Nymox Announces Updates in Regulatory Submissions For Fexapotide Treatment For Prostate Enlargement
Nymox Pharmaceutical Corporation (NASDAQ: NYMX) has successfully advanced its regulatory submission preparations, with most documentation completed despite pandemic-related challenges. CEO Dr. Paul Averback noted the team’s extraordinary effort in meeting timelines and expects to file applications by the end of Q3 or early Q4. The company remains optimistic about the future, highlighting the unmet medical need for treatments related to prostate issues. They commend their recent successes in intellectual property for Fexapotide, aimed at treating prostate enlargement and cancer.
- Majority of regulatory documentation completed despite pandemic challenges.
- Anticipating application filings by end of Q3 or early Q4.
- Positive outlook on Fexapotide's potential for unmet medical needs.
- Regulatory timeline impacted by COVID-19 delays.
HASBROUCK HEIGHTS, N.J., June 19, 2020 (GLOBE NEWSWIRE) -- Nymox Pharmaceutical Corporation (NASDAQ: NYMX) is very pleased to report that key steps in its regulatory submission preparations have been completed and the project is firmly on-track. The majority of its regulatory documentation has proceeded very well, despite the inherent limitations of the business environment in 2020. Certain tasks have been hampered by the Covid pandemic restrictions, similar to other companies in the sector. These remaining tasks are expected to be completed reasonably soon as the Company regains the ability to retrieve required documentation from external sites and to complete other required tasks and on-site activities that were hindered due to the global restrictions in place.
Dr. Paul Averback, CEO commented "We are extremely pleased with the progress we have been able to achieve despite these obvious limitations due to the pandemic restrictions as we reported in our 6K filing on April 24. I want to thank the whole team for putting in an extraordinary effort towards meeting our regulatory timeline goals. Extremely complex tasks have been coordinated and executed successfully. Given the ongoing reopening of the economy we now expect to attend to the remaining matters near-term. Taking into account the above factors, we are well within our projected timelines as corrected for by the addition of the previously announced Covid-related delay of several months. We are now expecting to file our applications with the authorities approximately by the end of Q3 or early Q4. We will continue to regularly update our shareholders as we complete the entire packages."
"Nymox management is very proud of the quality of our evidence and we not only look forward to the upcoming near-term submissions, but we are highly enthusiastic about the prospects for our Company and its shareholders. This is a field which has a substantial unmet medical need for safer and more effective treatments. The Company has achieved numerous major successes in the past couple years with its intellectual property applications around the world which have greatly extended the timeline value of the Company's Fexapotide treatments for prostate enlargement and for prostate cancer", Dr. Averback said.
For further in-depth detailed information about the Nymox treatments for prostate enlargement (BPH) and early stage prostate cancer please see peer review publications at the following links: https://doi.org/10.1007/s00345-018-2185-y and https://link.springer.com/article/10.1007/s00345-020-03127-w and visit www.nymox.com.
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, 2019, and its Quarterly Reports.
For Further Information Contact:
Erik Danielsen
Nymox Pharmaceutical Corporation
1-800-93NYMOX
www.nymox.com
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