Denali Therapeutics Announces Initiation of BLA Filing for Accelerated Approval of Tividenofusp Alfa for the Treatment of Hunter Syndrome (MPS II) and Positive Ongoing Interactions with FD...
Denali Therapeutics Inc. (DNLI)
Last denali therapeutics inc. earnings: 8/6 04:30 pm
Check Earnings Report
US:NASDAQ Investor Relations:
investors.denalitherapeutics.com
Company Research
Source: GlobeNewswire
Rolling submission of BLA initiated for tividenofusp alfa; preparations ongoing for potential U.S. commercial launch in late 2025 or early 2026Alignment through recent interactions with CDER on path to accelerated approval and conversion to full approval for tividenofusp alfaProductive collaboration continues under START for an accelerated development and approval path for DNL126 SOUTH SAN FRANCISCO, Calif., April 02, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ: DNLI), today announced that the company’s initiation of a rolling submission of a biologics license application (BLA) for accelerated approval of tividenofusp alfa for the treatment of Hunter syndrome (MPS II) has been received by the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA). Denali continues to have regular, collaborative, and productive engagement with CDER and is aligned with CDER on the content of the BLA data package, including the use of cerebrospinal
Show less
Read more
Impact Snapshot
Event Time:
DNLI
Last Price
Price Change
Price Change%
Volume Shares
Max Up
Max Down
%
Volume Ratio
Performance Comparison
Updated
|
Event Day
Stock performance from the time of news release until the following 4pm ET market close
|
Last price at news event
|
Since Event
Multi-day stock performance from the time of the news release
|
|---|---|---|
|
EVENT DAY
Stock performance from the time of news release until the following 4pm ET market close
|
LAST
PRICE AT NEWS EVENT |
SINCE EVENT
Multi-day stock performance from the time of the news release
|
| Last Price | ||
| VWAP | ||
|
High:
|
Max Up |
High:
|
|
Low:
|
Max Down |
Low:
|
|
%
|
Post news range |
%
|
|
|
Price change |
|
|
|
Price Change Percentage |
|
|
|
S&P 500 (SPX) |
|
|
%
|
Volume ratio |
%
|
| Volume | ||
| Ticks | ||
|
|
Avg transaction size |
|
Don't Miss Out On The Next BIG Stock Move
Event day
Event Day Chart will not be displayed beyond 90-day period of the event
Performance since event
Time And Velocity Analysis
Be the first to know
Opt in for alerts from News Quantifed
Sign Up Today
Opt-in for
DNLI alerts
Learn More With NQ
Reading the Impact Report
Help Me Understand This Data
Help Me Understand This Data
How NQ Works
What is news-based trading?
And why is it so successful?
And why is it so successful?
Movers & Shakers
The biggest gainers and losers and WHY it moved
DNLI alerts
High impacting Denali Therapeutics Inc. news events
Weekly update
A roundup of the hottest topics
DNLI
News
- Denali Therapeutics (NASDAQ:DNLI) had its price target lowered by analysts at Wedbush from $31.00 to $30.00. They now have an "outperform" rating on the stock.MarketBeat
- Denali Therapeutics Announces Pricing of Public Offering of Common Stock and Pre-Funded Warrants [Yahoo! Finance]Yahoo! Finance
- Denali Therapeutics Announces Pricing of Public Offering of Common Stock and Pre-Funded WarrantsGlobeNewswire
- Denali Therapeutics Announces Proposed Offering of Common Stock and Pre-Funded Warrants [Yahoo! Finance]Yahoo! Finance
- Denali Therapeutics Announces Proposed Offering of Common Stock and Pre-Funded WarrantsGlobeNewswire
DNLI
Earnings
- 11/6/25 - Beat
DNLI
Sec Filings
- 12/15/25 - Form 4
- 12/10/25 - Form 8-K
- 12/10/25 - Form 424B5
- DNLI's page on the SEC website