Adagene's Muzastotug Gets FDA Fast Track in Colorectal Cancer

MT Newswires Live12-17

Adagene (ADAG) said the US Food and Drug Administration granted Fast Track designation to its muzastotug drug in combination with Merck's (MRK) Keytruda for treating adults with microsatellite-stable metastatic colorectal cancer without active liver metastases.

The designation is supported by early data showing efficacy, durable responses and safety, and allows for the possibility of a rolling review of future marketing applications, Adagene said Tuesday in a statement.

Adagene plans to continue its randomized Phase 2 trial and expects a registration-enabling Phase 3 study to start in 2027.

The company's shares rose 3.6% in recent Tuesday trading.

Price: 1.73, Change: +0.06, Percent Change: +3.59

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

Comments

We need your insight to fill this gap
Leave a comment