IBRX Stock Set To Snap 2 Weeks In Red: Anktiva Joins Global Blockbusters On Macau Drug List

• The therapy also gained momentum in the U.S. after NCCN added it as a treatment option for papillary bladder cancer patients unresponsive to BCG.
• ImmunityBio has resubmitted its FDA application to expand Anktiva’s use, backed by clinical data showing strong cancer-free and bladder preservation rates.
• The company is advancing Anktiva globally, with lung cancer trials underway and recent approvals in markets including Saudi Arabia.

Shares of ImmunityBio, Inc. (IBRX) are set to snap a two-week losing streak after its cancer therapy Anktiva appeared on Macau’s latest drug list, adding to fresh momentum from a U.S. guideline expansion.

IBRX stock has gained over 5% this week, snapping a two-week losing streak that had erased nearly 15% of its value.

Anktiva Added To Macau Approved List

Anktiva, which is available under the generic name Nogapendekin alfa, is an immunotherapy that helps activate the body’s immune system to better fight cancer. It is approved in the U.S. for use with standard BCG treatment in patients with a type of bladder cancer that no longer responds to BCG, including those with or without certain tumor growths.

The Macau filing, with data as of March, lists Anktiva as a bladder cancer treatment, identifying Nogapendekin alfa as its active ingredient and noting it is given as an injection for bladder cancer. The list also includes therapies approved by regulators such as the U.S. Food and Drug Administration (FDA), China’s National Medical Products Administration (NMPA), and the European Medicines Agency (EMA).

Anktiva’s inclusion places it alongside a roster of globally approved therapies from major drugmakers, including Bristol Myers Squibb, Eli Lilly, Vertex Pharmaceuticals, Janssen, Gilead Sciences, and Moderna, positioning it among established treatments across oncology and specialty care.

NCCN Expansion Adds To Momentum

The Macau development comes in the same week that Anktiva was added to updated U.S. treatment guidelines. The National Comprehensive Cancer Network (NCCN) added Anktiva, used with BCG, as an “other recommended” option for patients with papillary bladder cancer that no longer responds to BCG and has not spread into muscle tissue.

Earlier versions of the guidelines had included the therapy only for carcinoma in situ. The update expands the potential patient population under clinical guidance, even as the indication is not yet formally approved by the FDA.

Anktiva Seeks Label Expansion

ImmunityBio is seeking to expand Anktiva’s label to include papillary bladder cancer and has resubmitted its supplemental biologics license application to the FDA after previously receiving a refusal-to-file letter. The filing includes additional data requested by the agency, including updated efficacy results and long-term follow-up.

Clinical data from the Phase 2/3 Quilt 3.032 study showed that 58.2% of patients remained cancer-free at 12 months, while more than 80% avoided bladder removal surgery over a three-year follow-up period, according to the company.

Global Push For Anktiva Grows

Beyond bladder cancer, ImmunityBio is advancing Anktiva in lung cancer, with two pivotal trials underway in first-line and second-line non-small cell lung cancer. The company said multiple countries have expressed interest in the program as it explores broader regulatory pathways.

The therapy has already received authorizations in the U.K., Europe and Saudi Arabia. In January, Saudi regulators granted approvals covering both bladder cancer and metastatic non-small cell lung cancer, including use in combination with checkpoint inhibitors.

ImmunityBio said product shipments are ready to begin for a Saudi launch of Anktiva for bladder cancer, following regulatory approvals, and that it has partnered with regional distributors to expand access across the Middle East and North Africa.

How Did Stocktwits Users React?

On Stocktwits, retail sentiment for IBRX slid to ‘bearish’ from the ‘extremely bullish’ zone over the past three months amid over a 300% surge in message volumes over the same period.

One user said, “Macau - China. I’d say that’s kinda global. And unstoppable.”

Another user said, “with NMPA - Macau - China approval apparent, FDA needs to get with it. This level of disfunction is a national embarrassment. China approves before US for a US company??? This is like a Saturday Night Live skit.”

IBRX stock has more than tripled over the past year.

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