Core Insights - Pharvaris is focused on developing oral bradykinin B2 receptor antagonists to address unmet needs in bradykinin-mediated diseases, particularly hereditary angioedema (HAE) and acquired angioedema due to C1 inhibitor deficiency (AAE-C1INH) [1][14] - The company outlined its strategic priorities for 2026, emphasizing long-term prophylaxis and on-demand treatment of HAE attacks [3][4] Clinical Development - The pivotal Phase 3 study, RAPIDe-3, demonstrated that deucrictibant significantly reduced the median time to onset of symptom relief to 1.28 hours compared to placebo (p<0.0001) [5] - Topline data from the CHAPTER-3 study, assessing deucrictibant for prophylactic treatment of HAE attacks, is expected in the third quarter of 2026 [4][5] - The NDA dossier for deucrictibant's on-demand treatment of HAE attacks is on track for filing in the first half of 2026 [4][5] Financial and Operational Updates - Pharvaris has an estimated cash runway into the first half of 2027, indicating strong financial management [4][11] - The company was added to the Nasdaq Biotechnology Index in December 2025, reflecting its compliance with market capitalization and trading volume requirements [11] Upcoming Events - Pharvaris will participate in several investor conferences and medical congresses in early 2026, showcasing its ongoing clinical studies and findings [8][10][12]

Pharvaris N.V. (NASDAQ:PHVS) is one of the best small cap stocks to buy with huge upside potential. Morgan Stanley analyst Maxwell Skor reiterated a Buy rating on Pharvaris N.V. (NASDAQ:PHVS) on December 15, setting a $41 price target. Pharvaris N.V. (NASDAQ:PHVS) also received a rating update from Oppenheimer on December 4, with the company reaffirming an Outperform rating on the stock and lifting the price target to $50 from $44. The firm told investors that the company reported positive top-line resul ...

Core Insights - Saturn V Capital Management has initiated a new position in Pharvaris N.V. (PHVS), acquiring 886,332 shares valued at approximately $22.1 million during the third quarter, indicating strong interest from a major hedge fund in the biotech sector [1][2]. Company Overview - Pharvaris N.V. is a clinical-stage biotechnology company focused on developing novel oral therapies for hereditary angioedema (HAE), a rare genetic disorder [6][9]. - The company has three pivotal programs underway: PHA121 (Phase II), PHVS416 (Phase II), and PHVS719 (Phase I), targeting both acute and prophylactic treatment needs [9][10]. - As of market close on the reporting date, Pharvaris shares were priced at $25.35, reflecting a 33% increase over the past year, outperforming the S&P 500, which rose by 12% in the same period [3][4]. Financial Metrics - Pharvaris has a market capitalization of $1.6 billion and reported a net income of -$163.7 million for the trailing twelve months (TTM) [4]. - The company had €329 million in cash on hand as of September 30, which is expected to finance operations into the first half of 2027, covering major data readouts [10]. Investment Implications - Saturn V's stake in Pharvaris represents about 4.9% of its 13F assets, aligning with the fund's focus on biotech investments and high-conviction clinical risks [3][11]. - Recent positive topline data from the RAPIDe-3 Phase 3 trial showed a median time to onset of symptom relief of 1.3 hours, highlighting the potential for future growth despite the company being pre-revenue [11][12].

Core Insights - Pharvaris (PHVS) shares increased nearly 22% following positive results from the phase III RAPIDe-3 study for its drug deucrictibant, aimed at treating hereditary angioedema (HAE) attacks in adults and adolescents aged 12 and older [2][8] Study Results - The RAPIDe-3 study achieved its primary endpoint, with patients experiencing symptom relief within 1.28 hours after taking deucrictibant, compared to over 12 hours with placebo [3] - All secondary endpoints were met, including a median time to substantial symptom relief of under 3 hours with deucrictibant versus over 12 hours with placebo, and complete symptom resolution in 11.95 hours compared to more than 24 hours for placebo [3] - 83% of HAE attacks were managed with a single dose of deucrictibant, and over 93% of attacks were treated without the need for backup treatment [4] Regulatory Plans - Pharvaris plans to submit a regulatory filing for deucrictibant in the first half of 2026, which could position it as the second oral on-demand therapy for HAE after KalVista Pharmaceuticals' Ekterly [5] Competitive Landscape - Comparisons between deucrictibant and KalVista's Ekterly highlight potential advantages for deucrictibant, as it showed faster symptom relief in the RAPIDe-3 study compared to the KONFIDENT study supporting Ekterly's approval [6] - Year-to-date, Pharvaris stock has risen 53%, outperforming the industry growth of 20% [7] Product Development - Pharvaris is developing two formulations of deucrictibant: an immediate-release capsule for acute treatment and an extended-release tablet for prophylactic treatment [10] - The extended-release tablet is being evaluated in the phase III CHAPTER-3 study for HAE prophylaxis, with top-line data expected in the second half of 2026 [11] - Additionally, the extended-release formulation is under evaluation in the CREAATE study for treating acquired angioedema with C1-inhibitor deficiency [12] Market Positioning - If approved, deucrictibant will compete in the on-demand treatment space against KalVista's Ekterly, with advantages over older injectable treatments like Firazyr and Kalbitor due to its oral administration [14] - In the prophylactic treatment segment, competitors include BioCryst Pharmaceuticals and Ionis Pharmaceuticals, with BioCryst's Orladeyo and Ionis' Dawnzera being notable products [15]

