News|Articles|September 7, 2025

HCPLive 5 Stories in Under 5: Week of 08/31

Fact checked by: Tim Smith

Listen

0:00 / 0:00

Key Takeaways

The FDA's decision on mitapivat for thalassemia is now expected in December 2025, following an extended review period.
Arcutis aims to expand roflumilast cream's indication to include young children with plaque psoriasis through a submitted sNDA.
Zilebesiran is advancing to a phase 3 trial to evaluate its impact on cardiovascular risk in patients with uncontrolled hypertension.
WVE-006 demonstrates durable serum AAT protein production in AATD, indicating potential for disease modification.
Amlitelimab shows effectiveness in improving disease severity and skin clearance in moderate-to-severe atopic dermatitis, according to phase 3 data.

An audio recap of the top 5 stories in healthcare news from the week of 08/31-9/5.

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let’s dive into the latest updates impacting clinicians and healthcare providers like you!

Interested in a more traditional, text rundown? Check out the HCPFive!

Top 5 Healthcare Headlines for August 31-September 5, 2025:

1. Mitapivat PDUFA for Thalassemia Delayed to December
The FDA extended the review timeline for mitapivat in thalassemia, with a new decision date set for December 2025.

2. Arcutis Submits sNDA for Roflumilast Cream 0.3% for Psoriasis in Children Aged 2-5 Years

Arcutis submitted an sNDA seeking to expand roflumilast cream’s indication to include plaque psoriasis in children as young as 2.

3. Zilebesiran, RNAi for Hypertension, Heads to Phase 3 Cardiovascular Outcomes Trial

Alnylam is advancing zilebesiran into a phase 3 outcomes trial to evaluate its impact on cardiovascular risk in patients with uncontrolled hypertension.

4. RestorAATion-2: WVE-006 Achieves Durable Serum AAT Protein Production in AATD

Wave Life Sciences reported durable serum AAT protein production with WVE-006 in AATD, supporting its potential for disease modification.

5. Phase 3 Data Show Amlitelimab Effective in Adults, Adolescents with Atopic Dermatitis

Sanofi announced phase 3 results showing amlitelimab improved disease severity and skin clearance in moderate-to-severe atopic dermatitis.

Join thousands of clinicians staying current on new therapies, trial data, and expert insights—subscribe to HCPLive today.

Latest CME

$Cases and Conversations™: Sorting Through the Expanding Treatment Options for Patients with Relapsed/Refractory Multiple Myeloma$

HCPLive 5 Stories in Under 5: Week of 08/31

Key Takeaways

Related Content

Tips for Safe Management of Skin Disease During Pregnancy, With Jenny Murase, MD

Pigmentation Pipeline: Vitiligo and Melasma Treatment Advances

Why Fewer Than Half of Referred Patients Reach Kidney Transplant Evaluation

Medical Ethics Unpacked: The History and Ethics of Brain Death

Saroglitazar and the Evolving PBC Treatment Landscape, With Raj Vuppalanchi, MD

Latest CME

Cases and Conversations™: Sorting Through the Expanding Treatment Options for Patients with Relapsed/Refractory Multiple Myeloma

Cases & Conversations™: Transforming AML Care—Precision Strategies, Evolving Therapies, and Clinical Insights

Medical Crossfire®: Improving Patient Outcomes in Myeloproliferative Neoplasms With Novel Therapeutic Approaches

Southern California Psychiatry Conference

Burst CME: Managing Fluid Overload in Patients with Chronic Kidney Disease (Part 1)

Looking Beneath the Surface: Latest Updates in Identifying and Managing Hypercortisolism in Patients with Type 2 Diabetes

Navigating Safety Data with Janus Kinase (JAK) Inhibitors in Atopic Dermatitis (AD) Management

Rapid Reviews in Retina™: Emerging Updates from Spring 2025—Addressing the Wealth of New Data in Treatments for Neovascular Retinal Disease

Interventional Dry Eye: A Stepwise Treatment & Management Approach

Assessing the Evidence for OX40-OX40L Axis Inhibition for the Treatment of Atopic Dermatitis

Burst CME: Managing Fluid Overload in Patients with Chronic Kidney Disease (Part 2)

Patient, Provider, and Caregiver Connection: Turning a New Leaf in Acute Pain Management – How Recent Advancements Impact the Treatment Paradigm

(CME Track) Collaborating Across the Continuum™: Best Practices in Patient-Centric Team Management of XLRP

Burst CME™: Optimizing Care for Patients with Psoriasis – Incorporating a Buy-and-Bill Model for Biologic Agents into Dermatological Practice

(CME Track) The Evolution of MacTel Management: Integrating Neuroprotective Therapies Into Clinical Practice

Live Expert Illustrations & Commentary™: Visualizing Novel Therapeutic Targets for Patients with Major Depressive Disorder

(CME Track) Rapid Reviews in Retina™: Emerging Updates from Summer 2025—Addressing the Wealth of New Data in Treatments for Neovascular Retinal Disease

(CME Track) A Forward Look at Anti-VEGF Therapies: A Paradigm Shift in Neovascular Retinal Disease Management

Cases and Conversations™: Biologic Matchmaking in Psoriasis – Finding the Right Therapy for the Right Patient

Collaborating Across the Continuum™: The Pediatrician’s Vital Role in Multidisciplinary Management of Pediatric PAH

Collaborating Across the Continuum™: The Pediatrician’s Vital Role in Multidisciplinary Management of Pediatric PAH

Collaborating Across the Continuum™: The Pediatrician’s Vital Role in Multidisciplinary Management of Pediatric PAH

