The stock price of Pharvaris N.V. (NASDAQ: PHVS), which released a business update today, increased 39.46% to $3.64 in early trading hours on Thursday.
What successes has PHVS had?
In addition to presenting its quarterly results for the third quarter that concluded on September 30, 2022, Pharvaris (PHVS) offered a business update today. The RAPIDe-1 study’s findings support Pharvaris’ belief in the viability of its HAE clinical development program.
New business developments:
Pharvaris is still working with the FDA to have the clinical trials for PHA121 unblocked in the United States. PHVS had a Type A meeting with the U.S. Food and Drug Administration after receiving the official letters pertaining to the holds on PHA121 clinical studies in the U.S. as previously disclosed (FDA).
In the discussion, PHVS put out possible solutions for each of the preventive and on-demand programs’ clinical holds. After receiving the formal meeting minutes, the business will disclose more details.
PHVS anticipates top-line data in 2H2023:
All active sites outside of the United States are still enrolling individuals in the CHAPTER-1 clinical investigation, and top-line results for PHVS416 is anticipated in the second half of 2023. PHVS informed the country-specific regulatory bodies in Canada, Europe, Israel, and the UK of the clinical holds in the U.S. after learning of them.
The CHAPTER-1 study’s regulatory status outside of the United States has not altered as of yet. Pharvaris expects to release top-line results from the CHAPTER-1 study in 2H2023, based on our current expectations about ex-U.S. regulatory status and enrolment.
Preclinical and clinical results for PH121 were given by PHVS:
At the Bradykinin Symposium in September, data describing the pharmacokinetic (PK), pharmacodynamic (PD), and safety profile of PHA121, as well as preliminary bioavailability and absorption data for the soft gel capsule formulation, PHVS416, and extended-release tablet formulation, PHVS719, were presented.
Additionally, it was displayed at the American College of Allergy, Asthma, and Immunology (ACAAI) Annual Scientific Meeting in November and the HAEi Global Leadership Workshop in October.
Positive RAPIDe-1 data announcement:
Top-line Phase 2 data showing statistically meaningful outcomes for PHVS416 as an oral on-demand therapy for HAE attacks were released by Pharvaris (PHVS) in a separate press release.