Core Insights - Pharvaris is a biopharmaceutical company focused on developing oral treatments for hereditary angioedema (HAE) using a bradykinin B2 antagonist approach, addressing both on-demand and preventive needs for patients [1][6] Stock Performance - As of December 3, 2025, Pharvaris (PHVS) stock was priced at $29.37, reflecting a 21.75% increase from the previous session, with fluctuations between $23.80 and $29.68 on that day [4] - The stock has experienced a yearly high of $29.67 and a low of $11.51, indicating its volatile nature [4] Market Analysis - Morgan Stanley set a price target of $41 for PHVS, suggesting a potential increase of approximately 39.62% based on the company's promising late-stage pipeline and anticipated phase 3 data by the end of 2025 [2][6] - Pharvaris has a market capitalization of approximately $1.91 billion, indicating a substantial presence in the biopharmaceutical sector [5] Clinical Development - The company has received a buy rating with a target price of $40, driven by strong phase 2 results and regulatory precedents [3][6] - The mechanism of Deucrictibant, a key component of their treatment, has been validated, with an estimated probability of success for the upcoming phase 3 readout exceeding 90% [3]

Core Insights - Pharvaris N.V. is focused on developing treatments for rare diseases, particularly Hereditary Angioedema (HAE) [1][6] - Morgan Stanley has an "Overweight" rating for Pharvaris, raising the price target from $37 to $41, with the current stock price at $29.37 [1][6] Study Results - The RAPIDe-3 Phase III study of Deucrictibant showed a median time to symptom relief of 1.28 hours, significantly faster than placebo [2][3][6] - The study involved 134 participants aged 12 and older, demonstrating the efficacy of Deucrictibant in treating HAE attacks [2] - 83% of attacks were treated with a single capsule, and 93.2% of participants did not require rescue medication within 12 hours [3] Future Plans - Pharvaris plans to use the RAPIDe-3 study data for marketing authorization applications, expected to be submitted in the first half of 2026 [3][6] - The positive results from the study have contributed to an increase in PHVS stock value by 21.75% [6] Market Performance - Pharvaris' current stock price is $29.37, reflecting a change of $5.25, with a market capitalization of approximately $1.91 billion [5][6] - The stock has fluctuated between $23.80 and $29.68 today, with a 52-week high of $29.67 and a low of $11.51 [5]

Core Insights - The announcement pertains to the topline data from the RAPIDe-3 Phase III clinical study of deucrictibant, which is an immediate-release capsule designed for the on-demand treatment of hereditary angioedema attacks [2]. Company Overview - Pharvaris is leading the communication regarding the RAPIDe-3 study and its implications for the treatment of hereditary angioedema [2]. - The webcast is part of Pharvaris's efforts to keep investors informed about the progress and potential of their clinical studies [2]. Clinical Study Details - The RAPIDe-3 study is a Phase III clinical trial, indicating it is in the later stages of testing before potential regulatory approval [2]. - The focus of the study is on the efficacy of deucrictibant in treating hereditary angioedema attacks on an on-demand basis [2].

Core Insights - Pharvaris N.V. announced topline data from the RAPIDe-3 Phase 3 trial of deucrictibant for treating hereditary angioedema (HAE) attacks, indicating positive results for the on-demand treatment [1][3] Study Results - The RAPIDe-3 trial enrolled 134 participants aged 12 years and older, evaluating the oral deucrictibant immediate-release (IR) capsule for HAE attacks [2] - Deucrictibant showed a faster median time to treatment response compared to placebo, with shorter median times for substantial symptom relief and complete symptom resolution [3] - The data indicated fewer attacks required a second dose or rescue medication within 12 hours [4] - 83.0% of attacks were treated with a single capsule of deucrictibant IR, and 93.2% of treated attacks did not require rescue medication [9] Safety and Tolerability - Deucrictibant was well tolerated, with no serious treatment-related adverse events reported, and no participants discontinued treatment due to adverse events [5] Future Plans - The data from the RAPIDe-3 study will support marketing authorization applications planned for submission in the first half of 2026 [3] Competitive Landscape - The FDA approved Ionis Pharmaceuticals' Dawnzera for HAE prophylaxis, which significantly reduced the monthly attack rate by 81% compared to placebo over 24 weeks [6] - KalVista Pharmaceuticals' Ekterly was also approved for acute HAE attacks, being the first oral on-demand treatment for HAE [7] Market Reaction - Pharvaris shares increased by 12.32% to $27.09 following the announcement of the trial results [7]

