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ImmunityBio Wins EU Nod for Bladder Cancer Combo Therapy, Stock Up
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Key Takeaways
IBRX soars 41.9% after the EC cleared Anktiva plus BCG for BCG-unresponsive NMIBC CIS in the EU.
The IBRX combo therapy showed a 71% complete response rate in the phase II/III QUILT-3.032 study.
IBRX to submit more data to confirm Anktiva's efficacy and safety, with EU approval subject to annual renewal.
Shares of ImmunityBio, Inc. (IBRX - Free Report) soared 41.9% on Wednesday after the company announced that the European Commission (EC) has granted conditional marketing authorization for Anktiva (nogapendekin alfa inbakicept) in combination with Bacillus Calmette-Guérin (BCG). The treatment is approved for adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS), with or without papillary tumors.
Anktiva, in combination with BCG, is the first immunotherapy authorized in Europe for the NMIBC indication. With this approval, the combo therapy is now cleared in 33 countries across four regulatory jurisdictions — the United States, the EU, the United Kingdom and Saudi Arabia — establishing a global commercial presence in less than two years since its initial FDA approval in 2024.
The EC approval was expected as the European Medicines Agency’s (EMA) advisory committee had earlier issued a positive opinion recommending marketing authorization in the EU for Anktiva plus BCG to treat BCG-unresponsive NMIBC CIS in adult patients. A conditional marketing authorization is an EU regulatory pathway intended to provide earlier access to medicines that address unmet medical needs. It allows the EC to approve a treatment when the benefits of making it available to patients right away outweigh the risks associated with the need for additional data.
Under this approval, ImmunityBio must submit long-term follow-up results from ongoing studies to further confirm Anktiva’s safety and effectiveness. The company will continue monitoring study participants and provide updated long-term safety and efficacy data to the EMA, and the authorization is subject to annual renewal.
In the past six months, ImmunityBio shares have skyrocketed 277.9% compared with the industry’s 21.8% growth.
Image Source: Zacks Investment Research
How Effective is IBRX’s Bladder Cancer Combo Therapy?
The EC approval is supported by results from the phase II/III QUILT-3.032 study, which included 100 adults with BCG-unresponsive NMIBC CIS, with or without papillary tumors. Patients received intravesical Anktiva in combination with BCG. The study demonstrated a 71% complete response rate, with some responses lasting more than 54 months and ongoing. Among responders, 66% maintained a complete response at 12 months and 42% at 24 months, with a median duration of complete response of six months. Cystectomy-free survival rates were 96% at 12 months, 90% at 24 months and 84% at 36 months, while disease-specific survival reached 99% at both 24 and 36 months.
Safety findings from pooled data across cohorts A and B of the QUILT-3.032 study showed that most treatment-related adverse events were mild to moderate in severity. The most common adverse reactions included dysuria, hematuria, pollakiuria, urinary tract infection, micturition urgency, fatigue, chills, musculoskeletal pain and pyrexia.
Bladder cancer remains a major health burden in the EU, ranking among the most common cancers. About three-quarters of diagnoses are NMIBC, which remains confined to the bladder lining. For patients whose disease does not respond to BCG therapy, treatment options have been limited until now, with radical cystectomy often serving as the primary alternative despite its significant impact on quality of life and suitability concerns for some patients.
Europe’s treatment landscape is also supported by broader availability of BCG, with roughly six approved strains in use compared with a single approved strain in the United States. This wider availability helps sustain supply and supports combination treatment approaches, while ongoing regulatory expansion is expected to shift focus toward pricing, reimbursement and patient access across EU markets. In the United States, ImmunityBio is currently working to address the ongoing BCG shortages.
Over the past 60 days, estimates for Harmony Biosciences’ 2026 earnings per share (EPS) have risen from $3.72 to $4.00. HRMY shares have lost 3.7% over the past six months.
Harmony Biosciences’ earnings beat estimates in two of the trailing four quarters, missing the mark on the other two occasions, with the average surprise being 7.20%.
Over the past 60 days, estimates for Alkermes’ 2026 EPS have increased from $1.54 to $1.91. ALKS shares have risen 10.5% over the past six months.
Alkermes’ earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average earnings surprise being 4.58%.
Over the past 60 days, estimates for Castle Biosciences’ 2026 loss per share have narrowed from $1.06 to 96 cents. CSTL shares have surged 70.2% over the past six months.
Castle Biosciences’ earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 66.11%.
