India, Nov. 11 -- NeOnc Technologies Holdings, Inc. (NTHI) announced that the U.S. FDA has granted a Type B End-of-Phase meeting to discuss a potential accelerated approval pathway for NEO100, an investigational intranasal treatment for patients with recurrent or progressive IDH-mutant grade 4 astrocytoma, an aggressive form of brain cancer.
The meeting is scheduled for January 2027 and will focus on whether existing clinical and nonclinical data could support a future regulatory submission under the FDA's accelerated approval program.
Phase 2 Results
The discussion will include data from the completed Phase 2a portion of the NEO100-01 study. According to NeOnc, the trial achieved a six-month progression-free survival rate of 48.9%, exce...