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Pharvaris (NASDAQ:PHVS) Gains Attention with Innovative HAE Treatments
Financial Modeling Prep· 2025-12-04 07:07
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 ...
Pharvaris N.V. (NASDAQ: PHVS) Achieves Milestone in HAE Treatment Development
Financial Modeling Prep· 2025-12-04 07:03
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 ...
Pharvaris Reports Third Quarter 2025 Financial Results and Provides Business Update
Globenewswire· 2025-11-12 11:50
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]
Data Supporting the Potentially Differentiated Pharvaris Portfolio Presented at ACAAI 2025 Annual Scientific Meeting
Globenewswire· 2025-11-10 11:50
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]
Pharvaris to Present Clinical Data at the ACAAI 2025 Annual Scientific Meeting
Globenewswire· 2025-10-23 10:50
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]
Pharvaris: Deucrictibant Advanced To Target Two Sets Of HAE Patient Populations
Seeking Alpha· 2025-07-23 19:15
Group 1 - The article is authored by Terry Chrisomalis, who operates the Biotech Analysis Central pharmaceutical service on Seeking Alpha Marketplace, offering a two-week free trial for new subscribers [1] - Biotech Analysis Central provides a library of over 600 biotech investing articles, a model portfolio of more than 10 small and mid-cap stocks, and various analysis and news reports to assist healthcare investors [2] - The subscription for Biotech Analysis Central is priced at $49 per month, with a yearly plan available at a discounted rate of $399, reflecting a 33.50% discount [1][2] Group 2 - The article does not contain any stock, option, or similar derivative positions in the companies mentioned, nor does it plan to initiate any such positions within the next 72 hours [3] - Seeking Alpha clarifies that past performance does not guarantee future results and that no specific investment recommendations are provided [4]
Pharvaris Presents Data Supporting Ongoing Clinical Development of Deucrictibant in Bradykinin-Mediated Angioedema
Globenewswire· 2025-06-02 10:50
Core Insights - Pharvaris is advancing its late-stage clinical development of deucrictibant, a novel oral bradykinin B2 receptor antagonist aimed at treating bradykinin-mediated diseases such as hereditary angioedema (HAE) and acquired angioedema due to C1 inhibitor deficiency (AAE-C1INH) [1][18] - The company plans to present pivotal data readouts for deucrictibant in the next 18 months, highlighting its commitment to addressing unmet medical needs in this area [2][4] Prophylaxis - The ongoing Phase 2 CHAPTER-1 open-label extension study shows that oral deucrictibant maintains a low attack rate for over a year and a half, regardless of baseline attack rates [3] - Participants in the CHAPTER-1 study reported significant improvements in health-related quality of life (HRQoL) and treatment satisfaction, with all participants indicating well-controlled HAE [4] - A pharmacokinetics study demonstrated that the extended-release (XR) formulation of deucrictibant supports once-daily dosing, showing a four-fold higher mean plasma concentration than the therapeutic threshold at 24 hours [5][7] On-Demand Treatment - A post-hoc analysis of the RAPIDe-1 and RAPIDe-2 trials indicated that 95-100% of HAE attacks treated with a single dose of deucrictibant achieved symptom relief without recurrence [9] - The median time to onset of symptom relief was reported as 1.1 hours, with 97.8% of attacks achieving relief within 12 hours [10][11] - Deucrictibant was well tolerated across various attack types, including upper airway attacks, with no treatment-related adverse events reported [11] Expansion Beyond HAE - Pharvaris is exploring a novel biomarker assay for diagnosing bradykinin-mediated angioedema, which could enhance the identification and management of related conditions [12] - The company is also assessing the patient experience and outcome measures for AAE-C1INH, aiming to develop a conceptual model to support clinical assessments [14] - A systematic literature review estimated the prevalence of HAE-C1INH in the EU and UK to be between 0.05-0.33 per 10,000 individuals, indicating a significant need for effective treatments [15]
Pharvaris to Present Deucrictibant Clinical Data and Exploratory Biomarker Data at Upcoming Congresses
GlobeNewswire News Room· 2025-05-19 10:50
Core Insights - Pharvaris is a late-stage biopharmaceutical company 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][8] - The company announced the acceptance of abstracts for presentation at three upcoming congresses, highlighting its ongoing research and development efforts [1] Upcoming Presentations - At the C1-Inhibitor Deficiency and Angioedema Workshop in Budapest, several presentations will focus on the clinical validation of biomarker assays, long-term prophylactic treatment with oral Deucrictibant, and patient experiences related to acquired angioedema [2] - The 2025 Eastern Allergy Conference and the EAACI Congress 2025 will also feature presentations on the long-term safety and efficacy of oral Deucrictibant for both prophylaxis and treatment of hereditary angioedema attacks [4][5] Research Focus - The presentations will cover various aspects of bradykinin-mediated angioedema, including clinical validation of novel biomarker assays, health-related quality of life improvements, and pharmacokinetics studies [2][3] - Pharvaris 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 [8]