ImmunityBio Secures EU Approval for Bladder Cancer Therapy Anktiva
The European Commission granted conditional marketing authorization for ImmunityBio's Anktiva for bladder cancer treatment across 27 EU countries. The company partnered with Accord Healthcare to deploy an 85-person sales force across 30 European countries.
The European Commission authorized Anktiva for use in combination with Bacillus Calmette-Guérin (BCG) for eligible patients with BCG-unresponsive non-muscle invasive bladder cancer carcinoma in situ, with or without papillary disease. The conditional marketing authorization expands access across 27 EU member states, as well as Iceland, Liechtenstein, and Norway.
ImmunityBio's stock surged 30% on Wednesday following the authorization. Anktiva is now approved in 33 countries, including the U.S., showcasing the company's regulatory success within just two years.
The decision came after an expert panel from the EU drug regulator endorsed the immunotherapy in December as part of a combination regimen for invasive bladder cancer. The authorization was based on ImmunityBio's Phase 2/3 QUILT-3.032 study, demonstrating the effectiveness of Anktiva in combination with Bacillus Calmette-Guérin (BCG) for adults with BCG-unresponsive non-muscle invasive bladder cancer.
As part of the conditional approval, ImmunityBio is required to provide EU regulators with long-term safety and efficacy data related to Anktiva.
ImmunityBio announced that it has expanded access to its product Anktiva in the EU through a new distribution partnership with Accord Healthcare, which is expected to enhance its market presence. As part of the partnership, Accord Healthcare will utilize over 100 sales, medical, and marketing professionals to drive the commercialization of Anktiva in the UK, European Union, as well as European Free Trade Association members Iceland, Liechtenstein, and Norway.
Accord Healthcare will deploy an 85-person sales force to drive Anktiva commercialization across 30 countries. ImmunityBio also established an Irish subsidiary in Dublin to support the company's distribution and commercialization strategy throughout Europe.
ImmunityBio is set to report earnings on Mar. 6, with an EPS estimate of a loss of 9 cents and revenue estimate of $37.51 million, up from $7.55 million. The stock carries a Buy Rating with an average price target of $11.80.