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CorMedix Q3 revenue hits $54.5M as DefenCath sales fall after TDAPA ends

🇺🇸 CorMedix Inc. (CRMD) · Thu 12 Nov 2026

CorMedix suspended 2027 DefenCath guidance after CMS reimbursement changes, while its Heron asset acquisition and a REZZAYO FDA Priority Review proceed.

CorMedix reported third-quarter 2026 revenue of $54.5M on 12 November, alongside a net loss of $14.7M and adjusted EBITDA of $3.1M.

DefenCath net sales came to $17.2M in the quarter. The company's reporting ties the lower pricing to the end of the product's TDAPA (transitional drug add-on payment adjustment) on 1 July 2026. TDAPA is a temporary Medicare add-on payment for certain new dialysis-related drugs.

Because of changes to the CMS reimbursement framework, CorMedix has suspended its 2027 guidance for DefenCath. The summary provided does not give details of the framework changes or any replacement outlook.

The company also described its pending acquisition of assets from Heron Therapeutics, which is backed by a term loan of up to $150M. Separately, the FDA is reviewing a supplemental NDA for REZZAYO for prophylaxis of invasive fungal disease under Priority Review, with an action expected in the first quarter of 2027.

What it means for your team

  • Market-access teams should note how quickly net pricing and sales can shift for a product once a temporary add-on payment such as TDAPA expires.
  • CorMedix's withdrawal of 2027 DefenCath guidance shows that uncertainty in the CMS reimbursement framework is affecting commercial planning.
  • Regulatory teams can mark Q1 2027 as the expected FDA action window for the REZZAYO prophylaxis sNDA, which is under Priority Review.
  • The Heron asset deal is still pending, so its impact on CorMedix's portfolio depends on completion.

Company's press release (SEC filing): CorMedix Inc. ↗

Article written by VigiEye from the official source (CorMedix Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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