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) approvals of caplacizumab-yhdp (Cablivi) for pediatric patients ≥ 12 years of age with acquired thrombotic thrombocytopenic purpura (aTTP) and Fibrinogen (Human) Lyophilized Powder for Reconstitution (Fibryga) for fibrinogen replacement in patients with acquired fibrinogen deficiency, Priority Review designations for a BLA atacicept for the treatment of adults with IgA nephropathy (IgAN) and an sBLA for teplizumab-mzwv to expand the age indication from ≥8 years to ≥1 year, aiming to delay the onset of stage 3 type 1 diabetes, and Breakthrough Therapy Designation for pemvidutide for the treatment of metabolic dysfunction-associated steatotic liver disease (MASH).

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 January 4, 2025—let’s jump in!

FDA Approves Caplacizumab-yhdp (Cablivi) as First Pediatric aTTP Therapy

On January 5, 2026, the FDA approved Sanofi’s caplacizumab-yhdp (Cablivi) for injection to treat pediatric patients ≥ 12 years of age with aTTP in combination with plasma exchange and immunosuppressive therapy. The decision builds upon caplacizumab’s initial 2019 approval for adults with aTTP and was supported by efficacy data from a retrospective chart review study of 30 patients 2-18 years of age showing 80% of patients achieved clinical remission. Of note, the approval made caplacizumab the first treatment for pediatric aTTP.

Pemvidutide Gets Breakthrough Therapy Designation for MASH

On January 5, 2026, the FDA granted Breakthrough Therapy Designation (BTD) to Altimmune’s pemvidutide for the treatment of MASH based on 24-week data from the phase 2b IMPACT trial demonstrating statistically significant MASH resolution without worsening of fibrosis and early and substantial improvements in liver fat and non-invasive tests (NITs) of fibrosis and hepatic inflammation.

Altimmune has aligned with the FDA on the parameters for a planned registrational phase 3 trial of pemvidutide for MASH patients with moderate to advanced liver fibrosis evaluating multiple pemvidutide doses over a 52-week treatment period and incorporating biopsy-based endpoints to support a potential accelerated approval and the use of AIM-MASH AI Assist, the first AI pathology tool qualified by the FDA for use in MASH clinical trials.

FDA Grants Priority Review Of Biologics License Application For Atacicept In IgA Nephropathy

On January 7, 2026, the FDA granted priority review to Vera Therapeutics’ Biologics License Application (BLA) for atacicept for the treatment of adults with IgAN. The BLA submission was supported by data from the phase 3 ORIGIN 3 trial’s prespecified interim analysis showing the trial met its primary endpoint for reduction in proteinuria at week 36, with a 46% reduction compared to baseline and a 42% reduction compared to placebo (

FDA Approves 2-Gram Presentation of Fibryga for Acquired Fibrinogen Deficiency

On January 7, 2026, the FDA approved a 2-gram presentation of Octapharma’s Fibrinogen (Human) Lyophilized Powder for Reconstitution (Fibryga) for fibrinogen replacement in patients with acquired fibrinogen deficiency. Initially approved as a 1-gram single-dose bottle in 2024, Fibryga is the first and only virus-inactivated, human plasma-derived fibrinogen concentrate approved for AFD in the US. The updated kit also contains 100 mL of Water for Infusion and continues to feature the nextaro reconstitution device.

FDA Accepts for Priority Review sBLA for Teplizumab for Children With Stage 2 T1D

On January 5, 2026, the FDA accepted for priority review the supplemental biologics license application (sBLA) for Sanofi’s teplizumab-mzwv to expand the age indication from ≥8 years to ≥1 year, aiming to delay the onset of stage 3 type 1 diabetes. The sBLA submission was based on positive interim one-year data from the ongoing PETITE-T1D phase 4 study, a 2 year single-arm, open-label, multicenter study of children <8 years with stage 2 T1D.

