Investors are focused on Anktiva’s next regulatory step, as ImmunityBio seeks to expand the therapy to BCG-unresponsive papillary bladder cancer.
- FDA Commissioner Marty Makary highlighted rapid approvals of the lung cancer drug Zongertinib and the multiple myeloma therapy Tec-Dara.
- Retail traders accused regulators of favoring big pharma, calling the approvals a “rubber stamp” and arguing the FDA moves faster for large drugmakers.
- IBRX shares slipped 0.4% to $8.96 on Thursday, marking a third straight decline, though the stock remains up more than 350% so far this year.
ImmunityBio, Inc. (IBRX) founder Patrick Soon-Shiong sparked fresh debate among retail investors after posting a brief “Congratulations GSK” message following the U.S. Food and Drug Administration (FDA) celebration of fast-tracked cancer drug approvals.
The comment came in response to a video on X posted by FDA commissioner Marty Makary, who highlighted the agency’s rapid approval of two cancer treatments under the National Priority Voucher program.
IBRX stock slipped for the third straight session after declining 0.4% on Thursday to $8.96. Shares have skyrocketed by more than 350% so far this year.
FDA Fast-Tracks Two Cancer Drugs
Makary said the FDA had approved two cancer drugs in a matter of weeks through the agency’s accelerated review initiative. One therapy, Zongertinib, targets a subtype of non-small cell lung cancer and was approved 44 days after filing. Makary said response rates for eligible patients increased from roughly 35% to 40% to about 76%.
He also highlighted the approval of Tec-Dara for relapsed or refractory multiple myeloma. The therapy was cleared 55 days after filing, with clinical trial data showing it reduced the risk of disease progression or death by 83% compared with standard treatment.
Tec-Dara combines Tecvayli and Darzalex, both developed by Johnson & Johnson. The combination works by targeting two proteins on myeloma cells, BCMA and CD38, triggering the immune system to attack the cancer.
The decision marked the third approval under the new Commissioner’s National Priority Voucher (CNPV) pilot program, which aims to expedite reviews of therapies addressing major public health priorities.
Why GSK Entered The Conversation
Soon-Shiong’s message specifically referenced GSK, a major competitor in the multiple myeloma treatment market.
GSK developed Blenrep, another therapy targeting BCMA (B-cell maturation antigen) for patients with relapsed or refractory multiple myeloma. The drug received FDA approval last year in combination with other medicines, following trials that showed significant survival benefits.
Since Blenrep competes in the same disease area as treatments such as Tec-Dara, new approvals and trial results in multiple myeloma often draw comparisons across therapies from different pharma companies.
Retail Traders Slam FDA Bias
Soon-Shiong’s brief post quickly sparked discussion across Stocktwits, where retail sentiment slipped to ‘bearish’ from ‘extremely bullish’ a month ago amid a 131% surge in 24-hour message volume.
One user said that the FDA was “moving with remarkable speed,” adding that the headline should really read “to approve big pharma drugs.” Another user described the agency’s fast approvals as a “rubber stamp” for major drugmakers.
Several traders tied the discussion to Anktiva, ImmunityBio’s immunotherapy, arguing that regulators had moved more slowly on expanding the drug’s approval. They said the FDA seemed “perfectly content to allow Saudi Arabia to be the world’s number one center for treating bladder cancer.”
Where ImmunityBio’s Anktiva Stands
Anktiva is an immune-activating therapy that stimulates 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 an early but aggressive form of bladder cancer, called carcinoma in situ, that no longer responds to standard BCG treatment.
Investors are now watching the next potential regulatory milestone. ImmunityBio is seeking to expand the drug’s approval to include papillary bladder cancer, which represents a significantly larger patient population.
The company previously received a refusal-to-file letter from the FDA for an application seeking to expand Anktiva’s use to patients with BCG-unresponsive papillary bladder cancer, and has said it plans to resubmit a biologics license application after further discussions with regulators.
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