OTLK Stock Falls on Failure to Meet Non-Inferiority Goal in AMD Study [Yahoo! Finance]
Outlook Therapeutics, Inc. (OTLK)
Last outlook therapeutics, inc. earnings: 2/14 08:00 am
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Source: Yahoo! Finance
treat patients with wet age-related macular degeneration (AMD). The NORSE EIGHT study is the second of two adequate and well-controlled clinical studies evaluating ONS-5010 for the AMD indication. Per the data readout, the candidate failed to meet the pre-specified non-inferiority endpoint at week 8 outlined in the special protocol assessment with the FDA. ONS-5010 is an investigational ophthalmic formulation of bevacizumab, which is being developed to treat AMD and other retinal diseases. Shares of Outlook Therapeutics plunged 65.2% on Wednesday in response to the news. The NORSE EIGHT non-inferiority study enrolled newly diagnosed wet AMD patients, who were randomly divided equally to receive either 1.25 mg ONS-5010 or 0.5 mg Lucentis (ranibizumab) intravitreal injections. All subjects were dosed thrice during the study period. The primary endpoint of the study was the mean change in best-corrected visual acuity from baseline to week eight. However, preliminary analysis of stu
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OTLK
News
- Outlook Therapeutics® Reports Financial Results for Fiscal Year 2024 and Provides Corporate UpdateGlobeNewswire
- Outlook Therapeutics® Streamlines OperationsGlobeNewswire
- Outlook Therapeutics® Announces NICE Recommendation of LYTENAVA™ (bevacizumab gamma) for the Treatment of Wet AMD [Yahoo! Finance]Yahoo! Finance
- Outlook Therapeutics® Announces NICE Recommendation of LYTENAVA™ (bevacizumab gamma) for the Treatment of Wet AMDGlobeNewswire
- Outlook Therapeutics® Announces Executive Leadership Transition [Yahoo! Finance]Yahoo! Finance
OTLK
Earnings
- 8/14/24 - Beat
OTLK
Sec Filings
- 12/27/24 - Form 8-K
- 12/16/24 - Form 8-K
- 12/4/24 - Form 8-K
- OTLK's page on the SEC website