Key Highlights

  • NeOnc Technologies shares closed up 31% at $4.22.
  • The company reported Phase 2a NEO100-01 results in recurrent IDH1-mutant high-grade glioma.
  • PFS6 reached 48.9% and median OS reached 26.1 months, outperforming historical benchmarks.
  • The company plans to engage the FDA on a randomized Phase 3 trial targeting accelerated approval.

NeOnc Technologies (NASDAQ: NTHI) shares closed up 31% at $4.22 after the company hosted an investor call highlighting favorable Phase 2a NEO100-01 results for recurrent IDH1-mutant high-grade glioma.

What Happened

The data showed a PFS6 of 48.9% and median OS of 26.1 months that notably outperformed historical benchmarks for this patient population.

The company now intends to engage with the FDA regarding a randomized Phase 3 trial aimed at accelerated approval, with overall survival serving as the primary endpoint against lomustine.

Market Reaction

Shares rose sharply as investors responded to the strength of the Phase 2a data relative to historical benchmarks and the clarity provided by the planned Phase 3 path with a defined primary endpoint and comparator.

Outlook

The outcome of the company's planned FDA engagement regarding the randomized Phase 3 trial design represents the next major disclosed milestone for NEO100 in IDH1-mutant high-grade glioma.