Common Stock, par value $0.0001
- Symbol
- NTHI
- Exchange
- NASDAQ
- Classification
- COMMON
- Status
- Current
Current Report · Items 7.01, 9.01 · 8-K
NeOnc Technologies Holdings, Inc.
NTHINASDAQEQUITYCurrent
Regulation FD Disclosure
Item 7.01. Regulation FD Disclosure. On September 28, 2026, NeOnc Technologies Holdings, Inc. (the “Company”) issued a press release announcing that it is scheduled to meet with the U.S. Food and Drug Administration on November 17, 2026, for an in-person End-of-Phase 1 Type B meeting concerning NEO212. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.…
Press release in this filing
NeOnc Technologies Announces FDA End of Phase 1 Meeting for NEO212 →Company context
NeOnc Technologies Holdings, Inc. is a clinical-stage biopharmaceutical company developing therapies for CNS cancers. Its investigational programs include intranasal NEO100 and oral NEO212. Neither product is approved by FDA for commercial use. The Company has licensed intellectual property from the University of Southern California relating to its development programs.
Current securities
Recent company filings
- Material Modification to Rights of Security Holders · Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year · Regulation FD DisclosureSep 21, 2026
- Regulation FD DisclosureSep 17, 2026
- 4 filingSep 15, 2026
- 4 filingSep 14, 2026
- Entry into a Material Definitive Agreement · Regulation FD DisclosureSep 10, 2026
Registered securities in this filing
NEONC TECHNOLOGIES HOLDINGS, INC. · 8-K · Filed 2026-09-28
Disclosure sections
Item 7.01Item 7.01 - Regulation FD Disclosure
Item 7.01. Regulation FD Disclosure.
On September 28, 2026, NeOnc Technologies Holdings,
Inc. (the “Company”) issued a press release announcing that it is scheduled to meet with the U.S. Food and Drug Administration
on November 17, 2026, for an in-person End-of-Phase 1 Type B meeting concerning NEO212. A copy of the press release is furnished as Exhibit
99.1 to this Current Report on Form 8-K.
The information in this Item 7.01 and Exhibit
99.1 furnished hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended
(the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference
in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in
such a filing.
Filed exhibits (1)
Exhibit 99.1 NeOnc Technologies Announces FDA End of Phase 1 Meeting for NEO212 November 17 meeting will address Phase 2 study design and potential regulatory pathways CALABASAS, Calif., Sept. 28, 2026 - NeOnc Technologies Holdings, Inc. (Nasdaq: NTHI) (“NeOnc” or the “Company”), a clinical-stage biopharmaceutical company developing therapies for central nervous system (CNS) cancers, today announced that it is scheduled to meet with the U.S. Food and Drug Administration (FDA) on November 17, 2026, for an in-person End-of-Phase 1 Type B meeting concerning NEO212. The meeting is scheduled to take place at FDA’s White Oak campus in Silver Spring, Maryland. The Company plans to seek FDA feedback on its NEO212 clinical development program, including an update to its proposed patient population, trial design, endpoints, dose selection and evidence needed to support a future marketing application. The meeting provides an opportunity for discussion; its scheduling does not establish FDA agreement on a trial design, an accelerated approval pathway or eventual approval of NEO212. In September 2025, FDA authorized the Company to proceed with the Phase 2a and Phase 2b portions of NEO212-0…
Open exhibit ↗