Core Insights - Pharvaris announced pivotal data from the RAPIDe-3 study, confirming the efficacy of deucrictibant for on-demand treatment of hereditary angioedema (HAE) attacks, with plans for marketing authorization applications in the first half of 2026 [1][7] Study Design and Results - The RAPIDe-3 study was a global Phase 3, placebo-controlled trial involving 134 participants from 24 countries, assessing the immediate-release (IR) capsule of deucrictibant (20 mg) for HAE treatment [2] - The study achieved statistical significance for the primary endpoint and all 11 secondary efficacy endpoints, making it the first on-demand HAE study compliant with the Core Outcome Set recommended in the AURORA consensus [2][3] Efficacy and Safety - Deucrictibant demonstrated a median time to onset of symptom relief of 1.28 hours, significantly faster than placebo (p<0.0001) [3][4] - All secondary efficacy endpoints were met, including a median time to End of Progression™ of 17.47 minutes and complete symptom resolution in 11.95 hours [3][4] - The safety profile of deucrictibant was well-tolerated, with no serious adverse events reported [5][9] Future Plans - Pharvaris is preparing to submit a New Drug Application (NDA) to the FDA in the first half of 2026 for deucrictibant as an on-demand treatment for HAE attacks [7][10] - An ongoing open-label extension study (RAPIDe-2 Part B) will provide additional efficacy and safety data [7] Company Overview - Pharvaris is focused on developing oral bradykinin B2 receptor antagonists to address unmet needs in bradykinin-mediated conditions, including HAE [10] - The company aims to provide therapies that combine injectable-like efficacy with the convenience of oral administration [10]

Core Insights - General Atlantic, L.P. has increased its stake in Pharvaris by acquiring an additional 500,000 shares, bringing its total holding to 8,031,252 shares valued at approximately $200.38 million as of September 30, 2025, indicating strong investor confidence in the company's upcoming clinical results [1][2][3] Company Overview - Pharvaris is a clinical-stage biotechnology company focused on developing oral therapies for hereditary angioedema, a rare genetic disorder, with a pipeline of differentiated drug candidates in various clinical phases [5][8] - The company's strategy emphasizes innovation in rare disease therapeutics, aiming to provide both acute and prophylactic treatment options to improve patient outcomes [6] Financial Metrics - As of November 12, 2025, Pharvaris shares were priced at $25.81, reflecting a one-year price change of 30.1%, outperforming the S&P 500 by 7.3 percentage points [3][10] - The market capitalization of Pharvaris is approximately $1.56 billion, with a net income of -$195.80 million for the trailing twelve months [3] Clinical Development - Pharvaris is developing small molecule therapies for hereditary angioedema, including PHA121 (Phase II), PHVS416 (on-demand, Phase II), and PHVS719 (prophylactic, Phase I) [8] - The company has received FDA clearance for both acute and prophylactic programs, which is a significant milestone as pivotal studies are underway [10] Investment Implications - The increase in General Atlantic's stake suggests that sophisticated investors anticipate a turning point for Pharvaris, particularly as the company approaches critical clinical readouts that could redefine its market valuation [9][11] - If the upcoming data cycle demonstrates efficacy and patient preference for oral therapy, Pharvaris could transition from a single-asset clinical company to a key player in the rare disease market [11]

Core Viewpoint - The article emphasizes the focus on non-consensus long-short investment ideas within the biotechnology sector, particularly targeting small to mid-cap companies in the US and EU markets, with an interest in clinical catalysts and new drug launches [1]. Group 1: Investment Focus - The investment strategy centers on small to mid-cap biotechnology companies that are publicly traded [1]. - The analysis includes a focus on clinical catalysts and earnings related to new drug launches [1]. Group 2: Analyst's Position - The analyst holds a beneficial long position in the shares of specific companies, namely PHVS and KALV, through various financial instruments [2]. - The article reflects the analyst's personal opinions and is not influenced by any business relationships with the mentioned companies [2]. Group 3: Content Disclaimer - The content is intended for informational and educational purposes only and should not be interpreted as financial or investment advice [3]. - There is a disclaimer regarding the accuracy and reliability of the information provided, indicating potential errors or omissions [3].

