2026-11-07 · America/New_York
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Johnson & Johnson reported that 58% of patients receiving icotrokinra 200 mg achieved ACR20 at Week 16 in ICONIC-PsA 1, versus 41% with placebo. The oral IL-23 receptor peptide also showed skin responses. The company reported no new safety signals through Week 24; active psoriatic arthritis remains an investigational indication.
A Frontiers in Pharmacology review compares direct MCL-1 inhibition with approaches that reduce its abundance, including transcriptional interventions and targeted degradation. The original abstract highlights limited single-agent activity and cardiac safety concerns with inhibitors, while positioning degradation as an unvalidated clinical strategy. Biomarker-guided combinations and dynamic BH3 profiling are discussed; this review does not report a new clinical trial.
A study in European Journal of Drug Metabolism and Pharmacokinetics modeled subcutaneous aqueous progesterone using single-dose crossover data from 50 healthy Chinese postmenopausal women. Machine-learning approaches screened potential covariates before conventional PopPK evaluation. Height and body-weight effects remained statistically identifiable but had limited clinical significance. Simulated repeated-dose exposure is model-derived, rather than an observed efficacy outcome in fertility patients.
Johnson & Johnson reported that ICONIC-ASCEND met its Week 16 co-primary endpoints: PASI 90 responses were 55.2% with icotrokinra versus 3.6% with placebo, and IGA 0/1 responses were 70.4% versus 9.5%. At Week 28, the oral peptide met noninferiority criteria versus ustekinumab across multiplicity-controlled key secondary skin-clearance endpoints.
Entera reported $265.9 million in cash and cash equivalents at September 30, plus $6.5 million in restricted cash. Its November 6 update targets first site activation for an approximately 900-patient EB613 osteoporosis Phase 3 trial in late 2026. EB613 is an oral PTH(1-34) program, included here as an adjacent oral-peptide delivery development, not a cyclic-peptide candidate.
A Nature Materials study describes mRNA-loaded LNPs that reprogram tumor-associated macrophages into Claudin18.2-targeting CAR macrophages. The lipid formulation also promotes TREM2 internalization and degradation, reshaping immune responses. The original abstract reports tumor suppression and longer survival with PD-1 blockade in mice, plus ex vivo patient-sample findings. These findings do not demonstrate clinical efficacy in treated patients.
Phio announced a November 7 SITC oral presentation of final Phase 1b findings for intratumoral PH-762, its PD-1-silencing siRNA candidate, in cutaneous carcinomas. The company described tolerability and potential tissue-sparing neoadjuvant use, while stating that additional safety and efficacy studies are needed. A Phase 2b study is planned for the first half of 2027.
Vir Biotechnology announced that Phase 3 ECLIPSE 1 results for elebsiran plus tobevibart in chronic hepatitis delta will be presented on November 8, with an investor discussion on November 9. Elebsiran is an HBV-targeting siRNA; tobevibart is an antibody. The release announces the forthcoming readout and expanded Phase 2 presentations but does not disclose the Phase 3 numerical results.
A Communications Chemistry study reports RaPiD-mAb-MS, combining plate-based preparation with direct-infusion mass spectrometry for antibody peptide mapping. The original abstract describes analysis of 96 samples in about 1.5–2 hours, routinely exceeding 95% sequence coverage, across 28 antibodies and more than 2,000 samples. The reported comparisons cover several modifications and sequence variants; broader method suitability still requires evaluation.
Moderna reported third-quarter 2026 revenue of $1.3 billion, up 29% year over year, and GAAP net income of $162 million, compared with a $200 million loss a year earlier. It raised expected full-year revenue growth to 15%–25% from up to 10%. The company attributed quarterly growth mainly to international COVID vaccine sales supported by government partnerships.
Phio announced a November 7 SITC oral presentation of final Phase 1b findings for intratumoral PH-762, its PD-1-silencing siRNA candidate, in cutaneous carcinomas. The company described tolerability and potential tissue-sparing neoadjuvant use, while stating that additional safety and efficacy studies are needed. A Phase 2b study is planned for the first half of 2027.
Indexed: Nov 7, 2026, 11:04 AM · Original date: 2026-11-06
Entera reported $265.9 million in cash and cash equivalents at September 30, plus $6.5 million in restricted cash. Its November 6 update targets first site activation for an approximately 900-patient EB613 osteoporosis Phase 3 trial in late 2026. EB613 is an oral PTH(1-34) program, included here as an adjacent oral-peptide delivery development, not a cyclic-peptide candidate.
Indexed: Nov 7, 2026, 11:04 AM · Original date: 2026-11-06
Johnson & Johnson reported that ICONIC-ASCEND met its Week 16 co-primary endpoints: PASI 90 responses were 55.2% with icotrokinra versus 3.6% with placebo, and IGA 0/1 responses were 70.4% versus 9.5%. At Week 28, the oral peptide met noninferiority criteria versus ustekinumab across multiplicity-controlled key secondary skin-clearance endpoints.
