BIO:ON Insight #14 · Sep 1, 2026
Nobody was supposed to clear that wall. Someone did, this week.
Roche bets up to $2.5B on Hanmi's muscle-sparing obesity drug, Regenxbio's gene therapy refiling hits an FDA hold, and Akeso's bispecific beats Keytruda head-to-head. Nobody was supposed to clear that wall. Someone did.
What I learned this week
If there's one line for this week, it's this: you clear a wall from a different angle, not with a harder push. I'll admit it was a little awkward to write "stand against a giant and you lose" and see a counterexample a week later. But looking closer, it's the same lesson: Akeso didn't fight the giant the giant's way either. See you next issue. 🙏
Yaehyun Lee · Quoted from the Editor's Insight I wrote for this issue.
Stories in this issue
- Pipeline Analysis
Roche bets up to $2.5B on Hanmi's obesity candidate
RocheHanmi Pharmaceutical
- FDA Approvals
FDA places Regenxbio's RGX-121 on clinical hold
RegenxbioRGX-121US FDA
- Clinical Trials
Akeso's ivonescimab beats Keytruda on survival in a lung cancer Phase 3
AkesoivonescimabKeytruda
AI summary
- 1Roche bet up to $2.5B on Hanmi's muscle-sparing obesity drug candidate.
- 2Regenxbio's Hunter syndrome gene therapy refiling was halted over spinal MRI findings.
- 3Akeso's bispecific ivonescimab beat Keytruda head-to-head in a lung cancer Phase 3.
Relevant rolesBDRegulatory affairsClinical development
Summary and tags generated by AI from the issue text.
References
- 1.Roche pens up-to-$2.5B pact for Hanmi's muscle-conserving obesity drug (opens in a new tab)
Fierce Biotech, Aug 24, 2026
- 2.Regenxbio's gene therapy refiling plan derailed by FDA hold (opens in a new tab)
Fierce Biotech, Aug 24, 2026
- 3.
Related insights
Other issues covering the same companies, drugs or topics
Same word, "success" — not the same grade of evidence
Summit and Akeso's ivonescimab beats Keytruda on final overall survival at WCLC in Seoul, AstraZeneca's oral SERD wins FDA approval despite a negative advisory vote, and oral Wegovy resolves obesity in 40% of teens. Same word, "success": three very different grades of evidence.
Shared: Akeso, ivonescimab, Keytruda, US FDA