Core Insights - Pharvaris N.V. is focused on developing innovative oral therapies for rare diseases, particularly hereditary angioedema (HAE) [3][2] - The company operates a clinical-stage biopharmaceutical model, investing in research and development to advance its pipeline through regulatory milestones for future commercialization [1][3] Company Overview - Pharvaris N.V. develops small molecule therapies for HAE, including PHA121, PHVS416, and PHVS719 [2] - The company leverages proprietary small molecule technology to address significant unmet medical needs in the rare disease space [3] Financial Performance - As of November 14, 2025, shares of Pharvaris N.V. were priced at $23.55, reflecting a 14.6% increase over the past year, outperforming the S&P 500 by 5.01 percentage points [4] - Bain Capital Life Sciences Investors, LLC sold 122,106 shares of Pharvaris N.V. during the third quarter, reducing its position value by $21.23 million, with remaining shares valued at $79.37 million [5][6] Market Context - Pharvaris stock has increased over 50% in the last six months, nearing its 52-week high of $26.33 [8] - Despite the sale of shares by Bain Capital, the total value of its Pharvaris stock increased from approximately $58 million at the end of Q2 to $79 million at the end of Q3 [9]

Core Insights - Pharvaris is a late-stage biopharmaceutical company focused on developing oral bradykinin B2 receptor antagonists for treating bradykinin-mediated diseases, including hereditary angioedema (HAE) and acquired angioedema due to C1 inhibitor deficiency (AAE-C1INH) [1][9] Business Updates - The company is on track to report data from the pivotal Phase 3 trial, RAPIDe-3, in Q4 2025, with additional data from the CHAPTER-3 trial expected in the second half of 2026 [2][3] - The recently initiated CREAATE study aims to evaluate deucrictibant for both prophylactic and on-demand treatment of AAE-C1INH attacks [3][4] - Pharvaris has a strong financial position with cash and cash equivalents of €329 million as of September 30, 2025, compared to €281 million at the end of 2024 [11] Development Pipeline - Topline data for RAPIDe-3, a Phase 3 study of deucrictibant immediate-release capsule for on-demand treatment of HAE attacks, is expected in Q4 2025 [3][4] - Enrollment in CHAPTER-3, a Phase 3 study of deucrictibant extended-release tablet for prophylaxis against HAE attacks, is progressing as planned, with topline data anticipated in the second half of 2026 [3][4] - The CREAATE study has been initiated to assess the efficacy and safety of deucrictibant for AAE-C1INH attacks, with a structured approach to treatment [4] Financial Performance - For Q3 2025, R&D expenses were €29.8 million, up from €25.8 million in Q3 2024, while G&A expenses decreased to €9.8 million from €12.1 million in the same period [11] - The company reported a loss of €37.1 million for Q3 2025, resulting in a basic and diluted loss per share of €0.60, compared to a loss of €41.7 million and a loss per share of €0.77 in Q3 2024 [11]

Core Insights - Pharvaris presented significant clinical data on deucrictibant at the 2025 ACAAI Annual Meeting, highlighting its potential impact on patients with bradykinin-mediated diseases [1][2] Long-Term Prophylaxis - The final analysis of the CHAPTER-1 study showed that deucrictibant reduced the mean attack rate from 2.18 attacks/month to 0.12 attacks/month over approximately 34 months, demonstrating a well-tolerated safety profile [3][4] - Clinically meaningful improvements in disease control and health-related quality of life were observed with deucrictibant treatment for up to 34 months [4][5] - Sustained therapeutic exposure was confirmed with the once-daily oral extended-release tablet, showing therapeutic effects lasting over 24 hours [5][6] On-Demand Therapy - Data from the RAPIDe-2 study indicated that approximately 85% of attacks treated with a single dose of deucrictibant achieved symptom resolution within 24 hours, with a median time to complete resolution of 10.6 hours [7][8] - The treatment was well-tolerated, with 97.8% of attacks achieving symptom relief within 12 hours [8][9] - A propensity score-matched analysis showed that deucrictibant-treated attacks had more favorable outcomes compared to standard care across most efficacy endpoints [10] Expansion Beyond HAE - Pharvaris developed a clinically validated kinin biomarker assay to measure bradykinin levels, which may aid in identifying and managing bradykinin-mediated angioedema [11][12] - The assay could potentially identify further applications for deucrictibant as a bradykinin B2 receptor antagonist [12] About Deucrictibant - Deucrictibant is an oral bradykinin B2 receptor antagonist in clinical development for preventing and treating bradykinin-mediated angioedema attacks [13][14] - It has received orphan drug designation from regulatory authorities, indicating its potential significance in treating rare diseases [14][15] About Pharvaris - Pharvaris is focused on developing oral therapies for bradykinin-mediated angioedema, aiming to provide injectable-like efficacy with the convenience of oral administration [15]