Articles

The FDA has approved caplacizumab-yhdp (Cablivi) for pediatric patients with aTTP, marking the first treatment for this age group. Pemvidutide received Breakthrough Therapy Designation for MASH, with promising phase 2b trial results. Atacicept's BLA for IgA nephropathy was granted priority review, supported by significant proteinuria reduction data. Fibryga's 2-gram presentation was approved for acquired fibrinogen deficiency, enhancing treatment options. Teplizumab's sBLA was accepted for priority review to expand its use in younger children with stage 2 type 1 diabetes, based on positive interim study data.

Stay updated with the latest healthcare breakthroughs, including FDA approvals and other regulatory updates, in this week’s essential news roundup.

News

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Hepatology

Nephrology

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Hematology

Endocrinology

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The HCPFive: Top News for Healthcare Providers from the Week of 01/04

Robert S. Rosenson, MD is a professor of cardiology at the Icahn School of Medicine at Mount Sinai.

Evinacumab May Lower Triglycerides in Severe Hypertriglyceridemia, With Robert Rosenson, MD

Evinacumab may be capable of lowering triglyceride concentrations in patients with 

 and a history of sHTG-associated acute pancreatitis (AP), according to a recent phase 2b study.

Evinacumab is a recombinant human monoclonal antibody which binds to and inhibits angiopoietin-like protein 3 (ANGPTL3), which leads to a reduction in LDL-C, HDL-C, and triglycerides. It reduces LDL-C irrespective of the presence of LDL receptors by promoting very low-density lipoprotein processing and clearance upstream of LDL formation.

“We know that individuals who have had episodes of pancreatitis are highly susceptible to having a recurrent hospitalization for pancreatitis in the next year. For these patients, the incident rate increases 24-fold,” Robert Rosenson, MD, professor of medicine and director of cardiometabolic disorders at the Icahn School of Medicine at Mount Sinai, said in an interview with 

. “These patients require our prompt attention with therapies that effectively lower triglycerides.”

Rosenson and colleagues conducted a phase 2b, randomized, double-blind, placebo-controlled study consisting of 3 periods – a screening period lasting ≥4 weeks, a double-blind treatment period of 52 weeks, and an off-drug safety follow-up of 20 weeks. Patients were eligible for inclusion if they had ≥1 of the following within 24 months prior to screening:

Fasting serum triglycerides >880 mg/dL with a history of 1 episode of HTG-associated AP

Fasting serum triglycerides >500 mg/dL with a history of ≥2 episodes of HTG-associated AP

Fasting serum triglycerides >500 mg/dL with a documented fasting triglyceride level of >1000 mg/dL and a history of ≥1 episode of HTG-associated AP

All patients were also required to be taking stable doses of lipid-lowering therapy for ≥8 weeks prior to the screening visit. Patients were excluded if they had FCS due to biallelic loss-of-function variants in LPL, if they had been hospitalized for AP within 4 weeks of screening, or if they had an AP episode within 12 weeks of screening.

Eligible patients were randomly assigned in a 1:1 ratio to intravenous evinacumab 20 mg/kg or matching placebo every 4 weeks for the duration of the 52-week treatment period. The study’s primary efficacy endpoint was the proportion of patients with ≥1 positively adjudicated episode of AP during this period. Key secondary endpoints included the percentage change from baseline to week 52 in fasting triglyceride and ApoC3 levels, as well as percentage change from baseline to week 52 in other lipid parameters like total cholesterol and non-HDL-C.

A total of 21 patients were enrolled and randomized to evinacumab (n = 11) or placebo (n = 10). However, the trial was terminated early by the sponsor. 20 patients did not complete the treatment period due to early termination (n = 16), adverse events (n = 2), patient decision (n = 1), and being lost to follow-up (n = 1). The 16 patients who discontinued due to the end of the trial terminated their treatments between days 1 and 169. Ultimately, 57.1% (n = 12) of patients completed the end-of-study visit.

