Denali's (DNLI) Candidate Selected for FDA's START Pilot Program [Yahoo! Finance]
Denali Therapeutics Inc. (DNLI)
Last denali therapeutics inc. earnings: 8/6 04:30 pm
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Source: Yahoo! Finance
The candidate is an investigational enzyme replacement therapy designed to cross the blood-brain barrier (BBB) for the potential treatment of MPS IIIA (Sanfilippo syndrome type A). MPS III, also known as Sanfilippo syndrome, is a rare, genetic lysosomal storage disease that causes neurodegeneration. The newly launched START Pilot program was initiated by the FDA on Sep 29, 2023, to further accelerate the pace of the development of novel drugs and biological products that are intended to address the significant need in the treatment of rare diseases. The pilot program was launched jointly by the FDA Center for Biologics Evaluation and Research's Office of Therapeutic Products and Center for Drug Evaluation and Research's Office of New Drugs. Some of the participants of the START Pilot Program are provided opportunities to obtain frequent advice and engage in more rapid ad hoc communication with the FDA review staff to address product-specific development issues. Denali is con
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News
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- Why Is Denali Therapeutics (DNLI) Up 15.6% Since Last Earnings Report? [Yahoo! Finance]Yahoo! Finance
DNLI
Earnings
- 2/27/24 - Miss
DNLI
Sec Filings
- 6/10/24 - Form 4
- 6/6/24 - Form 144
- 6/4/24 - Form 4
- DNLI's page on the SEC website