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) added industry veteran Peter Lebowitz, MD, Ph.D. to its Scientific and Strategic Advisory Board on April 14, 2026. Lebowitz will advise clinical and regulatory strategy for ADG126, highlighting tumor-selective activation via Adagene’s SAFEbody masking technology and reported clinical activity in late-line MSS CRC patients.
Adagene (Nasdaq: ADAG) priced an underwritten public offering of 18,666,000 ADSs at US$3.75 per ADS (the 30-day VWAP), generating gross proceeds of approximately US$70.0 million. The offering is expected to close on April 6, 2026, subject to customary conditions.
Joint book-running managers are Leerink Partners and LifeSci Capital, with Lucid Capital Markets as co-manager. The offering included participation from new and existing institutional investors and will be made pursuant to a Form F-3 shelf registration.
Adagene (Nasdaq: ADAG) announced a clinical collaboration with Incyte to evaluate muzastotug (ADG126) combined with Incyte’s TGFβR2×PD-1 bispecific INCA33890 in microsatellite stable colorectal cancer (MSS CRC). The Phase 1 study is expected to begin in 2026 and will include 3L chemotherapy-refractory patients with and without liver metastases.
Incyte will sponsor and conduct the study while Adagene will supply muzastotug. Muzastotug has FDA Fast Track designation and prior combinations showed encouraging responses in 3L MSS CRC.
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.