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OTLK / Outlook Therapeutics announces validation of marketing authorization application by EMA for ONS-5010 as treatment for wet AMD

Outlook Therapeutics announces validation of marketing authorization application by EMA for ONS-5010 as treatment for wet AMD
Outlook Therapeutics Inc (NASDAQ:OTLK) announced the validation of the company's Marketing Authorization Application (MAA) by the European Medicines Agency (EMA) for an investigational ophthalmic formulation of bevacizumab (ONS-5010) for the treatment of wet age-related macular degeneration (wet AMD). The formal review process of the application by the EMA's committee for medicinal products for human use (CHMP) is now set to begin and an estimated decision date is expected in early 2024. Read More
Posted: Dec 22 2022, 09:01
Author Name: Proactive Investors
Views: 101925

OTLK News  

Outlook Therapeutics® to Present at Guggenheim's 5th Annual Inflammation, Neurology & Immunology (INI) Conference

By GlobeNewsWire
November 1, 2023

Outlook Therapeutics® to Present at Guggenheim's 5th Annual Inflammation, Neurology & Immunology (INI) Conference

Live audio webcast fireside chat on Tuesday, November 7th at 1:50 PM ET Live audio webcast fireside chat on Tuesday, November 7th at 1:50 PM ET more_horizontal

Outlook Therapeutics® to Present at the 2023 Cantor Fitzgerald Global Healthcare Conference

By GlobeNewsWire
September 21, 2023

Outlook Therapeutics® to Present at the 2023 Cantor Fitzgerald Global Healthcare Conference

Live video webcast panel presentation on Tuesday, September 26th at 1:35 PM ET Live video webcast panel presentation on Tuesday, September 26th at 1:3 more_horizontal

Why Is Outlook Therapeutics (OTLK) Stock Down 78% Today?

By InvestorPlace
August 30, 2023

Why Is Outlook Therapeutics (OTLK) Stock Down 78% Today?

Outlook Therapeutics (NASDAQ: OTLK ) stock is taking a beating on Wednesday after getting a rejection letter from the FDA. That letter has to do with more_horizontal

Outlook Therapeutics collapses as FDA rejects application for eye drug

By Proactive Investors
August 30, 2023

Outlook Therapeutics collapses as FDA rejects application for eye drug

Outlook Therapeutics Inc (NASDAQ:OTLK) stock collapsed, losing some 70% of its value in premarket, after the drug discovery firm's potential treatment more_horizontal

US FDA declines to approve Outlook Therapeutics' eye disease drug

By Reuters
August 30, 2023

US FDA declines to approve Outlook Therapeutics' eye disease drug

Outlook Therapeutics said on Wednesday the U.S. Food and Drug Administration declined to approve its experimental eye disease drug, in part due to man more_horizontal

Should You Buy Outlook Therapeutics (OTLK) Ahead of Earnings?

By Zacks Investment Research
August 14, 2023

Should You Buy Outlook Therapeutics (OTLK) Ahead of Earnings?

Outlook Therapeutics (OTLK) is seeing favorable earnings estimate revision activity and has a positive Zacks Earnings ESP heading into earnings season more_horizontal

Outlook Therapeutics® to Present at the BTIG Virtual Biotechnology Conference 2023

By GlobeNewsWire
August 1, 2023

Outlook Therapeutics® to Present at the BTIG Virtual Biotechnology Conference 2023

ISELIN, N.J., Aug. 01, 2023 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve FDA appr more_horizontal

Outlook Therapeutics: August PDUFA May Be A Buy With Some Caveats

By Seeking Alpha
June 10, 2023

Outlook Therapeutics: August PDUFA May Be A Buy With Some Caveats

OTLK is developing an ophthalmic formulation of bevacizumab. There is a logic behind this, and there's also positive data. However, certain developmen more_horizontal


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