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FDA places clinical hold on Denali Therapeutics’ IND for Alzheimer candidate DNL919

Following the announcement, the company's stock price dipped significantly.

By Brian Buntz | January 13, 2022

Denali TherapeuticsDenali Therapeutics (NASDAQ:DNLI) has announced that the FDA has placed a clinical hold on the Investigational New Drug (IND) application for DNL919. The large-molecule drug candidate targets TREM2 or triggering receptor expressed on myeloid cells 2.

South San Francisco–based Denali said it received an email from FDA stating that the agency had placed the IND application for DNL919 on clinical hold. The agency said it would send an official letter to the company within approximately 30 days.

On January 10, the company projected that it would produce the first clinical data for DNL919 in 2022.

The company also revealed that Takeda (NYSE:TAK) had exercised its option to co-develop and co-commercialize DNL919 in Alzheimer’s disease. Takeda and Denali announced a pact to partner on developing therapies for neurodegenerative diseases in 2018.

In mid-day trading, DNL shares had fallen 12.92% to $33.57.

The company Vigil Neuroscience (Cambridge, Massachusetts) is also developing a TREM2 agonist known as VGL101. The company also cites another unnamed small-molecule TREM2 agonist on its website.


Filed Under: Neurological Disease
Tagged With: Alzheimer's disease, Denali Therapeutics, DNL919, eurodegenerative diseases, FDA, Takeda, TREM2, Vigil Neuroscience
 

About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.

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