NasdaqGS:DNLIBiotechs
Denali Therapeutics (DNLI): Assessing Valuation After FDA Advances Key Pipeline Approvals
If you have been following Denali Therapeutics (DNLI), this latest announcement is hard to ignore. The FDA’s acceptance of its biologics license application for tividenofuspalfa for priority review sets the stage for a key regulatory milestone. Not only has the company signaled progress in its lead programs, but it has also reached an important agreement with the FDA on a surrogate endpoint for accelerated approval of DNL126. This move could expedite access for patients with Sanfilippo...