Mabwell Biosciences presented at the European Respiratory Society Congress 2026 in Barcelona (September 5-9, 2026) — with syndicated press coverage continuing through Saturday September 12 — Phase 1b/2a results for 9MW1911, an anti-ST2 monoclonal antibody developed on Mabwell's B-lymphocyte screening platform in China. In the 9MW1911-C03 study of former smokers with moderate-to-severe COPD, the annualized rate of moderate-to-severe exacerbations was reduced by 81% at the 900 mg dose and 24% at the 600 mg dose versus placebo; annualized severe exacerbation rate reductions were 100% and 47% respectively. The Phase 3 trial is expected to initiate around end of 2026 in China; the FDA has cleared the IND application for a Phase 2a U.S. trial. 9MW1911 targets ST2 (the IL-33 receptor) — the same biological pathway targeted by Regeneron/Sanofi's itepekimab and GSK's depemokimab in COPD. Sanofi and Regeneron's Phase 3 AERIFY-1 and AERIFY-2 itepekimab trials in COPD had mixed results reported May 2025; Mabwell's data support continued ST2 blockade testing in the disease.
Pulmovant, a Roivant Sciences (NASDAQ: ROIV) company, announced Tuesday September 8, 2026 that the Phase 2 PHocus study of inhaled mosliciguat (a once-daily first-in-class inhaled soluble guanylate cyclase activator) met its primary endpoint in patients with pulmonary hypertension associated with interstitial lung disease. Placebo-adjusted pulmonary vascular resistance reduction was 56.3% at Week 16 (-51.3% mosliciguat vs +6.6% placebo, p<0.0001) — the largest PVR reduction reported in any randomized controlled pulmonary hypertension trial per Pulmovant. Secondary endpoints: placebo-adjusted six-minute walk distance +35.2 meters (p=0.0027) and NT-proBNP -357.7 pg/mL, a 53.2% reduction from baseline (p=0.0002). At Week 24 (exploratory), 6MWD was +52.7 meters placebo-adjusted and NT-proBNP was -487.1 pg/mL (-75.9%). Mosliciguat was well-tolerated with lower cough incidence (12.1%) than placebo (18.2%). The trial enrolled 135 patients across 87 sites in 20 countries. The Phase 3 PHrontier study is enrolling approximately 375 patients globally in a 1:1 randomized double-blind placebo-controlled design. Marc Humbert (Université Paris-Saclay) presented the data at the ERS Congress in Barcelona; Roivant shares closed up approximately 17% on the day. Mosliciguat activates sGC independently of heme and nitric oxide, differentiating it from sGC stimulators like riociguat.
Rein Therapeutics (NASDAQ: RNTX) presented Tuesday September 8, 2026 (poster PA6217, 12:30-2:00 p.m. CEST) at the European Respiratory Society Congress in Barcelona the Phase 1b randomized double-blind placebo-controlled dose-escalation study of inhaled LTI-03 in patients with idiopathic pulmonary fibrosis. LTI-03 is a first-in-class synthetic seven-amino-acid peptide derived from the caveolin-1 scaffolding domain (CSD), designed with a dual mechanism targeting alveolar epithelial cell survival and inhibition of profibrotic signaling. The trial randomized 24 IPF participants 3:1 to LTI-03 5 mg/day (N=9), LTI-03 10 mg/day (N=9), or placebo (N=6) for 14 days. LTI-03 was well-tolerated with no treatment-related discontinuations, no severe TEAEs, and no spirometry-based airway obstruction; both doses significantly reduced interleukin-11 (p=0.0406 at 5 mg/day; p=0.044 at 10 mg/day) and thymic stromal lymphopoietin. The results were published the same day in Nature Communications (Philip Molyneaux MD, Imperial College London, presenting). LTI-03 has FDA Orphan Drug and Fast Track designations (Fast Track granted August 2026); the Phase 2 RENEW trial is enrolling across five countries with interim data anticipated H2 2026.
