Trump/Cook, Nissan weakness, more tariffs and gold - what’s moving markets
ZUG, Switzerland - Pharvaris (PHVS), a biopharmaceutical company valued at $904.59 million, has shared new data on deucrictibant, an oral treatment for bradykinin-mediated angioedema, at the 14th C1-Inhibitor Deficiency and Angioedema Workshop. According to InvestingPro data, the company maintains a strong financial position with more cash than debt and a healthy current ratio of 11.1, though it’s currently in a cash-burning phase typical of clinical-stage biotech companies. The latest findings suggest that deucrictibant could be effective in both preventing and treating hereditary angioedema (HAE) attacks.
The ongoing Phase 2 CHAPTER-1 open-label extension study indicates that deucrictibant maintains a low attack rate over an extended period exceeding a year and a half. The drug’s dual potential as a prophylactic and on-demand treatment was highlighted, with evidence suggesting it can manage breakthrough attacks during prophylactic use. With four analysts recently revising their earnings estimates upward, market confidence in the company’s development pipeline appears to be growing. For more detailed analyst insights and financial metrics, consider subscribing to InvestingPro.
A separate Phase 1 pharmacokinetic study has shown that the extended-release (XR) tablet form of deucrictibant could support once-daily dosing, which would be convenient for patients. This is based on its sustained exposure over 24 hours and a plasma concentration four times higher than the therapeutic threshold at 24 hours post-dose.
In terms of on-demand treatment, a post-hoc analysis of the RAPIDe-1 trial and the RAPIDe-2 extension study showed that the majority of HAE attacks were effectively managed with a single dose of deucrictibant, with 95-100% of attacks in RAPIDe-1 and 98-100% in RAPIDe-2 not experiencing symptom reoccurrence. The RAPIDe-2 extension study also confirmed deucrictibant’s tolerability and efficacy, with a median time to symptom relief of 1.1 hours and complete attack resolution in 86.9% of cases within 24 hours.
Pharvaris is planning two pivotal data readouts in the next 18 months and is conducting a Phase 3 study, CHAPTER-3, to further evaluate the efficacy and safety of deucrictibant XR for prophylaxis of HAE attacks. Additionally, the RAPIDe-3 Phase 3 trial is ongoing to assess deucrictibant’s on-demand treatment capabilities.
The company is also exploring the use of a clinically validated biomarker assay for diagnosing bradykinin-mediated angioedema. This assay could broaden treatment opportunities for deucrictibant into additional forms of the condition.
These developments aim to address the unmet needs in the treatment of bradykinin-mediated angioedema, which includes HAE and acquired angioedema due to C1 inhibitor deficiency (AAE-C1INH). Pharvaris is committed to providing new therapeutic options for patients suffering from these debilitating conditions.
The data presented at the workshop is based on a press release statement from Pharvaris. Investors and stakeholders in the medical community are keenly observing the progress of deucrictibant as it moves through clinical trials.
In other recent news, Pharvaris has reported significant developments regarding its oral drug candidate deucrictibant, designed to treat hereditary angioedema (HAE). The company has released positive long-term data showing sustained effectiveness in reducing HAE attacks and improving patients’ quality of life, as presented at the AAAAI/WAO Joint Congress. Additionally, Pharvaris has received orphan designation from the European Commission for deucrictibant, following a similar acknowledgment by the U.S. FDA, which provides regulatory and financial incentives. Analysts at JMP Securities and Citizens JMP have maintained a Market Outperform rating for Pharvaris with a price target of $55, expressing confidence in the potential of deucrictibant, particularly with its Phase 3 data expected in the coming years. The drug is currently in pivotal Phase 3 trials for both on-demand and prophylactic treatment of HAE, with a focus on providing an oral alternative to injectable treatments. Pharvaris aims to capitalize on its unique offering in the HAE market with anticipated U.S. launches for deucrictibant in 2027 for acute settings and 2028 for prophylactic use. The ongoing studies and regulatory designations underscore the potential market impact and strategic positioning of Pharvaris in the therapeutic space. These developments reflect the company’s commitment to addressing unmet needs in the HAE community through innovative therapies.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.