Research analysts covering Pharvaris.
Recent press releases and 8-K filings for PHVS.
Pharvaris Outlines 2026 Strategic Priorities and Clinical Development Milestones
PHVS
New Projects/Investments
Guidance Update
Product Launch
- Pharvaris anticipates topline data from its pivotal Phase 3 CHAPTER-3 study for the prophylactic treatment of HAE attacks in the third quarter of 2026.
- The company is on track to file the New Drug Application (NDA) for deucrictibant for the on-demand treatment of HAE attacks in the first half of 2026.
- Recruitment is ongoing in the pivotal Phase 3 CREAATE study for deucrictibant in AAE-C1INH attacks.
- Pharvaris reported approximately €329 million in cash and cash equivalents as of September 30, 2025, providing an estimated cash runway into the first half of 2027.
Jan 12, 2026, 11:51 AM
Pharvaris Announces Positive Phase 3 RAPID-3 Study Results for Deucrictibant
PHVS
Product Launch
New Projects/Investments
Guidance Update
- Pharvaris announced positive top-line results from its RAPID-3 pivotal Phase 3 study of deucrictibant for the on-demand treatment of Hereditary Angioedema (HAE) attacks, meeting its primary endpoint and all secondary efficacy endpoints.
- Deucrictibant demonstrated a significantly faster onset of symptom relief with a median time of 1.28 hours compared to greater than 12 hours for placebo, and was well tolerated with no safety signals identified.
- The company aims to file for global marketing authorization for deucrictibant in the on-demand treatment of HAE attacks in the first half of 2026.
- Pharvaris is also developing an extended-release tablet of deucrictibant for prophylaxis, with results from the CHAPTER-3 study anticipated in the second half of 2026.
Dec 3, 2025, 1:00 PM
Pharvaris Announces Positive Topline Data from RAPIDe-3 Study for Deucrictibant
PHVS
Product Launch
- Pharvaris announced positive topline results from the RAPIDe-3 Phase III clinical study of deucrictibant immediate release capsule for the on-demand treatment of hereditary angioedema (HAE) attacks.
- Deucrictibant achieved the primary endpoint with a median time to onset of symptom relief of 1.28 hours, significantly faster than placebo (not estimable). Key secondary endpoints also showed strong efficacy, including end-of-progression within 17.5 minutes and substantial symptom relief within 2.85 hours.
- The treatment was very well tolerated, with most adverse events being mild or moderate and no safety signals identified.
- Pharvaris aims to submit a first global marketing authorization for deucrictibant for on-demand HAE treatment in the first half of 2026.
Dec 3, 2025, 1:00 PM
Pharvaris Announces Positive Topline Data from RAPID-3 Phase III Study for Deucrictibant
PHVS
Product Launch
New Projects/Investments
- Pharvaris announced positive topline data from its Phase III RAPID-3 clinical study of deucrictibant Immediate Release Capsule for the on-demand treatment of hereditary angioedema (HAE) attacks.
- Deucrictibant demonstrated a significantly faster onset of symptom relief with a median time of 1.28 hours, compared to "not estimable" (beyond 12 hours) for placebo.
- Approximately 85% of deucrictibant-treated attacks achieved onset of symptom relief by the four-hour mark, versus around 30% for placebo-treated attacks.
- The drug was very well tolerated, with most adverse events being mild or moderate, and no safety signals identified.
- Pharvaris plans to pursue global marketing authorization for deucrictibant for on-demand HAE treatment, with results from the prophylactic CHAPTER-3 study expected in the second half of next year.
Dec 3, 2025, 1:00 PM
PHVS Provides Update on Deucrictibant Clinical Study Results and Regulatory Timeline
PHVS
New Projects/Investments
Product Launch
Guidance Update
- Deucrictibant demonstrated significantly faster onset of symptom relief in 1.28 hours compared to placebo, where the median time was not estimable within 12 hours.
- The treatment also showed a faster End of Progression (EoP) in 17.47 minutes and earlier complete symptom resolution in 11.95 hours compared to placebo.
