Cormedix Stock Price, News & Analysis

CorMedix (Nasdaq: CRMD) announced that DefenCath, its FDA‑approved antimicrobial catheter lock solution, received an Innovative Technology designation from Vizient on Oct. 23, 2025.

DefenCath is approved for a limited population of adult patients on chronic hemodialysis via central venous catheter and in a Phase 3 LOCK IT-100 study showed a 71% reduction in risk of catheter-related bloodstream infections with adverse events comparable to control. CorMedix is conducting a real‑world evidence study in >2,000 patients and expects interim data around year-end. Vizient represents approximately $156 billion in annual purchasing volume.

Talphera (Nasdaq: TLPH) appointed Joe Todisco, CEO of CorMedix (Nasdaq: CRMD), to its Board of Directors effective Oct 21, 2025.

CorMedix made a strategic investment in Talphera in Sept 2025 and, under that transaction, gained the right to nominate a board representative and a 60-day exclusive negotiation period triggered by the announcement of primary endpoint and topline results from the NEPHRO CRRT clinical study. Talphera and CorMedix cite potential regulatory progress for Niyad with management referencing a possible approval in 2026.

CorMedix (Nasdaq: CRMD) reported preliminary unaudited Q3 2025 results and raised 2025 pro forma net revenue guidance. Key figures include Q3 pro forma net revenue >$125M, DefenCath Q3 net revenue >$85M, and Q3 unaudited company net revenue >$100M. Management raised full‑year 2025 pro forma net revenue guidance to at least $375M and expects Q3 adjusted EBITDA ≥ $70M.

The company forecasts at least $30M of go‑forward operating synergies before year‑end 2025 from the Melinta integration, with an additional $5–$15M targeted in 2026. Cash and short‑term investments were approximately $56M on Sept 30, 2025, with a projected year‑end cash balance of ~$100M. Clinical update: Phase III ReSPECT enrollment complete; data expected 2Q 2026.

CorMedix (NASDAQ: CRMD) has announced the completion of enrollment in its Phase III ReSPECT clinical trial for REZZAYO® (rezafungin). The study evaluates REZZAYO as a prophylactic treatment against Candida, Aspergillus, and Pneumocystis infections in patients undergoing allogeneic blood and marrow transplantation.

The trial, sponsored by Mundipharma, compares once-weekly REZZAYO to standard antimicrobial treatment. The dosing regimen includes a 400 mg loading dose followed by 200 mg weekly for 13 weeks. Topline results are expected in Q2 2026. The study's primary endpoint is fungal-free survival at day 90, with secondary endpoints including IFD incidence, toxicity-related discontinuation, and mortality.

CorMedix (NASDAQ:CRMD) has announced a strategic $5 million minority investment in Talphera (NASDAQ:TLPH), acquiring 9,090,909 shares at $0.55 per share. The investment is part of Talphera's private placement financing to fund its Phase 3 study of Niyad™, a breakthrough-designated anticoagulant for extracorporeal circuits.

As part of the deal, CorMedix receives exclusive first negotiation rights for a potential Talphera acquisition, with a 60-day exclusive period following Phase 3 results. Additionally, CorMedix gains the right to nominate one director to Talphera's board. Niyad targets an estimated 165,000 acute kidney injury patients annually who receive CRRT treatment and cannot tolerate heparin.

Talphera (NASDAQ:TLPH) has secured a private placement financing of up to $29 million led by CorMedix Inc. as the strategic investor, along with institutional investors including Nantahala Capital, Rosalind Advisors, and Rock Springs Capital. The financing includes $17 million in the first closing (expected September 10, 2025) and potential $12 million in a second tranche upon achieving the primary endpoint in the NEPHRO CRRT study.

The first closing involves issuing 25,036,363 shares at $0.55 per share and 5,845,455 pre-funded warrants at $0.549. CorMedix receives a 60-day exclusivity period to negotiate Talphera's acquisition following NEPHRO study results and gains board nomination rights. The funding is expected to support Talphera through the planned Niyad PMA approval in H2 2026.

CorMedix (NASDAQ:CRMD) has completed its acquisition of Melinta Therapeutics in a transformational deal valued at $300 million, comprising $260 million in cash and $40 million in equity. The acquisition brings seven marketed products to CorMedix's portfolio and is expected to generate significant financial benefits.

The company has raised its financial guidance, projecting pro forma 2025 combined revenues of $325-350 million and pro forma synergized adjusted EBITDA of $165-185 million. The transaction is expected to achieve annual run-rate synergies of $35-45 million and be accretive to EPS with double-digit accretion in 2026.

The deal includes potential additional payments of up to $25 million tied to regulatory milestones for REZZAYO™'s expanded indication, which could generate peak annual sales exceeding $200 million if approved.

CorMedix (NASDAQ:CRMD), a biopharmaceutical company specializing in therapeutic products for life-threatening conditions, announced its participation in two major healthcare investor conferences in September 2025.

The company's senior management will present at the Cantor Global Healthcare Conference on September 5 at 8:35am ET and the Morgan Stanley 23rd Annual Global Healthcare Conference on September 10 at 10:45am ET. Both presentations will be in a fireside chat format with webcasts available.

CorMedix (NASDAQ: CRMD) has announced a strategic acquisition of Melinta Therapeutics in a transformational deal valued at $300 million upfront, consisting of $260 million in cash and $40 million in CorMedix equity. The agreement includes an additional $25 million regulatory milestone payment and royalties.

Since its 2020 private acquisition by Deerfield Management, Melinta has achieved 85% revenue growth and profitability. The merger will expand CorMedix's portfolio with seven marketed products, including REZZAYO®, MINOCIN®, VABOMERE®, KIMYRSA®, ORBACTIV®, BAXDELA®, and TOPROL-XL®. A Phase III study for REZZAYO® is expected to complete in 1H2026.

The transaction is expected to close in September 2025, subject to regulatory approvals.