Ocuphire Pharma, Inc. (OCUP) ---> Fakten (Seite 14)
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ISIN: US67577R1023 · WKN: A2QG4Z · Symbol: R3X1
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Ocuphire Announces Topline Results from ZETA-1 Phase 2 Trial of Oral APX3330 in Diabetic Retinopathy
and Plans for End-of-Phase 2 Meeting with FDA
“Our goals in this initial retina Phase 2 trial were to explore multiple endpoints
to evaluate the potential for APX3330 as the first oral drug to safely benefit diabetic patients with eye disease,”
said Mina Sooch, MBA, founder and CEO of Ocuphire Pharma.
“Although we did not meet the primary endpoint (a precedented endpoint for local administration of anti-VEGF intravitreal injections), we are pleased that the ZETA-1 results on key pre-specified endpoints demonstrated positive outcomes with a favorable systemic and ocular safety profile that support our plans to move forward to an End-of-Phase 2 meeting with the FDA. Given the systemic delivery of APX3330, it is important to evaluate its effect on both eyes. APX3330 achieved statistical significance on a key pre-specified secondary endpoint – binocular 3-step or more worsening of DRSS (diabetic retinopathy severity score) – a clinically meaningful outcome that demonstrates the ability to slow the worsening of this progressive disease and is a potential Phase 3 registration endpoint. With the financial strength provided by our recent global Nyxol® license agreement, we have considerable flexibility to design and initiate the pivotal stage of the APX3330 program.
We thank the study participants, clinical investigators and their site staffs for participating in the trial.”
quelle https://finance.yahoo.com/news/ocuphire-announces-topline-re…
and Plans for End-of-Phase 2 Meeting with FDA
“Our goals in this initial retina Phase 2 trial were to explore multiple endpoints
to evaluate the potential for APX3330 as the first oral drug to safely benefit diabetic patients with eye disease,”
said Mina Sooch, MBA, founder and CEO of Ocuphire Pharma.
“Although we did not meet the primary endpoint (a precedented endpoint for local administration of anti-VEGF intravitreal injections), we are pleased that the ZETA-1 results on key pre-specified endpoints demonstrated positive outcomes with a favorable systemic and ocular safety profile that support our plans to move forward to an End-of-Phase 2 meeting with the FDA. Given the systemic delivery of APX3330, it is important to evaluate its effect on both eyes. APX3330 achieved statistical significance on a key pre-specified secondary endpoint – binocular 3-step or more worsening of DRSS (diabetic retinopathy severity score) – a clinically meaningful outcome that demonstrates the ability to slow the worsening of this progressive disease and is a potential Phase 3 registration endpoint. With the financial strength provided by our recent global Nyxol® license agreement, we have considerable flexibility to design and initiate the pivotal stage of the APX3330 program.
We thank the study participants, clinical investigators and their site staffs for participating in the trial.”
quelle https://finance.yahoo.com/news/ocuphire-announces-topline-re…
Ocuphire Corporate Presentation
January 2023 https://d1io3yog0oux5.cloudfront.net/_af8fa7fc96907fa6314cce… First Patient Enrolled
Ocuphire Pharma Announces First Patient Enrolled in VEGA-2 Pivotal Phase 3 Trial of Nyxol® in Presbyopia
... with the first patient enrolled in late December.
VEGA-2 is evaluating the efficacy and safety for two labels: Nyxol® alone
and Nyxol with adjunctive low-dose pilocarpine (LDP) therapy for presbyopia.
Estimated Study Start Date : December 12, 2022
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023
https://clinicaltrials.gov/ct2/show/NCT05646719?term=VEGA-2&…
quelle https://finance.yahoo.com/news/ocuphire-pharma-announces-fir…
License and Collaboration Agreement
On November 6, 2022, Ocuphire Pharma, Inc. (“Ocuphire”) entered into a License and Collaboration Agreement (the “License Agreement”) with FamyGen Life Sciences...
Pursuant to the License Agreement, Famy will make to Ocuphire an upfront cash payment of $35 million
weitere einzelheiten zum deal guckst du hier:
quelle https://ir.ocuphire.com/all-sec-filings/content/0001140361-2…
realtime https://de.advfn.com/p.php?pid=staticchart&s=ocup&t=37&p=0&d…
ADFVN https://de.advfn.com/borse/NASDAQ/OCUP/kurs
YAHOO https://finance.yahoo.com/quote/OCUP?p=OCUP&.tsrc=fin-srch
Pre-Market https://www.nasdaq.com/market-activity/stocks/ocup/pre-marke…
Big charts year https://bigcharts.marketwatch.com/advchart/frames/frames.asp…
ADFVN https://de.advfn.com/borse/NASDAQ/OCUP/kurs
YAHOO https://finance.yahoo.com/quote/OCUP?p=OCUP&.tsrc=fin-srch
Pre-Market https://www.nasdaq.com/market-activity/stocks/ocup/pre-marke…
Big charts year https://bigcharts.marketwatch.com/advchart/frames/frames.asp…
Trading Spotlight
Ocuphire Pharma Announces Submission of New Drug Application
https://finance.yahoo.com/news/ocuphire-pharma-announces-sub…
https://finance.yahoo.com/news/ocuphire-pharma-announces-sub…
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