Pharvaris Updates Timing of Topline Data Announcement for RAPIDe-3 Pivotal Phase 3 Study to the Fourth Quarter of 2025
Pharvaris (Nasdaq: PHVS) has updated the timeline for topline data from its RAPIDe-3 pivotal Phase 3 study of deucrictibant immediate-release (IR) capsule for hereditary angioedema (HAE) attacks. The company now expects to announce results in Q4 2025, with plans to submit a New Drug Application (NDA) to the FDA in 1H 2026.
The RAPIDe-3 study is evaluating a 20 mg single-capsule oral dose in approximately 120 participants aged 12 and older with HAE. The trial includes patients with C1 inhibitor deficiency and normal C1INH. The primary endpoint focuses on time to onset of symptom relief, with secondary endpoints including time to End of Progression, substantial symptom relief, and complete symptom resolution.
Pharvaris (Nasdaq: PHVS) ha aggiornato la tempistica per i dati principali dello studio pivotale di Fase 3 RAPIDe-3 sul deucrictibant in capsule a rilascio immediato (IR) per gli attacchi di angioedema ereditario (HAE). L'azienda prevede ora di annunciare i risultati nel quarto trimestre 2025, con l'intenzione di presentare una domanda di nuova autorizzazione all'immissione in commercio (NDA) alla FDA nella prima metà del 2026.
Lo studio RAPIDe-3 valuta una dose orale singola di 20 mg in capsula su circa 120 partecipanti di età pari o superiore a 12 anni affetti da HAE. La sperimentazione include pazienti con carenza di inibitore C1 e con C1INH normale. L'endpoint primario è il tempo di insorgenza del sollievo dai sintomi, mentre gli endpoint secondari comprendono il tempo fino alla fine della progressione, un sollievo sintomatico significativo e la completa risoluzione dei sintomi.
Pharvaris (Nasdaq: PHVS) ha actualizado el cronograma para los datos principales de su estudio pivotal de Fase 3 RAPIDe-3 sobre la cápsula de liberación inmediata (IR) de deucrictibant para ataques de angioedema hereditario (HAE). La compañía ahora espera anunciar los resultados en el cuarto trimestre de 2025, con planes de presentar una Solicitud de Nuevo Fármaco (NDA) a la FDA en la primera mitad de 2026.
El estudio RAPIDe-3 está evaluando una dosis oral única de 20 mg en cápsula en aproximadamente 120 participantes de 12 años o más con HAE. El ensayo incluye pacientes con deficiencia de inhibidor C1 y con C1INH normal. El criterio principal se centra en el tiempo hasta el inicio del alivio de los síntomas, con criterios secundarios que incluyen el tiempo hasta el fin de la progresión, alivio sustancial de los síntomas y resolución completa de los síntomas.
Pharvaris (나스�: PHVS)� 유전� 혈관부�(HAE) 발작 치료� 위한 deucrictibant 즉시 방출(IR) 캡슐� 대� RAPIDe-3 3� 임상시험� 주요 데이� 발표 일정� 업데이트했습니다. 회사� 이제 2025� 4분기� 결과� 발표� 예정이며, 2026� 상반�� FDA� 신약 허가 신청�(NDA)� 제출� 계획입니�.
RAPIDe-3 연구� 12� 이상 � 120명의 HAE 환자� 대상으� 20mg 단일 캡슐 경구 투여� 평가합니�. � 임상시험은 C1 억제� 결핍 환자와 정상 C1INH 환자� 포함합니�. 주요 평가 변수는 증상 완화 시작 시간이며, 2� 평가 변수로� 진행 종료 시간, 상당� 증상 완화, 완전� 증상 해소가 포함됩니�.
Pharvaris (Nasdaq : PHVS) a mis à jour le calendrier pour les données principales de son étude pivot de phase 3 RAPIDe-3 sur la capsule à libération immédiate (IR) de deucrictibant pour les crises d'angio-œdème héréditaire (HAE). La société prévoit désormais d'annoncer les résultats au 4e trimestre 2025, avec l'intention de soumettre une demande d'autorisation de mise sur le marché (NDA) à la FDA au 1er semestre 2026.
L'étude RAPIDe-3 évalue une dose orale unique de 20 mg en capsule chez environ 120 participants âgés de 12 ans et plus atteints de HAE. L'essai inclut des patients présentant une déficience en inhibiteur C1 ainsi que ceux avec un C1INH normal. Le critère principal porte sur le délai d'apparition du soulagement des symptômes, les critères secondaires incluant le temps jusqu'à la fin de la progression, un soulagement symptomatique substantiel et la résolution complète des symptômes.