The proportion of patients with ≥1 positively adjudicated AP episode during the treatment period was 27.3% (n = 3) with evinacumab versus 10% (n = 1) with placebo. All positively adjudicated AP episodes took place ≥58 days after the final dose, at which point evinacumab concentrations were near or below the limit of quantitation. Rosenson and colleagues also saw a median percentage change in triglycerides of -55.3% with evinacumab versus +1.5% with placebo. By week 16, evinacumab had reduced triglycerides by 95.7%, an effect which was maintained in 1 patient who received treatment through week 52.

Ultimately, although the sample size was too small to adequately determine whether it could prevent AP, investigators determined that the data gathered before the trial’s termination indicated evinacumab’s potential efficacy in lowering triglyceride concentrations in patients with sHTG and a history of sHTG-associated AP.

“I think this trial should encourage other pharmaceutical companies that have angiopoietin-like 3 inhibitors to explore this hypothesis with their inhibitors,” Rosenson said. “I’m not sure if this is going to be done with evinacumab again, but there are other RNA inhibitors of angiopoietin-like 3 that are in development by other companies, and this suggests that those inhibitors will have a profound effect on triglycerides and, hopefully, on the risk of acute pancreatitis.”

Rosenson RS, George RT, Sanchez RJ, et al. Efficacy of evinacumab in patients with severe hypertriglyceridemia and a history of severe hypertriglyceridemia-related acute pancreatitis: A phase 2B trial. Journal of Clinical Lipidology. Published online July 2025. 

Dingman R, Bihorel S, Gusarova V, Mendell J, Pordy R. Evinacumab: Mechanism of action, clinical, and translational science. 

Videos

Rosenson explains the data gained from a terminated phase 2b trial, highlighting evinacumab’s potential as a triglyceride-lowering therapy.

Cardiology

Cardiology condition center page is a comprehensive resource for clinical news and insights on cardiovascular and cardiometabolic diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for heart disease and cardiovascular events, as well as associated diabetes, renal failure, and more...

Dyslipidemia

Tim Smith joined the MJH Life Sciences team in 2022 and is currently an associate editor for HCPLive. He is also the executive producer of two podcasts: Skin of Color Savvy and The Medical Sisterhood. Previously, he was the producer of the Lungcast podcast. He graduated from UC Berkeley and worked in multimedia journalism as a staff writer prior to joining MJH. You can contact him at tsmith@mjhlifesciences.com.

Twelve months of low-level laser therapy (LLLT) provides sustained improvement in 

, new findings suggest, with men and women seeing hair counts and thickness gradually increasing with use.

These data supporting laser therapy’s role as a long-term therapeutic option for AGA were authored by a team of investigators, such as Jung-Won Shin, MD, PhD, an associate professor in the Department of Dermatology at Seoul National University Bundang Hospital. Shin et al had set out to evaluate at-home use of a helmet-type LLLT device among those with this hair loss condition.

Prior to this analysis, recent data had pointed to low-level laser therapy as a potentially promising, non-pharmacologic alternative for addressing AGA, with the team pointing to a 2018 systematic review showing gains of about 17 hairs per cm2 with LLLT use.

 However, most studies looked at relatively brief periods of treatment, typically ranging from 16 - 26 weeks.

“A 48-week, prospective, multicenter clinical trial was conducted to assess changes in hair density and thickness over time, with additional subgroup analyses by sex and disease severity,” Shin and coauthors wrote.

 “Furthermore, the safety of extended use of LLLT on the scalp was closely monitored, given the limited data on prolonged exposure in home settings.”

Over 48 weeks, the investigators conducted their analysis using a multicenter, prospective, open-label clinical trial design. They involved adults diagnosed with AGA who were between the ages of 19 - 65 years. Eligible men exhibited male-pattern hair loss noted as as Hamilton–Norwood stages IIa through V. Women deemed eligible presented with female-pattern hair loss corresponding to Ludwig or Sinclair stages I–II. A lack of prior treatment history for AGA was also required by Shin et al. Additional devices used for hair growth at the time of enrollment were also not permitted.

