Pharvaris Receives FDA Acceptance for New Drug Application
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1 day ago
0mins
Source: Newsfilter
- NDA Approval: Pharvaris's New Drug Application (NDA) for deucrictibant has been accepted by the FDA, potentially making it the first oral bradykinin B2 receptor antagonist for treating Hereditary Angioedema (HAE) attacks.
- Clinical Data Support: The NDA includes clinical data from over 1,300 HAE attacks, with the RAPIDe-3 study demonstrating significant rapid and sustained efficacy of deucrictibant IR, achieving a median time to symptom relief of 1.28 hours.
- Market Potential: The FDA has granted deucrictibant orphan drug designation, and its successful launch is expected to significantly improve the standard of care for HAE patients, addressing the urgent market need for rapid and effective treatments.
- Commercial Infrastructure: Pharvaris is actively building its commercial infrastructure to ensure the successful launch of deucrictibant IR, which, if approved, will provide new growth opportunities for the company.
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Analyst Views on PHVS
Wall Street analysts forecast PHVS stock price to rise
9 Analyst Rating
8 Buy
1 Hold
0 Sell
Strong Buy
Current: 33.220
Low
30.00
Averages
41.00
High
60.00
Current: 33.220
Low
30.00
Averages
41.00
High
60.00
About PHVS
Pharvaris NV is a Netherlands-based company primarily engaged in the biopharmaceutical industry. The Company focuses on developing oral bradykinin B2 receptor antagonists to treat and prevent hereditary angioedema (HAE) attacks. Their key product is Deucrictibant (PHA121, PHA-022121), which is a small-molecule bradykinin B2 receptor antagonist. It is intended for both the on-demand and prophylactic treatment of HAE attacks. Deucrictibant has been studied in vitro, ex vivo, and in vivo models to assess its effectiveness in blocking the bradykinin B2 receptor. The Company is developing deucrictibant for on-demand use as PHVS416, a softgel capsule, and for prophylactic use as PHVS719, an extended-release tablet.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Pharvaris' New Drug Application Accepted by FDA for Deucrictibant
- FDA Acceptance: Pharvaris N.V. announced that the FDA has accepted its New Drug Application for the 20 mg immediate-release capsule of deucrictibant for on-demand treatment of Hereditary Angioedema (HAE) attacks, with a target action date set for April 23, 2027, which could significantly enhance the company's market opportunities if approved.
- Clinical Data Support: The NDA includes data from the treatment of over 1,300 HAE attacks, demonstrating that deucrictibant IR provides rapid symptom relief and accelerates complete symptom resolution, indicating its competitive edge in the market.
- Successful Clinical Trials: The global, pivotal, placebo-controlled Phase 3 study, RAPIDe-3, met all primary and 11 secondary efficacy endpoints with statistical significance, confirming the effectiveness of deucrictibant IR in patients aged 12 and older with HAE, further bolstering its market prospects.
- Market Readiness: Should the FDA approve the launch of deucrictibant IR, Pharvaris will be well-positioned to meet the urgent demand for rapid and effective treatment among HAE patients, enhancing the company's standing in the biopharmaceutical sector.
See More
Pharvaris Receives FDA Acceptance for New Drug Application
- NDA Approval: Pharvaris's New Drug Application (NDA) for deucrictibant has been accepted by the FDA, potentially making it the first oral bradykinin B2 receptor antagonist for treating Hereditary Angioedema (HAE) attacks.
- Clinical Data Support: The NDA includes clinical data from over 1,300 HAE attacks, with the RAPIDe-3 study demonstrating significant rapid and sustained efficacy of deucrictibant IR, achieving a median time to symptom relief of 1.28 hours.
- Market Potential: The FDA has granted deucrictibant orphan drug designation, and its successful launch is expected to significantly improve the standard of care for HAE patients, addressing the urgent market need for rapid and effective treatments.
- Commercial Infrastructure: Pharvaris is actively building its commercial infrastructure to ensure the successful launch of deucrictibant IR, which, if approved, will provide new growth opportunities for the company.
See More
Pharvaris' NDA for Deucrictibant Accepted by FDA
- NDA Progress: Pharvaris N.V. announced that its New Drug Application (NDA) for Deucrictibant has been accepted by the FDA, and if approved, it will be the first oral treatment for Hereditary Angioedema (HAE) attacks, providing patients with a convenient alternative to injectable therapies.
- Clinical Trial Results: The NDA submission includes data from the Phase 3 RAPIDe-3 trial, which met its primary and all 11 secondary endpoints in participants aged 12 and older, demonstrating rapid symptom relief with a median onset time of 1.28 hours and complete resolution in 11.95 hours.
