NYMOX Provides Current Update
Rhea-AI Summary
Nymox Pharmaceutical (OTCQB:NYMXF) reported an update on Nymozarfex. The company is focusing on re-submitting for US marketing approval after the initial US filing was not accepted for review. Prior Denmark and UK submissions were fully reviewed but refused and would need updated re-submissions.
According to Nymox, reviewers questioned placebo effects and practical benefits of long-term efficacy, despite Phase 3 long-term double-blind data showing a p value of 0.0003 vs placebo. Management says additional financing is required to pursue further regulatory re-submissions.
AI-generated analysis. Not financial advice.
Positive
- Focus on US re-submission strategy for Nymozarfex marketing approval
- Denmark and UK agencies previously accepted Nymozarfex filings for full review
- Company believes existing clinical and scientific data can support updated re-submissions
- Independently audited double-blind Phase 3 long-term data p value 0.0003 vs placebo
- Management cites strong public demand for safer BPH and early prostate cancer treatments
Negative
- Initial US Nymozarfex submission was not accepted for review
- Denmark and UK regulators initially refused Nymozarfex applications after full review
- Company is not appealing the UK refusal at this time
- Reviewers expressed skepticism about placebo effects and practical long-term benefits
- CEO states updated re-submissions will require additional financing
News Market Reaction – NYMXF
On the day this news was published, NYMXF declined 15.40%, reflecting a significant negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
IRVINE, CA / ACCESS Newswire / June 2, 2026 / Nymox Pharmaceutical Corporation ("Nymox", "The Company") (OTCQB:NYMXF) reports that its plans for Nymozarfex (TM) are currently focused on re-submission in the US for marketing approval. The initial US submission was not accepted to be reviewed.
The Company's subsequent 2 submissions to Denmark and UK agencies were both accepted for full review but were initially refused and will require updated re-submission and re-review if the Company decides to pursue EU approvals further. The UK refused the application after review, and while the Company will not be appealing the UK decision at this time, updated re-submissions are a possibility. The Company believes Nymozarfex (TM) has the necessary clinical and scientific data required to formulate the required re-submissions. The reviewers remained skeptical re: 1. the one-year persistence of the significant placebo effect, despite the well established fact that the Nymozarfex non-oral placebo trial data was corroborated by the data in practically all non-oral BPH placebo groups in the entire published world literature; and 2. re what are the practical benefits of longer-term efficacy in this chronic long-term condition; and despite the primary endpoint symptom test scores being the universal endpoint used by urologists and agencies in the field for many decades.
Nymox CEO stated "Due to current financial limits, updated re-submissions will require additional financing. There remains great public demand for safe treatments for BPH and early prostate cancer, without the distressing side effects and discomforts of approved treatments. The Company is confident that with additional support, the treatments will become available to patients. The independently audited overall double blind Phase 3 long-term data has a p value of .0003 vs placebo, which we consider to be more than adequately solid."
For more information please contact info@nymox.com or 800-936-9669.
Forward Looking Statements
To the extent that statements contained in this press release are not descriptions of historical facts regarding Nymox, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements regarding the need for new options to treat BPH and prostate cancer, the potential of Fexapotide to treat BPH and prostate cancer and the estimated timing of further developments for Fexapotide. Such forward-looking statements involve substantial risks and uncertainties that could cause our clinical development program, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the clinical drug development process, including the regulatory approval process, the timing of Nymox's regulatory filings, Nymox's substantial dependence on Fexapotide, Nymox's commercialization plans and efforts and other matters that could affect the availability or commercial potential of Fexapotide. Nymox undertakes no obligation to update or revise any forward looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Nymox in general, see Nymox's current and future reports filed with the U.S. Securities and Exchange Commission, including its Annual Report on Form 20-F for the year ended December 31, 2024.
SOURCE: Nymox Pharmaceutical Corporation
View the original press release on ACCESS Newswire