Among the 82 patients initially screened by the investigative team, there were 68 who met all requirements for inclusion and were ultimately recruited for the study. For the study’s subgroup analyses, Shin and coauthors categorized baseline severity of participants’ AGA as mild, moderate, or severe. They described mild disease as Norwood II–III in men or Ludwig I in women and moderate disease as Norwood III Vertex–IV or Ludwig II. Severe disease was defined as Norwood V or Ludwig III.

A helmet-style LLLT device, intended for home utilization, was given to each study subject. 146 low-level laser diodes and 104 light-emitting diodes were incorporated in the LLLT device, arranged to allow for uniform scalp exposure. In total, there were 250 laser and LED light sources emitting red light to penetrate the scalp and reach the hair follicle level. Use of the laser therapy device was needed for 20 minutes per session, with Shin and colleagues requiring 3 times weekly on non-consecutive days. Additionally, subjects were recommended not to implement any concurrent hair loss treatments.

Outcomes evaluated by the investigative team to determine efficacy included measurements of hair shaft diameter and hair shaft density via phototrichogram analysis at predetermined points in time. During each visit, the team also used blinded global photographic assessments and patient-reported information on perceived hair growth. Safety monitoring consisted of clinical examinations along with a review of patient-reported events throughout the study period.

Results of At-Home Laser Therapy for Hair Loss

Mean hair density at 48-weeks rose significantly from 99.2 ± 27.7 hairs/cm² at the point of baseline to 124.2 ± 33.1 hairs/cm².

 According to the investigators, this represented a mean gain of 25.0 ± 28.1 hairs/cm² (

 < .0001). In looking at mean hair shaft thickness improvements, they noted thickness similarly increased 65.1 ± 11.8 μm to 74.9 ± 12.6 μm (

 < .0001). This corresponded to an approximate 15% increase.

Such improvements in patients’ hair were highlighted consistently across both sexes as well as all baseline categories of AGE severity.

 Shin et al noted, by the final visit, their global photographic assessment findings pointed to visible improvement in 59% of trial participants. They also noted more than 85% reporting satisfaction with the outcomes of LLLT treatment. There were also no device-related adverse events documented by the team. Participant adherence to the laser therapy regimen remained high over the course of the analysis.

“These findings support incorporating LLLT into routine clinical management of AGA and highlight the need for further research to refine treatment parameters—such as optimal wavelengths and frequency—and to explore its potential in combination with other therapeutic modalities for enhanced hair regrowth,” they wrote.

Shin JW, Paik K, Huh CH, et al. Long-Term Efficacy and Safety of Low-Level Laser Therapy for Androgenetic Alopecia: A 12-Month Prospective Trial, Dermatologic Therapy, 2026, 6621458, 8 pages, 2026. 

Delaney SW, Zhang P. Systematic review of low-level laser therapy for adult androgenic alopecia. J Cosmet Laser Ther. 2018 Aug;20(4):229-236. 

Low-level laser therapy (LLLT) has shown sustained improvement in androgenetic alopecia (AGA) over 12 months, with increased hair density and thickness in both men and women. A 48-week clinical trial involving a helmet-type LLLT device demonstrated significant gains in hair count and thickness, with no adverse events reported. The study highlighted the potential of LLLT as a long-term, nonpharmacologic treatment for AGA, with high patient satisfaction and adherence. Further research is needed to optimize treatment parameters and explore combination therapies for enhanced outcomes.

In this analysis, the 12-month use of a home-use helmet-type LLLT device was evaluated among individuals with androgenetic alopecia (AGA).

Alopecia

Dermatology

The HCPLive dermatology page is a resource for medical news and expert insights on skin disease. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for dermatologic conditions, and more.

