START is a pilot program newly launched jointly by the FDA CDER and CBER divisions to further accelerate the development of novel drug and biological products for rare diseasesDNL126 was selected as one of three CDER-regulated products based on eligibility criteria including the potential for clinical benefit for a rare neurodegenerative disease and the drug sponsor’s ability to advance development towards a marketing application Participation in START is expected to facilitate and accelerate de
The latest analyst coverage could presage a bad day for Denali Therapeutics Inc. ( NASDAQ:DNLI ), with the analysts...
Denali Therapeutics ( NASDAQ:DNLI ) First Quarter 2024 Results Key Financial Results Net loss: US$101.8m (loss narrowed...