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) reported updated Phase 1b/2 results for muzastotug plus pembrolizumab in late-line MSS colorectal cancer without liver metastases. Key highlights: confirmed ORR 31% at 20 mg/kg vs 13% at 10 mg/kg, median PFS 6.7 vs 4.8 months, mOS 19.8 months (10 mg/kg), no DLTs, and no Grade 4/5 TRAEs.
Randomized Phase 2 enrollment ongoing; results expected in 1H 2027 and FDA Fast Track designation supports a potential registration path.
Adagene (Nasdaq: ADAG) reported full-year 2025 results and corporate updates on April 1, 2026. Key clinical highlights include a 29% confirmed ORR (6/21) in 20 mg/kg muzastotug cohorts and median OS 19.4 months in 10 mg/kg cohorts (41 patients). Cash and equivalents were $74.5M at December 31, 2025, with proceeds from a 2026 ATM expected to fund operations into early 2028. Randomized Phase 2 enrollment is ahead of plan with results expected in 1H 2027, and a registrational trial planned after optimal dose selection.
Adagene (Nasdaq: ADAG) announced that muzastotug (ADG126), a masked anti-CTLA-4 antibody, will be highlighted in two poster presentations at the AACR Annual Meeting in San Diego, April 17-22, 2026.
Presentations are scheduled April 20, 2026 at 9:00 AM PT in Poster Sections 50 and 51 (Poster Board 14), covering a Ph1b evaluation in MSS colorectal cancer and phase 1b/2 Morpheus Liver study results in unresectable or metastatic HCC.
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.