Adagene Inc. Files 6-K for Regulatory Update

TL;DR

Adagene filed a 6-K for a clinical development update, details TBD.

AI Summary

Adagene Inc. filed a Form 6-K on July 15, 2025, to report a regulatory update on its clinical development. The filing includes a press release detailing this update, but specific details regarding the nature of the update, any associated timelines, or financial implications are not provided in the provided text.

Why It Matters

This filing indicates Adagene Inc. is providing an important update on its drug development pipeline, which could impact investor confidence and future stock performance.

Risk Assessment

Risk Level: medium — The filing itself is routine, but the 'regulatory update' could contain significant news, positive or negative, about Adagene's drug pipeline.

Key Players & Entities

• Adagene Inc. (company) — Registrant
• Peter Luo (person) — Chief Executive Officer
• July 15, 2025 (date) — Filing Date

FAQ

From the Filing

0001104659-25-067929.txt : 20250715 0001104659-25-067929.hdr.sgml : 20250715 20250715070059 ACCESSION NUMBER: 0001104659-25-067929 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20250715 FILED AS OF DATE: 20250715 DATE AS OF CHANGE: 20250715 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Adagene Inc. CENTRAL INDEX KEY: 0001818838 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] ORGANIZATION NAME: 03 Life Sciences EIN: 000000000 STATE OF INCORPORATION: E9 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-39997 FILM NUMBER: 251123056 BUSINESS ADDRESS: STREET 1: 4F, BUILDING C14, NO. 218, XINGHU STREET STREET 2: SUZHOU INDUSTRIAL PARK CITY: JIANGSU STATE: F4 ZIP: 00000 BUSINESS PHONE: 86-512-87773632 MAIL ADDRESS: STREET 1: 4F, BUILDING C14, NO. 218, XINGHU STREET STREET 2: SUZHOU INDUSTRIAL PARK CITY: JIANGSU STATE: F4 ZIP: 00000 6-K 1 tm2520965d1_6k.htm FORM 6-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a- 16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of July 2025 Commission File Number: 001-39997 Adagene Inc. 4F, Building C14, No. 218 Xinghu Street, Suzhou Industrial Park Suzhou, Jiangsu Province, 215123 People’s Republic of China +86-512-8777-3632 (Address of principal executive offices) Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F. Form 20-F x Form 40-F ¨ SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. Adagene Inc. By: /s/ Peter Luo Name: Peter Luo Title: Chief Executive Officer Date: July 15, 2025 EXHIBIT INDEX Exhibit Description 99.1 Press release titled “Adagene Announces Regulatory Update on Clinical Development Plan for Muzastotug in Microsatellite Stable Colorectal Cancer Following Productive Type B (End of Phase 1) Meeting with FDA.” EX-99.1 2 tm2520965d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Adagene Announces Regulatory Update on Clinical Development Plan for Muzastotug in Microsatellite Stable Colorectal Cancer Following Productive Type B (End of Phase 1) Meeting with FDA - Alignment gained on Phase 2 inclusion/exclusion criteria, primary and secondary endpoints, and study design, including sample size and dosing regimen - Company expects to begin enrolling patients in Phase 2 in 2H 2025 SAN DIEGO and SUZHOU, China, July 15, 2025 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene or the Company”) (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, today announced outcomes from its Type B meeting with the United States Food and Drug Administration (FDA). Adagene has received written feedback from the FDA on its clinical development plan to evaluate muzastotug (ADG126) in combination with Merck’s (known as MSD outside of the US and Canada) anti-PD-1 therapy, KEYTRUDA® (pembrolizumab: 200 mg, Q3W) in patients with microsatellite stable colorectal cancer (MSS CRC). ADG126 is a masked, anti-CTLA-4 SAFEbody® that targets a unique epitope of CTLA-4 in regulatory T cells (Tregs) in the tumor microenvironment. ADG126 is currently in phase 1b/2 clinical studies in combination with anti-PD-1 therapy, particularly focused on MSS CRC. To date, over 150 patients have received ADG126, either as monotherapy or in combination with anti-PD-1 therapy. Adagene has completed patient enrollment for the MSS CRC dose expansion cohorts of the ADG126 + pembrolizumab combination (NCT05405595). The phase 2 trial will be conducted primarily to identify which of the two doses of ADG126 will be used in the phase 3 trial. Key Outcomes from the FDA Type B Meeting ● Patient Population: Future trials will enroll late-line