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IBRX Stock Soars on Completing Filing for Cancer Therapy in EU & UK
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ImmunityBio (IBRX - Free Report) shares rallied 27.2% on Thursday after it announced that it has completed the regulatory filing process in the EU and the United Kingdom for Anktiva (nogapendekin alfa inbakicept) in combination with Bacillus Calmette-Guérin (BCG) to treat BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) patients with carcinoma in situ (CIS), with or without papillary tumors.
Acceptance of ImmunityBio’s applications seeking approval of the combo therapy by respective regulatory bodies in the EU and the United Kingdom for review is expected to be completed by the fourth quarter of 2025, with final decisions anticipated by 2026. A nod from the European Medicine Agency would make the Anktiva/BCG combo eligible for commercialization in all 27 EU counties, as well as Iceland, Norway and Liechtenstein.
Please note that Anktiva, in combination with BCG, received FDA approval in April 2024 to treat the same indication in the United States. Per ImmunityBio, the U.S. launch of the combo therapy for NMIBC CIS has already gained traction, with the product now broadly available through both commercial and government insurance programs.
The company recently announced that the Centers for Medicare & Medicaid Services in the United States has assigned a unique, permanent Healthcare Common Procedure Coding System J-code for Anktiva. This is expected to simplify the reimbursement process while increasing accessibility to patients. Currently, commercial and government insurance plans provide coverage for more than 240 million lives for Anktiva.
In the past three months, ImmunityBio shares have lost 14.4% compared with the industry’s 12.2% decline.
Image Source: Zacks Investment Research
IBRX Provides Other Regulatory Updates on Pipeline Programs
In a separate press release, ImmunityBio reported substantial progress in its ongoing discussions with the FDA concerning three therapeutic areas of its clinical development pipeline for NMIBC and non-small cell lung cancer (NSCLC). This has also likely fueled the stock price rise.
The company announced that it is currently gearing up to submit a supplemental BLA in 2025 for Anktiva + BCG to treat BCG-unresponsive NMIBC in the papillary indication. Clinical data has shown a disease-free rate of 55% at 12 months, 51% at 18 months, and 48% at 24 months, upon treatment with the combo therapy. Additionally, 93% of patients avoided cystectomy (removal of bladder) after a median follow-up of 20.7 months.
ImmunityBio believes that this immunotherapy, combining Anktiva with BCG, could provide an alternative for patients with BCG unresponsive NMIBC in papillary disease who have limited treatment options. Subject to approval, this immunotherapy could help patients avoid the high risks associated with radical total cystectomy while expanding the therapy's reach to a broader patient population.
IBRX is also planning to submit a BLA seeking approval for Anktiva as a monotherapy for second and third-line treatment of patients with NSCLC, who are progressing on checkpoint inhibitors. The regulatory filing will be supported by results from the mid-stage QUILT-3.055 study which demonstrated a median overall survival for all patients at 14.1 months upon treatment with the drug. In PD-L1 negative NSCL patients, the median overall survival extended to 15.8 months.
ImmunityBio is simultaneously evaluating Anktiva, either as a monotherapy or in combination with other agents, for other cancer indications in separate clinical studies across various stages of development.
In the past 30 days, Castle Biosciences’ earnings estimates for 2024 have remained constant at 34 cents per share. During the same timeframe, loss per share for 2025 has remained constant at $1.84. In the past three months, shares of Castle Biosciences have plunged 23.2%.
CSTL’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 172.72%.
In the past 30 days, estimates for CytomX Therapeutics’ 2024 loss per share have remained constant at 5 cents. Estimates for 2025 loss per share have remained constant at 35 cents during the same timeframe. In the past three months, shares of CytomX Therapeutics have lost 28.2%.
CTMX’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 115.70%.
In the past 30 days, estimates for BioMarin Pharmaceutical’s 2024 earnings per share have Improved from $3.28 to $3.29. Estimates for 2025 earnings per share have increased from $3.94 to $4.02 during the same timeframe. In the past three months, BioMarin Pharmaceutical shares have lost 12.6%.
BMRN’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 28.7%.
