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PHVS Stock Rises 10% in a Month: What Is Driving the Rally?
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Key Takeaways
Pharvaris' deucrictibant XR cut mean monthly HAE attack rates by 83% versus placebo in CHAPTER-3.
Deucrictibant XR showed protection within a week, sustained benefits over 24 weeks and was well-tolerated.
Pharvaris plans 2027 filings while testing deucrictibant XR for prevention of AAE-C1INH attacks.
Shares of Pharvaris (PHVS - Free Report) have gained 10% over the past month, due to the positive top-line data announced on Sept. 8, 2026, from the pivotal phase III CHAPTER-3 study, which evaluated its lead drug candidate, deucrictibant’s extended-release (XR) formulation for the prevention of hereditary angioedema (HAE) attacks.
Strong CHAPTER-3 Data Boost Deucrictibant's Potential
The phase III CHAPTER-3 study evaluated 40 mg of oral deucrictibant extended-release (XR) once daily for the prevention of HAE attacks in adolescents and adults. Notably, the study included patients with HAE type 1, type 2 and HAE with normal C1 inhibitor, making it the first phase III prophylaxis study to evaluate all three HAE types, according to Pharvaris.
The study met its primary endpoint with a statistically significant 83% reduction in the mean monthly HAE attack rate versus placebo across all HAE types. The effect was even stronger in patients with HAE type 1 or type 2, where the mean monthly attack rate was reduced by 87% versus placebo. All secondary efficacy endpoints also achieved statistical significance.
The data showed that deucrictibant XR began protecting within the first week of treatment, with the benefit sustained throughout the 24-week study period. The treatment increased the proportion of patients who remained free from HAE attacks.
The safety profile was also encouraging. Deucrictibant XR was well-tolerated, with most treatment-emergent adverse events being mild or moderate.
Following the positive CHAPTER-3 data, Pharvaris plans to use the data as the basis for filing marketing applications for deucrictibant XR. The company plans to present additional efficacy, safety and participant-experience data from the CHAPTER-3 study at upcoming medical congresses. Pharvaris expects to begin regulatory submissions in the first half of 2027. Specifically, Pharvaris plans to submit a new drug application (NDA) to the FDA for the prophylaxis of bradykinin-mediated angioedema attacks in the first half of 2027. Meanwhile, the CHAPTER-4 open-label long-term extension study of deucrictibant XR for the prophylaxis of HAE attacks is ongoing.
Year to date, the stock has soared 40.1% compared with the industry’s 4.9% growth.
Image Source: Zacks Investment Research
Two Potential Opportunities From the Same Drug
Pharvaris is developing deucrictibant in different formulations and treatment settings. The XR formulation is being developed for long-term prevention of HAE attacks, while the immediate-release (IR) formulation is intended for on-demand treatment of HAE attacks. This strategy could give Pharvaris two potential commercial opportunities from the same core molecule, preventing attacks in patients requiring long-term prophylaxis and treating attacks when they occur. The company's focus on oral administration could also provide a convenience advantage because several existing HAE therapies require injectable or other non-oral administration.
In July 2026, the FDA accepted PHVS’ NDA for deucrictibant IR capsule for the on-demand treatment of HAE attacks. The regulatory authority has assigned a PDUFA target action date of April 23, 2027. If approved, Pharvaris expects deucrictibant to become the first oral bradykinin B2 receptor antagonist for treating HAE attacks.
Potential Expansion Beyond Hereditary Angioedema
Beyond HAE, Pharvaris is also evaluating deucrictibant XR in the phase III CREAATE study for the prevention of acquired angioedema due to C1-inhibitor deficiency (AAE-C1INH) attacks. The additional indication could expand the candidate's addressable market if clinical development is successful. Patient enrollment is ongoing, with top-line data from part A of the study expected in the first quarter of 2027.
PHVS’ Competition in the HAE Space
Pharvaris intends to market deucrictibant as both an 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, which received approval for a similar indication in July 2025.
In the prophylactic treatment space, companies such as 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 prophylactic treatment for HAE attacks in individuals aged 12 years and older, Ionis’ Dawnzera was recently approved for a similar indication in August 2025.
