FDA Grants Fast Track Designation to ADAG's Colorectal Cancer Drug
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AAPL TSLA AMZN META AMD NVDA PEP COST ADBE GOOG AMGN HON INTC INTU NFLX ADP SBUX MRNA AAPL TSLA AMZN META AMD NVDA PEP COST ADBE GOOG AMGN HON INTC INTU NFLX ADP SBUX MRNA AAPL TSLA AMZN META AMD NVDA PEP COST ADBE GOOG AMGN HON INTC INTU NFLX ADP SBUX MRNA Stocks FDA Grants Fast Track Designation to ADAG's Colorectal Cancer Drug December 17, 2025 — 08:43 am EST Written by Zacks Equity Research for Zacks-> Adagene Inc. ADAG 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 ResearchMore on ADAG’s MuzastotugMuzastotug 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 ConsiderAdagene currently carries a Zacks Rank #3 (Hold).Some better-ranked stocks in the biotech sector are ANI Pharmaceuticals ANIP, CorMedix CRMD and Castle Biosciences CSTL. 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%. 5 Stocks Set to Double Each was handpicked by a Zacks expert as the #1 favorite stock to gain +100% or more in the coming year. While not all picks can be winners, previous recommendations have soared +112%, +171%, +209% and +232%. Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor. Today, See These 5 Potential Home Runs >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free reportANI Pharmaceuticals, Inc. (ANIP) : Free Stock Analysis ReportCorMedix Inc (CRMD) : Free Stock Analysis ReportCastle Biosciences, Inc. (CSTL) : Free Stock Analysis ReportAdagene Inc. Sponsored ADR (ADAG) : Free Stock Analysis ReportThis article originally published on Zacks Investment Research (zacks.com).Zacks Investment Research The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. Tags StocksInvesting Zacks Zacks is the leading investment research firm focusing on stock research, analysis and recommendations. In 1978, our founder discovered the power of earnings estimate revisions to enable profitable investment decisions. Today, that discovery is still the heart of the Zacks Rank. A wealth of resources for individual investors is available at www.zacks.com. More articles by this source-> Stocks mentioned ANIP CRMD CSTL ADAG More Related Articles This data feed is not available at this time. Data is currently not available • Sign up for the TradeTalks newsletter to receive your weekly dose of trading news, trends and education. Delivered Wednesdays.