Monthly pulmonology bulletin — October 9, 2026

Period covered: September 9 to October 9, 2026. Note for this month: the month was dominated by the ERS Congress (Barcelona, September 5–9). Three of the most important items were presented on September 7–8, one or two days before the start of the period; they are included because of their weight and are flagged. In infections, sleep and ventilation we found no verifiable news within the period, and we prefer to send fewer items rather than pad the issue. There were also no new verifiable data this month from the Dominican Republic or the rest of Latin America. Outside North America and Western Europe we could verify only one item (Korea), below our usual target of four.

Asthma and COPD

1. Tozorakimab (anti–IL-33) reduces COPD exacerbations in two phase 3 trials

[Clinical trial] [International; sponsor: AstraZeneca, United Kingdom] [Outside the period: September 8]

OBERON and TITANIA together randomized 2,306 patients with COPD and at least two moderate or one severe exacerbation in the prior year to tozorakimab 300 mg every four weeks or placebo for 52 weeks, added to inhaled maintenance therapy. In former smokers (primary population), the annual rate of moderate or severe exacerbations fell by 29% (OBERON) and 34% (TITANIA); in the overall population (current and former smokers), by 30% and 29%. In the pooled analysis of both trials by eosinophils in the overall population, the reduction was 23% with fewer than 150 cells/µL, 34% with 150 or more, and 43% with 300 or more. The results were published in NEJM, and the FDA accepted the application under priority review (decision expected in Q1 2027).

Why it matters: according to the manufacturer, it is the first biologic to show efficacy in a broad COPD population, including patients with low eosinophils, a group with no biologic option today; but the press release gives no confidence intervals, the trials are manufacturer-funded, the effect in low eosinophils is the most modest, and without approval or pricing it does not yet change practice in the Dominican Republic.

https://doi.org/10.1056/NEJMoa2606998
https://www.astrazeneca.com/media-centre/press-releases/2026/tozorakimab-demonstrated-statistically-significant-highly-clinically-meaningful-reduction-copd-exacerbations-oberon-titania-phase-iii-trials.html

2. Lunsekimig (bispecific anti-TSLP/IL-13) in moderate-to-severe asthma: full AIRCULES data

[Clinical trial] [International; sponsor: Sanofi, France]

In the randomized, double-blind, placebo-controlled phase 2b AIRCULES trial (NCT06102005), whose full data were presented at the ERS Congress (Barcelona, September 5–9), lunsekimig added to standard care reduced, according to HCPLive coverage dated September 9, the annualized exacerbation rate by about 39% versus placebo in the overall population and by about 55% at the highest dose (300 mg every four weeks). In patients with more than three prior exacerbations the reduction approached 80%, and the response was greater with high FeNO or eosinophils above 300 cells/µL, with FEV1 improvement. Adverse events were similar to placebo.

Why it matters: the effect is dose-dependent and concentrated in the T2-high phenotype, the same ground already covered by available biologics; it is phase 2b, the sample size is not reported in the coverage we consulted and the subgroups are exploratory, so phase 3 and a comparison against current biologics are needed.

https://www.hcplive.com/view/aircules-lunsekimig-benefit-scales-severity-lugogo
https://www.sanofi.com/en/media-room/press-releases/2026/2026-04-07-05-00-00-3268809

Interstitial lung disease and pulmonary hypertension

3. FDA expands the sotatercept label with HYPERION data in recently diagnosed PAH

[Regulatory FDA] [United States]

On September 22 the FDA approved adding the HYPERION results to the label of sotatercept (Winrevair, Merck): 320 adults with pulmonary arterial hypertension diagnosed within the prior 12 months, WHO functional class II or III and intermediate or high risk, randomized 1:1 to sotatercept or placebo on top of background therapy. The primary endpoint (death or first morbidity event) occurred in 10.6% versus 36.9% (HR 0.24; 95% CI, 0.14–0.41; P < .0001), a 76% relative reduction. The trial was stopped early after the positive interim ZENITH results.

Why it matters: it supports using sotatercept early rather than only as a last step; early stopping tends to overestimate the effect, the trial is manufacturer-funded, and cost plus the need for follow-up at a referral center limit access in our setting.

https://s2.q4cdn.com/584635680/files/doc_news/U-S--FDA-Approves-Update-to-the-Label-for-WINREVAIR-sotatercept-csrk-to-Include-Data-from-the-Phase-3-HYPERION-Trial-Evaluating-Adult-JNF2Q.pdf
https://www.hcplive.com/view/fda-updates-sotatercept-label-with-hyperion-data-in-early-pah

4. ERS guideline update for the treatment of pulmonary arterial hypertension

[Guideline] [Europe] [Outside the period: September 7]

The ERS published in the European Respiratory Journal an update to the 2022 guideline (Kovacs, Zeder, Humbert, et al.). It makes a strong recommendation, with high certainty, for add-on sotatercept in treated PAH patients who remain at intermediate-low, intermediate-high or high risk at follow-up; it makes no recommendation for low-risk patients because of low certainty of evidence. It conditionally suggests, with very low certainty, repeat right heart catheterization at follow-up in intermediate-low, intermediate-high or high-risk patients when the result would change management.