Image: Bigstock
PHVS Stock Rises 10% in a Month: What Is Driving the Rally?
Key Takeaways
Shares of Pharvaris (PHVS - Free Report) have gained 10% over the past month, due to the positive top-line data announced on Sept. 8, 2026, from the pivotal phase III CHAPTER-3 study, which evaluated its lead drug candidate, deucrictibant’s extended-release (XR) formulation for the prevention of hereditary angioedema (HAE) attacks.
Strong CHAPTER-3 Data Boost Deucrictibant's Potential
The phase III CHAPTER-3 study evaluated 40 mg of oral deucrictibant extended-release (XR) once daily for the prevention of HAE attacks in adolescents and adults. Notably, the study included patients with HAE type 1, type 2 and HAE with normal C1 inhibitor, making it the first phase III prophylaxis study to evaluate all three HAE types, according to Pharvaris.
The study met its primary endpoint with a statistically significant 83% reduction in the mean monthly HAE attack rate versus placebo across all HAE types. The effect was even stronger in patients with HAE type 1 or type 2, where the mean monthly attack rate was reduced by 87% versus placebo. All secondary efficacy endpoints also achieved statistical significance.
The data showed that deucrictibant XR began protecting within the first week of treatment, with the benefit sustained throughout the 24-week study period. The treatment increased the proportion of patients who remained free from HAE attacks.
The safety profile was also encouraging. Deucrictibant XR was well-tolerated, with most treatment-emergent adverse events being mild or moderate.
Following the positive CHAPTER-3 data, Pharvaris plans to use the data as the basis for filing marketing applications for deucrictibant XR. The company plans to present additional efficacy, safety and participant-experience data from the CHAPTER-3 study at upcoming medical congresses. Pharvaris expects to begin regulatory submissions in the first half of 2027. Specifically, Pharvaris plans to submit a new drug application (NDA) to the FDA for the prophylaxis of bradykinin-mediated angioedema attacks in the first half of 2027. Meanwhile, the CHAPTER-4 open-label long-term extension study of deucrictibant XR for the prophylaxis of HAE attacks is ongoing.
Year to date, the stock has soared 40.1% compared with the industry’s 4.9% growth.
Image Source: Zacks Investment Research
Two Potential Opportunities From the Same Drug
Pharvaris is developing deucrictibant in different formulations and treatment settings. The XR formulation is being developed for long-term prevention of HAE attacks, while the immediate-release (IR) formulation is intended for on-demand treatment of HAE attacks. This strategy could give Pharvaris two potential commercial opportunities from the same core molecule, preventing attacks in patients requiring long-term prophylaxis and treating attacks when they occur. The company's focus on oral administration could also provide a convenience advantage because several existing HAE therapies require injectable or other non-oral administration.
In July 2026, the FDA accepted PHVS’ NDA for deucrictibant IR capsule for the on-demand treatment of HAE attacks. The regulatory authority has assigned a PDUFA target action date of April 23, 2027. If approved, Pharvaris expects deucrictibant to become the first oral bradykinin B2 receptor antagonist for treating HAE attacks.
Potential Expansion Beyond Hereditary Angioedema
Beyond HAE, Pharvaris is also evaluating deucrictibant XR in the phase III CREAATE study for the prevention of acquired angioedema due to C1-inhibitor deficiency (AAE-C1INH) attacks. The additional indication could expand the candidate's addressable market if clinical development is successful. Patient enrollment is ongoing, with top-line data from part A of the study expected in the first quarter of 2027.
PHVS’ Competition in the HAE Space
Pharvaris intends to market deucrictibant as both an 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, which received approval for a similar indication in July 2025.
In the prophylactic treatment space, companies such as 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 prophylactic treatment for HAE attacks in individuals aged 12 years and older, Ionis’ Dawnzera was recently approved for a similar indication in August 2025.
Pharvaris N.V. Price and Consensus
Pharvaris N.V. price-consensus-chart | Pharvaris N.V. Quote
PHVS's Zacks Rank
Pharvaris currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.