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. develops antibody-based cancer immunotherapies as a Nasdaq-listed foreign issuer whose securities trade as ADSs under ADAG. The company uses computational biology and artificial intelligence through its proprietary Dynamic Precision Library platform, including NEObody, SAFEbody and POWERbody technologies, to design masked and engineered antibody programs.
Recurring company updates center on muzastotug (ADG126), a masked anti-CTLA-4 SAFEbody, clinical data in microsatellite stable colorectal cancer and hepatocellular carcinoma, combination studies with checkpoint and bispecific therapies, and FDA Fast Track designation in MSS metastatic colorectal cancer. Other developments include scientific meeting presentations, SAFEbody collaborations and licensing, advisory board changes, financial results and ADS capital offerings.
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.
Adagene (NASDAQ:ADAG) has received positive feedback from the FDA following a Type B meeting regarding the clinical development plan for muzastotug (ADG126) in combination with Merck's KEYTRUDA for treating microsatellite stable colorectal cancer (MSS CRC).
The FDA has endorsed key aspects of the Phase 2 trial design, which will enroll approximately 60 patients across two dosing arms (10 mg/kg and 20 mg/kg). Early data shows promising results with ORR increasing from 17% at 10 mg/kg to 29% at 20 mg/kg, while maintaining Grade 3 TRAEs at approximately 20%.
The company plans to begin Phase 2 enrollment in 2H 2025, focusing on late-line MSS CRC patients without liver metastases. The trial's primary endpoint will be overall response rate (ORR), with secondary endpoints including duration of response, progression-free survival, and overall survival.
Adagene (Nasdaq: ADAG) has partnered with ConjugateBio to develop novel bispecific Antibody Drug Conjugates (ADCs). Under the agreement, Adagene will provide a proprietary antibody for ConjugateBio's ADC development programs, receiving an undisclosed upfront payment plus milestone and royalty payments while retaining all non-ADC rights.
The collaboration aims to leverage Adagene's antibody discovery capabilities and ConjugateBio's ADC development expertise in a market expected to reach over $30 billion by 2030. The partnership builds on Adagene's track record with ADG126, demonstrating their ability to create safe and efficacious molecules.