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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 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.
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.