Akeso

Akeso shares rose nearly 5% to HK$94.8 after full results from the Phase‑III HARMONi‑2 study were presented. The bispecific antibody ivonescimab achieved a median overall survival of 30.8 months versus 22.6 months for pembrolizumab and reduced the risk of death by 27% in PD‑L1–positive, advanced non‑small‑cell lung cancer. The positive market reaction was supported by confirmed buy recommendations from several institutions, and the FDA has accepted a filing for a related indication for review; the PDUFA date is 14 November 2026. » Mere på de.investing.com

Ivonescimab, a PD-1/VEGF bispecific antibody from Akeso (licensed outside China to Summit Therapeutics), reduced the risk of death by 34% when added to chemotherapy in the Harmoni-6 Phase 3 trial in China, yielding median overall survival of 27.9 vs 23.7 months versus PD-1 plus chemotherapy. The result was statistically significant and supports a four-month survival benefit for patients with squamous non-small-cell lung cancer. Safety data showed higher rates of any-grade bleeding (~24% in the ivonescimab arm versus ~12% control) though severe bleeding was under 3%; a global Phase 3 program (Harmoni-3) is ongoing to assess broader applicability. » Mere på cnbc.com

Stifel reiterated a Buy rating on Summit Therapeutics with a $45 price target after Akeso said it will disclose an interim overall survival readout from the HARMONi-6 ivonescimab Phase 3 trial at ASCO 2026. HARMONi-6 has a ~33% larger sample size and all-squamous histology versus HARMONi-2, offering a first look at ivonescimab randomized against anti-PD-1 tislelizumab. Summit Therapeutics is developing ivonescimab, a potential first-in-class PD-1/VEGF bispecific antibody for NSCLC. » Mere på finance.yahoo.com

Summit Therapeutics’ stock rose as much as 15% intraday after Akeso reported positive interim results from the HARMONi-A study of ivonescimab, which showed a significant overall survival benefit. Analysts welcomed the news but see limited implications for Summit’s broader outlook because of a narrowed target population and uncertainty about whether the results will translate into approvals outside China. » Mere på de.investing.com

Akeso Inc. announced that two of its monoclonal antibodies (Gumokimab/AK111 and Manfidokimab/AK120) met all primary endpoints in separate Phase 3 trials, showing significant clinical improvements in ankylosing spondylitis and atopic dermatitis. Manfidokimab is planned for submission in a new drug application (NDA), Gumokimab is already in the approval process in China, and the company is further expanding its non‑oncology portfolio. Analysts note valuation risks due to regulatory uncertainty in the US, despite Akeso’s high margins and expected revenue growth. » Mere på de.investing.com