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Highlights
- Ocuphire Pharma announced the number of participants for the MIRA-3 Phase 3 trial.
- CEO Mina Sooch said the company will submit a new drug application (NDA) for Nyxol eye drops after the trial results.
- The company reported a net loss of US$US$4.23 in Q3, FY21.
Shares of Ocuphire Pharma, Inc. (Nasdaq:OCUP) jumped more than 34% on Wednesday after the company shared upbeat news regarding its MIRA-3 Phase 3 trial.
The stock was up 34.48% to US$4.68 at 10:55 am ET on Wednesday.
The Farmington Hills, Michigan-based company said that it has selected the subjects for the MIRA-3 Phase 3 pivotal trial regarding its new eye drop. The study will access the safety and efficiency of Nyxol eyedrops against mydriasis or dilation of the pupil.
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Ocuphire is a clinical-stage biopharmaceutical company and develops drugs for eye disorders.
The company expects top-line results from the MIRA-3 trial early next year or by the end of the first quarter of 2022. Six sites have already enrolled the subjects, and 10 more will start soon.
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Ocuphire President and CEO Mina Sooch said the safety and efficiency of Nyxol for the reversal of mydriasis have been demonstrated in the previous clinical trials of MIRA-1 Phase 2b and MIRA-2 Phase 3. She added that both the trials met their primary and secondary endpoints with "statistical significance".
In addition, Sooch said that although around half of their patient take "6 hours or longer, sometimes 24 hours" to return to their normal pre-dilated pupil size, the prior data on Nyxol showed that 50% of their patient comes back to the baseline by 90 minutes, while about 80% by three hours.
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Stock performance and financials
The Michigan-based company has a market cap of US$60.20 million, with a forward P/E one year of US$-0.91. Its stocks saw the highest price of US$13.81 and the lowest price of US$3.36 in the last 52 weeks. Its trading volume on Nov 23 was 157,191.
For the three months ended on Sep 30, 2021, the company's collaborations revenue was US$489 thousand. Also, the company reported a net loss of US$4.23 million, or US$0.25 per share, in the quarter, against a loss of US$1.24 million, US$0.33 per diluted share a year ago.
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Conclusion
CEO Mina Sooch said the company would submit a new drug application (NDA) for Nyxol if it achieves more positive results from MIRA-3. If the results come out more positive, it will be a major milestone for the company. Besides opening-up opportunities for steady revenue stream, the study would bolster its future research in the field. The OCUP stock fell 50.29% YTD.
