Outlook Therapeutics Offers Update After FDA Meeting About ONS-5010/LYTENAVA
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as of 03-10-2026 2:19pm EST
Outlook Therapeutics Inc is a clinical-stage biopharmaceutical company focused on developing and commercializing ONS-5010, a monoclonal antibody, or mAb, for various ophthalmic indications. The Company have received marketing authorization for an ophthalmic formulation of ONS-5010/LYTENAVA (bevacizumab-gamma) for use in treating wet age-related macular degeneration, or wet AMD, in the European Union, and United Kingdom. The product pipeline includes ONS-5010/LYTENAVA, which is in total eight NORSES; ONS-5010 Clinical Progress, Unmet Patient Needs, New Ophthalmic Anti-VEGF, and Potential First Line Therapy.
| Founded: | 2010 | Country: | United States |
| Employees: | N/A | City: | ISELIN |
| Market Cap: | 38.7M | IPO Year: | 2016 |
| Target Price: | $3.83 | AVG Volume (30 days): | 1.2M |
| Analyst Decision: | Buy | Number of Analysts: | 4 |
| Dividend Yield: | N/A | Dividend Payout Frequency: | N/A |
| EPS: | -0.38 | EPS Growth: | 55.91 |
| 52 Week Low/High: | $0.38 - $3.39 | Next Earning Date: | 06-02-2026 |
| Revenue: | $8,146,123 | Revenue Growth: | N/A |
| Revenue Growth (this year): | 1726.7% | Revenue Growth (next year): | 80.34% |
| P/E Ratio: | -1.07 | Index: | N/A |
| Free Cash Flow: | -52266744.0 | FCF Growth: | N/A |
SEC 8-K filings with transcript text
Feb 17, 2026 · 100% conf.
1D
-2.28%
$0.41
Act: -3.01%
5D
-6.12%
$0.40
Act: -2.68%
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-30.21%
$0.29
false 0001649989
0001649989
2026-02-17 2026-02-17
iso4217:USD
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Washington,
Pursuant to Section 13 OR 15(d) of
The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): February 17, 2026
Outlook Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
Delaware 001-37759 38-3982704
(State or other jurisdiction
of incorporation) (Commission File Number) (IRS Employer Identification No.)
111 S. Wood Avenue, Unit #100
Iselin, New Jersey 08830
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (609) 619-3990
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities pursuant to Section 12(b) of the Act:
Title of Each Class
Trading Symbol(s)
Name of Each Exchange on Which
Registered
Common Stock
The Nasdaq Stock Market LLC
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ¨
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Item 2.02Results of Operations and Financial Condition
On February 17, 2026, Outlook Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for its first fiscal quarter ended December 31, 2025. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information contained in this Item 2.02 and in the accompanying Exhibit 99.1 shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.
Item 9.01Financial Statements and Exhibits
(d) Exhibits
Exhibit No.
Description
99.1
Press Release dated February 17, 2026
104
Cover Page Interactive Data File (embedded within the Inline XBRL document)
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Outlook Therapeutics, Inc.
Date: February 17, 2026 By: /s/ Lawrence A. Kenyon
Lawrence A. Kenyon
Chief Financial Officer
Dec 19, 2025
false 0001649989
0001649989
2025-12-19 2025-12-19
iso4217:USD
xbrli:shares
iso4217:USD
xbrli:shares
Washington,
Pursuant to Section 13 OR 15(d) of
The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): December 19, 2025
Outlook Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
Delaware 001-37759 38-3982704
(State or other jurisdiction
of incorporation) (Commission File Number) (IRS Employer Identification No.)
111 S. Wood Avenue,
Unit #100
Iselin, New Jersey
08830
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (609) 619-3990
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities pursuant to Section 12 (b) of the Act:
Title of Each Class
Trading Symbol(s)
Name of Each Exchange on Which
Registered
Common Stock
The Nasdaq Stock Market LLC
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ¨
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Item 2.02Results of Operations and Financial Condition
On December 19, 2025, Outlook Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for its fourth fiscal quarter and year ended September 30,2025. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information contained in this Item 2.02 and in the accompanying Exhibit 99.1 shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.
Item 9.01Financial Statements and Exhibits
(d) Exhibits
Exhibit No.
Description
99.1
Press Release dated December 19, 2025
104
Cover Page Interactive Data File (embedded within the Inline XBRL document)
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Outlook Therapeutics, Inc.
Date: December 19, 2025 By: /s/ Lawrence A. Kenyon
Lawrence A. Kenyon
Chief Financial Officer
Aug 14, 2025
false 0001649989
0001649989
2025-08-14 2025-08-14
iso4217:USD
xbrli:shares
iso4217:USD
xbrli:shares
Washington,
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 14, 2025
Outlook Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
Delaware 001-37759 38-3982704
(State or other jurisdiction
of incorporation) (Commission File Number) (IRS Employer Identification No.)
111 S. Wood Avenue, Unit #100
Iselin, New Jersey
08830
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (609) 619-3990
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities pursuant to Section 12 (b) of the Act:
Title of Each Class
Trading Symbol(s)
Name of Each Exchange on Which
Registered
Common Stock
The Nasdaq Stock Market LLC
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ¨
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Item 2.02 Results of Operations and Financial Condition
On August 14, 2025, Outlook Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for its third fiscal quarter ended June 30, 2025. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information contained in this Item 2.02 and in the accompanying Exhibit 99.1 shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits
Exhibit No.
Description
99.1
Press Release dated August 14, 2025
104
Cover Page Interactive Data File (embedded within the Inline XBRL document)
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Outlook Therapeutics, Inc.
Date: August 14, 2025 By: /s/ Lawrence A. Kenyon
Lawrence A. Kenyon
Chief Financial Officer
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