Glaukos eyes FDA approval for ocular therapy after Phase III win [Yahoo! Finance]
Glaukos Corporation (GKOS)
Last glaukos corporation earnings: 2/27 04:15 pm
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Source: Yahoo! Finance
Epioxa (Epi-on) for treating keratoconus after the therapy met the primary endpoint in a Phase III trial. The study met its pre-specified primary efficacy endpoint showing a statistically significant change in maximum corneal curvature (Kmax) at 12 months compared with placebo. The California-based company noted that the primary endpoint fulfils the US FDA's efficacy criteria for keratoconus trials as it considers Kmax a key indicator of disease progression. The company intends to file for the therapy's approval by the end of the year. This Phase III trial, along with the first Phase III pivotal trial (NCT03442751), will form the basis of the new drug application (NDA) for Epioxa. Glaukos noted that the “proposed clinical data package is sufficient to support an NDA submission and review” as part of a pre-NDA meeting with the FDA. The news was favourably viewed by the company's investors. Glaukos stock was up by 1.6% in pre-market trading today. The company's market cap currentl
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News
- Glaukos Stock Soars 77.9% Year to Date: What's Behind the Rally? [Yahoo! Finance]Yahoo! Finance
- Glaukos Announces Participation in Upcoming Investor ConferencesBusiness Wire
- Glaukos Corporation (NYSE:GKOS) Just Reported Third-Quarter Earnings: Have Analysts Changed Their Mind On The Stock? [Yahoo! Finance]Yahoo! Finance
- Glaukos Third Quarter 2024 Earnings: Beats Expectations [Yahoo! Finance]Yahoo! Finance
- Glaukos (GKOS) Q3 Earnings: Taking a Look at Key Metrics Versus Estimates [Yahoo! Finance]Yahoo! Finance
GKOS
Earnings
- 11/4/24 - Beat
GKOS
Sec Filings
- 11/15/24 - Form 8-K
- 11/14/24 - Form SC
- 11/5/24 - Form 10-Q
- GKOS's page on the SEC website