HCPLive 5 Stories in Under 5: Week of 08/31
Update: 2025-09-07
Description
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.
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.
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