Core Insights - Pharvaris, a late-stage biopharmaceutical company, is focused on developing oral bradykinin B2 receptor antagonists to address unmet needs in bradykinin-mediated diseases such as hereditary angioedema (HAE) and acquired angioedema due to C1 inhibitor deficiency (AAE-C1INH) [1][4] Presentation Details - Pharvaris announced the acceptance of two abstracts for oral presentation and six for poster presentation at the American College of Allergy, Asthma, and Immunology (ACAAI) 2025 Annual Scientific Meeting scheduled for November 6-10, 2025, in Orlando, Florida [1][2] - The oral presentations include: - Clinical Validation of a Kinin Biomarker Assay to Characterize Bradykinin-Mediated Angioedema on November 8 at 4:43 p.m. ET [2] - Long-Term Safety and Efficacy of Oral Deucrictibant for Prophylaxis in Hereditary Angioedema: CHAPTER-1 Open-Label Extension on November 8 at 4:53 p.m. ET [2] - The poster presentations cover various aspects of Deucrictibant's efficacy and safety in treating hereditary angioedema, scheduled for November 7 [2] Company Overview - Pharvaris aims to provide injectable-like efficacy and placebo-like tolerability through oral therapies for the prevention and treatment of bradykinin-mediated angioedema attacks [4] - The company is currently evaluating the efficacy and safety of Deucrictibant in pivotal Phase 3 studies for both the prevention and on-demand treatment of HAE attacks [4]

Core Proposition - Deucrictibant offers an oral therapy option that addresses a specific unmet need in the treatment of hereditary angioedema (HAE) [2] - The preference for oral therapies among patients is high, indicating a demand for more convenient treatment options that enhance normalcy in patients' lives [2] - Efficacy remains the paramount proposition for any therapy, particularly in the context of HAE [2][3] Treatment Aspects - The oral formulation of deucrictibant is a key feature, but the company emphasizes that efficacy is equally important [2] - The combination of an oral delivery method with high efficacy is a significant aspect of the product's value proposition [3]

