B.Riley Reiterates Buy Rating on Denali Therapeutics Inc. (DNLI)

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Denali Therapeutics Inc. (DNLI) PT Raised to $29 at BofA Securities

September 3, 2024 11:47 AM EDT

(Updated - September 4, 2024 5:26 AM EDT)

BofA Securities analyst Tazeen Ahmad raised the price target on Denali Therapeutics Inc. (NASDAQ: DNLI) to $29.00 (from $25.00) while maintaining a Buy rating.

The analyst comments "After meeting with FDA, Denali (DNLI) has reached alignment with... More

Goldman Sachs Reiterates Buy Rating on Denali Therapeutics Inc. (DNLI)

September 3, 2024 11:46 AM EDT

Goldman Sachs analyst Salveen Richter reiterated a Buy rating and $46.00 price target on Denali Therapeutics Inc. (NASDAQ: DNLI).

The analyst comments "DNLI announced that it has reached alignment with the FDA on an accelerated pathway (i.e., that cerebrospinal fluid heparan sulfate can be used as a surrogate endpoint to support accelerated approval) and subsequent conversion to full approval for... More

Stifel Reiterates Hold Rating on Denali Therapeutics Inc. (DNLI)

September 3, 2024 10:22 AM EDT

Stifel analyst Paul Mattels reiterated a Hold rating and $22.00 price target on Denali Therapeutics Inc. (NASDAQ: DNLI)

The analyst comments "DNLI announced a recent successful meeting with FDA's CDER has provided a path to filing for accelerated approval of DNL310 in Hunter--filing... More

Denali Therapeutics (DNLI) Announces Successful Meeting with the FDA, Plans to File for Accelerated Approval of Tividenofusp Alfa

September 3, 2024 8:02 AM EDT

Denali Therapeutics Inc. (Nasdaq: DNLI) today announced the outcome of a recent successful meeting with the Center for Drug Evaluation and Research (CDER) division of the U.S. Food and Drug Administration (FDA) providing a path to filing a biologics license application (BLA) for accelerated approval and subsequent conversion to full approval for tividenofusp alfa (DNL310) for the treatment of MPS II (Hunter syndrome). Agreement was reached that cerebrospinal fluid heparan sulfate (CSF HS) is reasonably likely to predict clinical benefit and can be used as a surrogate endpoint to support accelerated... More