Cormedix Announces FDA Acceptance for Priority Review of Supplemental NDA for Rezzayo® (Rezafungin) for Prophylaxis of Invasive Fungal Diseases

PARSIPPANY, N.J., Oct. 19, 2026 (GLOBE NEWSWIRE) -- CorMedix Therapeutics (Nasdaq: CRMD) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the supplemental New Drug Application (sNDA) seeking approval of REZZAYO® (rezafungin for injection) for the prophylaxis of invasive fungal disease. The sNDA was submitted by Mundipharma, CorMedix's global development partner, and the FDA has granted Priority Review with a Prescription Drug User Fee Act (PDUFA) target action date in Q1 2027. The sNDA is supported by the Phase III ReSPECT pivotal study, for which CorMedix announced positive topline results in April. ReSPECT evaluated the efficacy and safety of once weekly rezafungin (rezafungin acetate) compared with a standard antimicrobial regimen (SAR) for the prophylaxis of invasive fungal diseases in adults undergoing allogeneic HSCT. If REZZAYO is approved for this new indication, CorMedix is targeting to begin promotional efforts beginning in H2 2027.

GlobeNewsWire • Oct 19, 2026

Actinium Pharmaceuticals Strengthens Leadership Team with Appointment of Matt David, M.D. as Chief Financial Officer

NEW YORK, Oct. 15, 2026 /PRNewswire/ -- Actinium Pharmaceuticals, Inc. (NYSE American: ATNM) ("Actinium" or the "Company"), a pioneer in the development of targeted radiotherapies, today announced the appointment of Matt David, M.D., as Chief Financial Officer.

PRNewsWire • Oct 15, 2026

CRMD vs. PRTA: Which Stock Should Value Investors Buy Now?

Investors with an interest in Medical - Biomedical and Genetics stocks have likely encountered both CorMedix (CRMD) and Prothena (PRTA). But which of these two stocks offers value investors a better bang for their buck right now?

Zacks Investment Research • Oct 8, 2026

Wall Street Analysts Think CorMedix (CRMD) Could Surge 67.73%: Read This Before Placing a Bet

The consensus price target hints at a 67.7% upside potential for CorMedix (CRMD). While empirical research shows that this sought-after metric is hardly effective, an upward trend in earnings estimate revisions could mean that the stock will witness an upside in the near term.

Zacks Investment Research • Sep 7, 2026

CorMedix Therapeutics to Participate in the Wells Fargo Healthcare Conference

PARSIPPANY, N.J., Sept. 01, 2026 (GLOBE NEWSWIRE) -- CorMedix Therapeutics (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announced that senior management will be participating in a fireside chat and investor meetings at the upcoming Wells Fargo 21st Annual Healthcare Conference being held in Boston on September 8 – 10, 2026.

GlobeNewsWire • Sep 1, 2026

CorMedix (CRMD) Upgraded to Buy: Here's Why

CorMedix (CRMD) has been upgraded to a Zacks Rank #2 (Buy), reflecting growing optimism about the company's earnings prospects. This might drive the stock higher in the near term.

Zacks Investment Research • Aug 31, 2026

Wall Street Analysts Believe CorMedix (CRMD) Could Rally 65.96%: Here's is How to Trade

The consensus price target hints at a 66% upside potential for CorMedix (CRMD). While empirical research shows that this sought-after metric is hardly effective, an upward trend in earnings estimate revisions could mean that the stock will witness an upside in the near term.

Zacks Investment Research • Aug 20, 2026

CRMD Stock Up as Q2 Earnings & Sales Beat on DefenCath, Melinta Gains

CorMedix stock rises 15% after Q2 earnings and revenues beat estimates, driven by solid DefenCath utilization and contributions from the Melinta portfolio.

Zacks Investment Research • Aug 14, 2026

CorMedix Q2 Earnings Call Highlights

CorMedix NASDAQ: CRMD reported second-quarter 2026 consolidated revenue of $101.9 million and adjusted EBITDA of $58.7 million, while reaffirming its full-year revenue outlook and raising adjusted EBITDA guidance. The company also said it signed a multiyear commercial supply agreement for DefenCath with an additional large dialysis organization, giving it supply agreements with each of the five largest U.S. dialysis providers.

MarketBeat • Aug 13, 2026

CorMedix Inc. (CRMD) Q2 2026 Earnings Call Transcript

CorMedix Inc. (CRMD) Q2 2026 Earnings Call Transcript

Seeking Alpha • Aug 13, 2026