ImmunityBio Inc. (IBRX) shares fell over 3% in premarket trading on Monday, despite founder Patrick Soon-Shiong’s claims of upcoming data submissions for the company’s cancer therapy Anktiva. The decline extends a four-day losing streak, with the stock closing at $8.67 on Friday after falling more than 3%.

Founder Signals Upcoming Data Submission

Soon-Shiong, a prominent figure in biotechnology, announced on X that additional data related to Anktiva, the company’s IL-15-based immune-activating therapy, will soon be submitted. He described the IL-15 mechanism as a long-recognized ‘game changer’ in cancer research. The data is tied to the company’s IL-15 cancer immunotherapy platform, which the founder said has been under review with the FDA for the past six months.

Soon-Shiong emphasized that the data submission aligns with the FDA’s growing emphasis on mechanism-based reviews, which he believes could accelerate patient access to therapies like Anktiva. ‘This is what we have been presenting to the FDA for the past 6 months to desperately allow the 13,000+ requests from Americans to access Anktiva via this pathway,’ he said.

Founder Cites Support For Anktiva’s Mechanism

In a separate post, Soon-Shiong cited comments from former FDA associate commissioner Peter Pitts and NIH Director Jay Bhattacharya, who acknowledged the mechanism of action described in Anktiva’s approved labeling supports the therapy’s scientific rationale. The founder argued that these endorsements could bolster the FDA’s case for fast-tracking Anktiva’s approval.

Soon-Shiong also expressed hope that FDA Commissioner Marty Makary would review the upcoming data closely. ‘Saving patients’ bladders matters. Prolonging life matters. Quality of life matters. T cell and NK cell expansion matters. Duration matters,’ he said.

FDA Pushes Faster Drug Reviews

The remarks come as the FDA has been signaling a push to accelerate review timelines for certain therapies. Makary recently highlighted on X the agency’s approval of a lung cancer treatment 44 days after filing, describing the process as moving at an ‘Operation Warp Speed’ pace to bring promising therapies to patients more quickly.

The agency has also reportedly launched initiatives to speed up drug reviews and recruit additional scientific staff to address regulatory backlogs and meet review deadlines. This move is part of a broader effort to improve patient access to innovative treatments, especially in areas like oncology.

Anktiva’s Regulatory Path Forward

ImmunityBio’s lead therapy, Anktiva, is designed to stimulate immune responses by activating natural killer cells and T cells, enabling the body to mount a stronger response against tumors. The therapy is currently approved in the U.S. for patients with BCG-unresponsive carcinoma in situ, an aggressive form of bladder cancer that no longer responds to standard BCG treatment.

ImmunityBio is now seeking to expand the drug’s approval to include BCG-unresponsive papillary bladder cancer, which represents a significantly larger patient population. However, the company previously received a refusal-to-file letter from the FDA for its application seeking that expanded indication and has said it plans to resubmit a biologics license application by the fourth quarter.

How Did Stocktwits Users React?

On Stocktwits, retail sentiment for IBRX was ‘bearish’ amid a 67% decrease in message volumes over the past week. One user said, ‘Feeling very bullish. I’m here for the long game. Waiting for some more catalysts and will be buying dips as always! Just remember all the institutions that are invested here!!’

Another user urged traders to ‘lock and load for this week.’ Despite the recent decline, IBRX stock has surged over 330% year-to-date, according to the platform.

Soon-Shiong’s recent appearance on a television interview with Chris Cuomo on NewsNation also highlighted policy developments and patient access to new cancer therapies. The founder has been vocal about the need for regulatory flexibility to bring life-saving treatments to patients faster.