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OTLK News and Press, Outlook Therapeutics Inc. From 12/22/23

Stock Information

Company Name: Outlook Therapeutics Inc.
Stock Symbol: OTLK
Market: NASDAQ
Website: outlooktherapeutics.com

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OTLK - Outlook Therapeutics® Reports Financial Results for Fiscal Year 2023 and Reiterates ONS-5010 Clinical and Regulatory Path Forward in the U.S. and EU

Commencement of ONS-5010 NORSE EIGHT clinical trial targeted for first calendar quarter of 2024 Company reaffirms potential for European approval for ONS-5010 with Marketing Authorization Application (MAA) decision date anticipated in the first half of 2024 Resubmission of the ONS...

OTLK - SHAREHOLDER DEADLINE: Outlook Therapeutics, Inc. (OTLK) Investors Are Reminded of Deadline in Securities Action

Philadelphia, Pennsylavnia--(Newsfile Corp. - December 20, 2023) - A securities fraud lawsuit has been filed against Outlook Therapeutics, Inc. ("Outlook") (NASDAQ: OTLK). The lawsuit is captioned Alsaidi v. Outlook Therapeutics, Inc. , No. 2:23-cv-21862 (D.N.J.), and is filed on behalf of purch...

OTLK - Outlook Therapeutics® Submits Special Protocol Assessment (SPA) to FDA for Non-Inferiority Study of ONS-5010

NORSE EIGHT study on track to commence in Q1 2024 Resubmission of ONS-5010 Biologics License Application (BLA) in the U.S. expected by the end of calendar year 2024 ISELIN, N.J., Dec. 19, 2023 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical c...

OTLK - Expected US Company Earnings on Monday, December 18th, 2023

Murata Manufacturing Co. Ltd. ADR (MRAAY) is expected to report $0.27 for Q2 2024 Quotient Limited (QTNTQ) is expected to report for quarter end 2023-09-30 Evaxion Biotech A/S (EVAX) is expected to report for Q3 2023 American Virtual Cloud Technologies Inc. (AVCTQ) is expected to repo...

OTLK - Expected US Company Earnings on Monday, December 11th, 2023

Lanvin Group Holdings Limited (LANV) is expected to report for quarter end 2023-09-30 Sonnet BioTherapeutics Holdings Inc. (SONN) is expected to report for Q4 2023 Shionogi & Co. Ltd. ADR (SGIOY) is expected to report for Q2 2024 Gelesis Holdings, Inc. (GLSHQ) is expected to repor...

OTLK - Outlook Therapeutics appoints new head of licensing and M&A

2023-12-06 11:05:44 ET More on Outlook Therapeutics Outlook sees resubmitting FDA application for eye drug by end of 2024 HC Wainwright ups Outlook Therapeutics to buy, cites FDA progress Seeking Alpha’s Quant Rating on Outlook Therapeutics Historical ...

OTLK - Outlook Therapeutics® Announces Strategic Organizational Realignment

Realignment focused on supporting ONS-5010 U.S. and EU regulatory and commercial priorities Continued progress toward commencement of additional adequate and well-controlled study to support the ONS-5010 Biologics License Application (BLA) in the U.S. European regulatory efforts...

OTLK - Expected US Company Earnings on Monday, December 4th, 2023

JanOne Inc. (JAN) is expected to report for Q4 2023 Staffing 360 Solutions Inc. (STAF) is expected to report $-0.31 for Q3 2023 American Virtual Cloud Technologies Inc. (AVCTQ) is expected to report for quarter end 2023-09-30 Quotient Limited (QTNTQ) is expected to report for quarter ...

OTLK - Outlook Therapeutics® Announces Receipt of Type A Meeting Minutes and Reiterates Regulatory Path Forward for ONS-5010

Resubmission of the ONS-5010 BLA on track for the end of calendar year 2024, pending final agreement on a clinical trial protocol with the FDA and successful completion of the required additional clinical trial Planned clinical trial expected to be a 3-month non-inferiority study with 60 ...

OTLK - Expected US Company Earnings on Monday, November 27th, 2023

Nippon Paint Holdings Co. Ltd. (NPCPF) is expected to report for Q3 2023 SMC Corporation ADR (SMCAY) is expected to report for Q2 2024 Arcimoto Inc. (FUV) is expected to report for Q3 2023 Ever-Glory International Group Inc. (EVKG) is expected to report for quarter end 2023-09-30 ...

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