Ocular Therapeutix™ Announces Plans to Accelerate NDA Submission Timeline for AXPAXLI™ in Wet AMD
Ocular Therapeutix, Inc. (OCUL)
Last ocular therapeutix, inc. earnings: 3/12 04:01 pm
Check Earnings Report
US:NASDAQ Investor Relations:
ocutx.com
Company Research
Source: GlobeNewswire
Ocular intends to submit AXPAXLI New Drug Application (NDA) for wet AMD shortly after year one data from SOL-1, if positive SOL-1 topline data remain on track for 1Q 2026 Ocular plans to leverage the 505(b)(2) regulatory pathway for new drug approvals which has the potential to shorten the review timeline for AXPAXLI If approved, AXPAXLI could be the first TKI to be commercialized in wet AMD, with a potential superiority label and best-in-class durability BEDFORD, Mass., Dec. 08, 2025 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”), an integrated biopharmaceutical company committed to redefining the retina experience, announced that following recent public statements from U.S. Food and Drug Administration (FDA) leadership and other recent interactions with the FDA’s Division of Ophthalmology, the Company now intends to submit a New Drug Application (NDA) for AXPAXLI™ (also known as OTX-TKI) for the treatment of wet age-related macular degeneration (wet AMD)
Show less
Read more
Impact Snapshot
Event Time:
OCUL
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
OCUL 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
OCUL alerts
High impacting Ocular Therapeutix, Inc. news events
Weekly update
A roundup of the hottest topics
OCUL
News
- Ocular Therapeutix (NASDAQ:OCUL) had its "buy" rating reaffirmed by analysts at Chardan Capital. They now have a $21.00 price target on the stock.MarketBeat
- Ocular Therapeutix (NASDAQ:OCUL) had its "buy" rating reaffirmed by analysts at Needham & Company LLC. They now have a $20.00 price target on the stock.MarketBeat
- Ocular Therapeutix (NASDAQ:OCUL) had its "buy" rating reaffirmed by analysts at HC Wainwright.MarketBeat
- Ocular Therapeutix (OCUL) Valuation After Accelerated AXPAXLI NDA Plan in Wet AMD [Yahoo! Finance]Yahoo! Finance
- Ocular Therapeutix™ Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)GlobeNewswire
OCUL
Earnings
- 11/4/25 - Beat
OCUL
Sec Filings
- 12/8/25 - Form SCHEDULE
- 12/5/25 - Form 8-K
- 11/26/25 - Form 4
- OCUL's page on the SEC website