
The HCPFive: Top News for Healthcare Providers from the Week of 09/13
Key Takeaways
- Replicate OBERON/TITANIA phase 3 data showed tozorakimab reduced moderate/severe COPD exacerbations 29–34% in former smokers, representing a first phase 3 success for IL-33 antagonism.
- Priority Review of zasocitinib (oral TYK2 inhibitor) is supported by LATITUDE PsO 3001/3002, with ~70% achieving sPGA 0/1 at week 16 versus placebo and apremilast.
Stay updated with the latest healthcare breakthroughs, including Bayer's finerenone expanding to type 1 diabetes-associated CKD.
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 recap of six late-breaking trials from ERS Congress 2026 in Barcelona spanning
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 September 13, 2026 — let's jump in!
1. ERS Congress 2026: 6 Late-Breaking Trials to Know
ERS Congress 2026, held September 5–9 in Barcelona, delivered a late-breaking program spanning COPD, asthma, IPF, and alpha-1 antitrypsin deficiency. Top highlights included replicate phase 3 data from the OBERON and TITANIA trials showing tozorakimab, an IL-33 receptor antagonist, reduced moderate and severe COPD exacerbations by 29–34% in former smokers — the first phase 3 IL-33 antagonist success in this indication — alongside eosinophil-guided ICS strategy data, nerandomilast long-term tolerability results from the FIBRONEER-ON extension, and early clinical findings from a genetic correction program in AATD.
2. Zasocitinib NDA Acceptance: What It Means for Psoriasis Treatment
On September 14, 2026, the FDA accepted Takeda's NDA for zasocitinib, an investigational once-daily oral TYK2 inhibitor, under Priority Review for adults with moderate-to-severe plaque psoriasis, with a PDUFA target action date in Q1 2027. The filing is supported by the phase 3 LATITUDE PsO 3001 and 3002 trials, in which zasocitinib met co-primary and all 44 ranked secondary endpoints, achieving sPGA 0/1 in roughly 70% of patients at week 16 versus 11–13% on placebo and 30–32% on apremilast. Dermatologist Raj Chovatiya, MD, PhD, told HCPLive that the drug's oral route and high clearance rates could broaden access for patients hesitant about biologics and for those with limited but burdensome disease.
3. Q&A: What the First FDA-Approved PDT for Skin Cancer Means for sBCC Care
On September 14, 2026, the FDA approved Biofrontera's Ameluz (aminolevulinic acid hydrochloride) topical gel, 10%, used with the BF-RhodoLED lamp series, for superficial basal cell carcinoma in adults — making it the first FDA-approved photodynamic therapy for any skin cancer. The approval was supported by phase 3 ALA-BCC-CT013 data (n=187) showing a 66% composite clinical and histological complete response rate at 12 weeks versus 5% with vehicle-PDT. Neal Bhatia, MD, told HCPLive the treatment may be particularly useful in cosmetically sensitive areas and could be used alongside imiquimod rather than in direct competition with Mohs surgery.
4. ASH Issues New Ferritin Thresholds for Iron Deficiency Diagnosis
The American Society of Hematology published new evidence-based clinical practice guidelines raising serum ferritin thresholds for the diagnosis of iron deficiency across multiple populations: ≤20 ng/mL for children aged 9 months to 4 years, ≤30 ng/mL for adults and menstruating or pregnant individuals, and ≤50 ng/mL for those with heavy menstrual bleeding or pregnancy with anemia. For patients with inflammation — including those with cancer, IBD, or infectious disease — the guidelines recommend using ferritin <100 ng/mL or transferrin saturation <20% to account for ferritin's behavior as an acute-phase reactant. The five GRADE-based recommendations are intended to support earlier and more accurate diagnosis, and treatment-focused guidance is expected in 2027.
5. FDA Approves Finerenone (Kerendia) for CKD and Type 1 Diabetes
On September 17, 2026, Bayer announced the FDA approved finerenone (Kerendia) to reduce UACR — and thereby lower the risk of sustained eGFR decline and end-stage kidney disease — in adults with CKD associated with type 1 diabetes, marking the first new treatment for this population in more than 30 years. The approval was supported by the phase 3 FINE-ONE trial (n=242), which showed a 25% UACR reduction over 6 months versus placebo (P=.0001), with results published concurrently in the New England Journal of Medicine. This is finerenone's third US indication, following approvals for CKD with type 2 diabetes and for heart failure with LVEF ≥40%, and makes it the only MRA approved for CKD associated with both T1D and T2D.
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