Why Shares of Pharvaris N.V. Are Up Tuesday
Shares of Pharvaris N.V. (NASDAQ: PHVS) 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.
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.
Source Fool.com
