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NYMOX Announces New Marketing Submission for NYMOZARFEX™ for BPH

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Nymox Pharmaceutical Corporation (NASDAQ: NYMX) announced the submission of a Marketing Authorization Application (MAA) in Europe for its treatment of benign prostatic hyperplasia (BPH), branded as NYMOZARFEX (TM). The application was submitted to Danish authorities, marking a significant step for the product. CEO Paul Averback expressed gratitude for the team's efforts and emphasized the unique innovation this treatment represents. Fexapotide has been tested on over 1,750 BPH patients, showing excellent safety and long-term efficacy compared to existing options.

Positive
  • Successful submission of MAA for NYMOZARFEX (TM) in Europe.
  • Fexapotide demonstrated significant long-term improvements in BPH patients.
  • The drug has an excellent safety profile with fewer side effects than current BPH treatments.
Negative
  • None.

IRVINE, Calif., Dec. 05, 2022 (GLOBE NEWSWIRE) -- Nymox Pharmaceutical Corporation (NASDAQ: NYMX) (the “Company”) is pleased to announce today that a new formal submission has been made by the Company in Europe for Fexapotide Triflutate for the treatment of benign prostatic hyperplasia (BPH). The trademarked name for the product in the application is NYMOZARFEX (TM). The Marketing Authorization Application (MAA) was submitted to the Danish authorities. The Company will provide further information, including other expected submissions, when the information becomes available.

Paul Averback MD, CEO of Nymox said, "We are extremely pleased to make this announcement today. We thank our team members and many very important collaborators for their efforts and perseverance involved in the ongoing process. This product is a major innovation and there is a great need for men to have access to this technology, which is unique. We will continue to provide updates and communications whenever appropriate. The Company is very grateful for the solid support of our stakeholders."

About NYMOZARFEX (TM) (Fexapotide)

NYMOZARFEX (TM) is given in an in-office procedure that is administered in a few minutes without need of anesthesia or analgesia. The drug has been tested in clinical trials involving overall more than 1750 BPH patients with over 1600 injections administered including over 1200 Fexapotide administrations. Fexapotide has led to significant long-term improvements and has shown an excellent safety profile without the side effects normally associated with existing BPH treatments.

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, 2021, and its Quarterly Reports.

For Further Information Contact:
Randall Lanham
Nymox Pharmaceutical Corporation 1-800-93NYMOX
www.nymox.com


FAQ

What is NYMOZARFEX (TM) and its purpose?

NYMOZARFEX (TM) is the trademarked name for Fexapotide, a treatment for benign prostatic hyperplasia (BPH).

When did Nymox submit its application for NYMOZARFEX (TM)?

Nymox submitted the Marketing Authorization Application (MAA) on December 5, 2022.

How many patients were involved in the clinical trials for Fexapotide?

Fexapotide has been tested in clinical trials with over 1,750 BPH patients.

What regulatory body received the MAA for NYMOZARFEX (TM)?

The MAA for NYMOZARFEX (TM) was submitted to the Danish authorities.

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