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The HCPFive: Top News for Healthcare Providers from the Week of 07/05
This week’s headlines include the FDA acceptance of mitapivat and roflumilast applications, the approval of atacicept for IgA nephropathy, and more.
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 acceptance of a New Drug Application (NDA) for deucrictibant for on-demand treatment of hereditary angioedema (HAE) attacks and supplemental NDAs (sNDA) for mitapivat in sickle cell disease and roflumilast cream 0.05% (Zoryve) for infants aged 3 months to younger than 24 months living with atopic dermatitis, as well as the accelerated approval of atacicept (Trutakna) to reduce proteinuria in adults with primary IgA nephropathy (IgAN) at risk for disease progression. Compass Pathways additionally reported 6-month data from the phase 3 COMP006 trial showing the benefit of 2 fixed doses of COMP360 in treatment-resistant depression.
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 5, 2026 — let's jump in!
FDA Accepts NDA for Oral Deucrictibant for HAE Attacks
On July 6, 2026, the FDA accepted Pharvaris' NDA for deucrictibant immediate-release (IR) capsules, an oral bradykinin B2 receptor antagonist intended for on-demand treatment of HAE attacks, with a Prescription Drug User Fee Act (PDUFA) target action date of April 23, 2027. If approved, deucrictibant IR would become the first oral agent in its drug class for acute HAE attack treatment.
FDA Grants Priority Review to Agios’ Mitapivat sNDA for Sickle Cell Disease
On July 7, 2026, the FDA accepted Agios Pharmaceuticals’ supplemental New Drug Application (sNDA) for mitapivat in sickle cell disease and granted the application Priority Review, along with assigning a Prescription Drug User Fee Act (PDUFA) goal date of November 1, 2026.
If approved, mitapivat would become the first oral pyruvate kinase (PK) activator for patients with sickle cell disease, providing a potential new treatment approach for a population with significant unmet medical needs.
FDA Approves Atacicept (Trutakna) for IgA Nephropathy
On July 7, 2026, the FDA granted accelerated approval to atacicept (Trutakna) to reduce proteinuria in adults with primary IgAN at risk for disease progression, offering patients an autoinjector for at-home self-administration of a once-weekly subcutaneous injection.
The decision was supported by data from a prespecified interim analysis of the ORIGIN 3 trial, where participants treated with atacicept achieved a 46% reduction from baseline in proteinuria, with a statistically significant and clinically meaningful 42% reduction compared to placebo (P <.0001) at 36 weeks.
COMP360 Psilocybin Sustains Depression Benefit Through 26 Weeks
On July 7, 2026, Compass Pathways reported 6-month data from the phase 3 COMP006 trial trial showing 2 fixed doses of COMP360, an investigational synthetic psilocybin formulation, produced a reduction in depressive symptoms that was maintained through 26 weeks in more than a third of participants with treatment-resistant depression.
FDA Accepts sNDA for Roflumilast Cream 0.05% in Infants Down to 3 Months with Eczema
On July 8, 2026, the FDA accepted a supplemental New Drug Application (sNDA) from Arcutis Biotherapeutics for the expansion of the indication for topical roflumilast cream 0.05% (Zoryve) to include infants aged 3 months to younger than 24 months living with mild to moderate atopic dermatitis. The Agency has assigned the medication a Prescription Drug User Fee Act (PDUFA) target action date of February 23, 2027.
If approved, the expanded indication for roflumilast cream 0.05% would make it the first once-daily, nonsteroidal, targeted topical option specifically indicated for atopic dermatitis in this younger age bracket. Currently, the drug is approved for children in the 2 - 5 year range with mild to moderate disease.