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ImmunityBio Wins EU Nod for Bladder Cancer Combo Therapy, Stock Up
Key Takeaways
Shares of ImmunityBio, Inc. (IBRX - Free Report) soared 41.9% on Wednesday after the company announced that the European Commission (EC) has granted conditional marketing authorization for Anktiva (nogapendekin alfa inbakicept) in combination with Bacillus Calmette-Guérin (BCG). The treatment is approved for adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS), with or without papillary tumors.
Anktiva, in combination with BCG, is the first immunotherapy authorized in Europe for the NMIBC indication. With this approval, the combo therapy is now cleared in 33 countries across four regulatory jurisdictions — the United States, the EU, the United Kingdom and Saudi Arabia — establishing a global commercial presence in less than two years since its initial FDA approval in 2024.
The EC approval was expected as the European Medicines Agency’s (EMA) advisory committee had earlier issued a positive opinion recommending marketing authorization in the EU for Anktiva plus BCG to treat BCG-unresponsive NMIBC CIS in adult patients. A conditional marketing authorization is an EU regulatory pathway intended to provide earlier access to medicines that address unmet medical needs. It allows the EC to approve a treatment when the benefits of making it available to patients right away outweigh the risks associated with the need for additional data.
Under this approval, ImmunityBio must submit long-term follow-up results from ongoing studies to further confirm Anktiva’s safety and effectiveness. The company will continue monitoring study participants and provide updated long-term safety and efficacy data to the EMA, and the authorization is subject to annual renewal.
In the past six months, ImmunityBio shares have skyrocketed 277.9% compared with the industry’s 21.8% growth.
Image Source: Zacks Investment Research
How Effective is IBRX’s Bladder Cancer Combo Therapy?
The EC approval is supported by results from the phase II/III QUILT-3.032 study, which included 100 adults with BCG-unresponsive NMIBC CIS, with or without papillary tumors. Patients received intravesical Anktiva in combination with BCG. The study demonstrated a 71% complete response rate, with some responses lasting more than 54 months and ongoing. Among responders, 66% maintained a complete response at 12 months and 42% at 24 months, with a median duration of complete response of six months. Cystectomy-free survival rates were 96% at 12 months, 90% at 24 months and 84% at 36 months, while disease-specific survival reached 99% at both 24 and 36 months.
Safety findings from pooled data across cohorts A and B of the QUILT-3.032 study showed that most treatment-related adverse events were mild to moderate in severity. The most common adverse reactions included dysuria, hematuria, pollakiuria, urinary tract infection, micturition urgency, fatigue, chills, musculoskeletal pain and pyrexia.
Bladder cancer remains a major health burden in the EU, ranking among the most common cancers. About three-quarters of diagnoses are NMIBC, which remains confined to the bladder lining. For patients whose disease does not respond to BCG therapy, treatment options have been limited until now, with radical cystectomy often serving as the primary alternative despite its significant impact on quality of life and suitability concerns for some patients.
Europe’s treatment landscape is also supported by broader availability of BCG, with roughly six approved strains in use compared with a single approved strain in the United States. This wider availability helps sustain supply and supports combination treatment approaches, while ongoing regulatory expansion is expected to shift focus toward pricing, reimbursement and patient access across EU markets. In the United States, ImmunityBio is currently working to address the ongoing BCG shortages.
ImmunityBio, Inc. Price and Consensus
ImmunityBio, Inc. price-consensus-chart | ImmunityBio, Inc. Quote
IBRX’s Zacks Rank and Other Stocks to Consider
ImmunityBio currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks in the biotech sector are Harmony Biosciences (HRMY - Free Report) , Alkermes (ALKS - Free Report) and Castle Biosciences (CSTL - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Harmony Biosciences’ 2026 earnings per share (EPS) have risen from $3.72 to $4.00. HRMY shares have lost 3.7% over the past six months.
Harmony Biosciences’ earnings beat estimates in two of the trailing four quarters, missing the mark on the other two occasions, with the average surprise being 7.20%.
Over the past 60 days, estimates for Alkermes’ 2026 EPS have increased from $1.54 to $1.91. ALKS shares have risen 10.5% over the past six months.
Alkermes’ earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average earnings surprise being 4.58%.
Over the past 60 days, estimates for Castle Biosciences’ 2026 loss per share have narrowed from $1.06 to 96 cents. CSTL shares have surged 70.2% over the past six months.
Castle Biosciences’ earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 66.11%.