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
$101.90M
Total Liabilities
-$14.44M
Stockholders' Equity
$-1.79
EPS
Recent SEC Filings
| Form Type | Date Filed | Document |
|---|---|---|
| 8-K Current report of material events | February 11, 2026 | View on SEC |
| SCHEDULE 13G/A Passive ownership amendment | February 5, 2026 | View on SEC |
| DEF 14A Definitive proxy statement | January 26, 2026 | View on SEC |
| 8-K Current report of material events | January 2, 2026 | View on SEC |
| 8-K Current report of material events | December 19, 2025 | View on SEC |
| 10-K Annual financial report | December 19, 2025 | View on SEC |
| 8-K Current report of material events | November 13, 2025 | View on SEC |
| 8-K Current report of material events | November 3, 2025 | View on SEC |
| SCHEDULE 13G/A Passive ownership amendment | October 21, 2025 | View on SEC |
| 4 Insider stock transaction report | October 3, 2025 | 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 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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