Appeals court upholds CorMedix (NASDAQ: CRMD) MINOCIN® patents and injunction
Rhea-AI Filing Summary
CorMedix Inc. reported that the U.S. Court of Appeals for the Federal Circuit has affirmed a prior district court judgment in patent litigation over MINOCIN® for Injection. The court agreed that Nexus Pharmaceuticals’ proposed generic minocycline product infringes two CorMedix patents and rejected Nexus’s invalidity challenge.
The Federal Circuit also upheld a permanent injunction that prevents Nexus from marketing its generic minocycline product before the MINOCIN® patents expire. This decision strengthens the intellectual property protection around CorMedix’s intravenous minocycline reformulation, an antibiotic used primarily in hospital and acute care settings.
Positive
- Federal Circuit affirms patent win and injunction, confirming that Nexus’s proposed generic minocycline product infringes MINOCIN® patents and upholding a permanent injunction that blocks Nexus from marketing its generic before patent expiration, which supports continued product exclusivity.
Negative
- None.
Insights
Federal Circuit win preserves MINOCIN® patent protection and blocks a Nexus generic.
CorMedix secured an appellate affirmation that its MINOCIN® for Injection patents are both valid and infringed by Nexus Pharmaceuticals’ proposed generic minocycline product. The ruling follows a four-day bench trial where a district court had already found in favor of CorMedix’s Melinta Therapeutics subsidiary.
The appeals court also left in place a permanent injunction barring Nexus from marketing its generic before patent expiration. This limits near-term generic competition specifically from Nexus and supports the exclusivity of MINOCIN® in hospital and acute care settings.
Future company filings may detail how this legal outcome influences MINOCIN® sales, patent life, and any additional enforcement steps against other potential generic entrants, if applicable.
8-K Event Classification
Key Figures
Key Terms
permanent injunction regulatory
FDA Orange Book regulatory
forward-looking statements regulatory
bench trial legal
intellectual property portfolio financial
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported):
(Exact name of registrant as specified in its charter)
| (State
or other jurisdiction of incorporation) |
(Commission File Number) | (IRS
Employer Identification No.) |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s
telephone number, including area code: (
N/A
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2, below):
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 7.01 Regulation FD Disclosure
On June 8, 2026, CorMedix, Inc. (the “Company”) issued a press release on the decision by the United States Court of Appeals for the Federal Circuit in Melinta Therapeutics, LLC, et al. v. Nexus Pharmaceuticals, Inc., which affirmed the district court’s judgment that Nexus Pharmaceuticals Inc.’s generic minocycline product infringed two of the Company’s patents and rejected Nexus’s invalidity challenge. A copy of the press release is furnished as Exhibit 99.1, attached hereto.
The information in this Item 7.01 (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Forward-Looking Statements
This Current Report on Form 8-K contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act, and Section 21E of the Exchange Act, that are subject to risks and uncertainties. Forward-looking statements are often identified by the use of words such as, but not limited to, “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “project,” “seek,” “should,” “target,” “will,” “would,” and similar expressions or variations intended to identify forward-looking statements. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or the Company’s prospects should be considered forward-looking statements. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, and readers are directed to the Risk Factors identified in the Company’s filings with the SEC, including its most recent Annual Report on Form 10-K, copies of which are available free of charge at the SEC’s website at www.sec.gov or upon request from the Company. The Company may not actually achieve the goals or plans described in its forward-looking statements, and such forward-looking statements speak only as of the date of this Current Report on Form 8-K. Investors should not place undue reliance on these statements. The Company assumes no obligation and does not intend to update these forward-looking statements, except as required by law.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits
| Exhibit No. | Description | |
| 99.1 | Press Release dated June 8, 2026 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
1
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.
| CORMEDIX INC. | ||
| Date: June 8, 2026 | By: | /s/ Joseph Todisco |
| Name: | Joseph Todisco | |
| Title: | Chief Executive Officer | |
2
Exhibit 99.1
U.S. COURT OF APPEALS FOR THE FEDERAL CIRCUIT AFFIRMS VICTORY FOR CORMEDIX THERAPEUTICS IN MINOCIN® PATENT LITIGATION
Parsippany, NJ – June 8, 2026 – CorMedix Therapeutics (Nasdaq: CRMD) today announced that the United States Court of Appeals for the Federal Circuit has affirmed the judgment of the U.S. District Court for the Northern District of Illinois that the patents covering its product MINOCIN® for Injection are valid and infringed by the product developed by Nexus Pharmaceuticals, Inc.
Following a four-day bench trial in 2023, the district court found in favor of CorMedix’s wholly owned subsidiary Melinta Therapeutics on all patent infringement and validity issues. The Federal Circuit’s decision on Friday upheld the district court’s findings that Nexus’ proposed generic minocycline product infringes the MINOCIN® patents and rejected Nexus’ invalidity challenge. The Federal Circuit also affirmed the district court’s permanent injunction barring Nexus from marketing its generic product prior to patent expiration. The patents-at-issue are FDA Orange Book listed and protect the company’s innovative reformulation of intravenous minocycline, marketed as MINOCIN® for Injection. MINOCIN® is a tetracycline derived antibiotic used primarily in hospital and acute care settings for patients with a variety of serious and drug-resistant infections.
“We are pleased that the Federal Circuit has affirmed the district court’s thorough and well-reasoned decision,” said Joseph Todisco, CorMedix Chairman and CEO. “This ruling validates the strength of the MINOCIN® intellectual property portfolio and recognizes the innovative work that led to important improvements in intravenous minocycline therapy for patients. The decision reinforces the importance of protecting pharmaceutical innovation and the substantial investments required to develop improved therapies. We will continue to protect and defend CorMedix’s intellectual property.”
About CorMedix
CorMedix Therapeutics is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases in the United States. CorMedix is focused on selling and marketing products in institutional settings of care in the US and has field based medical and commercial infrastructure deployed in hospitals, clinics and infusion centers. For more information visit: www.cormedix.com.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, as amended (the “Exchange Act”), that are subject to risks and uncertainties. Forward-looking statements are often identified by the use of words such as, but not limited to, “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “project,” “seek,” “should,” “target,” “will,” “would,” and similar expressions or variations intended to identify forward-looking statements. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects should be considered forward-looking statements including, but not limited to statements regarding financial and business guidance; sales, revenue and operating expense estimates; synergy estimates and timing; accretion estimates and Adjusted EBITDA estimates. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, and readers are directed to the Risk Factors identified in CorMedix’s filings with the SEC, including its most recent Annual Report on Form 10-K, copies of which are available free of charge at the SEC’s website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and such forward-looking statements speak only as of the date of this press release. In addition, pro forma financial information does not necessarily reflect the actual results that we would have achieved had the pro forma transaction been consummated as of the date indicated nor does it reflect the potential future results of the combined company. Investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law.
Investor Contact:
Dan Ferry
Managing Director
LifeSci Advisors
daniel@lifesciadvisors.com
(617) 430-7576