Shares of immunotherapy biotech ImmunityBio (IBRX +7.02%) initially popped today, and are up 9% as of 10:45 a.m. ET on Wednesday. After market close yesterday, ImmunityBio announced that the Food and Drug Administration (FDA) had accepted the company's supplemental biologics license application (BLA) for review, which could lead to a major label expansion for its core treatment, Anktiva.
NASDAQ: IBRX
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Currently, ImmunityBio's flagship Anktiva drug is approved to treat patients with bacillus Calmette-Guérin (BCG)-unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) who have Carcinoma in Situ (CIS). The new BLA would expand Anktiva's label to include its use in treating BCG-unresponsive NMIBC cases with papillary disease, in addition to CIS. Plenty of technical terms here, but this could be a big deal for ImmunityBio, so it is worth looking into for the following reason.
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In the press release, management noted, "Approximately 85% of the 64,000 people diagnosed with NMIBC in the U.S. each year present with papillary disease." Papillary disease is much more common than CIS, so this could greatly expand ImmunityBio's target market as it continues to grow its treatment indications. Since "CIS and papillary disease arise from the same cancer-inducing clone," many doctors have already been treating patients off-label with Anktiva. An FDA approval would cause insurers to cover the treatment going forward.
The FDA set a Prescription Drug User Fee Act (PDUFA) target action date for Jan. 6, 2027, so investors will want to keep this date in mind going forward. In addition to its bladder cancer treatments, ImmunityBio has a strong pipeline of clinical trials spanning lung and ovarian cancer, HIV, glioblastoma, Non-Hodgkin Lymphoma, and more. That said, ImmunityBio's stock has more than quadrupled year to date and currently trades at 58 times sales, so a lot of this potential is already priced into the company's valuation. Investors would be wise not to go "all-in" at once if they're interested in the promising biotech, but rather to make smaller bets over time.