- Safety Profile: The therapy showed a well-tolerated safety profile across more than 1,300 treated attacks, indicating its potential to offer better treatment options for HAE patients and improve their quality of life.
- Market Outlook: Pharvaris CEO Berndt Modig described the FDA acceptance as a major milestone after a decade of development, emphasizing the company's commitment to delivering a differentiated oral therapy that could enhance the standard of care for HAE patients, which is expected to positively impact the company's future market performance.
See More
Pharvaris to Present Research Findings at EAACI Congress
- Research Presentation: Pharvaris will showcase eight research findings at the 2026 EAACI Congress, including one oral presentation and seven poster presentations, highlighting advancements in treating hereditary angioedema, which is expected to enhance the company's visibility in the biopharmaceutical sector.
- Oral Presentation Highlights: The oral presentation will be led by Dr. Mauro Cancian, focusing on the immediate treatment effects of oral Deucrictibant capsules for hereditary angioedema attacks, providing crucial data support for clinical applications and potentially increasing market acceptance of the product.
- Poster Presentation Content: Several poster presentations will cover safety assessments of Deucrictibant and its applications in various treatment regimens, likely attracting the attention of clinicians and fostering future collaborations and research opportunities.
- Market Authorization Preparation: Pharvaris is preparing marketing authorization applications for the Deucrictibant immediate-release capsule and conducting a global pivotal Phase 3 study, with significant data expected in Q3 2026, which will lay the groundwork for the company's future growth.
See More
Pharvaris Reports Q1 2026 Financial Results
- Financial Performance: Pharvaris reported a GAAP EPS of -€0.59 for Q1 2026, indicating challenges in profitability that could negatively impact investor confidence and stock performance.
- Cash Position: As of March 31, 2026, the company's cash and cash equivalents stood at €247 million, down from €292 million on December 31, 2025, reflecting liquidity pressures that may affect future operations.
- Funding Activity: Pharvaris is planning a $115 million stock offering aimed at strengthening its capital base, although this may dilute existing shareholders and potentially exert downward pressure on the stock price in the short term.
- Conference Presentations: Pharvaris showcased its research at several key conferences, including the CIIC Spring Conference and the AAAAI Annual Meeting, aiming to enhance its visibility and influence in the industry while fostering potential collaboration opportunities.
See More
Analysis of Insider Stock Transaction at Pharvaris N.V.
- Insider Stock Sale: On May 1, 2026, Pharvaris N.V.'s Chief Medical Officer, Peng Lu, sold 14,166 common shares for approximately $427,000 through a scheduled option exercise and immediate sale, indicating routine portfolio management rather than opportunistic trading.
- Equity Exposure Analysis: Post-transaction, Lu retains 66,083 direct shares valued at about $1.95 million, reflecting a 17.65% reduction in direct holdings, yet maintains substantial equity exposure through 205,000 stock options, aligning with shareholder interests.
- Financial Overview: Pharvaris N.V. has a market capitalization of $1.97 billion, and despite a net loss of $175.7 million in 2025, the company invested €124 million in R&D, showcasing its long-term strategic focus in the rare disease treatment sector.
- Clinical Progress and Market Outlook: The company is advancing therapies like PHA121 and PHVS416 for hereditary angioedema, with plans to submit a new drug application in the first half of 2026, which could solidify its competitive position in the market.
See More
Pharvaris' New Drug Application Accepted by FDA for Deucrictibant
- FDA Acceptance: Pharvaris N.V. announced that the FDA has accepted its New Drug Application for the 20 mg immediate-release capsule of deucrictibant for on-demand treatment of Hereditary Angioedema (HAE) attacks, with a target action date set for April 23, 2027, which could significantly enhance the company's market opportunities if approved.
- Clinical Data Support: The NDA includes data from the treatment of over 1,300 HAE attacks, demonstrating that deucrictibant IR provides rapid symptom relief and accelerates complete symptom resolution, indicating its competitive edge in the market.
- Successful Clinical Trials: The global, pivotal, placebo-controlled Phase 3 study, RAPIDe-3, met all primary and 11 secondary efficacy endpoints with statistical significance, confirming the effectiveness of deucrictibant IR in patients aged 12 and older with HAE, further bolstering its market prospects.
- Market Readiness: Should the FDA approve the launch of deucrictibant IR, Pharvaris will be well-positioned to meet the urgent demand for rapid and effective treatment among HAE patients, enhancing the company's standing in the biopharmaceutical sector.
See More
Pharvaris Receives FDA Acceptance for New Drug Application
- NDA Approval: Pharvaris's New Drug Application (NDA) for deucrictibant has been accepted by the FDA, potentially making it the first oral bradykinin B2 receptor antagonist for treating Hereditary Angioedema (HAE) attacks.
