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.
EmeraNova has entered a commercialization collaboration involving Hyalomatrix, an established hyaluronic acid-based wound dressing, to expand access across hospitals, wound clinics and surgical settings. The arrangement adds another tissue restoration technology to its portfolio but does not represent a new FDA clearance or acquisition.
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.
Pilatus Biosciences has dosed its first patient in Hong Kong in the ongoing Phase 1 study of PLT012, an investigational CD36-targeting antibody for advanced cancers. The new hepatocellular carcinoma cohort will examine safety, early clinical activity and biomarkers associated with tumor metabolism and immune suppression.
Akamis Bio has completed enrollment of 33 patients in its Phase 1b FORTRESS study of NG-350A combined with chemoradiotherapy for mismatch repair-proficient rectal cancer. Earlier results showed a 50% composite response in ten patients, while the full dataset is expected in the first half of 2027.
Coya Therapeutics plans to extend treatment beyond 48 weeks for eligible ALSTARS participants receiving COYA 302 for amyotrophic lateral sclerosis. The decision follows completion of targeted enrollment, while randomized efficacy results remain expected in early 2027 and a separate frontotemporal dementia study has been delayed.
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