Pharvaris (Nasdaq: PHVS) hat den Zeitplan für die Ergebnismitteilung der primären Endpunkte seiner entscheidenden Phase-3-Studie RAPIDe-3 zum deucrictibant Sofortfreisetzungskapsel (IR) bei hereditärem Angioödem (HAE) aktualisiert. Das Unternehmen erwartet nun die Bekanntgabe der Ergebnisse im 4. Quartal 2025 und plant, im 1. Halbjahr 2026 einen Zulassungsantrag (NDA) bei der FDA einzureichen.
Die RAPIDe-3-Studie untersucht eine einmalige orale Dosis von 20 mg in Kapsel bei etwa 120 Teilnehmern ab 12 Jahren mit HAE. Die Studie umfasst Patienten mit C1-Inhibitor-Mangel sowie mit normalem C1INH. Der primäre Endpunkt ist die Zeit bis zum Beginn der Symptombesserung, sekundäre Endpunkte umfassen die Zeit bis zum Ende der Progression, eine deutliche Symptomlinderung und die vollständige Symptomauflösung.
- None.
- Delayed timeline for topline data announcement to Q4 2025
- NDA submission pushed to 1H 2026
Insights
Pharvaris pushes RAPIDe-3 data readout to Q4 2025, delaying potential HAE therapy approval timeline by shifting NDA submission to 1H2026.
Pharvaris has updated the timeline for its pivotal Phase 3 RAPIDe-3 study of deucrictibant immediate-release (IR) capsule, now expecting topline data in Q4 2025 rather than earlier in the year, with NDA submission planned for first half of 2026. This represents a delay in the company's clinical development timeline for their oral bradykinin B2 receptor antagonist targeting hereditary angioedema (HAE).
The ongoing Phase 3 study is evaluating the efficacy of deucrictibant's 20mg immediate-release capsule as an on-demand treatment for HAE attacks. What makes this trial particularly noteworthy is its inclusive enrollment criteria, which extends beyond adults with HAE types 1 and 2 to include participants with normal C1 inhibitor HAE and adolescents aged 12-17, as well as evaluating efficacy in treating potentially life-threatening laryngeal attacks.
The primary endpoint focuses on time to onset of symptom relief as measured by Patient Global Impression of Change (PGI-C). Secondary endpoints include critical measures like time to End of Progression (EoP) of attack symptoms, substantial symptom relief, complete resolution, and the proportion of attacks resolved with a single dose. These endpoints are particularly important in HAE, where rapid symptom control can prevent potentially life-threatening complications.
If successful, deucrictibant would represent a significant advancement in HAE treatment as an oral therapy in a field currently dominated by injectable and infused medications. The potential convenience of a single-capsule oral dose that can effectively treat attacks could offer substantial quality-of-life improvements for HAE patients, provided the efficacy and safety profile match or exceed existing therapies.
Company expects to submit deucrictibant IR capsule NDA to the U.S. FDA for the on-demand treatment of HAE attacks in 1H2026
ZUG, Switzerland, July 10, 2025 (GLOBE NEWSWIRE) -- (Nasdaq: PHVS), a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to address unmet needs of those living with bradykinin-mediated diseases such as hereditary angioedema (HAE) and acquired angioedema due to C1 inhibitor deficiency (AAE-C1INH), updated the guidance for the disclosure of topline data from the ongoing RAPIDe-3 pivotal Phase 3 study evaluating deucrictibant immediate-release (IR) capsule for the on-demand treatment of HAE attacks. Pharvaris anticipates announcing topline data from RAPIDe-3 in the fourth quarter of 2025 and, pending positive data, expects to submit a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) in the first half of 2026.
“The attack data in RAPIDe-3 have continued to accrue following the achievement of target enrollment in the study; we now estimate that our RAPIDe-3 topline data announcement will be in the fourth quarter of this year,� said Berndt Modig, Chief Executive Officer of Pharvaris. “Our phase 3 data may provide evidence of deucrictibant IR’s potential to address the desire of people living with HAE for an on-demand therapy that combines efficacy—from rapid end of progression to fast and complete resolution—and a favorable safety profile, with the convenience of a single-capsule oral dose.�
Peng Lu, M.D., Ph.D., Chief Medical Officer of Pharvaris, added, “We aim to confirm the findings from our Phase 2 studies in a larger Phase 3 trial, RAPIDe-3. Importantly, this study is assessing the effects of deucrictibant for people with high unmet need beyond adults with HAE type 1 and 2, such as participants with HAE with normal C1 inhibitor and adolescents between 12 and 17 years and will be evaluating the effects of deucrictibant in treating laryngeal attacks. We want to thank the clinical trial participants, the investigators and their study site collaborators for their ongoing commitment to this important trial.�
RAPIDe-3 () is a global Phase 3 study evaluating deucrictibant immediate-release capsule (20 mg) for the on-demand treatment of angioedema attacks in approximately 120 adult and adolescent (12 years and older) participants with HAE, including forms with C1 inhibitor deficiency and forms with normal C1INH. The primary endpoint is time to onset of symptom relief, as measured by Patient Global Impression of Change (PGI-C) rating of at least “a little better.� Other endpoints include time to End of Progression (EoP) in attack symptoms, substantial symptom relief, complete symptom resolution and proportion of complete symptom resolution achieved with one dose of deucrictibant as measured by Patient Global Impression of Severity (PGI-S), PGI-C, and by Angioedema Symptom Rating Scale (AMRA), and incidence of treatment-emergent adverse events (TEAEs).
