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 (ADAG) announced first-patient dosing in a Phase 1 study combining muzastotug with Incyte’s INCA33890 for microsatellite stable colorectal cancer.
The open-label trial, in which treatment is known, includes dose escalation and expansion in third-line patients whose cancer progressed on prior therapies, with or without liver metastases, meaning cancer spread to the liver. Incyte is sponsoring and conducting the study, while Adagene supplies muzastotug under the collaboration announced in April 2026. Adagene said the study will evaluate whether the combination can deepen and sustain antitumor responses with an acceptable safety profile.
Adagene (ADAG) announced that senior management will participate in the Guggenheim Securities 3rd Annual Healthcare Innovation Conference on November 9, 2026.
The fireside chat runs from 9:00–9:25 a.m. ET, alongside one-on-one meetings, at the Boston conference. A webcast will be available in the company website’s Investors section for at least 30 days following the conference.
Adagene (ADAG) will participate in the H.C. Wainwright 4th Annual Immune Cell Engager Virtual Conference on October 15, 2026.
Chief Executive Officer and President of R&D Peter Luo will join a fireside chat from 1:30 to 2:00 p.m. ET. The webcast will be accessible in the Investors section of Adagene’s website for at least 30 days following the conference.
Adagene (ADAG) received clearance from China’s National Medical Products Administration for its investigational new drug application for ADG138, a double-masked HER2×CD3 bispecific T-cell engager built on the SAFEbody® precision masking platform.
The company expects to start a first-in-human, open-label Phase 1 trial in patients with advanced solid tumors in China in the fourth quarter of 2026. The study is designed to assess safety, preliminary efficacy and determine the recommended Phase 2 dose. Preclinical data showed potent T-cell–mediated anti-tumor activity, including in tumor models refractory or resistant to Enhertu (DS-8201), with reduced cytokine release and an expanded therapeutic window compared with an unmasked T-cell engager, as well as strong synergy with several checkpoint and co-stimulatory antibodies.
Adagene (ADAG) announced that partner Third Arc Bio has selected the first lead candidate under their amended strategic collaboration to develop masked CD3 T cell engagers using Adagene’s NEObody® and SAFEbody® platforms.
The November 2025 licensing agreement has been broadened into an integrated asset and technology partnership. Third Arc Bio will now sponsor and fund clinical development of the selected program. In line with the expanded scope, total potential payments to Adagene from development and commercial milestones have increased. Adagene retains a no-cost option to develop and commercialize candidate molecules in Greater China, Singapore and South Korea.
Adagene (ADAG) achieved a preclinical milestone under its collaboration and license agreement with Exelixis, triggering a $2.0 million milestone payment related to ADC candidate XB404. XB404 uses Adagene’s SAFEbody masking technology and is designed to deliver a cytotoxic payload to ROR1/2-expressing tumors while reducing on-target, off-tumor effects.
An additional payment was also triggered by Exelixis’ selection of candidates for another SAFEbody antibody-drug conjugate program. Exelixis has rights to use the SAFEbody platform to generate masked monoclonal antibodies for ADC development, and Adagene is eligible for further development and commercialization milestones plus royalties on net sales of resulting products.
Adagene (Nasdaq: ADAG) announced that senior management will participate in three investor conferences in New York in September 2026. The company will attend the Cantor Global Healthcare Conference (September 9–11; 1x1 meetings), Morgan Stanley 24th Annual Global Healthcare Conference (fireside chat on September 15, 2026, 10:45–11:20 AM ET, plus 1x1s), and H.C. Wainwright 28th Annual Global Investment Conference (fireside chat on September 16, 2026, 9:00–9:30 AM ET, plus 1x1s). Webcasts of the fireside chats will be available in the Investors section of Adagene’s website for at least 30 days after each conference.
Adagene (Nasdaq: ADAG) reported financial results for the six months ended June 30, 2026 and detailed progress for lead CTLA-4 SAFEbody muzastotug (ADG126). Cash and cash equivalents rose to $127.9 million including an April 2026 equity offering of about $70 million, providing a cash runway into late 2028. Net revenue reached $1.6 million, mainly from Sanofi and Exelixis collaborations, while net loss attributable to shareholders increased to $16.4 million.
Clinically, updated MSS colorectal cancer data for muzastotug plus pembrolizumab showed a 31% ORR at 20 mg/kg cohorts and low discontinuation (4%), supporting a randomized Phase 2 trial with results expected in 1H 2027 and a potential registration trial thereafter. In first-line HCC, a muzastotug, atezolizumab and bevacizumab triplet showed a 66.7% ORR in a small cohort, with safety comparable to the doublet control. Additional trials include a triple combination with pembrolizumab and fruquintinib in MSS CRC, a neoadjuvant MSS CRC study, and a Sanofi-sponsored global Phase 1/2 basket trial.
Adagene (Nasdaq: ADAG) will participate in two upcoming investor conferences. Senior management plans one-on-one meetings and a fireside chat at the Stifel Annual Virtual Oncology Event on May 19-20, 2026, and one-on-one meetings at the Jefferies Global Healthcare Conference June 2-4, 2026.
The Stifel fireside chat is scheduled for May 19, 2026, at 2:30 PM Eastern Time. Webcasts of the presentations will be available in the Investors section of Adagene’s website for at least 30 days.
Adagene (Nasdaq: ADAG) presented interim Phase 1b/2 data at AACR 2026 showing muzastotug in two triplet regimens produced higher response rates and manageable safety profiles in HCC and MSS CRC.
In HCC, the muzastotug triplet showed ORR 66.7% vs 32.5% (control) and mPFS 8.2 vs 5.5 months; in MSS CRC, dose-dependent ORRs were 25% (10 mg/kg) and 40% (15 mg/kg). FDA previously granted Fast Track for muzastotug+pembrolizumab in MSS mCRC without active liver metastases.