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CRMD Positive Sentiment Score: 65/100

CorMedix Inc. to Participate in Two Upcoming Investor Conferences

Key Takeaway: CorMedix Inc. will participate in two upcoming investor conferences, the JMP Securities Life Sciences Conference and the RBC Capital Markets Global Healthcare Conference, both in New York later in May 2023. The company is focused on its lead product DefenCath, which has received Fast Track and Qualified Infectious Disease Product (QIDP) designations from the FDA. Despite positive developments, the company faced challenges with a second Complete Response Letter from the FDA regarding manufacturing deficiencies. A resubmission of the New Drug Application (NDA) for DefenCath is expected in mid-May.

Market Sentiment Analysis

POSITIVE FACTORS

  • Participation in two significant investor conferences may boost visibility.
  • DefenCath has received Fast Track designation and QIDP status from FDA.
  • NDA resubmission is planned for mid-May 2023, indicating progress.
  • Commitment to pediatric study could enhance market exclusivity.

CONCERNS & RISKS

  • Received a second Complete Response Letter from FDA due to deficiencies.
  • Concerns regarding manufacturing and supplier issues for heparin API.

Full Press Release Details

BERKELEY HEIGHTS, N.J., May 03, 2023 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases, today announced that management will be participating in fireside chats and investor meetings at both the JMP Securities Life Sciences Conference being held in New York on May 15 – 16, 2023 and the 2023 RBC Capital Markets Global Healthcare Conference being held in New York on May 16 – 17, 2023. Details for each fireside chat is as follows:
JMP Securities Life Sciences Conference
Date: Tuesday, May 16, 2023
Time: 11:30am EDT
Webcast: Click here
RBC Capital Markets Global Healthcare Conference
Date: Wednesday, May 17, 2023
Time: 2:35pm EDT
Webcast: Click here
A replay of each fireside chat will also be available in the “Events and Presentations” page on the investor relations portion of the Company’s website at: www.cormedix.com.
CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. The Company is focused on developing its lead product DefenCath™, a novel, non-antibiotic antimicrobial 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 original New Drug Application (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 second Complete Response Letter from the FDA last August related to deficiencies at both its primary contract manufacturer and its supplier of heparin API. The Company conducted a Type A meeting with FDA in April of 2023 and subsequently announced its intention to resubmit the NDA for DefenCath by mid-May of 2023. CorMedix also intends to develop DefenCath as a catheter lock solution for use in other patient populations, and the Company is working with top-tier researchers to develop taurolidine-based therapies for rare pediatric cancers. For more information visit: www.cormedix.com.

Frequently Asked Questions

What is the focus of CorMedix Inc.?

CorMedix Inc. specializes in developing therapeutic products for serious conditions.

When will CorMedix participate in investor conferences?

CorMedix will participate in two conferences: May 16 and 17, 2023.

What is DefenCath™ designed to prevent?

DefenCath™ aims to prevent bloodstream infections related to central venous catheters.

What designation did the FDA give DefenCath?

DefenCath received Fast Track and Qualified Infectious Disease Product designations.

What is the future plan for DefenCath?

CorMedix plans to develop DefenCath for use in different patient populations.

Last updated: May 3, 2023