๐ข ๐๐๐๐ ๐๐: FDA Accepts $ImmunityBio(IBRX.US) ImmunityBioโs ANKTIVA Label Expansion Application
๐ ๐๐๐ฒ ๐๐ข๐ ๐ก๐ฅ๐ข๐ ๐ก๐ญ๐ฌ:โค FDA accepts ImmunityBioโs ๐ฌ๐ฎ๐ฉ๐ฉ๐ฅ๐๐ฆ๐๐ง๐ญ๐๐ฅ ๐๐๐ for ANKTIVA plus BCG.โค Filing targets ๐๐๐-๐ฎ๐ง๐ซ๐๐ฌ๐ฉ๐จ๐ง๐ฌ๐ข๐ฏ๐ bladder cancer with papillary disease.โค FDA assigns ๐๐๐ง. ๐, ๐๐๐๐ target action date.โค Expansion seeks inclusion of patients without ๐๐๐ซ๐๐ข๐ง๐จ๐ฆ๐ ๐ข๐ง ๐ฌ๐ข๐ญ๐ฎ.โค QUILT 3.032 trial showed ๐๐.๐% 12-month disease-free survival rate.โค Approximately ๐๐% of NMIBC patients present with ๐ฉ๐๐ฉ๐ข๐ฅ๐ฅ๐๐ซ๐ฒ ๐๐ข๐ฌ๐๐๐ฌ๐.โค Safety profile remained consistent with ๐๐๐ ๐๐ฅ๐จ๐ง๐, company says
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๐ข ๐๐๐๐ ๐๐: $ImmunityBio(IBRX.US) ImmunityBio Reports Favorable Bladder Cancer Data at ๐๐๐ ๐๐๐๐
๐ ๐๐๐ฒ ๐๐ข๐ ๐ก๐ฅ๐ข๐ ๐ก๐ญ๐ฌ:โค ๐๐๐๐๐๐๐ยฎ + BCG showed stronger complete response outcomes versus competitors.โค NAI+BCG patients were ๐ร more likely to achieve complete response versus nadofaragene.โค Median complete response duration reached ๐๐.๐ months versus ๐.๐ months.โค NAI+BCG reduced ๐๐ฒ๐ฌ๐ญ๐๐๐ญ๐จ๐ฆ๐ฒ risk by ๐๐% versus nadofaragene.โค Compared with TAR-200, NAI+BCG showed numerically higher ๐๐-๐ฆ๐จ๐ง๐ญ๐ก CR rates.โค NAI+BCG demonstrated significantly fewer ๐ญ๐ซ๐๐๐ญ๐ฆ๐๐ง๐ญ-๐ซ๐๐ฅ๐๐ญ๐๐ adverse events than TAR-200.โค Data presented at ๐๐๐ ๐๐๐๐ for BCG-unresponsive bladder cancer patients. - H
โก ๐๐๐๐๐๐: $ImmunityBio(IBRX.US) ImmunityBio Secures Exclusive U.S. Rights to Tokyo Strain BCG
๐ ๐๐๐ฒ ๐๐ข๐ ๐ก๐ฅ๐ข๐ ๐ก๐ญ๐ฌ:โค ImmunityBio signs exclusive U.S. agreement with ๐๐๐ฉ๐๐ง ๐๐๐ ๐๐๐๐จ๐ซ๐๐ญ๐จ๐ซ๐ฒ.โค Deal targets long-standing ๐.๐. ๐๐๐ ๐ฌ๐ก๐จ๐ซ๐ญ๐๐ ๐ in bladder cancer treatment.โค Agreement covers development and commercialization of ๐๐จ๐ค๐ฒ๐จ-๐๐๐ ๐๐๐.โค Phase III SWOG S1602 study showed ๐ง๐จ๐ง-๐ข๐ง๐๐๐ซ๐ข๐จ๐ซ๐ข๐ญ๐ฒ versus TICE BCG.โค Tokyo strain achieved ๐๐% ๐-๐ฒ๐๐๐ซ high-grade recurrence-free survival.โค Product remains ๐ข๐ง๐ฏ๐๐ฌ๐ญ๐ข๐ ๐๐ญ๐ข๐จ๐ง๐๐ฅ and unapproved by the FDA in the U.S.โค ImmunityBio plans FDA engagement and ๐๐๐ submission using S1602 data. - W
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