Live News • Aug 14
Pharvaris Moves Ahead With Phase 3 Trial and US EU Reviews for Deucrictibant Pharvaris is progressing its pivotal Phase 3 CHAPTER-3 trial of deucrictibant XR for prophylaxis of hereditary angioedema attacks, with topline data expected in Q3 2026, while the FDA reviews its on-demand deucrictibant capsule under a PDUFA action date of 23 April 2027 and the EMA conducts a parallel review that began in July 2026.
These late-stage trials, dual U.S. and European regulatory reviews, and the launch of an Expanded Access program collectively mark a critical stage for Pharvaris as it moves deucrictibant toward potential entry in the hereditary angioedema treatment market.
Pharvaris shares trade at US$34.04, with the stock up 28.5% year to date, reflecting the market’s focus on the company’s late-stage pipeline progress and upcoming data and regulatory decisions.
The key read-through is that Pharvaris is now tightly linked to clinical and regulatory execution risk around deucrictibant, with timelines into 2026 to 2027 likely to drive sentiment and volatility. Announcement • Aug 06
Pharvaris Publishes Results from First In-Depth Qualitative Study Assessing Experiences of People with Aae-C1inh and Validates Relevant Patient-Reported Outcome Measures Pharvaris announced that results from the first in-depth qualitative study assessing the experiences of people with AAE-C1INH and validating relevant patient-reported outcome (PRO) measures have been published in Frontiers in Immunology. The study findings directly informed the design of and endpoint selection for the ongoing Phase 3 CREAATE study (NCT07266805) investigating deucrictibant for the prophylaxis and on-demand treatment of AAE-C1INH attacks. The study represents the first in-depth qualitative assessment in AAE-C1INH, an ultra-rare and serious disease with no approved therapies for the prevention or treatment of bradykinin-mediated angioedema attacks. Findings provide foundational insights into disease burden and establish a framework to support the selection of clinical endpoints for clinical trials in this condition. Interviews with people diagnosed with AAE-C1INH characterized disease manifestations, the impact on daily life, and perspectives on treatment benefit. Study results demonstrated that AAE-C1INH imposes a significant and multifaceted burden on patients, with participants reporting frequent, painful swelling attacks that disrupt daily functioning, often following prolonged initial periods of misdiagnosis and emergency care. Interviews also revealed broad impact across physical, emotional, social, and work-related domains, with individuals commonly unable to carry out routine activities, travel, or maintain employment during attacks. All participants relied on off-label therapies, underscoring the unmet needs associated with the absence of approved treatment options. The study evaluated the relevance and interpretability of established PRO instruments, including the Patient Global Impression of Change (PGI-C), Patient Global Impression of Severity (PGI-S), and Patient Global Assessment (PGA) measures, in the AAE-C1INH population. Results demonstrated that these tools are meaningful and applicable for assessing treatment benefits in this disease context, helping to define clinically relevant thresholds for symptom improvement and resolution. The study showed that a PGI-C rating of “better” was most consistently deemed meaningful across all participants at time points of up to 4 hours post treatment. The full publication can be found here: Angioedema due to acquired C1 inhibitor deficiency: patient experience, conceptual disease model, and assessment of patient-reported outcome measures. 