- 83.0% of attacks were treated with a single capsule of deucrictibant (vs. 33.0% for placebo), and 93.2% of attacks were treated without rescue medication (vs. 63.6% for placebo), with the treatment being well tolerated and no discontinuations due to treatment-emergent adverse events (TEAEs).
- Pharvaris plans to file a New Drug Application (NDA) for deucrictibant for Hereditary Angioedema (HAE) On-Demand in the first half of 2026.
Dec 3, 2025, 1:00 PM
Pharvaris Announces Positive Topline Data from RAPIDe-3 Pivotal Study
PHVS
Product Launch
New Projects/Investments
- On December 3, 2025, Pharvaris N.V. announced positive topline data from its RAPIDe-3 pivotal study for deucrictibant, an oral treatment for hereditary angioedema (HAE) attacks.
- The study met its primary endpoint, demonstrating a median time to onset of symptom relief of 1.28 hours, significantly faster than placebo (p<0.0001).
- All secondary efficacy endpoints were also met, including a median time to End of Progression of 17.47 minutes and complete symptom resolution in 11.95 hours.
- Deucrictibant exhibited a well-tolerated safety profile with no treatment-related serious adverse events.
- Pharvaris plans to submit marketing authorization applications, including a New Drug Application (NDA) with the U.S. FDA, for deucrictibant in the first half of 2026.
Dec 3, 2025, 11:56 AM
Pharvaris Reports Q3 2025 Financial Results and Provides Business Update
PHVS
Earnings
Guidance Update
New Projects/Investments
- Pharvaris reported cash and cash equivalents of €329 million as of September 30, 2025, following a public offering in July 2025 that generated net proceeds of approximately €160.3 million, extending the company's cash runway well into the first half of 2027.
- The company anticipates topline data for the RAPIDe-3 pivotal Phase 3 study in 4Q2025 and for the CHAPTER-3 pivotal Phase 3 study in 2H2026.
- For the third quarter ended September 30, 2025, Pharvaris reported a net loss of €37.1 million and basic and diluted loss per share of €0.60.
- Research and development expenses increased to €29.8 million in Q3 2025 from €25.8 million in Q3 2024, while general and administrative expenses decreased to €9.8 million from €12.1 million over the same period.
Nov 12, 2025, 1:00 PM
Pharming Group Reports Strong Q3 2025 Financial Results and Raises Full-Year Guidance
PHVS
Earnings
Guidance Update
Revenue Acceleration/Inflection
- Pharming Group reported a 30% increase in total third quarter 2025 revenues to US$97.3 million, driven by strong growth in RUCONEST® revenue (up 29% to US$82.2 million) and Joenja® revenue (up 35% to US$15.1 million).
- The company's operating profit significantly increased by 285% to US$15.8 million in the third quarter of 2025, compared to US$4.1 million in the same period last year.
- Pharming generated US$32.0 million in cash flow from operations during the third quarter of 2025, bringing the year-to-date total to US$44.0 million.
- The company raised its 2025 total revenue guidance to US$365 - US$375 million, an increase from the prior guidance of US$335 - US$350 million.
- The FDA granted priority review for the sNDA for leniolisib for children aged 4 to 11 years with APDS, with a decision expected by January 2026.
Nov 6, 2025, 6:00 AM
Pharvaris Provides Updates on Ducrytobant Development and Commercialization Plans
PHVS
New Projects/Investments
Product Launch
Guidance Update
- Pharvaris is developing ducrytobant for hereditary angioedema (HAE), with Phase III data readouts expected in Q4 2025 for on-demand treatment and the second half of 2026 for prophylaxis.
- The company anticipates filing for U.S. approval in the first half of 2026, with a potential launch in early 2027.
- Pharvaris plans to initiate a new trial for acquired angioedema patients by the end of 2025.
- Ducrytobant aims to provide injectable-like efficacy with the convenience of an oral treatment for both on-demand and prophylactic use.
Sep 3, 2025, 4:40 PM
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