Summary of Conference Call on Pharvaris and Deucrictibant Company and Industry Overview - **Company**: Pharvaris - **Industry**: Hereditary Angioedema (HAE) Treatment Key Points and Arguments 1. **Deucrictibant's Value Proposition**: Deucrictibant is an oral therapy that addresses a significant unmet need in HAE treatment, combining oral convenience with high efficacy comparable to injectable therapies [1][2] 2. **Treatment Segments**: The prophylactic treatment segment has grown to approximately 67% of the population and 80% of the market value, while the on-demand segment remains viable due to its flexibility [3][4] 3. **Patient-Centric Approach**: The choice between prophylactic and on-demand treatment is highly individualized, influenced by patient preferences and anxiety levels regarding attacks [5][6] 4. **Mechanism of Action**: Deucrictibant is unique as it is the only therapy with formulations for both prophylactic and on-demand use, acting as a bradykinin B2 receptor antagonist [9][10] 5. **Phase 3 Trials**: The timeline for the RAPIDe-3 Phase 3 trial has been moved up to Q4 2025, with expectations of strong efficacy and safety data based on Phase 2 results [11][17] 6. **Efficacy Metrics**: In Phase 2 trials, deucrictibant showed an 87% reduction in attacks compared to placebo, with 49% of patients experiencing zero attacks [21][22] 7. **Market Opportunity**: There are approximately 150 to 300 new HAE patients diagnosed annually, with a significant portion expressing dissatisfaction with current treatments, indicating a strong market opportunity for deucrictibant [25][26] 8. **Regulatory Milestones**: The FDA has accepted TQT waivers for both formulations of deucrictibant, which will streamline the regulatory process and reduce costs [30][32] 9. **Financial Position**: Pharvaris reported around $200 million in cash, extending its runway to the first half of 2027, with plans for a U.S. sales and marketing infrastructure [40][41] 10. **Future Developments**: Pharvaris plans to initiate trials for acquired angioedema and aims for a broad label for deucrictibant, targeting not just type 1 and 2 angioedema [36][37] Additional Important Insights - **Patient Satisfaction**: A survey indicated that 67% of patients are not satisfied with their current treatment, highlighting the demand for more effective options [25] - **Competitive Landscape**: The company is closely monitoring competitors and the evolving market dynamics, particularly in the context of pricing and payer expectations [28][29] - **AI Utilization**: Pharvaris is exploring the use of AI for data analysis and medical writing, indicating a forward-looking approach to technology integration [43] - **Regulatory Interactions**: Positive interactions with the FDA have been reported, with no major concerns regarding tariffs or regulatory changes impacting the company [45][46]

Summary of Pharvaris Conference Call Company Overview - Pharvaris is a late-stage biopharmaceutical company focused on developing oral bradykinin B2 receptor antagonists for treating hereditary angioedema (HAE) and other bradykinin-mediated diseases [4][5] Key Points Clinical Development - Pharvaris is conducting two pivotal Phase 3 studies, with results expected in the next 12 months [4] - The on-demand program for deucrictibant is anticipated to read out in Q4 2025, while the prophylactic program is expected to provide top-line data in the second half of 2026 [4][10] - An acquired angioedema Phase 3 pivotal study is planned to be initiated this year [4][14] Market Potential - The HAE market is projected to reach approximately $4.7 billion by 2036 [4] - Pharvaris aims to broaden the indication for deucrictibant beyond hereditary angioedema to include other bradykinin-mediated angioedema [4][15] Product Differentiation - Deucrictibant operates at the bottom of the angioedema pathway, contrasting with other treatments that act higher up in the kallikrein system [5] - The product features two formulations: an extended-release formulation for prophylactic use and an immediate-release capsule for on-demand treatment [6][10] Clinical Efficacy - In Phase II studies, deucrictibant demonstrated: - End of progression in 25-26 minutes [8] - Onset of symptom relief in 1.1 hours, compared to 2.4 hours for standard care [9] - Complete symptom resolution in 10.6 hours [9] - 85% reduction in overall attacks at injectable levels [11] - 93% attack reduction in open-label extension data [11] Safety Profile - Deucrictibant has shown placebo-like tolerability and received a QT waiver, indicating a favorable safety profile [9][11] Strategic Positioning - Pharvaris intends to launch the on-demand program first, followed by the prophylactic program, leveraging the dual portfolio to expand beyond hereditary angioedema [18] - The company has orphan drug designation in Europe and the U.S. for bradykinin-mediated angioedema, which may facilitate priority review discussions with regulators [15] Competitive Landscape - The company believes that the best product can become a market leader, emphasizing the importance of patient services and marketing in the HAE space [16][17] - There is a significant unmet need for effective oral therapies in the HAE market, as evidenced by the uptake of existing oral treatments [16] Future Opportunities - Pharvaris estimates that the population with normal C1 could represent an additional 20% of the current HAE types I and II population, indicating potential for market expansion [25] Additional Insights - The ability to use both on-demand and prophylactic therapies in concert is seen as a differentiator for payer and physician adoption [23] - The company is exploring opportunities for identifying patients with acquired angioedema and HAE of unknown mutations through a biomarker [25]