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) 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.
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.