Nymox MAA Expires with Danish Medicines Agency
Ticker: NYMXF · Form: 6-K · Filed: Jul 16, 2024 · CIK: 1018735
| Field | Detail |
|---|---|
| Company | Nymox Pharmaceutical CORP (NYMXF) |
| Form Type | 6-K |
| Filed Date | Jul 16, 2024 |
| Risk Level | medium |
| Pages | 1 |
| Reading Time | 1 min |
| Sentiment | neutral |
Sentiment: neutral
Topics: regulatory, filing, pharmaceutical
TL;DR
Nymox's Danish drug application expired, pushing back potential approval.
AI Summary
Nymox Pharmaceutical Corporation announced on July 16, 2024, that its marketing authorization application (MAA) submission to the Danish Medicines Agency (DKMA) has expired. The company will need to extend the MAA application process, which may impact its timeline for potential product approval in Denmark.
Why It Matters
The expiration of the MAA submission could delay Nymox's ability to market its product in Denmark, potentially impacting future revenue streams and market entry.
Risk Assessment
Risk Level: medium — The expiration of a key regulatory submission introduces uncertainty and potential delays in product commercialization.
Key Players & Entities
- Nymox Pharmaceutical Corporation (company) — Registrant
- Danish Medicines Agency (company) — Regulatory body
- July 16, 2024 (date) — Announcement date
FAQ
What is the status of Nymox Pharmaceutical Corporation's marketing authorization application (MAA) with the Danish Medicines Agency?
The MAA submission to the Danish Medicines Agency has expired as of July 16, 2024.
What action must Nymox Pharmaceutical Corporation take regarding its MAA submission?
The company will be required to extend the MAA application process.
When was the announcement regarding the MAA expiration made?
The announcement was made on July 16, 2024.
What is the principal executive office address for Nymox Pharmaceutical Corporation?
The principal executive office is located at Bay & Deveaux Streets, Nassau, The Bahamas.
Does Nymox Pharmaceutical Corporation file annual reports under Form 20-F or Form 40-F?
Nymox Pharmaceutical Corporation files annual reports under cover of Form 20-F.
Filing Stats: 264 words · 1 min read · ~1 pages · Grade level 14.7 · Accepted 2024-07-16 13:13:09
Filing Documents
- nymox_6k.htm (6-K) — 11KB
- nymox_ex991.htm (EX-99.1) — 14KB
- nymox_ex991img3.jpg (GRAPHIC) — 4KB
- nymox_ex991img4.gif (GRAPHIC) — 5KB
- 0001640334-24-001122.txt ( ) — 40KB
From the Filing
nymox_6k.htm UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 OF THE SECURITIES EXCHANGE ACT OF 1934 For the Month of July, 2024 Commission File Number: 001-12033 Nymox Pharmaceutical Corporation (Translation of registrant's name into English) Bay & Deveaux Streets, Nassau, The Bahamas (Address of principal executive office) Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40F. Form 20-F Form 40-F Changes in Registrant's Certifying Accountants (a) Dismissal of Independent Registered Public Accounting Firm On July 16, 2024, Nymox Pharmaceutical Corporation (the "Company") issued a press release regarding its announcement that the Company's marketing authorization application ("MAA") submission to the Danish Medicines Agency (the "DKMA") expired and that the Company will be required to extend the MAA application to the DKMA by re-submission. This press release is furnished as Exhibit 99.1 to this report on Form 6-K and shall not be deemed to be "filed" for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section. 2 EXHIBIT INDEX Exhibit No. Description 99.1 Press Release of Nymox Pharmaceutical Corporation, dated July 16, 2024 3 SIGNATURE Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. Date: July 16, 2024 NYMOX PHARMACEUTICAL CORPORATION By: /s/ Paul Averback Name: Paul Averback Title: President and Chief Executive Officer 4