Nymox Must Resubmit Application to DKMA

Nymox Pharmaceutical Corporation, based in Irvine, California, announced that their Marketing Authorization Application (MAA) to the Danish Medicines Agency (DKMA) has expired. To move forward, the company must re-submit their application along with a new fee. The DKMA stated that the current application does not satisfy the criteria necessary for issuing a marketing authorization, despite numerous questions being resolved by Nymox. However, additional responses are still required, which will entail more time. Nymox is evaluating possible approaches to address the remaining questions but cannot confirm they will all be resolved.

One of the primary reasons for the delay is the DKMA's demand for a more stringent assay and method for ensuring impurities in Nymozarfex™ are below 0.1%, as opposed to the 0.2% initially submitted. Although Nymox has developed the required method to meet this specification, the process took longer than the DKMA allowed. Once the updated method for identification, assay, and related substances with an acceptable limit of quantitation (LOQ) of at least 0.1% is available, the corresponding information in the dossier will need to be updated.

Additionally, the DKMA required Nymox to provide evidence that their long-term follow-up (LTFU) studies were double-blinded. Nymox submitted an independent audit report confirming this, but the DKMA requested further information to supplement the audit certificates. Although Nymox has the necessary data, the submission process was incomplete due to time constraints.

Despite these setbacks, the data analysis for Nymozarfex was found to be robust, though some major questions remain. Nymox believes it has solid answers to these questions but will need additional submission cycles to provide the necessary information. Importantly, no major safety issues for Nymozarfex were identified in human clinical trials.

In the United Kingdom, Nymox's MAA to the Medicines and Healthcare products Regulatory Agency (MHRA) is actively progressing, with the company responding to questions from the MHRA. Updates on this process will be provided when appropriate.

Nymox is currently working on obtaining approval to market their first-in-class drug, NYMOZARFEX™, designed to treat the symptoms of benign prostatic hyperplasia (BPH), a common condition affecting middle-aged and elderly men globally. BPH can severely impact the quality of life for sufferers, and current treatments often have intolerable side effects, including sexual dysfunction and associations with prostate cancer, depression, and gynecomastia. Many patients discontinue existing medications due to these side effects, and surgery, often needed for advanced BPH, carries its own risks and discomforts, including permanent retrograde ejaculation in many cases.

Recently, Nymox reported new 10-year follow-up data from a U.S. clinical trial of NYMOZARFEX™ for treating low-grade localized prostate cancer. The long-term data confirmed that NYMOZARFEX™ provides significant benefits in reducing the progression of prostate cancer.

NYMOZARFEX™ is administered during a brief in-office procedure without the need for anesthesia or analgesia. Clinical trials have involved over 1,750 patients and more than 1,600 injections, including over 1,200 administrations of NYMOZARFEX™. The drug has demonstrated significant long-term improvements and an excellent safety profile, free from the side effects commonly associated with current BPH treatments.