Sharen schreef op 22 augustus 2022 16:18:
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Ach, inderdaad… prima nieuws weer voor Pharming !
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ZUG, Switzerland, Aug. 22, 2022 (GLOBE NEWSWIRE) -- Pharvaris (Nasdaq: PHVS), a clinical-stage company developing novel, oral bradykinin-B2-receptor antagonists to treat and prevent hereditary angioedema (HAE) attacks, today announced that the U.S. Food and Drug Administration (FDA) verbally informed Pharvaris that, based on its review of nonclinical data, the agency is placing a clinical hold on the clinical trials of PHA121 in the U.S. under two Pharvaris Investigational New Drug (IND) applications for the treatment of HAE. The FDA indicated it will provide a formal clinical hold letter to Pharvaris in approximately 30 days. The company plans to provide additional updates following interactions with the FDA.
“We are fully committed to working closely with the FDA to address the agency’s concerns,” said Berndt Modig, chief executive officer of Pharvaris. “Pharvaris remains dedicated to providing new therapeutic choices for the treatment of HAE and is working diligently to bring PHA121 to people living with HAE.”
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Koers Pharvaris staat inmiddels -27 %