Adagene Reports Updated Phase 1b/2 Study Data

TL;DR

Adagene dropped updated Phase 1b/2 data for Muzast, check the press release for deets.

AI Summary

Adagene Inc. filed a Form 6-K on May 22, 2025, to report updated data from its Phase 1b/2 study of Muzast. The press release, Exhibit 99.1, details these findings, though specific data points and their implications are not detailed in this filing document.

Why It Matters

This filing provides an update on clinical trial progress for Adagene's drug candidate, Muzast, which could impact future development and investor sentiment.

Risk Assessment

Risk Level: medium — Clinical trial data updates can significantly impact a biotech company's stock price, introducing volatility.

Key Players & Entities

• Adagene Inc. (company) — Registrant
• Peter Luo (person) — Chief Executive Officer
• Muzast (drug) — Drug candidate in Phase 1b/2 study

FAQ

From the Filing

0001104659-25-052040.txt : 20250522 0001104659-25-052040.hdr.sgml : 20250522 20250522170523 ACCESSION NUMBER: 0001104659-25-052040 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20250522 FILED AS OF DATE: 20250522 DATE AS OF CHANGE: 20250522 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: 25978164 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 tm2515682d1_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 May 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: May 22, 2025 EXHIBIT INDEX Exhibit Description 99.1 Press release titled “Adagene Announces Updated Data from Phase 1b/2 Study of Muzastotug (ADG126) in Combination with KEYTRUDA ® (pembrolizumab) in Colorectal Cancer at the American Society of Clinical Oncology (ASCO) Annual Meeting.” EX-99.1 2 tm2515682d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Adagene Announces Updated Data from Phase 1b/2 Study of Muzastotug (ADG126) in Combination with KEYTRUDA ® (pembrolizumab) in Colorectal Cancer at the American Society of Clinical Oncology (ASCO) Annual Meeting CTLA-4 inhibitor ADG126 can be dosed at 20 mg/kg Q6W in combination with pembrolizumab with <20% Grade 3 adverse events In combination with pembrolizumab, ADG126 showed a 29% confirmed overall response rate (ORR) in microsatellite stable colorectal cancer All six responders in the 20 mg/kg cohorts remain on treatment, with four patients on study for over forty weeks Median overall survival (OS) for the 10 mg/kg cohorts was 19.4 months, with a median follow-up of 17.8 months and only 1 out of 41 patients was censored due to early withdrawal within the first 12 months SAN DIEGO and SUZHOU, China, May 22, 2025 -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, today announced updated data from its Phase 1b/2 study of ADG126 in advanced microsatellite stable colorectal cancer (MSS CRC) with no liver metastases at ASCO. Dr. Marwan Fakih, Professor of Medical Oncology and Therapeutics Research at City of Hope added, “The 20 mg/kg Q6W dose has demonstrated a significant reduction in treatment-related toxicities - with fewer than 20% Grade 3 adverse events and no discontinuations - while maintaining a near 30% ORR, including in patients with peritoneal involvement. Notably, responders in the 20 mg/kg cohorts remain on treatment, supported by tumor assessments, CEA levels, and ctDNA biomarkers.” Dr. Fakih continued, “It is exciting to see the higher ORR and durable responses. There is also early separation shown on the Kaplan-Meier over