Tuesday, September 07, 2021 11:16:16 AM
It's like the company is intentionally driving the stock price into the gutter.
Read this BS...no details.
CorMedix Inc. Announces Regulatory Update
BERKELEY HEIGHTS, N.J., Sept. 07, 2021 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, today provided an update with respect to its resubmission timeline for the DefenCath New Drug Application (“NDA”). CorMedix has encountered delays at its third-party contract manufacturer (“CMO”). The Company was informed by the CMO that there are issues that are unrelated to DefenCath manufacturing activities. The timeline for CorMedix and the CMO to address deficiencies at the facility that are required for resubmission of the DefenCath NDA is uncertain at this time. We will provide an update when more information becomes available.
About CorMedix
CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory diseases. The Company is focused on developing its lead product DefenCath™, a novel, antibacterial and antifungal solution designed to prevent costly and life-threatening bloodstream infections associated with the use of central venous catheters in patients undergoing chronic hemodialysis. DefenCath has been designated by FDA as Fast Track and as a Qualified Infectious Disease Product (QIDP), and the NDA received priority review in recognition of its potential to address an unmet medical need. QIDP provides for an additional five years of marketing exclusivity, which will be added to the five years granted to a New Chemical Entity upon approval of the NDA. CorMedix also committed to conducting a clinical study in pediatric patients using a central venous catheter for hemodialysis when the NDA is approved, which will add an additional six months of marketing exclusivity when the study is completed. The Company received a Complete Response Letter from FDA stating that the NDA could not be approved until satisfactory resolution of deficiencies at the contract manufacturing facility, including in-process controls for the filling operation. CorMedix also intends to develop DefenCath as a catheter lock solution for use in oncology and total parenteral nutrition patients. It is leveraging its taurolidine technology to develop a pipeline of antimicrobial medical devices, with programs in surgical sutures and meshes, and topical hydrogels. The Company is also working with top-tier researchers to develop taurolidine-based therapies for rare pediatric cancers. Neutrolin® is CE Marked and marketed in Europe and other territories as a medical device. 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 that are subject to risks and uncertainties. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects, future financial position, financing plans, future revenues and projected costs should be considered forward-looking. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, including: the results of our discussions with the FDA regarding the DefenCath development path for marketing authorization; the resources needed to secure approval of the new drug application for DefenCath from the FDA; the risks and uncertainties associated with CorMedix’s ability to manage its limited cash resources and the impact on current, planned or future research, including the continued development of DefenCath/Neutrolin and research for additional uses for taurolidine; obtaining additional financing to support CorMedix’s research and development and clinical activities and operations; preclinical results are not indicative of success in clinical trials and might not be replicated in any subsequent studies or trials; and the ability to retain and hire necessary personnel to staff our operations appropriately. We continue to assess to what extent the uncertainty surrounding the Coronavirus pandemic may impact our business and operations. These and other risks are described in greater detail in CorMedix’s filings with the SEC, 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 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
(617) 430-7576
Recent CRMD News
- CorMedix Inc. Announces CMS Grants TDAPA to DefenCath • GlobeNewswire Inc. • 04/19/2024 12:30:00 PM
- CorMedix Inc. Announces U.S. Inpatient Commercial Availability of DefenCath® (Taurolidine and Heparin) • GlobeNewswire Inc. • 04/15/2024 12:30:00 PM
- CorMedix Inc. Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update • GlobeNewswire Inc. • 03/12/2024 11:30:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/30/2024 10:26:20 PM
- Form 4/A - Statement of changes in beneficial ownership of securities: [Amend] • Edgar (US Regulatory) • 01/18/2024 09:53:09 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/18/2024 01:11:54 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/18/2024 01:10:50 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/18/2024 01:09:42 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/18/2024 01:04:10 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/15/2023 01:39:55 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/14/2023 09:05:32 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 11/21/2023 09:00:20 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/16/2023 09:11:33 PM
- CorMedix Inc. Reports Third Quarter and Nine Month 2023 Financial Results and Provides Business Update • GlobeNewswire Inc. • 11/14/2023 09:05:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/30/2023 08:35:11 PM
- CorMedix Inc. Announces Abstract Presentation at Upcoming IDWeek Conference • GlobeNewswire Inc. • 10/11/2023 12:30:00 PM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 09/13/2023 09:25:27 PM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 09/13/2023 09:20:10 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 09/08/2023 08:21:55 PM
- CorMedix Inc. Announces Publication of Phase 3 LOCK IT-100 Study Data in the Clinical Journal of The American Society of Nephrology • GlobeNewswire Inc. • 09/08/2023 12:30:00 PM
- CorMedix Inc. Announces Issuance of U.S. Patent Covering Lead Product Defencath • GlobeNewswire Inc. • 08/30/2023 12:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/17/2023 12:30:07 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/08/2023 12:12:04 PM
VPR Brands LP Reports Record Annual Financial Performance for Fiscal Year 2023 • VPRB • Apr 19, 2024 11:24 AM
Coinllectibles' Subsidiary, Grand Town Development Limited, Acquires Rare Song Dynasty Ceramics Worth Over USD28million • COSG • Apr 18, 2024 8:03 AM
ILUS Provides Form 10-K Filing Update • ILUS • Apr 17, 2024 9:54 AM
Glucotrack Announces Expansion of Its Continuous Glucose Monitoring Technology to Epidural Glucose Monitoring • GCTK • Apr 17, 2024 8:00 AM
Maybacks Global Entertainment To Fire Up 24 New Stations in Louisiana • AHRO • Apr 16, 2024 1:30 PM
Cannabix Technologies Begins Certification of Contactless Alcohol Breathalyzer, Re-Brands product series to Breath Logix • BLOZF • Apr 16, 2024 8:52 AM