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Nmibc

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ImmunityBio’s ANKTIVA Delivers 700% Revenue Jump, Expands to 33 Countries and Secures First Lung Cancer Approval
business1 month ago

ImmunityBio’s ANKTIVA Delivers 700% Revenue Jump, Expands to 33 Countries and Secures First Lung Cancer Approval

ImmunityBio reports 2025 ANKTIVA net product revenue of about $113 million (up ~700% YoY) with 750% unit growth, expanding approvals to 33 countries across four jurisdictions and securing Saudi Arabia’s first lung-cancer approval, while strengthening European and Middle East partnerships and outlining a 3-year plan to use ANKTIVA as the Cancer BioShield backbone across multiple trials.

via ImmunityBio|
#anktiva#business#immunitybio
biotechnology2 months ago

ImmunityBio Pursues FDA Path to Resubmission for ANKTIVA in Papillary NMIBC

ImmunityBio announced a productive Type B End‑of‑Phase meeting with the FDA regarding its supplemental Biologics License Application for ANKTIVA plus BCG in BCG‑unresponsive papillary NMIBC. The FDA asked for additional information (not new trials) to support a potential resubmission, which ImmunityBio will provide within 30 days. Long‑term QUILT‑3.032 data in 80 patients show about 96% bladder cancer‑specific survival at 36 months and high cystectomy‑free survival (roughly 82–93% at 12–36 months), underscoring a bladder‐sparing, chemo‑free approach. ANKTIVA is already approved for CIS in the US, UK, and Saudi Arabia, with EU conditional status for CIS and ongoing EMA discussions to extend labeling to papillary disease if US approval is achieved.

via Business Wire|
#antkiva#biotechnology#bladder-cancer