Adagene Receives FDA Fast Track Designation for muzastotug in MSS Colorectal Cancer
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 16 2025
0mins
Source: Newsfilter
- FDA Fast Track Designation: Adagene's muzastotug, in combination with Merck's KEYTRUDA®, has received FDA Fast Track designation, aimed at providing a more effective treatment option for MSS colorectal cancer patients without liver metastases, marking a significant advancement for the company in the oncology field.
- Clinical Data Support: Preliminary clinical evidence shows muzastotug demonstrates promising efficacy and safety in heavily pretreated patients, potentially offering extended survival opportunities and reshaping existing treatment paradigms, thereby enhancing the company's competitive position in the biopharmaceutical market.
- Future Trial Design: Adagene plans to initiate a registration trial in 2027, with Phase 2 and Phase 3 designs confirmed by the FDA, ensuring scientific rigor and effectiveness in clinical trials, paving the way for future drug approvals.
- Innovative Technology Potential: Muzastotug employs Adagene's SAFEbody® technology to reduce systemic toxicity while enhancing antitumor potency, showcasing the company's innovative capabilities in antibody therapies and potentially providing new directions for future treatment options.
Discover Tomorrow's Bullish Stocks Today
Receive free daily stock recommendations and professional analysis to optimize your portfolio's potential.
Sign up now to unlock expert insights and stay one step ahead of the market trends.
Analyst Views on ADAG
Wall Street analysts forecast ADAG stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for ADAG is 8.50 USD with a low forecast of 8.00 USD and a high forecast of 9.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
2 Analyst Rating
2 Buy
0 Hold
0 Sell
Moderate Buy
Current: 2.910
Low
8.00
Averages
8.50
High
9.00
Current: 2.910
Low
8.00
Averages
8.50
High
9.00
About ADAG
Adagene Inc is a platform-driven, clinical-stage biopharmaceutical company committed to transforming the discovery and development of novel antibody-based cancer immunotherapies. The Company is principally engaged in the research, development and production of monoclonal antibody drugs for cancers. The Company’s main products include: ADG106 is being developed for the treatment of advanced solid tumors and non-Hodgkin's lymphoma, or NHL. ADG126 is designed to address the toxicity and efficacy issues related to the MOA of existing approved CTLA-4 immuno-oncology therapies and to expand the potential of CTLA-4 as a target for the treatment of cancer. ADG116 is designed to target a unique conserved epitope of CTLA-4. And ADG104, a monospecific antibody that targets PD-L1 and is in Phase Ib and Phase II clinical trials concurrently in China.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
FDA Approves Fast Track Status for ADAG's Colorectal Cancer Treatment
FDA Fast Track Designation: Adagene Inc. received Fast Track designation from the FDA for its immuno-oncology candidate, muzastotug, in combination with Merck’s Keytruda for treating microsatellite-stable metastatic colorectal cancer, leading to a 13.8% surge in ADAG shares.
Clinical Development: Muzastotug, developed using SAFEbody masking technology, shows promising efficacy and safety in ongoing clinical trials, with plans for a phase III study to begin in 2027.
Market Performance: Despite the recent positive news, ADAG shares have declined 6.9% over the past year, contrasting with a 16.3% rise in the industry.
Comparative Stock Analysis: Other biotech stocks like ANI Pharmaceuticals, CorMedix, and Castle Biosciences have shown strong performance and earnings growth, with Zacks Rank #1 ratings, indicating potential investment opportunities.
Continue Reading
Adagene Receives FDA Fast Track Designation for muzastotug in MSS Colorectal Cancer
- FDA Fast Track Designation: Adagene's muzastotug, in combination with Merck's KEYTRUDA®, has received Fast Track designation from the FDA, aimed at providing a more effective treatment option for MSS colorectal cancer patients without liver metastases, marking a significant advancement for the company in the oncology field.
- Clinical Trial Design Confirmation: The FDA has confirmed Adagene's randomized Phase 2 and Phase 3 trial designs, which will enroll late-line MSS CRC patients, further validating the efficacy and safety of muzastotug and reinforcing the company's leadership in cancer immunotherapy.
- Enhanced Efficacy and Safety: Muzastotug employs advanced SAFEbody® technology to improve efficacy while reducing systemic toxicity, with clinical evidence showing promising efficacy and tolerability in heavily pretreated patients, potentially reshaping existing treatment paradigms.
- Future Development Plans: Adagene plans to initiate its registration trial in 2027 and will share updated Phase 1b/2 clinical data in the coming months, demonstrating the company's ongoing innovation and market potential in the oncology treatment landscape.
Continue Reading