Tag

Immunitybio

All articles tagged with #immunitybio

business10 days 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

markets1 month 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

markets1 month 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-news1 month 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

stock-market2 years ago•1 min saved

"Cramer's Lightning Round: Assessing the Risk of ImmunityBio Stock"

Jim Cramer, host of "Mad Money," shared his thoughts on several stocks during his lightning round. He expressed caution about ImmunityBio, citing its financial losses and the potential risks if it fails to obtain desired approvals. Cramer expressed enthusiasm for Trane and recommended buying Walmart at its current level, although he noted that Costco is a better option. He liked Air Lease Corp but suggested that those interested in the company should also consider investing in Boeing.

via CNBC|

#air-lease-corp #immunitybio #stock-market

healthcare2 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

healthcare2 years ago•1 min saved

ImmunityBio's bladder cancer therapy rejected by FDA, stock plummets.

The FDA has declined to approve ImmunityBio's combination therapy for bladder cancer due to deficiencies in the company's application related to manufacturing issues. The company's shares slumped nearly 57% in premarket trading, and it reiterated doubts about its ability to remain in business. The FDA did not request any new preclinical or late-stage clinical trials to evaluate the safety or efficacy of the therapy, but requested the company to provide more data and a safety update in its resubmission. ImmunityBio plans to request a meeting with the FDA to address the matter and seek approval as fast as possible.

via Reuters|

#bladder-cancer #fda #healthcare

biotech2 years ago•6 min saved

ImmunityBio's bladder cancer therapy rejected by FDA, stock plummets.

The FDA has rejected ImmunityBio's biologics license application for a specific bladder cancer, citing deficiencies related to an inspection of a third-party contract manufacturer. The rejection caused the biotech's shares to tumble about 50%. ImmunityBio's Anktiva, or N-803, will need a satisfactory resolution of the observations before a BLA approval.

via Endpoints News|

#biologics-license-application #biotech #bladder-cancer