12 Months of Low-Level Laser Therapy at Home Improves Androgenetic Alopecia

This segment looks ahead to remaining challenges in FCS diagnosis and access, and to the broader implications of APOC3 inhibition for hypertriglyceridemia management.

Perspectives on Ongoing Unmet Need and the Future of FCS Care

Despite major therapeutic advances, substantial unmet need remains in the diagnosis and management of familial chylomicronemia syndrome (FCS).

In their closing reflections, Nihar R. Desai, MD, and Anthony Giamo, MD, note that many patients first present to hospital-based internists with acute pancreatitis and markedly elevated triglycerides, where distinguishing FCS from multifactorial chylomicronemia can be challenging. They emphasize the importance of early referral to lipid specialists and point to resources such as the National Lipid Association’s directory of lipidologists to facilitate expert evaluation and confirmatory testing.

The experts also highlight real‑world obstacles related to coverage, access, and cost of newly approved APOC3‑targeted therapies. Transitioning from controlled trial settings and modeling exercises to broad clinical impact requires that patients can reliably obtain and continue treatment. In addition, long‑term data on pancreatitis reduction, quality of life, and potential cardiovascular outcomes are still needed, and there is strong interest in head‑to‑head comparisons and expanded indications.

Looking forward, advances in FCS are expected to inform the management of broader populations with severe or mixed hypertriglyceridemia. The mechanistic insights gained from APOC3 inhibition may spur development of additional agents and rational combination strategies targeting triglyceride‑driven disease. The faculty characterize this moment as an inflection point in preventive cardiology and lipidology, in which a historically refractory condition now has effective targeted therapies, and ongoing education, research, and systems‑level efforts will be critical to fully realizing their potential for patients.

Video Series

This segment emphasizes the clinical and quality‑of‑life value of achieving deep triglyceride reductions, particularly below 500 mg/dL, in FCS.

Importance of Reducing Triglycerides in FCS Care

Achieving profound triglyceride reductions is central to optimizing outcomes in familial chylomicronemia syndrome. In their exchange, Anthony Giamo, MD, and Nihar R. Desai, MD, emphasize that the American Heart Association defines severe hypertriglyceridemia as triglycerides ≥500 mg/dL and that lowering levels below this threshold is associated with substantial reduction in acute pancreatitis risk. The ability of APOC3‑targeted agents to bring a large proportion of patients below 500 mg/dL therefore represents a clinically meaningful advance.

Beyond hard clinical endpoints, the faculty highlight the impact of triglyceride control on daily functioning and psychosocial well‑being. Patients with FCS frequently live under strict dietary constraints that can preclude routine social activities, such as attending a restaurant meal or holiday gathering, for fear of precipitating pancreatitis. As triglycerides are better controlled with APOC3 inhibitors, clinicians may cautiously liberalize dietary restrictions, de‑escalate reliance on largely ineffective adjunctive agents (such as fibrates and omega‑3 fatty acids), and thereby improve quality of life while maintaining safety.

Desai notes that the consistent advantage seen for plozasiran in simulations—showing a greater proportion of patients crossing below the 500‑mg/dL threshold compared with olezarsen—may translate over time into fewer pancreatitis episodes, reduced medication burden, and better patient‑reported outcomes. Both experts stress the need for future research to quantify these benefits with rigorous clinical endpoints and validated quality‑of‑life measures. Nonetheless, current evidence supports aggressive triglyceride lowering with targeted therapies as a cornerstone of contemporary FCS management.

This segment addresses practical considerations in choosing between newly approved APOC3 inhibitors for patients with FCS. 

Embracing Newly FDA Approved Therapies for FCS Management

This segment explores the mechanisms of APOC3‑targeting agents and compares the triglyceride‑lowering profiles of olezarsen and plozasiran in FCS.

Assessing Therapeutic Options in FCS Management

This segment frames the longstanding unmet clinical need in FCS and the limitations of traditional management strategies.

