NYMOX Announces Submission of New Drug Application (NDA) to the FDA for Fexapotide Triflutate
Nymox Pharmaceutical Corporation (NASDAQ: NYMX) announced the submission of its New Drug Application (NDA) to the FDA for Fexapotide Triflutate, aimed at treating benign prostatic hyperplasia (BPH). This marks a significant step towards potential marketing approval in the U.S. However, the company highlighted that there are no guarantees regarding the submission outcomes. Nymox plans to submit applications in other major markets shortly and will continue to update stakeholders on the application process and related developments.
- Successful NDA submission for Fexapotide Triflutate for BPH treatment.
- Plans for future submissions in other major markets.
- No guarantees on submission outcomes, highlighting regulatory uncertainties.
- Substantial dependence on Fexapotide for future growth.
IRVINE, Calif., March 03, 2022 (GLOBE NEWSWIRE) -- Nymox Pharmaceutical Corporation (NASDAQ: NYMX) (the “Company”) is pleased to announce today that it has submitted the Company’s New Drug Application (NDA) to the FDA for Fexapotide Triflutate to seek marketing approval in the U.S. for Fexapotide Triflutate for the treatment of men with benign prostatic hyperplasia (BPH).
The submission of the application does not involve any guarantees or forward looking statements regarding outcomes of the submission. The Company will continue to make updates on all material and required developments with the application, and in accordance with prior statements provided in the Company’s regular SEC filings.
Nymox intends to submit applications in other major markets in the near term and will provide updates at the appropriate times in due course.
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, 2020, and its Quarterly Reports.
For Further Information Contact:
Randall Lanham
Nymox Pharmaceutical Corporation 1-800-93NYMOX
www.nymox.com
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