Adagene Presents New Data on Muzastotug at AACR Meeting
Adagene presented new data from two ongoing Phase 1b/2 studies of muzastotug in triple combination regimens at the American Association of Cancer Research annual meeting 2026, held April 17-22 in San Diego. Results support muzastotug's mechanistic advantages over traditional anti-CTLA-4 therapies, and its continued development as a potential backbone therapy in combination regimens for difficult-to-treat cancers. FDA has previously designated muzastotug in combination with Merck's anti-PD-1 therapy, KEYTRUDA, as a Fast Track product for adult patients with microsatellite stable metastatic colorectal cancer without current or active liver metastases. "At AACR, Adagene shared new data from two triplet regimens supporting muzastotug's potential as a combination backbone for multiple tumor types," said Peter Luo, CEO at Adagene. "In HCC, adding muzastotug to the atezolizumab plus bevacizumab combo resulted in higher efficacy, with a safety profile consistent with historical studies of the doublet alone. In MSS CRC, adding muzastotug to pembrolizumab plus fruquintinib showed dose-dependent response rates, with no DLTs or Grade 4 or 5 treatment related adverse events. As muzastotug continues to generate more data in additional settings, we are increasingly convinced that its intentionally designed wider therapeutic index has potential to improve the efficacy of current immunotherapies without worsening the toxicity for patients with difficult to treat solid tumors."
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- Significant Efficacy Improvement: In a Phase 1b/2 trial for locally advanced or metastatic hepatocellular carcinoma (HCC), the triple combination of muzastotug with atezolizumab and bevacizumab achieved a 66.7% overall response rate, markedly higher than the 32.5% in the control arm, indicating substantial potential for enhanced treatment outcomes.
- Good Safety Profile: The triple regimen demonstrated a safety profile comparable to historical studies of the doublet, with 50% of patients experiencing grade 3 or higher treatment-related adverse events, supporting the continuous dosing of muzastotug and potentially offering better tolerability for patients.
- Dose-Dependent Response: In a Phase 1b/2 trial for microsatellite stable colorectal cancer, the combination of muzastotug with pembrolizumab and fruquintinib exhibited response rates of 25% and 40% at doses of 10 mg/kg and 15 mg/kg, respectively, highlighting the regimen's efficacy across different dosing levels.
- FDA Fast Track Designation: The combination of muzastotug with KEYTRUDA has received FDA Fast Track designation, underscoring its potential in treating microsatellite stable metastatic colorectal cancer and further advancing Adagene's strategic development in cancer immunotherapy.
- New Member Addition: Adagene has announced the appointment of Dr. Peter Lebowitz to its Scientific and Strategic Advisory Board, whose extensive experience in expediting breakthrough therapies is expected to enhance the clinical development of ADG126, particularly in strategic planning for registration studies.
- Technological Innovation: Lebowitz highlighted the innovative nature of Adagene's SAFEbody technology in CTLA-4 targeted therapies, enabling tumor-selective activation of ADG126 and precise depletion of regulatory T cells in the tumor microenvironment, demonstrating promising clinical activity in late-line MSS CRC patients.
- Industry Experience: Previously, Lebowitz served as the Global Head of Oncology R&D at Johnson & Johnson, where he successfully brought 13 new drugs to market with over 60 approvals, and his innovative approach to drug development will provide valuable insights and strategic guidance for Adagene.
- Future Outlook: Adagene is committed to developing novel antibodies to address globally unmet patient needs through its Dynamic Precision Library platform, and Lebowitz's addition is expected to further enhance the company's R&D capabilities and market competitiveness.
- Offering Pricing: Adagene announced the pricing of 18.67 million American depositary shares (ADSs) at $3.75 each, with expected gross proceeds of approximately $70 million, demonstrating the company's ability to raise capital in the market.
- Investor Participation: The offering attracted participation from both new and existing investors, including Janus Henderson Investors, Deerfield Management, and Columbia Threadneedle Investments, indicating strong market confidence and support for Adagene.
- Closing Timeline: The public offering is expected to close on April 6, 2026, reflecting the company's proactive planning for future funding needs aimed at supporting its business growth.
- Market Reaction: Following the announcement of the offering, Adagene's stock price rose 12.03% in pre-market trading to $4.0552, showcasing a positive investor response to the financing activity.
- Stock Price Plunge: Adagene Inc. (ADAG) shares fell nearly 13% in pre-market trading on Thursday, reflecting negative market sentiment following the company's latest announcements, particularly regarding the public offering pricing.
- Public Offering Pricing: The company priced its $70 million public offering at $3.75 per ADS, representing a nearly 19% discount from Wednesday's closing price, indicating investor concerns about the company's future prospects.
- Clinical Trial Update: Adagene also provided an update on the Phase 1b/2 study of Muzastotug in combination with Keytruda for patients with microsatellite stable colorectal cancer, revealing improved durability of response among trial participants, potentially offering new hope for future treatments.
- Bearish Market Sentiment: Retail sentiment on Stocktwits around Adagene trended in the 'bearish' territory, suggesting a lack of confidence among investors regarding the company's future performance, which could further impact its stock price trajectory.
- Stock Price Decline: Adagene's stock fell approximately 14% during pre-market trading on Thursday, reflecting market concerns over its pricing, as the public offering was set at $3.75 per ADS, below its 30-day volume-weighted average price, which may impact investor confidence.
- Fundraising Goals: The public offering aims to raise approximately $70 million in gross proceeds by offering around 18.67 million ADSs, with each ADS representing 1.25 ordinary shares, and the funds will be used to support the development of its antibody-based cancer immunotherapy pipeline.
- Investor Participation: The offering attracted participation from both new and existing investors, including Janus Henderson Investors, Deerfield Management, Invus, Sirenia, and Columbia Threadneedle Investments, indicating market confidence and support for Adagene's future growth.
- Use of Proceeds: Adagene plans to utilize the funds raised to advance its clinical development and regulatory activities for its antibody-based cancer immunotherapy, aiming to accelerate product launch timelines and enhance its competitiveness in the biopharmaceutical sector.
- Offering Size: Adagene has announced a public offering of 18.67 million American depositary shares at $3.75 each, expected to raise approximately $70 million in gross proceeds, reflecting strong market confidence in its antibody therapies.
- Investor Participation: The offering attracted participation from both new and existing investors, including Janus Henderson and Deerfield Management, indicating market recognition and support for Adagene's future growth, which may strengthen its capital base.
- Offering Arrangement: The public offering is being managed by Leerink Partners and LifeSci Capital, with an expected closing date of April 6, 2026, further solidifying Adagene's financing capabilities in the biotechnology sector.
- Strategic Implications: This financing will enable Adagene to accelerate the development of its antibody-based cancer immunotherapies, leveraging the raised funds to commercialize its innovative technologies and enhance its competitive position in the market.