Roivant Sciences (NASDAQ: ROIV) and its Pulmovant subsidiary announced Sunday September 6, 2026 that Phase 2 PHocus topline results for mosliciguat (a once-daily inhaled soluble guanylate cyclase activator) in pulmonary hypertension associated with interstitial lung disease (PH-ILD) will be presented Tuesday September 8, 2026 at 12:15 CEST (6:15 a.m. ET) at the European Respiratory Society Congress 2026 in Barcelona by Marc Humbert MD PhD (Université Paris-Saclay; French National Reference Center for Pulmonary Hypertension). The randomized double-blind placebo-controlled global trial enrolled 135 adults with PH-ILD; the primary endpoint is change from baseline in pulmonary vascular resistance at week 16, with the controlled period running through week 24. Roivant will host an investor call at 8:00 a.m. ET the same day. Mosliciguat is an sGC activator that works independently of heme and nitric oxide, differentiating it from sGC stimulators like riociguat. In the earlier Phase 1b ATMOS study a single inhaled dose produced a mean peak reduction in pulmonary vascular resistance of up to 38%. The PVR change versus placebo is the metric investors are watching; the same endpoint anchored the Phase 3 program for United Therapeutics' Tyvaso (treprostinil) in PH-ILD.
Vicore Pharma Holding AB (STO: VICO) presented the trial-design abstract for its global 52-week Phase 2b ASPIRE trial of buloxibutid (a first-in-class oral angiotensin II type 2 receptor agonist small molecule) in idiopathic pulmonary fibrosis at the European Respiratory Society Congress 2026 on Monday September 7, 2026 in Barcelona. The randomized double-blind placebo-controlled parallel-group trial enrolled more than 360 IPF patients across 14 countries and 100 sites (29 in the United States), stratified between patients on background nintedanib standard of care and those without antifibrotic therapy. The primary endpoint is change in forced vital capacity (FVC) over 52 weeks, the regulatory endpoint for IPF. Buloxibutid activates AT2R to promote alveolar-epithelial-cell repair and downregulate aberrant fibrotic signalling. Enrollment completed in April 2026; topline results are guided for mid-2027 with cash runway into H2 2028. The ASPIRE readout will land in a crowded IPF competitive landscape following the March 2026 FDA approval of Boehringer's nerandomilast (BI 1015550) as the first non-antifibrotic mechanism approved for IPF in over a decade.
Insmed Incorporated (NASDAQ: INSM) presented late-breaking Phase 3b ENCORE results for ARIKAYCE (amikacin liposome inhalation suspension) in an oral session Sunday September 6, 2026 at the European Respiratory Society Congress in Barcelona. The 12-month study evaluated ARIKAYCE plus multidrug therapy (azithromycin 250 mg plus ethambutol 15 mg/kg) versus multidrug therapy alone in patients with a new occurrence of Mycobacterium avium complex (MAC) lung infection who had not received antibiotics — a substantially different population from ARIKAYCE's current U.S. label limited to refractory MAC. ENCORE met its primary endpoint of improvement in respiratory symptom score at month 13 and all multiplicity-controlled secondary endpoints; culture conversion at month 6 was 87.8% with ARIKAYCE plus multidrug versus 57.0% with multidrug alone. Insmed plans to file a supplemental new drug application in the second half of 2026 to expand the U.S. label to newly diagnosed MAC lung disease and convert the current accelerated approval in refractory MAC to traditional approval. Five Insmed abstracts total were accepted at the meeting including brensocatib (Brinsupri, DPP1 inhibitor) bronchiectasis analyses.
Trevi Therapeutics (NASDAQ: TRVI) confirmed via its September 3, 2026 conference-participation announcement that Marlies Wijsenbeek MD PhD (Erasmus MC) will deliver an oral presentation on quality-of-life outcomes measured by the Leicester Cough Questionnaire (LCQ) from the Phase 2b CORAL trial of nalbuphine extended-release (Haduvio, an oral kappa-opioid agonist / mu-opioid antagonist) in idiopathic pulmonary fibrosis patients with chronic cough at the European Respiratory Society Congress in Barcelona. The 165-patient Phase 2b CORAL topline (reported June 2025) documented statistically significant reductions in 24-hour objective cough frequency across all Haduvio dose groups at week 6, with reductions seen at week 2 (the first time point measured). Trevi has completed the End-of-Phase 2 FDA meeting and continued Phase 3 initiation preparation through 2026. Chronic cough affects approximately 85% of IPF patients and has no FDA-approved treatment; the Merck-Bellus P2X3 antagonist gefapixant (Lyfnua) was approved for refractory chronic cough in adults in 2024 but was not developed for IPF-specific cough.