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Nymox Pharmaceutical Corporation (symbol: NYMX) is a biopharmaceutical company dedicated to the research and development of innovative drugs targeting the aging population. Founded in 1989 and headquartered in Nassau, Bahamas, Nymox operates internationally, including in Canada, the United States, and Europe.
The company's lead drug candidate, Fexapotide Triflutate (NX-1207), is designed to treat benign prostatic hyperplasia (BPH). Having successfully completed Phase III clinical trials, NX-1207 is now in Phase II trials for treating low-grade localized prostate cancer and is also undergoing preclinical studies for hepatocellular carcinoma.
Nymox offers several diagnostic products, such as Nicalert and TobacAlert test strips, which use urine or saliva to detect nicotine and tobacco product use. Another significant product is Alzheimalert, a proprietary urine assay that helps physicians diagnose Alzheimer's disease.
Recently, Nymox made headlines with the issuance of several important U.S. patents for NYMOZARFEX, showcasing significant progress in their research efforts. The latest studies indicate that a minimal treatment of 15 mg NYMOZARFEX leads to a significant long-term reduction in prostate cancer surgeries and radiotherapies for patients with low-grade prostate cancer.
With a commitment to advancing healthcare solutions for an aging demographic, Nymox Pharmaceutical Corporation continues to be at the forefront of biopharmaceutical innovation, making impactful strides in the detection and treatment of age-related diseases.
Nymox Pharmaceutical Corporation (NASDAQ: NYMX) announced that its submission for the treatment of benign prostatic hyperplasia (BPH), branded as NYMOZARFEX, has been validated by Danish authorities, initiating the formal review process. The Marketing Authorization Application (MAA) was submitted in December 2022, following extensive clinical trials involving over 1,750 BPH patients. The treatment offers a short in-office procedure without anesthesia and has demonstrated significant long-term benefits with a favorable safety profile compared to existing treatments. CEO Paul Averback expressed gratitude for the support received and commitment to further updates.
Nymox Pharmaceutical Corporation (NASDAQ: NYMX) received a deficiency letter from Nasdaq on January 4, 2023, due to its stock trading below $1.00 and insufficient stockholders' equity. The company has appealed the decision, seeking to avoid delisting set for January 13, 2023. In a positive development, Nymox submitted a new application for Fexapotide Triflutate, branded as NYMOZARFEX, for treating benign prostatic hyperplasia. The drug has shown promise in clinical trials involving over 1,750 patients, demonstrating significant long-term improvements without common side effects.
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.
Nymox Pharmaceutical Corporation (NASDAQ: NYMX) received a deficiency notice from NASDAQ on November 18, 2022, indicating it does not meet the minimum market value requirement of $35 million. The company has 180 days, until May 17, 2023, to comply with this requirement by sustaining a market value above $35 million for at least 10 consecutive business days. Failure to do so may result in delisting, although the company can appeal this decision if necessary.
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.
Nymox Pharmaceutical Corporation (NASDAQ: NYMX) provided an update on its business activities, assuring shareholders that plans are progressing and ongoing initiatives are advancing positively. Dr. Paul Averback, President and CEO, emphasized that the company is well-funded and has made advancements in key projects despite setbacks. Nymox anticipates sharing important updates during the summer and in Q3 and Q4. The company acknowledges the inherent risks and uncertainties in clinical drug development, particularly relating to its primary product, Fexapotide, for treating BPH and prostate cancer.
Nymox Pharmaceutical Corporation (NASDAQ: NYMX) announced on July 7, 2022, that it received a deficiency letter from NASDAQ regarding non-compliance with Listing Rule 5550(a)(2). The company has 180 days to restore compliance by achieving a closing bid price of $1.00 or more for at least 10 consecutive business days. If compliance is not met within this timeframe, Nymox could face delisting, but has the option to appeal NASDAQ's determination. The company emphasized its focus on treating BPH and prostate cancer through its product Fexapotide, amidst various operational uncertainties.
Nymox Pharmaceutical Corporation (NASDAQ: NYMX) announced it received a Refusal to File letter from the FDA regarding its New Drug Application for Fexapotide Triflutate on May 20, 2022. The FDA cited the need for longer-term safety data, which was not previously requested. Nymox contends that the safety profile of Fexapotide is superior to conventional BPH treatments and that they have met prior safety data requirements. The company will seek clarifications and plans to provide further updates as they become available.
Nymox Pharmaceutical Corporation (NASDAQ: NYMX) has successfully completed a financing round, raising $6.4 million through the sale of 3,878,789 common shares at $1.65 per share. The offering included unregistered warrants for the same number of shares at an exercise price of $2.00 each, expiring in five years. The proceeds will support general corporate purposes and working capital. Notably, long-term shareholders showed strong support for this offering, with a director participating in the round. The amount raised increased from an initial estimate of $5 million.
Nymox Pharmaceutical Corporation (NASDAQ: NYMX) announced a registered direct offering of 3,030,304 common shares at $1.65 per share, aiming for gross proceeds of approximately $5 million. The company will also issue unregistered warrants for the same number of shares, exercisable at $2.00 each for five years. The proceeds will support general corporate purposes, including working capital. The offering's closing is expected on or about March 22, 2022. A.G.P./Alliance Global Partners acts as the placement agent.
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