Patient, Provider, and Caregiver Connection™: Addressing Patient Challenges With Holistic Approaches to Vitiligo Management

(CME Track) Community Collaborative Connections™: Optimizing the Collaborative Care of Neovascular Retinal Disease in a New Age of Treatment

(CME Track) SoCal Psych 2025: Overcoming Barriers to Long-Acting Injectable Agents in Schizophrenia

Cases and Conversations™: Mineralocorticoid Receptor Antagonists in Patients With HF—Augmenting Current Guidelines with Emerging Evidence

Hidradenitis Suppurativa: Diving Deeper Into Disease Pathogenesis, Severity Assessment, and Holistic Management Approaches

Burst CME CGM: Continuous Glucose Monitoring Considerations – Maximizing Quality of Life for Patients

Progress in Hyperlipidemia Management to Reduce ASCVD Risk: An Illustrated Update

Navigating Advances in Neovascular Retinal Disease: Translating Evidence to Practice in AMD, DME, and RVO

(CME Track) Beyond the Collarette: Empowering Patients in the Management of Demodex Blepharitis

(COPE Track) Beyond the Collarette: Empowering Patients in the Management of Demodex Blepharitis

IgAN Case Files: Real Conversations, Evolving Evidence

Expert Illustrations & Commentaries™: Visualizing the Role of Dystrophin Dysregulation as a Therapeutic Target in Duchenne Muscular Dystrophy and MD STARnet

Shining a Light on an Ultra-Rare Disease – A Closer Look at Thymidine Kinase 2 Deficiency (TK2d)

Shining a Light on an Ultra-Rare Disease – A Closer Look at Thymidine Kinase 2 Deficiency (TK2d)

Identifying and Treating Generalized Myasthenia Gravis in the Modern Era

Addressing Unmet Needs for Patients With Spinal Muscular Atrophy—Understanding Patient Challenges and Management Approaches

Rewiring Recovery: Evidence-Based Approaches to Managing Chronic Inflammatory Demyelinating Polyneuropathy

Navigating Ocular Toxicities: A Multidisciplinary Roadmap for Managing Adverse Events in Targeted Cancer Therapy

(CME Track) Antibody–Drug Conjugates in Oncology: The Essentials of AE Management for Better Patient Outcomes

Clinical Consultations™: Tailoring Treatment for Cystic Fibrosis (CF) Across Life Stages and Evolving Health Needs

Clinical Consultations™: Tailoring Treatment for Cystic Fibrosis (CF) Across Life Stages and Evolving Health Needs

Clinical Consultations™: Tailoring Treatment for Cystic Fibrosis (CF) Across Life Stages and Evolving Health Needs

SimulatEd™: Partnering for Precision – A Framework for Personalized Care Planning in Acute Lymphoblastic Leukemia

Putting the Patient First in Acute Pain Management: The PA’s Guide to Incorporating Cutting-Edge Science Into Their Treatment Strategies

Putting the Patient First in Acute Pain Management: The PA’s Guide to Incorporating Cutting-Edge Science Into Their Treatment Strategies

Expert Illustrations & Commentaries™: Visualizing the Role of B Cells as Therapeutic Targets for Generalized Myasthenia Gravis

Rapid Reviews in Retina™: Emerging Updates from Fall 2025—Addressing the Wealth of New Data in Treatments for Neovascular Retinal Disease

Targeting the Cortisol Cascade: Diagnosis and Treatment Strategies in Patients with Hypertension

Targeting the Cortisol Cascade: Diagnosis and Treatment Strategies in Patients with Hypertension

Patient, Provider, and Caregiver Connection™: Individualizing Care in C3 Glomerulopathy – Understanding Patient Challenges and the Role of Innovative Treatment

Biomarker Testing in HER2+ GEA: Diagnosis and Treatment Implications

Navigating the Adverse Event Landscape in HER2+ GEA Therapy

Unlocking the Future of Glioma Care: Integrating Recent Advances to Personalize Treatment

Screening for Type 1 Diabetes and Delaying Its Onset—An Innovative View

Clear Skin, Clear Mind: Integrating Mental Health into Psoriasis Care

Clear Skin, Clear Mind: Integrating Mental Health into Psoriasis Care

Expert Illustrations & Commentary: Visualizing the Role of Novel Muscarinic Agents in the Management of Schizophrenia

Bridging Regional Challenges in Retinal Disease Management: Applying Advanced Anti-VEGF Therapy in Community Practice - NYC Metro

Bridging Regional Challenges in Retinal Disease Management: Applying Advanced Anti-VEGF Therapy in Community Practice - California

(CME Track) Tackling Oncologic Emergencies in Patients Treated With High-Dose Methotrexate

From Clue to Care: Rapid Recognition and Coordinated Management of Paraneoplastic LEMS in SCLC

Burst CME™: Optimal Management of Complications of Sickle Cell Disease

Burst CME™: Optimal Management of Complications of Sickle Cell Disease

Burst CME™: Transition from Pediatric to Adult Care in Sickle Cell Disease

Burst CME™: Transition from Pediatric to Adult Care in Sickle Cell Disease

Burst CME™: Disease-Modifying vs. Curative Therapy – Which Way to Go in Sickle Cell Disease?

Burst CME™: Disease-Modifying vs. Curative Therapy – Which Way to Go in Sickle Cell Disease?

Burst CME™ in Gaucher Disease: Patient Evaluation and Management

Optimizing Lipid-Lowering Strategies for ASCVD Risk Reduction: Bridging the Gap in Treatment Intensification