Zymeworks Says FDA Has Cleared Investigational New Drug Application For ZW191
Portfolio Pulse from Benzinga Newsdesk
Zymeworks announced that the FDA has cleared its Investigational New Drug (IND) application for ZW191, a novel folate receptor-⍺ targeted topoisomerase I inhibitor antibody-drug conjugate. The company plans to seek regulatory authorization for clinical studies outside the US in the second half of 2024. ZW191 is the first of three ADC molecules incorporating Zymeworks' proprietary ZD06519 payload, with additional IND filings for ZW220 and ZW251 expected in 2025.
July 22, 2024 | 10:02 am
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Zymeworks received FDA clearance for its IND application for ZW191, a novel ADC targeting folate receptor-⍺. The company plans to initiate clinical studies outside the US in the second half of 2024 and has additional IND filings scheduled for 2025.
FDA clearance for the IND application is a significant milestone for Zymeworks, indicating regulatory progress and potential future revenue streams. The planned clinical studies and additional IND filings suggest a robust pipeline, likely to positively impact investor sentiment.
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