Contextualizing Historic Unmet Need in FCS in a Contemporary Landscape

Chelsie Derman is an associate editor for 

who covers psychiatry, sleep medicine, geriatrics, migraine, and allergy. She joined MJH Life Sciences in September 2023 after graduating from The College of New Jersey with a bachelor’s degree in journalism and professional writing. In her free time, she enjoys creative writing and reading.

An 18-month study of children with up to 5 nut allergies found that a 30-mg per-nut maintenance dose significantly improved tolerated doses without serious adverse events.

Allergy

Allergy condition center page is a comprehensive resource for clinical news and insights on allergic and inflammatory diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for food and seasonal allergies, as well as allergic asthma and related conditions.

Anaphylaxis

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Very Low-Dose OIT Safely Increases Multi-Nut Tolerance in Young Children

Alex Hillenbrand is an assistant editor for 

. She earned her BA in English from Lafayette College in 2023 and went on to write for pop culture, entertainment, and sports media outlets before joining MJH Life Sciences in 2025. In her free time, Alex enjoys cooking, going on walks, and meeting new people. Contact her at mjhlifesciences.com.

A prospective study reports an association between diabetes mellitus and anuria with high post-void residual post-transplantation. 


Chronic Kidney Disease

Diabetes, Anuria May Predict High Postvoid Residual After Kidney Transplantation

Laura Wingate is the Chief Education, Support & Advocacy Officer at the Crohn's & Colitis Foundation.

Wingate reviews new Crohn’s and Colitis Foundation data on insurance barriers faced by young adults with IBD and offers practical insights for overcoming these challenges.

Gastroenterology

Gastroenterology condition center page is a comprehensive resource for clinical news and insights on digestive and GI conditions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for 

, IBS and IBD, Crohn's disease, and more.

Inflammatory Bowel Disease

On the HCPLive inflammatory bowel disease page, resources on the topics of medical news and expert insight into IBD can be found. Content includes articles, interviews, videos, podcasts, and breaking news on IBD and more.

Strategic Alliance Partnership

Bridging the Insurance Gap in Transition-Age IBD Care, With Laura Wingate

Abigail Brooks is an assistant managing editor for 

She joined MJH Life Sciences in August 2023 shortly after graduating from Monmouth University where she earned her BA in Communication with a concentration in Public Relations/Journalism and later an MA in Interactive Digital Media. She enjoys traveling, running, and reading books. She can be reached at abrooks@mjhlifesciences.com.

Topline 52 week results show durable growth without compromising safety or tolerability, as well as benefits beyond linear growth with combination treatment.

Combination Navepegritide, Lonapegsomatropin Shows Durable Benefit in Phase 2 Pediatric Achondroplasia Trial

Mishaela Rubin, MD, MS, is a professor of medicine at Columbia University Irving Medical Center.

Rubin discusses the recently released best practice recommendations for HypoPT treatment, explaining how clinicians can help turn this dangerous disease around.

Thyroid Disorders

Managing Renal Function and Serum Calcium in Hypoparathyroidism, With Mishaela Rubin, MD, MS

According to new research, investigators project a rising chronic kidney disease burden in young adults and a declining incidence in children by 2050.


Global CKD Burden Projected to Rise in Young Adults and Decline in Children by 2050

In this post hoc analysis, investigators used phase 3 data on vunakizumab to investigate the impact of early response on long-term efficacy in those with psoriasis.

Plaque Psoriasis

The HCPLive plaque psoriasis page is a resource for medical news and expert insights on psoriasis. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for psoriatic disease, and more.

Latest News

The HCPFive: Top News for Healthcare Providers from the Week of 01/04

Evinacumab May Lower Triglycerides in Severe Hypertriglyceridemia, With Robert Rosenson, MD

12 Months of Low-Level Laser Therapy at Home Improves Androgenetic Alopecia

Perspectives on Ongoing Unmet Need and the Future of FCS Care

Importance of Reducing Triglycerides in FCS Care