Outlook Therapeutics, Inc.
Company Information
Industry
Biological Products, (No Diagnostic Substances)
SIC Code
2836
Entity Type
operating
SEC Category
Non-accelerated filerSmaller reporting company
State of Incorporation
DE
Business Address
111 S. WOOD AVENUE, ISELIN, NJ, 08830
Mailing Address
111 S. WOOD AVENUE, ISELIN, NJ, 08830
Phone
6096193990
Fiscal Year End
0930
EIN
383982704
Financial Overview
FY2025
-$62.42M
Net Income
$28.82M
Total Assets
$101.90M
Total Liabilities
$14.93M
Cash & Equivalents
$-1.79
EPS
Recent SEC Filings
| Form Type | Date Filed | Document |
|---|---|---|
| 424B5 Prospectus supplement | March 25, 2026 | View on SEC |
| 8-K Current report of material events | March 25, 2026 | View on SEC |
| 424B5 Prospectus supplement | March 23, 2026 | View on SEC |
| 8-K Current report of material events | March 16, 2026 | View on SEC |
| 8-K Current report of material events | March 11, 2026 | View on SEC |
| 8-K Current report of material events | March 10, 2026 | View on SEC |
| 8-K Current report of material events | March 5, 2026 | View on SEC |
| 8-K Current report of material events | February 18, 2026 | View on SEC |
| 10-Q Quarterly financial report | February 17, 2026 | View on SEC |
| 8-K Current report of material events | February 17, 2026 | View on SEC |
Annual Reports
10-K
December 19, 2025
- This year was critical for pushing ONS-5010 towards FDA approval, which is the single most important factor for the company's future.
- Outlook Therapeutics is heavily invested in getting ONS-5010 approved for wet AMD.
Material Events
8-K
Other
March 5, 2026
High Impact
- Outlook Therapeutics is actively engaging with the FDA to address the Complete Response Letter (CRL) for ONS-5010.
- The Type A meeting is a standard, formal process to clarify FDA deficiencies and establish an agreed-upon path for resubmission.
8-K
Financial Distress
February 18, 2026
High Impact
- Outlook Therapeutics' lead product candidate, ONS-5010 for wet AMD, is crucial for its future success.
- The company is actively working on the resubmission of its Biologics License Application (BLA) for ONS-5010 to the FDA.
8-K
Other
February 11, 2026
High Impact
- FDA issued a Complete Response Letter (CRL) for ONS-5010, Outlook Therapeutics' sole late-stage investigational drug.
- Outlook Therapeutics believes the identified deficiencies related to Chemistry, Manufacturing, and Controls (CMC) and clinical data are addressable.
8-K
Other
January 2, 2026
High Impact
- Outlook Therapeutics received a Complete Response Letter (CRL) from the FDA for its eye drug ONS-5010 (Lytenava), indicating it's not yet approved.
- The FDA cited concerns regarding manufacturing (CMC) and additional clinical trial data requirements.
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Investor Resources
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Important Disclaimer
This AI-generated analysis is for informational purposes only and does not constitute financial or investment advice. Always consult with qualified professionals and conduct your own research before making investment decisions.