A late-stage biotech with three pivotal trials underway just landed a major hedge-fund backer — here’s why the timing matters.On November 14, Austin-based Saturn V Capital Management disclosed a new position in Pharvaris N.V. (PHVS), acquiring 886,332 shares valued at approximately $22.1 million during the third quarter.What HappenedAccording to a Securities and Exchange Commission (SEC) filing dated November 14, Saturn V Capital Management initiated a new position in Pharvaris N.V. (PHVS). The fund reporte ...

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) rose nearly 22% on Wednesday after the company announced positive results from the phase III RAPIDe-3 study evaluating its lead pipeline drug deucri ...

Pharvaris is developing oral treatments for hereditary angioedema (HAE), leveraging its bradykinin B2 antagonist franchise.Morgan Stanley set a price target of $41 for PHVS, indicating a potential increase of approximately 39.62%.The company's strong phase 2 results and high probability of phase 3 success have led to a buy rating and a target price of $40.Pharvaris (NASDAQ:PHVS) is a biopharmaceutical company focused on developing oral treatments for hereditary angioedema (HAE). The company is gaining atten ...

Morgan Stanley maintains an "Overweight" rating for NASDAQ:PHVS, raising its price target from $37 to $41. Pharvaris' RAPIDe-3 Phase III study of Deucrictibant shows promising results for treating Hereditary Angioedema (HAE), with a median time to symptom relief of just 1.28 hours. The company plans to use the study data for marketing authorization applications, starting in the first half of 2026, as the stock value increases by 21.75%.Pharvaris N.V. (NASDAQ:PHVS) is a biopharmaceutical company focused on ...

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]

Pharvaris (NasdaqGS:PHVS) Update / Briefing December 03, 2025 08:00 AM ET Company ParticipantsLaura Chico - Managing DirectorPeng Lu - Chief Medical OfficerMarc Riedl - Professor of MedicineSteven Seedhouse - Biotechnology Equity ResearchMaxwell Skor - VP and Biotech Equity ResearchMaggie Beller - Head of Corporate and Investor CommunicationsPatrick Trucchio - Managing DirectorWim Souverijns - CCOBerndt Modig - CEOConference Call ParticipantsJeff Jones - Managing Director of Senior AnalystJacob Mekhael - Eq ...

RAPIDe-3 Topline Data Disclosure December 3, 2025 ©2025 1 Disclaimer This Presentation contains certain "forward‐looking statements" within the meaning of the federal securities laws that involve substantial risks and uncertainties. All statements contained in this Presentation that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements relating to our future plans, studies and trials, and any statements containing the words "be ...

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]