Summary of RAPID-3 Topline Data Webcast Company and Industry - **Company**: Pharvaris - **Industry**: Biotechnology, specifically focusing on treatments for Hereditary Angioedema (HAE) Core Points and Arguments 1. **Introduction of Deucrictibant**: The RAPID-3 study is a phase 3 clinical trial for deucrictibant, an immediate release capsule designed for on-demand treatment of hereditary angioedema attacks [2][6] 2. **Study Design**: RAPID-3 was a double-blind crossover study involving 124 adults and 10 adolescents, treating various severities of HAE attacks [13][14] 3. **Diversity of Participants**: The study included a diverse population with approximately 70% Caucasians, over 14% Asians, and around 7% Black or African Americans, making it the most representative HAE study to date [14] 4. **Efficacy Results**: Deucrictibant demonstrated a median time to onset of symptom relief of 1.28 hours, significantly faster than placebo, which had a median time of over 12 hours [16][19] 5. **Substantial Symptom Relief**: 85% of deucrictibant-treated attacks achieved symptom relief within four hours, compared to around 30% for placebo [17] 6. **End-of-Progression Milestone**: The end-of-progression was achieved within 17.5 minutes for deucrictibant-treated attacks, indicating rapid absorption and effectiveness [18] 7. **Safety Profile**: Deucrictibant was well tolerated, with most adverse events being mild or moderate. There were no significant safety signals identified [19][20] 8. **Market Positioning**: Deucrictibant's dual formulation for both on-demand and prophylactic treatment is seen as a strategic advantage, potentially enhancing market share and patient adoption [24][25] 9. **Future Plans**: Pharvaris aims to submit for global marketing authorization for deucrictibant in the on-demand treatment of HAE attacks in 2026 [22][37] Other Important Content 1. **Unmet Needs in HAE Treatment**: Despite advancements in long-term prophylactic treatments, there remains a critical need for effective on-demand therapies due to the unpredictable nature of HAE attacks [9][10] 2. **Patient-Centric Approach**: The development of deucrictibant aligns with the company's mission to provide patient choice and reduce treatment burden [25][26] 3. **Upcoming Data Presentations**: Further data from the RAPID-3 study will be presented at the AAAAI conference in February 2024, with additional studies planned for the prophylactic treatment of HAE [26][37] 4. **CYP3A4 Interaction**: Deucrictibant is primarily metabolized by CYP3A4, and caution is advised when used with strong CYP3A4 inhibitors or inducers [32] 5. **Patient Preferences**: A significant majority (80%-85%) of patients expressed interest in switching to oral rescue treatments, although some may prefer injectable options due to familiarity and perceived effectiveness [50] This summary encapsulates the key findings and strategic insights from the RAPID-3 Topline Data webcast, highlighting the potential impact of deucrictibant on the treatment landscape for hereditary angioedema.

RAPIDe-3 Study Design and Demographics - The RAPIDe-3 study was a double-blind crossover trial evaluating deucrictibant IR 20 mg versus placebo for HAE attacks[17] - The efficacy analyses were based on 88 paired attacks[19] - The study enrolled 134 participants, including 10 adolescents (7.5%) and 124 adults (92.5%)[20] - The median age of participants was 38 years, and 56.7% were female[23] Efficacy Endpoints - Deucrictibant significantly reduced the time to onset of symptom relief to 1.28 hours compared to placebo (p < 0.0001)[35] - Deucrictibant significantly reduced the time to End of Progression (EoP) to 17.47 minutes compared to placebo (p < 0.0001)[38] - Deucrictibant significantly reduced the time to substantial symptom relief by PGI-C to 2.85 hours compared to placebo (p < 0.0001)[42] - Deucrictibant significantly reduced the time to substantial symptom relief by PGI-S to 2.41 hours compared to placebo (p < 0.0001)[47] - Deucrictibant significantly reduced the time to complete symptom resolution to 11.95 hours compared to placebo (p < 0.0001)[51] Treatment and Safety - 83% of attacks were treated with a single capsule of deucrictibant[54] - 93.2% of attacks were treated without rescue medication with deucrictibant versus 63.6% with placebo[54]