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ZUG, Switzerland - Pharvaris (Market cap: $851.46M), a biopharmaceutical company focused on developing treatments for bradykinin-mediated diseases, has received orphan designation from the European Commission for its drug candidate deucrictibant, intended for bradykinin-mediated angioedema. This follows a similar designation by the U.S. Food and Drug Administration in March 2022. According to InvestingPro data, the company maintains a strong financial position with more cash than debt on its balance sheet, positioning it well for continued drug development.
The company’s Chief Medical Officer, Peng Lu, M.D., Ph.D., stated that this acknowledgment by European regulators highlights deucrictibant’s potential as a bradykinin B2 receptor antagonist to meet the needs of angioedema conditions beyond hereditary angioedema (HAE). Deucrictibant is designed to block the effects of bradykinin, which is responsible for angioedema attacks. With a current ratio of 19.08, InvestingPro analysis shows the company has ample liquidity to fund its clinical programs, though analysts anticipate continued losses this year.
Deucrictibant is currently in phase 3 clinical trials, assessing its efficacy and safety in preventing HAE attacks, with Pharvaris actively discussing a pivotal trial for acquired angioedema due to C1 inhibitor deficiency (AAE-C1INH) with regulators.
The investigational drug is a novel, potent, oral small-molecule bradykinin B2 receptor antagonist. Pharvaris is developing two formulations: an extended-release tablet for prophylactic treatment and an immediate-release capsule for on-demand treatment.
Pharvaris aims to provide an alternative to injectable treatments for bradykinin-mediated angioedema with the convenience of an oral therapy. The company has reported positive data from Phase 2 studies in both prophylaxis and on-demand treatment settings and is now conducting pivotal Phase 3 studies (CHAPTER-3 for prevention and RAPIDe-3 for on-demand treatment).
The orphan drug designation by the EC and FDA is significant as it provides regulatory and financial incentives for companies to develop and market therapies for rare diseases or conditions.
This announcement is based on a press release statement from Pharvaris. The company’s forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. These include interactions with regulatory authorities, the progress and success of clinical development programs, the impact of epidemic diseases on business operations, and the ability to obtain regulatory approvals and commercialize product candidates. Investors should note that the company’s next earnings report is scheduled for April 24, 2025, which may provide crucial updates on the clinical development pipeline. Get deeper insights into Pharvaris’s financial health and 7 additional key ProTips with InvestingPro.
In other recent news, Pharvaris has reported positive long-term data for its oral drug deucrictibant, intended for the treatment of hereditary angioedema (HAE). The CHAPTER-1 Open-Label Extension study showed that participants experienced a median of zero days with HAE symptoms each month over an average treatment period of 12.8 months. Additionally, the RAPIDe-2 extension study demonstrated that deucrictibant effectively relieved symptoms of upper airway attacks with a median time to relief of 0.9 hours. Analysts at Citizens JMP and JMP Securities have maintained their Market Outperform ratings for Pharvaris, both setting a price target of $55.00. JMP Securities highlighted the company’s progress in its clinical trials, particularly the Phase 3 study of the extended-release version of deucrictibant. This trial is expected to yield results in the second half of 2026. The analyst noted the potential for deucrictibant to capture a significant share of the prophylactic market, given its oral formulation. Pharvaris continues to advance deucrictibant through pivotal Phase 3 studies, aiming to confirm its safety and efficacy profile.
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