CorMedix Inc. to Report Third Quarter 2020 Financial Results and Provide a Corporate Update on November 5

Rhea-AI Summary

CorMedix Inc. (NYSE American: CRMD) announced it will release its third-quarter financial results on November 5, 2020, after market close, followed by a conference call at 4:30 PM EST. The company is focused on developing its lead product, Defencath®, designed to prevent bloodstream infections in patients with central venous catheters. Defencath's New Drug Application (NDA) has been accepted for priority review by the FDA, with a PDUFA date set for February 28, 2021. Additionally, Defencath is designated as a Qualified Infectious Disease Product, potentially extending its marketing exclusivity.

Positive

• Defencath's NDA accepted for priority review with PDUFA date on February 28, 2021.
• Defencath designated as a Qualified Infectious Disease Product, granting five additional years of marketing exclusivity.
• Focus on expanding Defencath as a catheter lock solution for oncology and total parenteral nutrition.

Negative

• No significant revenue updates or guidance provided.

BERKELEY HEIGHTS, N.J., Oct. 29, 2020 (GLOBE NEWSWIRE) -- CorMedix Inc. (NYSE American: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, today announced that it will report its financial results for the third quarter ended September 30, 2020, after the market close on Thursday, November 5, and will host a corporate update conference call at 4:30pm EST.

Thursday, November 5th @ 4:30pm EST
Domestic:	800-917-9975
International:	212-231-2901
Conference ID:	21971218
Webcast:	Webcast Link

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’s NDA has been filed and accepted for priority review with a PDUFA date of February 28, 2021. Defencath has been designated by FDA as Fast Track and as a Qualified Infectious Disease Product, which provides 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 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.

Investor Contact:
Dan Ferry
Managing Director
LifeSci Advisors
daniel@lifesciadvisors.com
(617) 430-7576

FAQ

When will CorMedix report its financial results?

CorMedix will report its financial results for the third quarter on November 5, 2020, after market close.

What is the PDUFA date for Defencath?

The PDUFA date for Defencath is February 28, 2021.

What is Defencath and its significance?

Defencath is a novel antibacterial and antifungal solution aimed at preventing bloodstream infections in patients with central venous catheters.

What designation has Defencath received from the FDA?

Defencath has been designated as a Fast Track and a Qualified Infectious Disease Product by the FDA.