Ocuphire Pharma, Inc. (OCUP) ---> Fakten (Seite 12)
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ISIN: US67577R1023 · WKN: A2QG4Z · Symbol: OCUP
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Annual Report
Annual Report
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Ocuphire Pharma Announces Financial Results for Fourth Quarter and Year Ended 2022 and Provides Corporate Update
Key Anticipated Future Milestones seite 5
As of December 31, 2022, Ocuphire had cash and cash equivalents of approximately $42.6 million.
The Company has no debt. Based on current projections, management believes
the present cash on hand will be sufficient to fund operations into 2025.
Ocuphire Pharma Announces Financial Results for Fourth Quarter and Year Ended 2022 and Provides Corporate Update
Key Anticipated Future Milestones seite 5
As of December 31, 2022, Ocuphire had cash and cash equivalents of approximately $42.6 million.
The Company has no debt. Based on current projections, management believes
the present cash on hand will be sufficient to fund operations into 2025.
presentatin maerz
https://d1io3yog0oux5.cloudfront.net/_8498f524855c4f551d2800…
mit auswertung ZETA-1 ab seite 12 bis seite 19
ZETA-1: Baseline Demographics and Characteristics
https://d1io3yog0oux5.cloudfront.net/_8498f524855c4f551d2800…
mit auswertung ZETA-1 ab seite 12 bis seite 19
ZETA-1: Baseline Demographics and Characteristics
Ocuphire Announces FDA Acceptance of New Drug Application and PDUFA Date of September 28, 2023 for Nyxol® Eye Drops for Reversal of Mydriasis
https://finance.yahoo.com/news/ocuphire-announces-fda-accept…
https://finance.yahoo.com/news/ocuphire-announces-fda-accept…
presentation 31.01.2023
Initiate Nyxol Phase 3 Presbyopia Trials (VEGA2/3) and Long-term Safety Trial (LYRA-1)
EOP2 FDA Meeting for APX3330 to Confirm Endpoints and Advance into Phase 3 - (2H 2023)
Potential Approval of Nyxol NDA for RM - (Late 2023)
Report Nyxol 1st VEGA-2 Phase 3 Presbyopia Data - (Late 2023)
quelle https://d1io3yog0oux5.cloudfront.net/_dfe6878ac93fc42a11a145…
Initiate Nyxol Phase 3 Presbyopia Trials (VEGA2/3) and Long-term Safety Trial (LYRA-1)
EOP2 FDA Meeting for APX3330 to Confirm Endpoints and Advance into Phase 3 - (2H 2023)
Potential Approval of Nyxol NDA for RM - (Late 2023)
Report Nyxol 1st VEGA-2 Phase 3 Presbyopia Data - (Late 2023)
quelle https://d1io3yog0oux5.cloudfront.net/_dfe6878ac93fc42a11a145…
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ZETA-1 APX3330 Topline Results
ZETA-1 Trial: Key Takeaways - seite 5• Prevention of 3-step worsening (binocular) is a suitable endpoint for an oral, systemically drug
---> Ocuphire plans to go forward with this potential registration endpoint in Phase 3
• following confirmation with the FDA in EOP2 meeting - seite 30 - EOP2 FDA Meeting for APX3330 (2H 2023)
• Oral APX3330 demonstrated favorable safety and tolerability
• If approved, APX3330 could be an important new primary preventative therapeutic option
that could be used in a large number of diabetic patients who are earlier in their disease
Key Takeaways and Next Steps ---> seite 29
• Further analysis of ZETA-1 Phase 2 data, including insights for Phase 3 registration trial design
• Plan for the EOP2 FDA meeting for APX3330 in DR indication
• Data presentations at medical meetings
• Advance APX3330 development (cGMP drug, NDA-enabling work, first Phase 3 trial,regional partnerships)
https://d1io3yog0oux5.cloudfront.net/_6ac6c6fcc3f1d9077d66f9…
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… 
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