Outlook Therapeutics Re-Submits Biologics License Application for ONS-5010
Outlook Therapeutics, Inc. (OTLK)
Last outlook therapeutics, inc. earnings: 2/14 08:00 am
Check Earnings Report
Company Research
Source: GlobeNewswire
ISELIN, N.J., Nov. 03, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on optimizing the standard of care for bevacizumab for the treatment of retina diseases, today announced it has re-submitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ONS-5010, after receiving the official minutes from the FDA Type A meeting conducted in September 2025. ONS-5010 is an investigational ophthalmic formulation of bevacizumab which, if approved, will be branded as LYTENAVA™ (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wet AMD). “The resubmission of our BLA for ONS-5010 marks an important step forward in our mission to deliver a safe and effective ophthalmic bevacizumab for the treatment of wet AMD in the United States. Based on our productive meeting with the FDA in September, we believe this resubmission will resolve the outstanding issue highlighted in the Comple
Show less
Read more
Impact Snapshot
Event Time:
OTLK
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
OTLK 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
OTLK alerts
High impacting Outlook Therapeutics, Inc. news events
Weekly update
A roundup of the hottest topics
OTLK
News
- Oncobiologics (NASDAQ:OTLK) had its "sell (d-)" rating reaffirmed by analysts at <a style="font-weight:bold" href="https://weissratings.com/">Weiss Ratings</a>.MarketBeat
- Outlook Therapeutics to Present at the Piper Sandler 37th Annual Healthcare ConferenceGlobeNewswire
- Oncobiologics (NASDAQ:OTLK) had its "sell (e+)" rating reaffirmed by analysts at <a style="font-weight:bold" href="https://weissratings.com/">Weiss Ratings</a>.MarketBeat
- Outlook Therapeutics Announces Acceptance of Biologics License Application by U.S. FDA for ONS-5010 as a Treatment for Wet AMDGlobeNewswire
- Oncobiologics (NASDAQ:OTLK) had its "sell (d-)" rating reaffirmed by analysts at <a style="font-weight:bold" href="https://weissratings.com/">Weiss Ratings</a>.MarketBeat
OTLK
Earnings
- 8/14/25 - Miss
OTLK
Sec Filings
- 11/3/25 - Form 8-K
- 10/21/25 - Form SCHEDULE
- 10/3/25 - Form 4
- OTLK's page on the SEC website