Estuary Biotherapeutics has launched with $103 million in committed financing to develop kidney-targeted gene therapies for autosomal dominant polycystic kidney disease. Its two lead programmes target PKD2 and PKD1 mutations, building on mouse research suggesting that restoring polycystin activity can reverse some features of established kidney disease.
The EMA's CHMP has maintained its negative opinion on narsoplimab for transplant-associated thrombotic microangiopathy, citing unresolved clinical evidence concerns. Omeros disputes aspects of the re-examination and is shifting attention toward US commercialization and alternative patient access arrangements.
Virion Therapeutics will present extended Phase 1b follow-up for VRON-0200 at AASLD 2026. Earlier published results showed continued hepatitis B surface antigen declines in most patients receiving the experimental immunotherapy alone, but a functional cure has not been established.
Palleon Pharmaceuticals will present interim Phase 2 results for HLX79 plus a rituximab biosimilar in membranous nephropathy. A publicly available abstract reports 17 remissions among 26 patients, although the blinded analysis includes patients receiving rituximab without HLX79.
China's NMPA has authorized clinical investigation of NW001, a PD-L1-targeted antibody conjugate carrying a histone deacetylase inhibitor. Chipscreen reports activity in checkpoint-resistant preclinical cancer models, but human safety, dosing and efficacy remain unestablished.
Long-term findings from the 100-patient QUILT-3.032 cohort show a 71% complete response rate with ANKTIVA plus BCG and 84.2% cystectomy-free survival at three years among responders. The findings strengthen evidence for sustained bladder preservation, although the study was nonrandomized and the preservation estimate does not apply to all treated patients.
The FDA has approved BRYTLY, Alcon's 0.125% apraclonidine eye drops, for temporary relief of redness caused by minor irritation in people aged 12 and older. Alcon claims effects within one minute lasting up to 12 hours, although its longer-duration comparison with Lumify is based on product labeling rather than a disclosed head-to-head trial.
Pelage has dosed the first participant in AWAKEN, a 600-patient Phase 2/3 trial of topical PP405 for male pattern hair loss. The programme follows an exploratory Phase 2a finding in which 31% of selected treated men achieved more than 20% improvement in hair density, compared with none receiving placebo.
Zai Lab will present initial Phase 1 data for ZL-1503 at ACAAI 2026 on November 13, evaluating safety, pharmacokinetics and inflammatory biomarkers in healthy volunteers. The investigational bispecific antibody targets IL-13 and IL-31 receptor signaling, but clinical efficacy in patients with atopic dermatitis remains unreported.
Verastem reports a 50% confirmed response rate in eight second-line pancreatic cancer patients receiving VS-7375, with a 41% rate across 22 previously treated patients at the selected 900 mg dose. The company is preparing a first-line Phase 3 study while pursuing broader development in lung and colorectal cancers.