Why it matters: it brings sotatercept into the ERS recommendations and reinforces the goal of reaching low risk; it updates rather than replaces the 2022 ESC/ERS guideline, and our reading is based on a secondary summary, so the full text should be reviewed.

https://doi.org/10.1183/13993003.01178-2026
https://www.pharmacytimes.com/view/ers-adds-sotatercept-to-pah-treatment-guidelines

5. Inhaled mosliciguat lowers pulmonary vascular resistance in pulmonary hypertension associated with ILD

[Clinical trial] [International, 20 countries; sponsor: Pulmovant/Roivant, United States] [Outside the period: September 8]

PHocus, a randomized, double-blind, placebo-controlled phase 2 trial, enrolled 135 adults with PH-ILD at 87 sites. At week 16, mosliciguat (a once-daily inhaled soluble guanylate cyclase activator) reduced pulmonary vascular resistance by 51.3% versus a 6.6% increase with placebo (placebo-adjusted difference 56.3%; P < .0001). Six-minute walk distance, a secondary endpoint, improved by 35.2 m versus placebo. Cough occurred in 12.1% versus 18.2%. The phase 3 PHrontier trial (about 375 patients) is already enrolling.

Why it matters: PH-ILD currently has few options, essentially inhaled treprostinil formulations approved only in some countries; but the primary endpoint is hemodynamic, not clinical, the data come from a manufacturer press release without peer-reviewed publication, and phase 3 will need to show benefit in exercise capacity or clinical events.

https://www.santelog.com/actualites-sante-nasdaq/pulmovant-announces-positive-results-phocus-study-mosliciguat-patients

Lung cancer and pulmonary nodules

6. AI-driven pulmonary nodule program versus low-dose CT screening

[Meeting] [United States; presented in Korea, WCLC 2026]

At the World Conference on Lung Cancer (Seoul, September 15), Memorial Cancer Institute (Florida) presented its integrated pulmonary nodule program, in which AI connected to the electronic health record detects and classifies nodules on chest imaging. From February 2023 to March 2026 it reviewed 348,989 studies, referred 6,533 patients (1.9%) for follow-up and led to 49 lung cancer diagnoses; the proportion diagnosed at an early stage rose from 53% in 2024 to 73% in 2026. At the same center, the low-dose CT screening program (1,429 patients between July 2021 and March 2026) diagnosed 32. (source in Korean)

Why it matters: systematically managed incidental findings may capture patients who do not meet screening criteria; but this compares two non-equivalent cohorts from different periods at a single center, unpublished and disseminated in an article with commercial interest, so it is hypothesis-generating.

https://www.hitnews.co.kr/news/articleView.html?idxno=79157

Infections, sleep and ventilation

No verifiable news within the period. The candidate items we reviewed (for example, the phase 3 SynAIRgy trial of AD109 in obstructive sleep apnea or tuberculosis data from the Dominican Republic) date from May and July and no longer belong in this issue.

Upcoming meetings and dates

• CHEST 2026: October 18–21, 2026, Phoenix, Arizona, United States. https://www.naquitline.org/news/733484/October-18-21---CHEST-2026-See-Whats-on-the-Horizon.htm

Monthly pulmonology bulletin — October 9, 2026

6 verified items from NEJM, the European Respiratory Journal, the FDA, and the ERS and WCLC meetings.

Three worth your time:
• Tozorakimab (anti–IL-33) cut COPD exacerbations by 29% and 34% in former smokers (OBERON and TITANIA, 2,306 patients), with an effect even at low eosinophils. Caveat: manufacturer-funded, not yet approved.
• The FDA added HYPERION to the sotatercept label: in recently diagnosed PAH, clinical worsening 10.6% vs 36.9% (HR 0.24). Caveat: trial stopped early.
• Inhaled mosliciguat lowered pulmonary vascular resistance by 56% vs placebo in PH-ILD (PHocus, 135 patients). Caveat: hemodynamic endpoint, press release only.

Full bulletin, with a critical appraisal of each study and links to its sources:
https://boletinesmedicos.com/en/neumologia/2026-10-09.html

#Pulmonology #COPD #PulmonaryHypertension #ERS2026

COPD: tozorakimab cuts exacerbations 29–34% (OBERON/TITANIA, NEJM). PAH: FDA adds HYPERION to sotatercept label, HR 0.24 in early disease. Pulmonology bulletin:
https://boletinesmedicos.com/en/neumologia/2026-10-09.html