Pharvaris Announces RAPIDe-3 Pivotal Data Confirming Deucrictibant's Treatment Potential
Pharvaris announced RAPIDe-3 pivotal data confirming the potential of deucrictibant's differentiated profile for the on-demand treatment of hereditary angioedema - HAE attacks -. The data from Pharvaris' first pivotal Phase 3 study will serve as the basis for marketing authorization applications, which are planned to be filed starting in the first half of 2026. The RAPIDe-3 global Phase 3, placebo-controlled study evaluated orally administered deucrictibant immediate-release capsule for the on-demand treatment of attacks in people 12 years and older with HAE. The primary endpoint and all 11 secondary efficacy endpoints, assessed sequentially under a multiplicity-control procedure, achieved statistical significance. Compared to placebo, deucrictibant demonstrated efficacy: faster median time to onset of treatment response, shorter median time to substantial symptom relief, earlier complete symptom resolution. Deucrictibant was well tolerated with no treatment-related serious adverse events and no participants discontinuing treatment due to treatment-emergent adverse events. An open-label extension of deucrictibant for the on-demand treatment of HAE attacks, RAPIDe-2 Part B, is ongoing. Pharvaris remains on track to submit a New Drug Application with the FDA in the first half of 2026 for the on-demand treatment of acute attacks of HAE.
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Pharming Reports $376M Preliminary 2025 Revenue, Exceeding Guidance by 27%
- Significant Revenue Growth: Pharming anticipates approximately $376 million in revenue for 2025, exceeding the revised guidance of $365-$375 million by 27%, reflecting strong market demand for RUCONEST and Joenja.
- Strong RUCONEST Performance: RUCONEST generated $231.2 million in revenue during the first nine months of 2025, representing a 34% increase from the previous year, which enhances the company's financial stability in a competitive hereditary angioedema market.
- Rising Demand for Joenja: Joenja contributed $38.4 million in revenue, up 20% year-over-year, indicating successful new drug promotion and increasing acceptance in the U.S. market, which is expected to further drive future revenue growth.
- Positive Future Outlook: Pharming expects continued revenue growth in 2026 and plans to provide detailed updates on its clinical pipeline and financial guidance during the Investor Day on February 3, 2026, demonstrating the company's commitment to long-term value creation.
Pharming Reports $376 Million Revenue for 2025, Exceeding Guidance by 27%
- Significant Revenue Growth: Pharming's estimated revenue for 2025 is approximately $376 million, exceeding the revised guidance range of $365 to $375 million, reflecting a robust 27% year-over-year growth driven by strong demand for RUCONEST® and Joenja®.
- Commitment to Cost Control: The company expects its operating expenses for 2025 to be within the range of $304 to $308 million, underscoring its commitment to cost discipline, which will enhance overall profitability.
- Advancement of Clinical Pipeline: Pharming plans to provide updates on its clinical pipeline during the Investor Day on February 3, 2026, including leniolisib for primary immunodeficiencies and KL1333 for mitochondrial diseases, demonstrating ongoing efforts in innovative drug development.
- Expert Participation Enhances Confidence: The Investor Day will feature presentations from leading clinical experts discussing the latest insights into immune dysregulation and mitochondrial diseases, boosting investor confidence and expectations for Pharming's future growth.
