- ImmunityBio will submit long-term safety and efficacy data to the European Medicines Agency as part of the conditional authorization, the company said.
- Earlier this year, the Saudi Food and Drug Authority also granted approval to Anktiva including in NMIBC CIS with or without papillary tumors as well as for metastatic non-small cell lung cancer.
- Anktiva is now approved in 33 countries, including in the U.S.
Shares of ImmunityBio (IBRX) rose 30% on Wednesday after the European Commission granted conditional marketing authorization for its immunotherapy Anktiva, while also expressing the need for additional data.
The European Commission approved Anktiva in combination with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ (CIS) with or without papillary tumors.
ImmunityBio will submit long-term safety and efficacy data to the European Medicines Agency as part of the conditional authorization, the company said.
ImmunityBio Expands Across Geographies
The authorization allows the company to market its drug across 27 European Union member states in addition to Iceland, Liechtenstein, and Norway. Anktiva is now approved in 33 countries, including in the U.S. where the Food and Drug Administration (FDA) granted it approval in April 2024 for BCG-unresponsive NMIBC CIS.
Until the conditional approval, there was no authorized treatment for BCG-unresponsive NMIBC CIS across Europe, leaving patients with only surgery as a treatment option.
Earlier this year, the Saudi Food and Drug Authority also granted approval to Anktiva including in NMIBC CIS with or without papillary tumors as well as for metastatic non-small cell lung cancer.
Executive Takeaway
“Reaching 33 countries in under two years from our first regulatory approval is a testament to the strength of the clinical evidence and the urgency of the unmet need in BCG-unresponsive bladder cancer,” said ImmunityBio CEO Richard Adcock.
“We are now focused on working with EU member states to ensure timely pricing, reimbursement, and patient access across Europe,” he added.
How Did Stocktwits Users React?
On Stocktwits, retail sentiment around IBRX stock rose from ‘bearish’ to ‘neutral’ territory over the past 24 hours, while message volume improved from ‘low’ to ‘normal’ levels.
A Stocktwits user highlighted the various perks of the new approval, including reduced regulatory risk.
Another voiced optimism for the stock rallying further higher up to $10.
According to data from Koyfin, the 12-month average price target on the stock is $11.80, representing a potential upside of over 50% from current trading levels.
IBRX stock has gained 134% over the past 12 months.
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