Welcome to our dedicated page for Adagene news (Ticker: ADAG), a resource for investors and traders seeking the latest updates and insights on Adagene stock.
Adagene Inc. (Nasdaq: ADAG) is a platform-driven, clinical-stage biotechnology company focused on antibody-based cancer immunotherapies, and its news flow reflects ongoing clinical, regulatory, scientific, and partnering activity. The company reports that it combines computational biology and artificial intelligence within its Dynamic Precision Library platform, which includes NEObody, SAFEbody, and POWERbody technologies, to design novel antibodies for oncology.
News about Adagene frequently centers on its lead program, ADG126 (muzastotug), a masked, anti-CTLA-4 SAFEbody targeting regulatory T cells in the tumor microenvironment. Recent announcements have covered Phase 1b/2 data in metastatic microsatellite-stable colorectal cancer without liver metastases, initiation of a randomized Phase 2 dose optimization study in combination with pembrolizumab, and the FDA’s Fast Track Designation for muzastotug plus pembrolizumab in a defined MSS metastatic colorectal cancer population. Regulatory updates, such as outcomes from a Type B (End of Phase 1) meeting with the FDA and alignment on Phase 2 and Phase 3 trial designs and endpoints, are also key elements of the company’s news.
Adagene’s press releases additionally highlight strategic collaborations and transactions. Examples include a strategic investment and clinical collaboration with Sanofi to support development of ADG126 and additional SAFEbody discovery programs, an expanded collaboration with Exelixis to develop masked antibody-drug conjugates, a licensing agreement with Third Arc Bio for masked CD3 T cell engagers, and a partnership with ConjugateBio to provide a proprietary antibody for bispecific ADC development. Corporate updates, participation in investor conferences, and leadership appointments in immuno-oncology are also part of the company’s public communications.
Investors and observers following ADAG news can expect coverage of clinical trial progress for ADG126, regulatory milestones, data presentations at scientific meetings, and developments in Adagene’s collaborations that leverage its SAFEbody precision masking technology and Dynamic Precision Library platform.
Adagene (Nasdaq: ADAG) said its Chief Strategy Officer, Mickael Chane-Du, will take part in one-on-one investor meetings and fireside chats at two investor conferences: the Oppenheimer 36th Annual Healthcare Life Sciences Conference (virtual) on Feb 25, 2026 and the Leerink Global Healthcare Conference in Miami on Mar 9, 2026.
Webcasts will be available and accessible via the company website for at least 30 days; interested investors should contact conference representatives to request meetings.
Adagene (Nasdaq: ADAG) reported unaudited cash and cash equivalents of $74.5 million as of December 31, 2025 and outlined 2026 objectives focused on clinical progress for muzastotug. Key 2025 milestones include updated Phase 1b/2 MSS CRC data presented at ASCO, FDA Fast Track designation for muzastotug+pembrolizumab in MSS metastatic colorectal cancer without active liver metastases, End-of-Phase 1 regulatory alignment, and initiation of a randomized Phase 2 dose-optimization study.
Strategic partnerships include a Sanofi investment of up to $25 million, collaborations with Third Arc Bio, Exelixis and ConjugateBio. Q1 2026 plans include a data update for muzastotug+pembrolizumab (41 patients at 10 mg/kg; 26 at 20 mg/kg) and additional trial readouts and collaborations.
Adagene (Nasdaq: ADAG) announced that the U.S. FDA granted Fast Track Designation to muzastotug (ADG126) in combination with pembrolizumab for adult patients with MSS metastatic colorectal cancer without active liver metastases on Dec 16, 2025. The designation cites emerging clinical evidence of encouraging efficacy, deep durable responses, and a favorable safety profile in heavily pretreated patients. Fast Track may enable more frequent FDA interactions and rolling review. Adagene is conducting a randomized Phase 2 (10 mg/kg vs 20 mg/kg; up to 30 patients per arm; primary endpoint ORR) and plans a Phase 3 with OS as primary endpoint and a registration trial planned to begin in 2027.
Adagene (Nasdaq: ADAG) and Third Arc Bio announced a licensing agreement on Nov 13, 2025 for two masked CD3 T cell engagers using Adagene’s SAFEbody technology.
Third Arc Bio receives worldwide rights to research, develop and commercialize two candidate molecules; Adagene receives a $5 million upfront payment, is eligible for up to $840 million in development and commercial milestones if all conditions are met, and will earn royalties on end-user sales. Adagene retains a no-cost option to develop and commercialize these candidates in Greater China, Singapore and South Korea.
