ImmunityBio expects November results from a 366-patient Anktiva trial and plans a fourth-quarter FDA filing.
- The FDA expanded approval of Anktiva plus BCG to include papillary-only bladder tumors earlier this month.
- A separate study reported a 71% complete response rate, with some responses lasting more than 53 months.
- Recent sector deals include AbbVie’s $10.9 billion acquisition of Apogee Therapeutics and Viatris’s $1.65 billion agreement to buy Pacira BioSciences.
ImmunityBio (IBRX) shares rose nearly 1% overnight heading into Tuesday after CNBC host Jim Cramer called it a “very good spec,” citing a wave of biotech acquisitions as the company advances plans to expand the use of its flagship drug, Anktiva, in bladder cancer.
IBRX stock closed Monday down about 5% at $7.81, logging its fourth straight session in the red.
Biotech Deal Wave Fuels Cramer’s IBRX Call
Cramer backed ImmunityBio as a speculative bet during Monday’s Mad Money Lightning Round, saying it could pay off even when index funds disappoint.
“I don’t mind you taking a position in that, because that’s one of those that you could look back and say, you know what? I was in my index funds, they didn’t really do well, but man, did I clean up on a very good spec,” he said.
He pointed to biotech takeovers as part of the appeal. “The biotechs are being taken over like mad, you want to be in one,” Cramer said. The call echoes his June stance, when he encouraged investors to limit speculation to one holding. “Let Immunitybio be your speculation,” he said then.
Cramer’s takeover pitch follows a string of recent big drugmaker deals. Earlier this month, Viatris agreed to buy Pacira BioSciences for $1.65 billion, with closing expected by year-end. AbbVie completed its $10.9 billion acquisition of Apogee Therapeutics in September, while Eli Lilly agreed in August to acquire Merida Biosciences for up to $2.875 billion, including milestone payments.
IBRX Eyes Earlier Treatment With November Readout
Cramer’s backing comes ahead of a November readout that could help ImmunityBio bring Anktiva to patients earlier in bladder cancer treatment. Last week, the company finished checking data from a 366-patient trial comparing Anktiva plus BCG with BCG alone in non-muscle invasive bladder cancer, clearing the way for the final analysis.
The study focuses on patients receiving BCG-based treatment for the first time. Anktiva’s current approval covers patients whose disease has not responded to BCG.
ImmunityBio also plans to submit an application to expand FDA approval in the fourth quarter. The analysis will assess how many patients achieve a complete response, meaning no detectable cancer under the study’s criteria, and how long those responses last.
Anktiva Gains Broader Approval And Fresh Long-Term Data
Earlier this month, the FDA expanded ANKTIVA plus BCG’s approval to include patients with BCG-unresponsive non-muscle invasive bladder cancer with papillary-only tumors. That builds on its 2024 approval for disease with carcinoma in situ, with or without papillary tumors.
The company also released long-term results this month from a Phase 2/3 study of 100 patients whose cancer had not responded to BCG. It reported a 71% complete response rate, with some responses lasting more than 53 months. Among responders, three-year survival without bladder-removal surgery was 84%.
How Do Retail Traders Feel About IBRX?
On Stocktwits, retail sentiment slipped to ‘bearish’ from ‘bullish’ levels a week ago amid a 274% surge in 24-hour message volumes.
One user said, “$IBRX cramer has never been so bullish on Ibrx as he was yesterday. Last time the stock traded in the 7’s , cramer was bullish on Ibrx and started the rally to 10+ “
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Another user said, “$IBRX I buy the dips and exhaust my powder, it goes so much lower and I cannot buy more.”
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IBRX stock has surged 294% year-to-date.
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