About Deucrictibant
Deucrictibant is a novel, potent, orally bioavailable small-molecule bradykinin B2 receptor antagonist currently in clinical development. Deucrictibant is being investigated for its potential to prevent the occurrence of bradykinin-mediated angioedema attacks and to treat the manifestations of attacks if/when they occur by inhibiting bradykinin signaling through the bradykinin B2 receptor. Pharvaris is developing two formulations of deucrictibant for oral administration: an extended-release tablet to enable sustained absorption and efficacy as prophylactic treatment, and an immediate-release capsule to enable rapid onset of activity for on-demand treatment. Deucrictibant has been granted orphan drug designation for the treatment of bradykinin-mediated angioedema by the U.S. Food and Drug Administration and orphan designation by the European Commission.
About Pharvaris
Pharvaris is a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to potentially address all types of bradykinin-mediated angioedema. Pharvaris intends to provide injectable-like efficacy� and placebo-like tolerability with the convenience of oral therapies to prevent and treat bradykinin-mediated angioedema attacks. With positive data in both Phase 2 prophylaxis and on-demand studies in HAE, Pharvaris is currently evaluating the efficacy and safety of deucrictibant in a pivotal Phase 3 study for the prevention of HAE attacks (CHAPTER-3) and a pivotal Phase 3 study for the on-demand treatment of HAE attacks (RAPIDe-3). For more information, visit .
Forward Looking Statements
This press release contains certain forward-looking statements that involve substantial risks and uncertainties. All statements contained in this press release 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 “believe,� “anticipate,� “expect,� “estimate,� “may,� “could,� “should,� “would,� “will,� “intend� and similar expressions. These forward-looking statements are based on management’s current expectations, are neither promises nor guarantees, and involve known and unknown risks, uncertainties and other important factors that may cause Pharvaris� actual results, performance or achievements to be materially different from its expectations expressed or implied by the forward-looking statements. Such risks include but are not limited to the following: uncertainty in the outcome of our interactions with regulatory authorities, including the FDA; the expected timing, progress, or success of our clinical development programs, especially for deucrictibant immediate-release capsules and deucrictibant extended-release tablets, which are in late-stage global clinical trials; our ability to replicate the efficacy and safety demonstrated in the RAPIDe-1, RAPIDe-2, and CHAPTER-1 Phase 2 and Phase 3 studies in ongoing and future nonclinical studies and clinical trials; risks arising from epidemic diseases, , which may adversely impact our business, nonclinical studies, and clinical trials; our ability to potentially use deucrictibant for alternative purposes, for example to treat C1-INH deficiency (AAE-C1INH); the outcome and timing of regulatory approvals; the value of our ordinary shares; the timing, costs and other limitations involved in obtaining regulatory approval for our product candidates, or any other product candidate that we may develop in the future; our ability to establish commercial capabilities or enter into agreements with third parties to market, sell, and distribute our product candidates; our ability to compete in the pharmaceutical industry, including with respect to existing therapies, emerging potentially competitive therapies and with competitive generic products; our ability to market, commercialize and achieve market acceptance for our product candidates; our ability to produce sufficient amounts of drug product candidates for commercialization; our ability to raise capital when needed and on acceptable terms; regulatory developments in the United States, the European Union and other jurisdictions; our ability to protect our intellectual property and know-how and operate our business without infringing the intellectual property rights or regulatory exclusivity of others; our ability to manage negative consequences from changes in applicable laws and regulations, including tax laws (including the Biosecure Act), our ability to maintain an effective system of internal control over financial reporting; changes and uncertainty in general market conditions; disruptions at the FDA and other agencies; political conditions, such as the current war between Russia and Ukraine; economic conditions, including continuing inflation concerns; and the other factors described under the headings “Cautionary Statement Regarding Forward-Looking Statements� and “Item 3. Key Information—D. Risk Factors� in our Annual Report on Form 20-F and other periodic filings with the U.S. Securities and Exchange Commission. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. While Pharvaris may elect to update such forward-looking statements at some point in the future, Pharvaris disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing Pharvaris� views as of any date subsequent to the date of this press release.

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