$NTHIOct 5, 2026, 9:51 AM ETAI processed
NTHI heads to Nov 17 FDA End-of-Phase 1 meeting; ALEC inks $1.27B Genentech deal; PCVX posts positive Phase 3 VAX-31 topline
AI Summary
Alector (ALEC) signed an exclusive global license with Genentech for AL050 (100M upfront, up to $1.17B in milestones) with Genentech taking development/commercialization while Alector retains its ABC brain-delivery platform. NeOnc (NTHI) has an in-person FDA End-of-Phase 1 meeting for NEO212 on Nov 17 as it prepares Phase 2 strategy (recommended Phase 2 dose 610 mg) and its intranasal program NEO100 reported a positive Phase 2a (48.9% 6-month PFS vs 20% benchmark, p=0.0047); Vaxcyte (PCVX) reported positive OPUS-1 Phase 3 topline for VAX-31 meeting immunogenicity and safety endpoints versus PCV20/PCV21.
Positives
- Alector struck exclusive AL050 deal with Genentech: $100M upfront and up to $1.17B in milestones; Genentech assumes global development and commercialization
- Vaxcyte’s VAX-31 met all prespecified OPUS-1 Phase 3 immunogenicity and safety endpoints versus PCV20/PCV21; company plans BLA submission in H1 2028
- NeOnc’s NEO100 Phase 2a met its primary endpoint (48.9% six‑month PFS vs 20% benchmark, p=0.0047) with median OS ~26.1 months
Negatives
- The Nov 17 End-of-Phase 1 Type B meeting for NEO212 does not guarantee FDA agreement on trial design, an accelerated pathway, or eventual approval
- Alector ceded AL050 development and commercialization to Genentech, leaving Alector’s economic upside largely tied to milestones and royalties
- Vaxcyte still requires OPUS-2/3 readouts and a BLA review cycle, so potential commercialization remains years away