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Performance in Q1 was primarily driven by a $25 million milestone payment from Chiesi following the European Commission's approval of Elfabrio's every 4 weeks dosing regimen.

The new every 4 weeks dosing flexibility in Europe is expected to reduce treatment burden for patients, strengthening Elfabrio's competitive position and supporting broader adoption over time.

Management attributes the decrease in selling goods revenue to timing and inventory dynamics regarding Elelyso purchases by Pfizer and Fiocruz, rather than a shift in underlying demand.

The company is focusing its long-term strategy on rare renal diseases, believing its platform offers a clear advantage and a business model that limits downside risk while preserving clinical upside.

Management maintains a long-term target of 15% to 20% global market share for Elfabrio by 2031, supported by a projected $3.2 billion total addressable market.

Reaffirmed 2026 total revenue guidance of approximately $78 million to $83 million, which includes the $25 million milestone already received.

The company expects Elfabrio product revenues to range between $33 million and $35 million for the full year, with growth weighted toward the second half of 2026.

The Phase II RELEASE study for PRX-115 is expected to complete enrollment by the end of 2026, with top-line results anticipated in the second half of 2027.

Management intends to provide specific indication details for the PRX-119 program by the end of the current quarter to clarify the clinical development path.

The company ended the quarter with $51 million in cash and no outstanding debt or warrants, which management states provides sufficient funds for the Phase II RELEASE study.

R&D expenses increased to $5.4 million from $3.5 million year-over-year, reflecting a deliberate capital allocation shift toward the PRX-115 clinical program.

Net income reached $18.3 million for the quarter, a significant shift from a prior year loss, though this was heavily influenced by the one-time milestone revenue.

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Management expects the second half of 2026 to be stronger for Elfabrio sales as Chiesi navigates country-by-country local reimbursement approvals for the new dosing regimen.

The company is sticking to its current guidance for now, suggesting it is too early to raise outlooks based on the March approval.

Management believes the segment for uncontrolled gout patients will remain robust despite next-generation competitors, providing ample room for their Uricase-based treatment.

Management noted it is too early for specific uptake data, but reported that partner Chiesi remains optimistic about the progress and expects visible results in the second half of the year.

Chiesi is pursuing several additional geographic targets over the next 12 months, with management committing to report new approvals as they occur.