Tag

Anktiva

All articles tagged with #anktiva

health7 days ago•12 min saved

FDA Reviews Expanded ANKTIVA+BCG Indication for Papillary NMIBC; PDUFA Set for January 2027

ImmunityBio disclosed that the FDA has accepted for review a supplemental Biologics License Application to expand ANKTIVA when combined with BCG to treat BCG-unresponsive non-muscle invasive bladder cancer with papillary disease (no CIS). The FDA assigned a PDUFA target date of January 6, 2027. The submission relies on QUILT-3.032 Cohort B data and literature suggesting papillary NMIBC shares a biological profile with CIS, potentially allowing extrapolation from CIS trials. If approved, the expansion would broaden ANKTIVA+BCG to papillary-only NMIBC, offering a bladder-sparing, immunotherapy option and potentially delaying cystectomy, with safety data consistent with BCG alone and support from NCCN Category 2A guidance.

via ImmunityBio|

#anktiva #bcg #fda

business8 days ago•9 min saved

ImmunityBio's NAI+BCG Delivers More Durable Complete Responses in BCG-Unresponsive NMIBC at AUA 2026

ImmunityBio presented indirect treatment comparison analyses at AUA 2026 showing nogapendekin alfa inbakicept-pmln (NAI) plus BCG achieving higher and longer-lasting complete responses than nadofaragene firadenovec-vncg in BCG-unresponsive NMIBC with CIS (anytime CR 69.7% vs 53.4%; median CR duration 22.1 vs 9.7 months; cystectomy-free HR 0.40). In comparison with TAR-200, NAI+BCG had a higher 12‑month CR (49.2% vs 45.9%) and substantially fewer treatment-related adverse events (61.7% vs 83.5%) based on MAIC analyses. Results are from unanchored indirect comparisons and should be interpreted with caution, but support IL-15–driven, bladder-sparing immunotherapy potential in NMIBC with CIS. The company also cites ongoing BCG development efforts, including Tokyo strain and recombinant BCG programs.

via ImmunityBio|

#anktiva #aua-2026 #bladder-cancer

business3 months ago•19 min saved

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

markets4 months ago•16 min saved

ImmunityBio stock climbs as FDA maps resubmission route for ANKTIVA

ImmunityBio (IBRX) shares rose about 26% after the FDA outlined a potential resubmission path for ANKTIVA in BCG-unresponsive papillary non-muscle invasive bladder cancer, saying additional information is needed to support a supplemental Biologics License Application but no new clinical trials are required, a development investors view as de-risking the regulatory process and potentially enabling a broader label. Trading volume surged on Nasdaq amid the regulatory update and ongoing volatility around ANKTIVA’s commercialization prospects.

via Nasdaq|

#anktiva #bladder-cancer #fda

markets4 months ago•2 min saved

ImmunityBio's 700% Revenue Surge Spurs Hedge Fund Bets on Anktiva

ImmunityBio reported 2025 revenue of about $113 million, a 700% year-over-year increase, with Q4 revenue of $38.3 million up 431% driven by rapid scaling of lead oncology therapy Anktiva; major funds such as Citadel and Renaissance increased their holdings, signaling investors are betting on faster commercialization rather than trial risk as the stock climbs year-to-date.

via Benzinga|

#anktiva #hedge-funds #ibrx

market-news4 months ago•15 min saved

ImmunityBio's Anktiva Sparks 700% Sales Leap and Global Approvals

ImmunityBio (IBRX) stock jumped over 30% after 2025 preliminary results showed Anktiva sales up about 700% year-over-year to roughly $113 million, with Q4 2025 revenue up 431% to $38.3 million. Regulatory wins expanding Anktiva’s reach include Saudi approvals for NSCLC combinations and for bladder cancer with BCG, while Phase 2b enrollment for first-line bladder cancer is progressing. Analysts sketch a bullish picture with a Strong Buy rating and a roughly $7.33 price target, implying substantial upside potential.

via TipRanks|

#anktiva #biotech #ibrx

healthcare3 years ago•2 min saved

ImmunityBio's Stock Plummets After FDA Rejects Bladder Cancer Therapy

The FDA has rejected ImmunityBio's bladder cancer treatment, Anktiva, due to deficiencies with the company's third-party contract manufacturer. The FDA provided recommendations to resolve specific issues but did not request new preclinical or Phase III studies for safety or efficacy. ImmunityBio has requested a meeting with the regulator to address the Complete Response Letter (CRL) and timeline to resolve issues and "seek approval as expeditiously as possible." The company has a potential partner lined up for the commercialization of Anktiva despite the CRL.

via BioSpace|

#anktiva #bladder-cancer #crl