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Pharvaris Stock Gains on HAE Drug Meeting Late-Stage Study Goals
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Key Takeaways
Pharvaris surged after RAPIDe-3 showed deucrictibant delivering far faster HAE symptom relief than placebo.
The study met all primary and secondary endpoints, with most attacks treated by a single deucrictibant dose.
PHVS plans to file for approval in 2026, as investors compare results with KALV's recently approved Ekterly.
Shares of Pharvaris (PHVS - Free Report) rose nearly 22% on Wednesday after the company announced positive results from the phase III RAPIDe-3 study evaluating its lead pipeline drug deucrictibant in the hereditary angioedema (HAE) indication.
This study evaluated an immediate-release capsule version of the drug for the on-demand treatment of HAE attacks in adults and adolescents aged 12 years and older.
The RAPIDe-3 study achieved its primary endpoint — patients began experiencing symptom relief within 1.28 hours of taking the drug compared with more than 12 hours with placebo. The study also met all its secondary endpoints, including shorter median time to substantial symptom relief (under 3 hours with deucrictibant compared with more than 12 hours with placebo) and earlier complete symptom resolution (11.95 hours compared with more than 24 hours).
Pharvaris also noted that while 83% of HAE attacks in the RAPIDe-3 study were addressed with just one dose of deucrictibant, more than 93% of the attacks were treated with the drug without the need for any backup treatment.
A rare genetic disease, HAE is marked by severe and potentially fatal swelling of the arms, legs, face and throat.
PHVS to Seek FDA Nod for HAE Drug
Based on the above results, Pharvaris intends to submit a regulatory filing for deucrictibant in the first half of 2026. If approved, it will be the second oral on-demand therapy in the market after KalVista Pharmaceuticals’ (KALV - Free Report) Ekterly, which received approval for a similar indication in July.
This sets up a natural comparison between the two therapies. Some investors have highlighted the potential superiority of deucrictibant over KalVista’s Ekterly by comparing the primary endpoint results of the RAPIDe-3 study with those from the late-stage KONFIDENT study, which supported Ekterly’s approval. In this late-stage study, patients treated with the KALV drug began experiencing symptom relief after 1.61-1.79 hours, falling just shy of the numbers posted by Pharvaris. PHVS shares jumped primarily due to this comparison.
Year to date, the stock has soared 53% compared with the industry’s 20% growth.
Image Source: Zacks Investment Research
More on Pharvaris’ Deucrictibant
The company is developing two formulations of deucrictibant — an immediate-release capsule version to enable rapid onset of activity for acute treatment, and an extended-release tablet to allow sustained absorption and efficacy in prophylactic treatment.
Pharvaris is evaluating the extended-release tablet formulation of the drug in the phase III CHAPTER-3 study for the prophylaxis against HAE attacks in adults and adolescents aged 12 years and older. Top-line data from this study is expected in the second half of 2026.
The extended-release tablet version of deucrictibant is also being evaluated in the late-stage CREAATE study for the prophylactic and on-demand treatment of attacks caused due to acquired angioedema with C1-inhibitor deficiency (AAE-C1INH) — a rare condition resembling HAE.
PHVS’ Competition in the HAE Space
Pharvaris intends to market deucrictibant as both on-demand and prophylaxis treatment of HAE attacks.
In the on-demand treatment space, if the drug is approved, it will face stiff competition from KalVista’s Ekterly. Therapies like deucrictibant and Ekterly hold an edge over previously approved on-demand treatments like Firazyr and Kalbitor — both marketed by Takeda — as they are administered via injections, which can be challenging for patients in a crisis. The convenience of a tablet, which can be taken at the first signs of an attack, can drive broader adoption and enhance patient compliance.
Concerning the prophylactic treatment space, companies like BioCryst Pharmaceuticals (BCRX - Free Report) and Ionis Pharmaceuticals (IONS - Free Report) market drugs in this segment. While BioCryst’s Orladeyo was approved by the FDA in 2020 as the first oral treatment for HAE attacks in individuals aged 12 years and older, Ionis’ Dawnzera was recently approved for a similar indication in August.
