clinical_trial_results

Harbour BioMed, Windward Bio Post Phase 2 Data for Twice-Yearly Asthma Antibody

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Harbour BioMed, Windward Bio Post Phase 2 Data for Twice-Yearly Asthma Antibody

Cambridge, Massachusetts – September 11, 2026 -- Harbour BioMed (HKEX: 02142) and partner Windward Bio reported positive Phase 2 interim results for HBM9378/WIN378, a twice-yearly TSLP-blocking antibody, from the 147-patient POLARIS-1 asthma trial, clearing the path for two Phase 3 studies.

Interim data show up to 174 mL lung-function gain after single dose

The Phase 2 interim analysis, conducted on the first 98 of 147 enrolled patients with uncontrolled moderate-to-severe asthma, found FEV1 increases of up to 174 mL, with a placebo-adjusted mean increase of 256 mL (p=0.033) at Week 24 after a single dose.

Biomarkers for airway inflammation drop sharply

FeNO fell by up to 24 ppb, a 43% reduction (p=0.006), while blood eosinophil counts dropped by up to 200 cells/μL, a 51% decline (p0.0001). Near-maximal effects appeared as early as Week 2 and were sustained through Week 24.

Pulnovo's PADN Cuts Clinical Worsening Risk 51% in NEJM-Published Trial

Shanghai – September 08, 2026 -- Pulnovo Medical's pulmonary artery denervation (PADN) system reduced the risk of clinical worsening by 51% in patients with pulmonary hypertension linked to left heart disease (PH-LHD), according to results from the PADN-HF-PH trial presented at the European Society of Cardiology (ESC) Congress 2026 and simultaneously published in The New England Journal of Medicine.

Trial enrolled 264 patients across multiple centers under academician Yaling Han

The multicenter, randomized controlled study, led by academician Yaling Han of the General Hospital of Northern Theater Command, evaluated PADN as an add-on to guideline-directed medical therapy (GDMT) versus GDMT alone. Corresponding authors on the NEJM paper include Professor Shao-Liang Chen of Nanjing First Hospital and Professor Gregg W. Stone of Mount Sinai Hospital.

Pulnovo's PADN Device Cuts Heart Failure Risk 51% in Trial

Shanghai – September 08, 2026 -- Pulnovo Medical's pulmonary artery denervation (PADN) system reduced the risk of clinical worsening by 51% in patients with pulmonary hypertension linked to left heart disease, according to results from the PADN-HF-PH trial presented at the European Society of Cardiology (ESC) 2026 Congress and published simultaneously in The New England Journal of Medicine (NEJM).

Trial of 264 patients shows 51% risk reduction over two-year follow-up

The multicenter, randomized controlled trial, led by academician Yaling Han of the General Hospital of Northern Theater Command, enrolled 264 patients with pulmonary hypertension associated with left heart disease (PH-LHD). Over a median follow-up of 338 days, the estimated two-year incidence of clinical worsening was 25.7% in the PADN-plus-GDMT group versus 51.5% in the guideline-directed medical therapy (GDMT)-alone group (hazard ratio 0.49; 95% CI, 0.30 to 0.82; p=0.006).

Jazz's Ziihera Shows Significant Survival Edge Over Trastuzumab in GEA Trial

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Jazz's Ziihera Shows Significant Survival Edge Over Trastuzumab in GEA Trial

Dublin – September 03, 2026 -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that Ziihera (zanidatamab-hrii) combined with chemotherapy produced a statistically significant and clinically meaningful overall survival (OS) benefit versus trastuzumab plus chemotherapy in a second interim analysis of the Phase 3 HERIZON-GEA-01 trial in first-line HER2-positive gastroesophageal adenocarcinoma (GEA).

OS hazard ratio for Ziihera plus chemotherapy improved versus the first interim analysis

The company said the survival advantage strengthened compared with earlier data, reinforcing Ziihera's position following its FDA approval on August 25, 2026. No new safety signals emerged relative to previously reported HERIZON-GEA-01 data or the known profiles of the individual agents.