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IBRX Stock Soars on Completing Filing for Cancer Therapy in EU & UK
ImmunityBio (IBRX - Free Report) shares rallied 27.2% on Thursday after it announced that it has completed the regulatory filing process in the EU and the United Kingdom for Anktiva (nogapendekin alfa inbakicept) in combination with Bacillus Calmette-Guérin (BCG) to treat BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) patients with carcinoma in situ (CIS), with or without papillary tumors.
Acceptance of ImmunityBio’s applications seeking approval of the combo therapy by respective regulatory bodies in the EU and the United Kingdom for review is expected to be completed by the fourth quarter of 2025, with final decisions anticipated by 2026. A nod from the European Medicine Agency would make the Anktiva/BCG combo eligible for commercialization in all 27 EU counties, as well as Iceland, Norway and Liechtenstein.
Please note that Anktiva, in combination with BCG, received FDA approval in April 2024 to treat the same indication in the United States. Per ImmunityBio, the U.S. launch of the combo therapy for NMIBC CIS has already gained traction, with the product now broadly available through both commercial and government insurance programs.
The company recently announced that the Centers for Medicare & Medicaid Services in the United States has assigned a unique, permanent Healthcare Common Procedure Coding System J-code for Anktiva. This is expected to simplify the reimbursement process while increasing accessibility to patients. Currently, commercial and government insurance plans provide coverage for more than 240 million lives for Anktiva.
In the past three months, ImmunityBio shares have lost 14.4% compared with the industry’s 12.2% decline.
Image Source: Zacks Investment Research
IBRX Provides Other Regulatory Updates on Pipeline Programs
In a separate press release, ImmunityBio reported substantial progress in its ongoing discussions with the FDA concerning three therapeutic areas of its clinical development pipeline for NMIBC and non-small cell lung cancer (NSCLC). This has also likely fueled the stock price rise.
The company announced that it is currently gearing up to submit a supplemental BLA in 2025 for Anktiva + BCG to treat BCG-unresponsive NMIBC in the papillary indication. Clinical data has shown a disease-free rate of 55% at 12 months, 51% at 18 months, and 48% at 24 months, upon treatment with the combo therapy. Additionally, 93% of patients avoided cystectomy (removal of bladder) after a median follow-up of 20.7 months.
ImmunityBio believes that this immunotherapy, combining Anktiva with BCG, could provide an alternative for patients with BCG unresponsive NMIBC in papillary disease who have limited treatment options. Subject to approval, this immunotherapy could help patients avoid the high risks associated with radical total cystectomy while expanding the therapy's reach to a broader patient population.
IBRX is also planning to submit a BLA seeking approval for Anktiva as a monotherapy for second and third-line treatment of patients with NSCLC, who are progressing on checkpoint inhibitors. The regulatory filing will be supported by results from the mid-stage QUILT-3.055 study which demonstrated a median overall survival for all patients at 14.1 months upon treatment with the drug. In PD-L1 negative NSCL patients, the median overall survival extended to 15.8 months.
ImmunityBio is simultaneously evaluating Anktiva, either as a monotherapy or in combination with other agents, for other cancer indications in separate clinical studies across various stages of development.
ImmunityBio, Inc. Price and Consensus
ImmunityBio, Inc. price-consensus-chart | ImmunityBio, Inc. Quote
IBRX’s Zacks Rank and Stocks to Consider
ImmunityBio currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the sector are Castle Biosciences (CSTL - Free Report) , CytomX Therapeutics (CTMX - Free Report) and BioMarin Pharmaceutical (BMRN - Free Report) , each sportinga Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, Castle Biosciences’ earnings estimates for 2024 have remained constant at 34 cents per share. During the same timeframe, loss per share for 2025 has remained constant at $1.84. In the past three months, shares of Castle Biosciences have plunged 23.2%.
CSTL’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 172.72%.
In the past 30 days, estimates for CytomX Therapeutics’ 2024 loss per share have remained constant at 5 cents. Estimates for 2025 loss per share have remained constant at 35 cents during the same timeframe. In the past three months, shares of CytomX Therapeutics have lost 28.2%.
CTMX’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 115.70%.
In the past 30 days, estimates for BioMarin Pharmaceutical’s 2024 earnings per share have Improved from $3.28 to $3.29. Estimates for 2025 earnings per share have increased from $3.94 to $4.02 during the same timeframe. In the past three months, BioMarin Pharmaceutical shares have lost 12.6%.
BMRN’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 28.7%.