- Clinical Data Support: The NDA includes clinical data from over 1,300 HAE attacks, with the RAPIDe-3 study demonstrating significant rapid and sustained efficacy of deucrictibant IR, achieving a median time to symptom relief of 1.28 hours.
- Market Potential: The FDA has granted deucrictibant orphan drug designation, and its successful launch is expected to significantly improve the standard of care for HAE patients, addressing the urgent market need for rapid and effective treatments.
- Commercial Infrastructure: Pharvaris is actively building its commercial infrastructure to ensure the successful launch of deucrictibant IR, which, if approved, will provide new growth opportunities for the company.
See More
Pharvaris' NDA for Deucrictibant Accepted by FDA
- NDA Progress: Pharvaris N.V. announced that its New Drug Application (NDA) for Deucrictibant has been accepted by the FDA, and if approved, it will be the first oral treatment for Hereditary Angioedema (HAE) attacks, providing patients with a convenient alternative to injectable therapies.
- Clinical Trial Results: The NDA submission includes data from the Phase 3 RAPIDe-3 trial, which met its primary and all 11 secondary endpoints in participants aged 12 and older, demonstrating rapid symptom relief with a median onset time of 1.28 hours and complete resolution in 11.95 hours.
- Safety Profile: The therapy showed a well-tolerated safety profile across more than 1,300 treated attacks, indicating its potential to offer better treatment options for HAE patients and improve their quality of life.
- Market Outlook: Pharvaris CEO Berndt Modig described the FDA acceptance as a major milestone after a decade of development, emphasizing the company's commitment to delivering a differentiated oral therapy that could enhance the standard of care for HAE patients, which is expected to positively impact the company's future market performance.
See More
Pharvaris to Present Research Findings at EAACI Congress
- Research Presentation: Pharvaris will showcase eight research findings at the 2026 EAACI Congress, including one oral presentation and seven poster presentations, highlighting advancements in treating hereditary angioedema, which is expected to enhance the company's visibility in the biopharmaceutical sector.
- Oral Presentation Highlights: The oral presentation will be led by Dr. Mauro Cancian, focusing on the immediate treatment effects of oral Deucrictibant capsules for hereditary angioedema attacks, providing crucial data support for clinical applications and potentially increasing market acceptance of the product.
- Poster Presentation Content: Several poster presentations will cover safety assessments of Deucrictibant and its applications in various treatment regimens, likely attracting the attention of clinicians and fostering future collaborations and research opportunities.
- Market Authorization Preparation: Pharvaris is preparing marketing authorization applications for the Deucrictibant immediate-release capsule and conducting a global pivotal Phase 3 study, with significant data expected in Q3 2026, which will lay the groundwork for the company's future growth.
See More
Pharvaris Reports Q1 2026 Financial Results
- Financial Performance: Pharvaris reported a GAAP EPS of -€0.59 for Q1 2026, indicating challenges in profitability that could negatively impact investor confidence and stock performance.
- Cash Position: As of March 31, 2026, the company's cash and cash equivalents stood at €247 million, down from €292 million on December 31, 2025, reflecting liquidity pressures that may affect future operations.
- Funding Activity: Pharvaris is planning a $115 million stock offering aimed at strengthening its capital base, although this may dilute existing shareholders and potentially exert downward pressure on the stock price in the short term.
- Conference Presentations: Pharvaris showcased its research at several key conferences, including the CIIC Spring Conference and the AAAAI Annual Meeting, aiming to enhance its visibility and influence in the industry while fostering potential collaboration opportunities.
See More
Analysis of Insider Stock Transaction at Pharvaris N.V.
- Insider Stock Sale: On May 1, 2026, Pharvaris N.V.'s Chief Medical Officer, Peng Lu, sold 14,166 common shares for approximately $427,000 through a scheduled option exercise and immediate sale, indicating routine portfolio management rather than opportunistic trading.
- Equity Exposure Analysis: Post-transaction, Lu retains 66,083 direct shares valued at about $1.95 million, reflecting a 17.65% reduction in direct holdings, yet maintains substantial equity exposure through 205,000 stock options, aligning with shareholder interests.
- Financial Overview: Pharvaris N.V. has a market capitalization of $1.97 billion, and despite a net loss of $175.7 million in 2025, the company invested €124 million in R&D, showcasing its long-term strategic focus in the rare disease treatment sector.
- Clinical Progress and Market Outlook: The company is advancing therapies like PHA121 and PHVS416 for hereditary angioedema, with plans to submit a new drug application in the first half of 2026, which could solidify its competitive position in the market.
See More
