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FDA Grants Fast Track Designation to ADAG's Colorectal Cancer Drug
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Key Takeaways
ADAG shares rose 13.8% post Fast Track tag for muzastotug plus pembrolizumab in MSS mCRC.
Adagene says its SAFEbody-based CTLA-4 antibody aims to improve survival versus conventional therapies.
ADAG plans a randomized phase II study with ORR as the primary endpoint and targets a phase III start in 2027.
Adagene Inc. (ADAG - Free Report) announced that the FDA has granted Fast Track designation to its lead clinical-stage immuno-oncology candidate, muzastotug (ADG126).
The designation was granted to muzastotug in combination with Merck’s anti-PD-1 therapy Keytruda (pembrolizumab) for the treatment of adult patients with microsatellite-stable metastatic colorectal cancer (MSS mCRC) without current or active liver metastases.
Following the announcement, ADAG shares surged 13.8%.
The designation is generally granted by the FDA to facilitate drug development and expedite the review of therapies intended to treat serious diseases with unmet medical needs.
Over the past year, ADAG’s shares have declined 6.9% against the industry’s 16.3% rise.
Image Source: Zacks Investment Research
More on ADAG’s Muzastotug
Muzastotug is a next-generation anti-CTLA-4 antibody developed using the company’s proprietary SAFEbody masking technology.
Unlike conventional CTLA-4 therapies, muzastotug in combination with pembrolizumab has the potential to reshape the treatment paradigm by improving survival and quality of life for patients.
The Fast Track designation is supported by emerging clinical data showing encouraging efficacy, deep and durable responses, and a favorable safety profile of muzastotug in a heavily pretreated patient population.
A phase II study is ongoing. The primary endpoint of the study is the overall response rate. Secondary endpoints include duration of response, progression-free survival, and overall survival.
The company plans to initiate a phase III study in 2027.
If clinical studies continue to demonstrate significant and durable efficacy with improved tolerability, muzastotug could reshape the CTLA-4 treatment paradigm.
The Fast Track designation allows frequent interactions with the FDA and may allow for rolling reviews of future marketing applications.
Over the past 60 days, estimates for ANI Pharmaceuticals’ 2025 earnings per share (EPS) have increased from $7.29 to $7.56. Over the same period, EPS estimates for 2026 have surged from $7.81 to $8.08. Shares of ANIP have surged 50.5% in the past year.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 21.24%.
Over the past 60 days, estimates for CorMedix’s 2025 EPS have increased from $1.85 to $2.87, while 2026 EPS estimates have risen from $2.49 to $2.88 over the same period. Shares of CRMD have surged 40.9% over the past year.
CorMedix’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 27.04%.
Over the past 60 days, the 2025 loss per share estimate for Castle Biosciences has narrowed to 34 cents from 65 cents. Over the same period, the loss per share estimate for 2026 has improved from $2.10 to $1.06. CSTL stock has rallied 47.2% over the past year.
Castle Biosciences’ earnings beat estimates in three of the trailing four quarters and missed in the remaining quarter, with the average surprise being 66.11%.
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FDA Grants Fast Track Designation to ADAG's Colorectal Cancer Drug
Key Takeaways
Adagene Inc. (ADAG - Free Report) announced that the FDA has granted Fast Track designation to its lead clinical-stage immuno-oncology candidate, muzastotug (ADG126).
The designation was granted to muzastotug in combination with Merck’s anti-PD-1 therapy Keytruda (pembrolizumab) for the treatment of adult patients with microsatellite-stable metastatic colorectal cancer (MSS mCRC) without current or active liver metastases.
Following the announcement, ADAG shares surged 13.8%.
The designation is generally granted by the FDA to facilitate drug development and expedite the review of therapies intended to treat serious diseases with unmet medical needs.
Over the past year, ADAG’s shares have declined 6.9% against the industry’s 16.3% rise.
Image Source: Zacks Investment Research
More on ADAG’s Muzastotug
Muzastotug is a next-generation anti-CTLA-4 antibody developed using the company’s proprietary SAFEbody masking technology.
Unlike conventional CTLA-4 therapies, muzastotug in combination with pembrolizumab has the potential to reshape the treatment paradigm by improving survival and quality of life for patients.
The Fast Track designation is supported by emerging clinical data showing encouraging efficacy, deep and durable responses, and a favorable safety profile of muzastotug in a heavily pretreated patient population.
A phase II study is ongoing. The primary endpoint of the study is the overall response rate. Secondary endpoints include duration of response, progression-free survival, and overall survival.
The company plans to initiate a phase III study in 2027.
If clinical studies continue to demonstrate significant and durable efficacy with improved tolerability, muzastotug could reshape the CTLA-4 treatment paradigm.
The Fast Track designation allows frequent interactions with the FDA and may allow for rolling reviews of future marketing applications.
ADAG’s Zacks Rank & Stocks to Consider
Adagene currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are ANI Pharmaceuticals (ANIP - Free Report) , CorMedix (CRMD - Free Report) and Castle Biosciences (CSTL - Free Report) . ANIP, CRMD and CSTL currently sport a Zacks Rank #1 (Strong Buy) each. You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for ANI Pharmaceuticals’ 2025 earnings per share (EPS) have increased from $7.29 to $7.56. Over the same period, EPS estimates for 2026 have surged from $7.81 to $8.08. Shares of ANIP have surged 50.5% in the past year.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 21.24%.
Over the past 60 days, estimates for CorMedix’s 2025 EPS have increased from $1.85 to $2.87, while 2026 EPS estimates have risen from $2.49 to $2.88 over the same period. Shares of CRMD have surged 40.9% over the past year.
CorMedix’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 27.04%.
Over the past 60 days, the 2025 loss per share estimate for Castle Biosciences has narrowed to 34 cents from 65 cents. Over the same period, the loss per share estimate for 2026 has improved from $2.10 to $1.06. CSTL stock has rallied 47.2% over the past year.
Castle Biosciences’ earnings beat estimates in three of the trailing four quarters and missed in the remaining quarter, with the average surprise being 66.11%.