Image: Bigstock
Pharvaris Stock Gains on HAE Drug Meeting Late-Stage Study Goals
Key Takeaways
Shares of Pharvaris (PHVS - Free Report) rose nearly 22% on Wednesday after the company announced positive results from the phase III RAPIDe-3 study evaluating its lead pipeline drug deucrictibant in the hereditary angioedema (HAE) indication.
This study evaluated an immediate-release capsule version of the drug for the on-demand treatment of HAE attacks in adults and adolescents aged 12 years and older.
The RAPIDe-3 study achieved its primary endpoint — patients began experiencing symptom relief within 1.28 hours of taking the drug compared with more than 12 hours with placebo. The study also met all its secondary endpoints, including shorter median time to substantial symptom relief (under 3 hours with deucrictibant compared with more than 12 hours with placebo) and earlier complete symptom resolution (11.95 hours compared with more than 24 hours).
Pharvaris also noted that while 83% of HAE attacks in the RAPIDe-3 study were addressed with just one dose of deucrictibant, more than 93% of the attacks were treated with the drug without the need for any backup treatment.
A rare genetic disease, HAE is marked by severe and potentially fatal swelling of the arms, legs, face and throat.
PHVS to Seek FDA Nod for HAE Drug
Based on the above results, Pharvaris intends to submit a regulatory filing for deucrictibant in the first half of 2026. If approved, it will be the second oral on-demand therapy in the market after KalVista Pharmaceuticals’ (KALV - Free Report) Ekterly, which received approval for a similar indication in July.
This sets up a natural comparison between the two therapies. Some investors have highlighted the potential superiority of deucrictibant over KalVista’s Ekterly by comparing the primary endpoint results of the RAPIDe-3 study with those from the late-stage KONFIDENT study, which supported Ekterly’s approval. In this late-stage study, patients treated with the KALV drug began experiencing symptom relief after 1.61-1.79 hours, falling just shy of the numbers posted by Pharvaris. PHVS shares jumped primarily due to this comparison.
Year to date, the stock has soared 53% compared with the industry’s 20% growth.
Image Source: Zacks Investment Research
More on Pharvaris’ Deucrictibant
The company is developing two formulations of deucrictibant — an immediate-release capsule version to enable rapid onset of activity for acute treatment, and an extended-release tablet to allow sustained absorption and efficacy in prophylactic treatment.
Pharvaris is evaluating the extended-release tablet formulation of the drug in the phase III CHAPTER-3 study for the prophylaxis against HAE attacks in adults and adolescents aged 12 years and older. Top-line data from this study is expected in the second half of 2026.
The extended-release tablet version of deucrictibant is also being evaluated in the late-stage CREAATE study for the prophylactic and on-demand treatment of attacks caused due to acquired angioedema with C1-inhibitor deficiency (AAE-C1INH) — a rare condition resembling HAE.
PHVS’ Competition in the HAE Space
Pharvaris intends to market deucrictibant as both on-demand and prophylaxis treatment of HAE attacks.
In the on-demand treatment space, if the drug is approved, it will face stiff competition from KalVista’s Ekterly. Therapies like deucrictibant and Ekterly hold an edge over previously approved on-demand treatments like Firazyr and Kalbitor — both marketed by Takeda — as they are administered via injections, which can be challenging for patients in a crisis. The convenience of a tablet, which can be taken at the first signs of an attack, can drive broader adoption and enhance patient compliance.
Concerning the prophylactic treatment space, companies like BioCryst Pharmaceuticals (BCRX - Free Report) and Ionis Pharmaceuticals (IONS - Free Report) market drugs in this segment. While BioCryst’s Orladeyo was approved by the FDA in 2020 as the first oral treatment for HAE attacks in individuals aged 12 years and older, Ionis’ Dawnzera was recently approved for a similar indication in August.
Pharvaris N.V. Price
Pharvaris N.V. price | Pharvaris N.V. Quote
PHVS Zacks Rank
Pharvaris currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.