CorMedix CEO Expects Supplemental Filing For Fungal Disease Treatment By Q3 – CRMD Stock Sees Best Day In Nearly 10 Months After Earnings Beat

CorMedix expects to submit its supplemental Rezzayo application in Q3, with a potential FDA decision in the first half of 2027.

• CorMedix reported Q2 revenue of $101.9 million, above Wall Street’s estimate of about $96.05 million, according to Fiscal.ai.
• The firm raised its adjusted earnings before interest, tax, depreciation and amortization guidance to between $125 million and $140 million.
• CorMedix signed a multi-year DefenCath catheter lock solution supply agreement with an unnamed major dialysis operator

Shares of CorMedix Therapeutics (CRMD) surged 17% on Thursday after the company reported better-than-expected second-quarter results and said it plans to seek an expanded indication with the U.S. Food and Drug Administration for its antifungal treatment.

CRMD stock clocked its biggest single-day gains since October 2025 and also hit the crucial 200-day moving average (200-DMA) for the first time in over a month.

Q2 Revenue, Earnings Fly Past Wall Street Estimates

CorMedix reported second-quarter (Q2) revenue of $101.9 million, up sharply from $39.7 million a year earlier and above Wall Street’s estimate of about $96.05 million, according to Fiscal.ai. Diluted earnings came in at $0.29 per share, topping analysts’ estimate of $0.24 per share.

CorMedix also said it expects to submit the supplemental application to the Food and Drug Administration (FDA) for Rezzayo in the third quarter. If accepted for review, an FDA decision is expected in the first half of 2027. The proposed indication would expand Rezzayo’s use to the prevention of invasive fungal disease.

“We also made meaningful progress across our pipeline and expect the near-term submission of the Rezzayo sNDA for prophylaxis,” said CEO Joseph Todisco.

CorMedix also signed a multi-year DefenCath catheter lock solution supply agreement with an unnamed major dialysis operator.

CRMD Raises FY26 EBITDA Guidance

CorMedix raised its adjusted earnings before interest, tax, depreciation and amortization (EBITDA) guidance to between $125 million and $140 million, from $115 million to $135 million previously. The company maintained its 2026 revenue guidance of $325 million to $345 million.

CorMedix ended June with $256.7 million in cash and short-term investments, which it believes is sufficient to fund operations for at least the next 12 months.

During the quarter, CorMedix’s unit Melinta Therapeutics secured a key legal win after a U.S. appeals court upheld a ruling in favor of Melinta in its patent dispute with Nexus Pharmaceuticals.

The court found that Nexus’ proposed generic antibiotic infringed patents covering Minocin for injection and rejected its challenge to their validity. Nexus remains barred from selling the generic until the patents expire. Minocin is an intravenous antibiotic used to treat serious and drug-resistant infections.

Retail’s Take On CRMD

Retail sentiment surrounding CRMD on Stocktwits flipped to ‘extremely bullish’ from ‘neutral’ a day earlier, amid a 140% jump in message volumes.

One bullish user said the next few days could be crazy.

View this Stocktwits post

The stock is down nearly 32% year-to-date.

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