest healthcare breakthroughs, including phase 3 plozasiran data in hypertriglyceridemia and the FDA approval of Furoscix ReadyFlow.

The HCPFive: Top News for Healthcare Providers from the Week of 07/26

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 Agios’ discontinuation of tebapivat’s clinical development program for sickle cell disease, the US Food and Drug Administration (FDA) approval of olopatadine hydrochloride and mometasone furoate (Ryaltris) nasal spray, 665 mcg/25 mcg per spray, for the treatment of seasonal 

 symptoms in children aged 6 to 11 years, positive topline results for the global phase 3 SHASTA-3 and SHASTA-4 clinical studies of plozasiran in patients with severe 

, the FDA acceptance of BridgeBio’s New Drug Application (NDA) for encaleret for the treatment of 

autosomal dominant hypocalcemia type 1 (ADH1)

, and the FDA approval of MannKind Corporation’s furosemide injection (Furoscix ReadyFlow) for the treatment of edema (fluid overload) in adults with 

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 19, 2026 — let's jump in!

Agios Ends Tebapivat Development in Sickle Cell Disease After Phase 2

On July 21, 2026, Agios announced topline results from a phase 2 trial of tebapivat in patients aged ≥16 years with sickle cell disease showing improvements in hemoglobin and markers of hemolysis. However, the results did not demonstrate sufficient differentiation to support continued development of the pyruvate kinase (PK) activator, prompting the Company to discontinue the program.

"These phase 2 data further reinforce PK activation as a clinically validated mechanism in sickle cell disease, with tebapivat demonstrating hematologic activity consistent with this class of medicine," said Sarah Gheuens, MD, PhD, chief medical officer and head of research and development at Agios, in a statement. "However, the results did not establish the level of differentiation we believe is necessary to support continued development."

FDA Approves Ryaltris for Children Aged 6 to 11 With Seasonal Allergic Rhinitis

On July 21, 2026, the FDA expanded the approved use of olopatadine hydrochloride and mometasone furoate (Ryaltris) nasal spray, 665 mcg/25 mcg per spray, to include the treatment of seasonal allergic rhinitis symptoms in children aged 6 to 11 years. With the approval, the treatment is now indicated for adults and pediatric patients aged ≥ 6 years in the United States, broadening access to a younger population than the drug's original 2022 approval for patients aged ≥ 12 years.

Plozasiran Meets Primary Endpoint in SHASTA-3, SHASTA-4 sHTG Trials

On July 22, 2026, Arrowhead Pharmaceuticals announced topline results for the global phase 3 SHASTA-3 and SHASTA-4 clinical studies of plozasiran in patients with severe hypertriglyceridemia. Both trials successfully met the primary endpoint of triglyceride reduction versus placebo and met all prespecified secondary endpoints, including a statistically significant reduction in the rate of acute pancreatitis compared to placebo.

FDA Accepts NDA for Encaleret for Autosomal Dominant Hypocalcemia Type 1

Only July 22, 2026, the FDA accepted BridgeBio’s New Drug Application (NDA) for encaleret for the treatment of ADH1, assigning a Prescription Drug User Fee Act (PDUFA) date of May 8, 2027. If approved, encaleret will be the only therapy indicated specifically for patients with ADH1. The orally administered small molecule designed to selectively negatively modulate the calcium sensing receptor has previously received Fast Track Designation from the FDA and Orphan Drug Designation in the US, European Union, and Japan.

FDA Approves Furosemide Injection (Furoscix ReadyFlow) for Edema in HF, CKD

On July 24, 2026, the FDA approved MannKind Corporation’s furosemide injection (Furoscix ReadyFlow) for the treatment of edema (fluid overload) in adults with heart failure or chronic kidney disease, making it the first and only autoinjector delivering subcutaneous furosemide with IV-equivalent exposure (based on comparisons of AUC and PD endpoints), providing a full 80 mg/mL dose in a simple, patient-friendly format administered in < 10 seconds.

Key regulatory and pipeline updates span hematology, allergy, metabolic disease, rare endocrinology, and cardiorenal care. Agios halted tebapivat after phase 2 sickle cell data showed hematologic activity yet inadequate differentiation. FDA expanded Ryaltris intranasal olopatadine/mometasone to ages 6–11, extending the ≥12-year indication. Arrowhead reported SHASTA-3/4 phase 3 success for plozasiran in severe hypertriglyceridemia, including reduced acute pancreatitis. FDA accepted BridgeBio’s encaleret NDA for ADH1 with a May 2027 PDUFA. MannKind gained approval for Furoscix ReadyFlow with IV-equivalent exposure profiles.

Stay updated with the latest healthcare breakthroughs, including phase 3 plozasiran data in hypertriglyceridemia, the FDA approval of Furoscix ReadyFlow, and more.

The HCPFive: Top News for Healthcare Providers from the Week of 07/19

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 

 (IgAN), the FDA approval of enlicitide (Lipfendra) as the first oral PCSK9 inhibitor for 

, phase 2a data from the SIGNAL-AA trial showing bempikibart effective for 

 at 36 weeks, 12-month open-label extension data for treprostinil palmitil inhalation powder (TPIP) in 

 (PAH), and phase 3 topline results for soficitinib in moderate-to-severe 

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.

Traditional FDA approval of iptacopan in primary IgA nephropathy was supported by 2-year APPLAUSE-IgAN data showing a 48% slowing of eGFR decline versus placebo, with distribution restricted via REMS due to encapsulated-bacteria infection risk. The FDA also approved enlicitide as the first oral PCSK9 inhibitor, delivering ~56%–59% LDL-C reductions in phase 3 trials, with outcomes data pending. Additional updates include phase 2a efficacy and tolerability signals for bempikibart in alopecia areata, durable 12‑month OLE improvements with once-daily TPIP in PAH, and phase 3 topline success for the TYK2 inhibitor soficitinib in atopic dermatitis.

Stay updated with the latest healthcare breakthroughs, including FDA approvals, phase 3 data, and open-label extension results.