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#3307
Opus Genetics, Inc. - Common Stock
3.6 9 USD
-0.04%
Market Price
Sektor: Gesundheitswesen
Basis: USD
Gewinnwährung: USD
Tagesspanne
3.69
3.69
Jahresspanne
2.82
5.81
Tagesänderung
-4.16%
Monatliche Änderung
-4.16%
6 month change
-9.56%
Jahresänderung
-0.81%
Vorheriger Schlusskurs
3.8 5
Open
3.6 9
Tief
3.6 9
Hoch
3.6 9
Volumen
59
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Financials

Übersicht Finanzbericht Statistik Documents

2026

Current report, Q3 FY2026
Opus Genetics, Inc. current report, Q3 FY2026
8-K
Quarterly report, Q2 FY2026
Opus Genetics, Inc. quarterly report, Q2 FY2026
10-Q
Current report, Q2 FY2026
Opus Genetics, Inc. current report, Q2 FY2026
8-K
Current report, Q2 FY2026
Opus Genetics, Inc. current report, Q2 FY2026
8-K
Current report, Q2 FY2026
Opus Genetics, Inc. current report, Q2 FY2026
8-K
Current report, Q2 FY2026
Opus Genetics, Inc. current report, Q2 FY2026
8-K
Current report, Q2 FY2026
Opus Genetics, Inc. current report, Q2 FY2026
8-K
Current report, Q2 FY2026
Opus Genetics, Inc. current report, Q2 FY2026
8-K
Current report, Q2 FY2026
Opus Genetics, Inc. current report, Q2 FY2026
8-K
Quarterly report, Q1 FY2026
Opus Genetics, Inc. quarterly report, Q1 FY2026
10-Q

Opus Genetics, Inc. current report, 04 November 2011

Full document

Business Context and Reporting Period

This Form 8-K was filed by Rexahn Pharmaceuticals, Inc. on November 4, 2011. The report discloses the results of a Phase IIb clinical trial for the company's investigational drug, Serdaxin, intended for the treatment of major depressive disorder (MDD). Note: The request metadata referenced "Opus Genetics, Inc.," but the filing text explicitly identifies the issuer as Rexahn Pharmaceuticals, Inc.

Key Financial Metrics

The filing text does not provide specific financial data such as revenue, profit, cash flow, margins, debt, or liquidity. This report focuses exclusively on clinical trial outcomes and does not contain a financial statement or quantitative financial metrics.

Material Changes and Clinical Results

  • Primary Endpoint Failure: The Phase IIb study did not demonstrate Serdaxin's efficacy compared to placebo when measured by the Montgomery-Asberg Depression Rating Scale (MADRS).
  • Study Design: The randomized, double-blind, placebo-controlled study compared two doses of Serdaxin (0.5 mg and 5 mg) against a placebo over an 8-week period.
  • Outcome Data: All treatment groups, including placebo, showed an approximate -14 point improvement in the MADRS primary endpoint.
  • Safety Profile: The study indicated that Serdaxin was safe and well tolerated.

Outlook, Risks, and Management Commentary

Management commentary is limited to the announcement of the trial results. The failure to meet the primary efficacy endpoint represents a significant negative development for the Serdaxin program. The filing does not provide specific future guidance, revised timelines, or detailed contingency plans beyond the disclosure of the results. The primary risk highlighted is the lack of demonstrated efficacy for the lead candidate in this specific trial.

Investor Verification Checklist

  • Verify the company name discrepancy between the request metadata (Opus Genetics) and the filing (Rexahn Pharmaceuticals).
  • Review the full text of the attached press release (Exhibit 99.1) for any additional context on the statistical analysis or secondary endpoints.
  • Assess the impact of this Phase IIb failure on the company's overall pipeline and cash runway, as this filing does not address financial implications.
  • Monitor subsequent filings for potential changes in the development strategy for Serdaxin or the initiation of new trials.