Adagene (Nasdaq: ADAG) announced the first patient was dosed in a randomized Phase 2 dose-optimization cohort of muzastotug (ADG126) plus KEYTRUDA in microsatellite stable colorectal cancer (MSS CRC) without liver metastases on Oct 31, 2025.
The trial randomizes patients to 10 mg/kg or 20 mg/kg (up to 30 patients per arm), uses ORR as the primary endpoint, and follows FDA-aligned Phase 3 design. Company expects trial completion in early 2027 and additional Phase 1b/2 updates in 2026–2027.
Adagene (Nasdaq: ADAG) has expanded its collaboration with Exelixis by amending their 2021 agreement to develop a third novel masked antibody-drug conjugate (ADC). Under the expanded agreement, Exelixis will use Adagene's SAFEbody technology platform to create a masked monoclonal antibody targeting solid tumors.
The SAFEbody platform is designed to make antibodies invisible until reaching tumor cells, avoiding unwanted binding to healthy cells. Adagene will receive development and commercialization milestones plus royalties on net sales. The company's lead SAFEbody candidate, ADG126, is advancing in a Phase 1b/2 study for metastatic microsatellite-stable colorectal cancer, with Phase 2 expected to start by end of 2025.
Adagene (Nasdaq: ADAG) announced that its ADG126 (muzastotug) therapy will be featured in two oral presentations at the 2025 CSCO Meeting in Jinan, China from September 10-14. The presentations will highlight ADG126's combination with pembrolizumab in treating microsatellite stable (MSS) colorectal cancer.
The masked anti-CTLA-4 therapy has shown promising results in Phase 1b/2 trials, achieving an objective response rate of ~30% with durable response and over 80% disease control in refractory/resistant MSS CRC patients with no liver metastasis. The treatment demonstrated a median overall survival of 19.4 months in the 10 mg/kg cohorts, while maintaining less than 20% Grade 3 treatment-related adverse events.
Adagene (Nasdaq: ADAG) has appointed renowned immuno-oncology pioneer Dr. Axel Hoos as Executive Advisor. Dr. Hoos, former CEO of Scorpion Therapeutics and creator of the term 'Immuno-Oncology', brings extensive experience including the development of YERVOY®, the first FDA-approved immune checkpoint inhibitor.
The appointment comes as Adagene advances its innovative antibody pipeline targeting CTLA-4, including ADG116 for enhanced T-reg depletion and ADG126 featuring a masked CTLA-4 binder designed for improved efficacy and reduced toxicity. Dr. Hoos highlighted the potential of these programs to expand CTLA-4 targeting in cancer immunotherapy, particularly in cold tumors like MSS CRC where current immunotherapies show limited effectiveness.
[ "Appointment of highly experienced immuno-oncology pioneer Dr. Axel Hoos, former CEO of Scorpion Therapeutics ($2.5B acquisition)", "Development of innovative CTLA-4 targeting antibodies with potential for broader therapeutic applications", "Advanced technology platform (SAFEbody™) showing promise in expanding treatment to new cancer populations", "Strategic timing of appointment coinciding with ADG126's key clinical development phase" ]Adagene (Nasdaq: ADAG), a company focused on antibody-based therapy development, announced its participation in two upcoming investor conferences in New York this September.
The company's Chief Strategy Officer, Mickael Chane-Du, will attend the H.C. Wainwright Global Investment Conference on September 8 at 11:00 AM ET and the Morgan Stanley Global Healthcare Conference on September 10 at 7:00 AM ET. Both events will feature fireside chats and one-on-one investor meetings.
Webcasts of the presentations will be available on Adagene's website for 30 days following the events.
Adagene (NASDAQ:ADAG) reported significant progress in its H1 2025 financial results and pipeline developments. The company's flagship product ADG126 demonstrated impressive results in Phase 1b/2 trials, showing 19.4-month median overall survival in MSS CRC patients at 10 mg/kg dosing, with 20 mg/kg cohorts' median OS not yet reached. The drug achieved a 29% confirmed overall response rate in MSS CRC.
Notable corporate developments include a strategic investment of up to $25 million from Sanofi, which will conduct a Phase 1b/2 trial of ADG126 combinations. The company reported $62.8 million in cash as of June 30, 2025, with a reduced net loss of $13.5 million compared to $17.0 million in the same period of 2024. FDA alignment on Phase 2 and 3 trial designs positions ADG126 for advancement, with Phase 2 enrollment planned for 2H 2025.