Denali Therapeutics (DNLI) said Wednesday the US Food and Drug Administration has given breakthrough therapy designation for tividenofusp alfa to treat people with Hunter syndrome, a rare genetic disease.
The designation was created to quicken the development and review of candidate drugs to treat serious or life-threatening diseases, the company said.
The label is in addition to fast track designation, orphan drug designation, and rare pediatric disease designation that were all previously given by the FDA for tividenofusp alfa to treat Hunter syndrome, Denali added.
Denali said it plans to file a biologics license application for tividenofusp alfa early this year.
The company's shares were rising 1.6% in recent trading.
Price: 21.52, Change: +0.34, Percent Change: +1.61
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.