Cormedix Stock Price, News & Analysis

CorMedix Therapeutics (Nasdaq: CRMD) announced executive and board changes on January 8, 2026. CEO Joseph Todisco signed an extended employment contract and will also become Chairman of the Board, succeeding Myron Kaplan, who will move to a newly created role of Lead Independent Director. CorMedix said it has evolved into a multi-product, diversified commercial company with positive cashflow and a strong pipeline. The company also appointed Mike Seckler as EVP & Chief Commercial Officer; Seckler brings prior roles as CEO of Evome Medical Technologies, COO of FerGene, and head of global marketing at Ferring.

CorMedix (Nasdaq: CRMD) reported preliminary unaudited results for Q4 and FY 2025 and provided FY 2026 guidance and program updates. Key metrics: Q4 2025 net revenue ~$127M, FY 2025 net revenue ~$310M, FY 2025 pro forma net revenue ~$400M, Q4 2025 adjusted EBITDA $77M–$81M, and cash and short-term investments ~$148M as of Dec 31, 2025. Management introduced FY 2026 revenue guidance $300M–$320M (DefenCath $150M–$170M) and FY 2026 adjusted EBITDA $100M–$125M. Company expects REZZAYO Phase 3 prophylaxis topline in Q2 2026. DefenCath reimbursement will transition on Jul 1, 2026, which the company says will reduce net pricing in H2 2026; estimated higher 2027 pricing if CMS applies prior methodology. Analyst Day scheduled for Feb 10, 2026.

CorMedix (Nasdaq: CRMD) reported interim results from its ongoing real‑world evidence study of DefenCath in adult hemodialysis patients with central venous catheters, conducted with U.S. Renal Care. Based on data through Sept 30, 2025 for ~7,000 patients in Year 1, DefenCath use showed a 72% reduction in catheter‑related bloodstream infections (CRBSI) and a 70% reduction in hospitalizations secondary to CRBSI versus historical controls. More than 3,000 patients per month are receiving DefenCath at USRC facilities. The company highlighted potential healthcare cost reductions given CMS estimates of >$3B annual CRBSI costs in ESRD and average CRBSI hospitalization costs of ~$63,000.

Talphera (Nasdaq: TLPH) reported third quarter 2025 results and a corporate update on November 12, 2025. Key items: Talphera closed a $17.0 million first tranche of a potential $29.0 million private placement led by CorMedix (Nasdaq: CRMD); cash and investments were $21.3 million at September 30, 2025. Five of nine target NEPHRO CRRT study sites are active and study completion is expected in H1 2026. Q3 combined R&D and SG&A were $3.4 million (ex-stock comp $3.3M). Q3 net loss from continuing operations was $4.4 million ($0.11 per share). 2025 cash operating expense guidance was reduced to $14–15 million.

CorMedix (Nasdaq: CRMD) reported Q3 2025 net revenue $104.3M and pro forma net revenue $130.8M, driven by higher-than-expected outpatient DefenCath utilization and partial-quarter Melinta sales. The company posted Q3 net income $108.6M and adjusted EBITDA $71.9M, with basic and diluted EPS of $1.42 and $1.26. Management raised FY 2025 pro forma net revenue guidance to $390–$410M and fourth-quarter revenue guidance to $115–$135M, and increased fully synergized pro forma adjusted EBITDA guidance to $220–$240M. The Melinta acquisition closed August 29, 2025; estimated 2025 synergy capture is ~$30M of an expected $35–$45M annual run rate. Cash and short-term investments were $55.7M at Sept. 30, 2025, with projected year-end cash ~$100M. ReSPECT Phase III enrollment completed; top-line data expected in 2Q 2026.

CorMedix (Nasdaq: CRMD) will report third-quarter 2025 financial results for the period ended September 30, 2025, before the market opens on November 12, 2025, and will host a corporate update conference call at 8:30 AM ET that day.

The company is commercializing DefenCath for prevention of catheter-related bloodstream infections in adult hemodialysis patients and, following its August 2025 acquisition of Melinta Therapeutics, is commercializing a portfolio of anti-infective products (including MINOCIN, REZZAYO, VABOMERE, ORBACTIV, BAXDELA, KIMYRSA) and TOPROL-XL.

CorMedix has ongoing DefenCath studies in total parenteral nutrition and pediatric populations, and REZZAYO has an ongoing Phase III prophylaxis study with topline results expected in Q2 2026.

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.