HC Wainwright has initiated coverage on ImmunityBio, Inc (NASDAQ:IBRX). The company's lead asset is Anktiva (nogapendekin alfa inbakicept-pmln) solution for intravesical use, approved by the Food and Drug Administration indicated with Bacillus Calmette-Guérin (BCG) for adult patients with BCG-unresponsive bladder carcinoma in situ (CIS) with or without papillary tumors.

Also Read: ImmunityBio Stock Trading Higher On Updates From Bladder Cancer Trials: Details

HC Wainwright analyst Andres Y. Maldonado writes that Anktiva will follow a different market path than the two latest FDA-approved treatments for high-risk bladder cancer—Merck & Co Inc's (NYSE:MRK) Keytruda and Ferring Pharmaceutical's Adstiladrin—both of which have faced hurdles after launch.

Keytruda's adoption has been slow because urologists are hesitant to refer patients to oncologists and worry about its side effects. Adstiladrin, on the other hand, has struggled with supply issues, though Ferring says availability has recently improved.

HC Wainwright projects 2025 Anktiva revenue of $137.4 million, growing to $4.3 billion by 2034. The analyst has initiated with a Buy rating and an $8 price target.

In the fourth quarter, ImmunityBio reported product revenue of $7.21 million and $14.2 million in the fiscal year 2024. The increase was driven by sales of ANKTIVA after FDA approval in April 2024.

Recently, the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation for Anktiva and CAR-NK (PD-L1 t-haNK) for the reversal of lymphopenia in patients receiving standard-of-care chemotherapy/radiotherapy and in multiply relapsed locally advanced or metastatic pancreatic cancer.

While many are watching the competition between CG Oncology Inc's (NASDAQ:CGON) cretostimogene and Johnson & Johnson's (NYSE:JNJ) TAR-200 in the NMIBC market, Anktiva stands out with a first-mover advantage in a market potentially worth over $5 billion, the analyst says.

“Ultimately, we believe ANKTIVA's profile coupled with ease of administration will weigh more heavily in treatment decisions than comparisons of complete response (CR) rates at various time points to unapproved products,” the analyst writes.

Price Action: IBRX stock is down 2.47% at $2.98 at last check Thursday.

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