Indexed: Nov 7, 2026, 11:04 AM · Original date: 2026-11-06
Moderna announced Canadian authorization of mFLUSIVA, its mRNA influenza vaccine, and mCOFLU, its combined influenza and COVID-19 vaccine, for adults 50 and older. The November 5 announcement cites Phase 3 efficacy evidence for mFLUSIVA and immunogenicity comparisons for mCOFLU. The company said it would engage Canadian authorities and immunization partners on future availability.
Indexed: Nov 7, 2026, 11:04 AM · Original date: 2026-11-05
Johnson & Johnson reported that 58% of patients receiving icotrokinra 200 mg achieved ACR20 at Week 16 in ICONIC-PsA 1, versus 41% with placebo. The oral IL-23 receptor peptide also showed skin responses. The company reported no new safety signals through Week 24; active psoriatic arthritis remains an investigational indication.
Indexed: Nov 7, 2026, 11:04 AM · Original date: 2026-11-07
Alex Chen’s long-form report compares salt selection, solid-state evidence, formulations and oral absorption for enlicitide and icotrokinra. Start with a short overview, then explore the full bilingual report through its chapter directory, comparison tables and original references.
Indexed: Nov 7, 2026, 9:12 AM · Original date: 2026-09-11 · Older source added
Historical methods study (2017): 213 sites from 11 academic trials were randomised; audits covered 156 sites and 1,618 patients. Risk-adapted monitoring met the specified non-inferiority criterion for major audit findings while using fewer resources. High-risk trials were excluded. The findings inform monitoring design, not the performance of any Chinese CRO.
Indexed: Nov 7, 2026, 9:10 AM · Original date: 2017-08-08 · Older source added
A Nature Materials study describes mRNA-loaded LNPs that reprogram tumor-associated macrophages into Claudin18.2-targeting CAR macrophages. The lipid formulation also promotes TREM2 internalization and degradation, reshaping immune responses. The original abstract reports tumor suppression and longer survival with PD-1 blockade in mice, plus ex vivo patient-sample findings. These findings do not demonstrate clinical efficacy in treated patients.
Indexed: Nov 7, 2026, 8:02 AM · Original date: 2026-11-06
Evommune licensed EVO570, formerly HC118, from Hinova for development and commercialization outside Greater China. Upfront consideration totals $30 million: $20 million cash and $10 million in pre-funded warrants. Additional development, regulatory, and commercial milestones could reach approximately $1.1 billion, plus royalties. Phase 1 was expected to begin shortly; the announcement does not establish human efficacy.
Indexed: Nov 7, 2026, 8:02 AM · Original date: 2026-11-05
A Nature Communications study reports a peptide–oligonucleotide nanohybrid for bone-targeted miR-26a-5p delivery. The original abstract describes reduced GSK-3β expression and stabilization of HIF-1α, supporting coupled bone formation and angiogenesis. Systemic administration limited skeletal and vascular injury in a rat glucocorticoid-induced bone-loss model. This is preclinical miRNA delivery, not oral cyclic peptide therapy or human efficacy evidence.
Indexed: Nov 7, 2026, 8:02 AM · Original date: 2026-11-05
FDA granted accelerated approval to amivantamab and hyaluronidase-lpuj for adults with recurrent or metastatic head and neck squamous cell carcinoma after platinum chemotherapy and an anti-PD-(L)1 antibody. HPV-associated oropharyngeal cancer is excluded. In the 102-patient OrigAMI-4 efficacy population, response rate was 42%. Continued approval requires confirmatory clinical benefit; this is not traditional full approval.
Indexed: Nov 7, 2026, 8:02 AM · Original date: 2026-11-05
A Frontiers in Pharmacology review compares direct MCL-1 inhibition with approaches that reduce its abundance, including transcriptional interventions and targeted degradation. The original abstract highlights limited single-agent activity and cardiac safety concerns with inhibitors, while positioning degradation as an unvalidated clinical strategy. Biomarker-guided combinations and dynamic BH3 profiling are discussed; this review does not report a new clinical trial.
Indexed: Nov 7, 2026, 8:02 AM · Original date: 2026-11-06
This narrative review summarizes icotrokinra, an oral macrocyclic IL-23-receptor antagonist, using literature through December 2025 plus conference, company and trial-registry sources. It reviews Phase 2–3 evidence; it is not a new trial or a current regulatory-status assessment.
Indexed: Nov 7, 2026, 6:15 AM · Original date: 2026-03-12 · Older source added
This 2020 study added a SORT component to lipid nanoparticles to alter tissue targeting and deliver mRNA or CRISPR cargoes. It provides preclinical evidence for extrahepatic delivery, rather than proof of human tissue targeting or clinical benefit.
Indexed: Nov 7, 2026, 6:15 AM · Original date: 2020-04-06 · Older source added
The 2022 study delivered CAR-encoding mRNA with CD5-targeted lipid nanoparticles, generating transient CAR T cells in mice. The abstract reports reduced cardiac fibrosis and improved function after injury. This is preclinical evidence, not human efficacy.
Indexed: Nov 7, 2026, 6:15 AM · Original date: 2022-01-06 · Older source added