Sigilon Hemophilia Cell Therapy On Clinical Hold, But May Not Be Drug-Related
SIG-001 Seen As Potential Competitor To AAV Gene Therapies
A patient developed Factor VIII inhibitors, but he had also recently received a COVID-19 vaccine and was genetically predisposed.
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The FDA may want longer follow-up data for companies developing treatments for hemophilia A as well as hemophilia B.
Public Company Edition: Lixte’s small uplisting was the only biopharma initial public offering in the US during Thanksgiving week, but IPOs are ramping up again. Also, LifeSci launched its second SPAC and in follow-on offerings Reata brought in $281m and Intellia grossed $175m.
BioMarin’s confidence that its first-ever hemophilia gene therapy would be cleared by the US FDA was shaken by a complete response letter that the company claims changed the requirements for approval.