Outlook Therapeutics Submits IND Application for ONS-5010 to the FDA
Outlook Therapeutics, Inc. (OTLK)
Last outlook therapeutics, inc. earnings: 2/14 08:00 am
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Source: GlobeNewswire
CRANBURY, N.J., March 01, 2019 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ:OTLK) (the “Company”) announced today the submission of its Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for ONS-5010. ONS-5010 is an innovative monoclonal antibody (mAb) therapeutic product candidate being developed for wet age related macular degeneration (wet AMD), diabetic macular edema (DME) and branch retinal vein occlusion (BRVO). Once effective, the IND will allow the Company to begin enrolling patients in the U.S. portion of its ONS-5010-002 Phase 3 clinical trial in patients with wet AMD. ONS-5010-002 is the second of two adequate and well controlled Phase 3 clinical trials evaluating ONS-5010 against ranibizumab (Lucentis®) for wet AMD. ONS-5010-002 was recently initiated in Australia and is expected to begin enrolling patients in Australia and New Zealand in March 2019 and in the United States (once the IND is effective) in April 2019
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News
- Outlook Therapeutics® Announces Closing of Private Placement of $5.0 MillionGlobeNewswire
- Outlook Therapeutics: De-Risked Regulatory Tracks Are Lining Up For Possible ONS-5010 Approval [Seeking Alpha]Seeking Alpha
- Outlook Therapeutics, Inc. (NASDAQ: OTLK) was upgraded by analysts at BTIG Research from a "neutral" rating to a "buy" rating. They now have a $50.00 price target on the stock.MarketBeat
- Outlook Therapeutics, Inc. (NASDAQ: OTLK) had its price target raised by analysts at HC Wainwright from $1.50 to $30.00. They now have a "buy" rating on the stock.MarketBeat
- Outlook Therapeutics stock jumps on positive EU CHMP opinion for its wet AMD treatment [Seeking Alpha]Seeking Alpha
OTLK
Earnings
- 2/14/24 - Beat
OTLK
Sec Filings
- 4/17/24 - Form SC
- 4/17/24 - Form 4
- 4/16/24 - Form D
- OTLK's page on the SEC website