NYMOX Provides Current Update
Nymox Pharmaceutical Corporation (NASDAQ: NYMX) has provided an update on its business developments regarding Fexapotide, a novel treatment for BPH. The company has engaged with the FDA and received feedback for the resubmission of its New Drug Application (NDA). Nymox is also preparing to submit a marketing application for Fexapotide in Europe in Q4 2022. The drug has been administered in over 1,600 injections with significant safety and efficacy, suggesting a promising alternative for patients with lower urinary tract symptoms.
- Engaged with FDA for resubmission of NDA.
- Plans to submit marketing application for Fexapotide in Europe in Q4 2022.
- Fexapotide shows significant long-term improvements for BPH with a strong safety profile.
- Dependence on Fexapotide may expose the company to risks during regulatory approval.
IRVINE, Calif., Sept. 13, 2022 (GLOBE NEWSWIRE) -- Nymox Pharmaceutical Corporation (NASDAQ: NYMX) is pleased to provide a current update on business developments.
The Company has corresponded with and has met with the FDA during the past few months. The agency has provided very helpful feedback to the Company. FDA has specified what additional information is required in resubmission of the NDA; and the Company is in the process of preparing the requested documentation for the resubmission of requested data, and for further interactions with FDA for additional guidance.
The Company expects to submit a marketing application for Fexapotide in Europe in the upcoming 4th quarter of this year and will provide further information as the time for the Fexapotide submission approaches in the near future.
Paul Averback, CEO of Nymox said, "We are very fortunate to have the benefit of expert advisors both in the US and in Europe who have greatly contributed to the overall project. In addition, the authorities have provided consistently helpful feedback. The Company and its extended team are working constantly to make sure that no stone is left unturned to help this remarkable new treatment become available for the vast number of men who are in need of safer more effective choices to manage their bothersome and distressing lower urinary tract BPH symptoms."
Fexapotide is an office injection 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
1-800-93NYMOX
www.nymox.com
FAQ
What is the latest update on Nymox Pharmaceutical Corporation regarding Fexapotide?
What clinical data supports Fexapotide's efficacy for BPH?
When does Nymox plan to submit the marketing application for Fexapotide in Europe?
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