Today we announced detailed positive results from the Phase 3 INTerpath-001 study evaluating intismeran autogene (mRNA-4157 or V940), an investigational mRNA-based individualized neoantigen therapy, in combination with KEYTRUDA® (pembrolizumab), @Merck's anti-PD-1 therapy, in patients with high-risk melanoma (stage IIB-IV) following complete resection. These late-breaking results will be presented during a Presidential Symposium at the 2026 European Society for Medical Oncology (@myESMO) Congress. Read more: feeds.issuerdirect.com/news-…

#ACG2026: 🇨🇳Hengrui’s Oral miR-124 Modulator HRS-7085 Shows Promising Phase 2 Interim Results in Ulcerative Colitis HRS-7085 is an oral small-molecule miR-124 modulator. HRS-7085-201 trial (NCT07229950) comprises a randomized, double-blind Part 1 and an open-label Part 2. Part 1 randomized patients 2:2:1 to: - HRS-7085 10 mg BID, titrated from 5 mg BID for 7 days; - HRS-7085 20 mg BID, titrated from 5 mg BID to 10 mg BID and then 20 mg BID; - Placebo. Interim analysis: At Week 8, complete efficacy assessments were available for 6 placebo-treated patients, 11 patients receiving 10 mg BID and 9 receiving 20 mg BID. The HRS-7085 groups had a higher proportion of patients with a baseline endoscopic subscore of 3—72.7% in the 10 mg BID group and 75.0% in the 20 mg BID group, versus 42.9% with placebo At Week 8, mean changes in fecal calprotectin from baseline were: - HRS-7085 10 mg BID: −302.0 mg/kg - HRS-7085 20 mg BID: −143.0 mg/kg - Placebo: +227.8 mg/kg TEAEs were predominantly mild to moderate across the three groups.

BREAKING: Vivek Ramaswamy crashes to new all-time low in the odds to win Ohio's governor race. 30% chance.

Analysts focus on RFS hazard ratio magnitude vs Keytruda alone in INTerpath-001 (Phase 3, resected stage IIB-IV melanoma), plus DMFS, safety consistency, and OS trends. Phase 2b showed ~0.51 HR (49% risk cut). Consensus expects ~0.65 HR (35% reduction) to match priced-in upside; Goldman sees <0.70 needed for current valuation. Above expectations: HR near/better than 0.51, tight CIs, consistent subgroups, clean safety, positive early OS.

🇨🇳 China IND Tracker (October 12–18) 16 novel drugs received their first IND clearances in China during the week, according to China’s Center for Drug Evaluation (CDE) disclosures. Notable INDs: 1. $ANL Adlai Nortye (阿诺生物) — AN4035 Injection MOA: CEACAM5-targeting ADC conjugated with a highly potent pan-RAS(ON) inhibitor Indication: Advanced or metastatic solid tumors with RAS mutations and enriched CEACAM5 expression, including colorectal cancer, pancreatic ductal adenocarcinoma, and non-small cell lung cancer 2. Yuekang Pharma (悦康药业) — YKYY036 Injection MOA: INHBE-targeting siRNA conjugated with GalNAc ligand Indication: Obesity or overweight 3. Precision Biotech (精准生物) — TC-13-183 Cell Therapy MOA: Cell therapy Indication: CEA-positive advanced peritoneal metastatic colorectal cancer 4. CSPC (石药集团) — SYS6088 Injection MOA: PD-1/VEGFA/CTLA-4 trispecific antibody Indication: Advanced or metastatic solid tumors 5. Qilu Pharma (齐鲁制药) — QLS2401 Injection MOA: PSMA/STEAP1/CD3 trispecific antibody Indication: Advanced prostate cancer 6. Institute of Biophysics, Chinese Academy of Sciences / Sinovac Biotech (中科院生物物理所/科兴集团) — SNA01 Injection MOA: Long-acting anti-RSV mab for intramuscular administration Indication: Prevention of RSV lower respiratory tract infections in neonates and infants 7. Essight Biotech (灵识质源) — ES502 Injection MOA: RAS G12V-targeting TCR-TCE Indication: RAS G12V positive advanced solid tumors 8. Chipscreen (微芯生物) — NW001 for Injection MOA: Epigenetic immune-modulating antibody-drug conjugate (EIMAC), comprising a humanized anti-PD-L1 mab conjugated to an engineered HDACi payload Indication: Advanced malignancies, including solid tumors and lymphomas 9. Innostellar Biotherapeutics (朗昇生物) — LX111 Injection MOA: Gene therapy Indication: RVO-ME and DME 10. Metis TechBio (剂泰科技) — MTS109 Injection MOA: mRNA encoding a CD3×CD19×BCMA trispecific T-cell engager (TCE), delivered via LNPs Indication: SLE

Jensen Huang on The smartest person he's ever met: