What happened
Shares of Pharvaris N.V. (PHVS 2.55%) were up more than 10% at 11:30 a.m. on Tuesday, a day after the Food and Drug Administration (FDA) lifted a clinical hold on an individual new drug (IND) application for Pharvaris' therapy to treat hereditary angioedema (HAE), which causes severe swelling under the skin and lining of the gut and lungs. The stock is up more than 46% this year.
So what
Pharvis is a clinical-stage biotech company that focuses on therapies to treat rare diseases, especially angioedema and other bradykinin-mediated diseases.
On Monday, the company announced that the FDA had lifted the clinical hold for its IND application for deucritibant as an on-demand treatment of HAE, based on a review of data of a 26-week nonclinical study of the therapy. The company said it plans to submit data from the study to address a hold the FDA has on the IND application as a prophylactic (preventative) treatment for HAE attacks. It also said it plans an end-of-phase-2 trial meeting with the FDA. It added that it plans to have the phase 2 proof-of-concept study of deucritibant completed by the end of the year.
The FDA's decision was a big deal because deucrictibant is the only therapy the company has in clinical trials. It is being tested to treat HAE in a solution formulation as well as an immediate-release capsule and an extended-release tablet. Deucrictibant is a small-molecule selective B2-receptor antagonist.
Now what
The FDA placed the original clinical hold on deucrictibant in August, when the therapy was known as PHA121. The decision takes away a cloud that had been hanging over the company and opens the door for continued clinical trials for the HAE therapy. In the first quarter, the company reported it had 135 million euros (roughly $147 million) in cash. However, since then, it announced it was doing a $70 million private placement to institutional investors, likely allowing the company to fund operations into 2025, considering the company's current burn rate.