ImmunityBio, Inc. (IBRX) Posts 3-Year Data: 84% Cystectomy Avoidance

ImmunityBio (IBRX) published long-term data from its Phase 2/3 study on ANKTIVA for bladder cancer, showing 71% complete response rate and 98.2% disease-specific survival at three years. The treatment received FDA approval in 2024, with an expanded indication this month. The study reported no severe adverse events, with most being localized bladder symptoms.

H.C. Wainwright reiterated a Buy rating and $15.00 price target on Immunitybio (IBRX) after FDA expanded ANKTIVA's approval. The stock is up 400% YTD to $9.91, with a $10.5B market cap. The FDA approved ANKTIVA for high-risk BCG-unresponsive NMIBC papillary-only disease, representing 60% of such patients. Analysts expect sales growth. Immunitybio also received marketing authorization in the UAE for ANKTIVA.

ImmunityBio's drug Anktiva gained US label expansion for bladder cancer without needing a separate Phase III trial. The FDA initially requested this but later agreed it wasn't necessary. Johnson & Johnson is running a Phase III trial for its NMIBC therapy Inlexzo. Anktiva is expected to reach blockbuster status by 2029 and generate over $4bn in global sales by 2032, according to GlobalData.

ImmunityBio (IBRX) announced the FDA expanded ANKTIVA's approval to include BCG-unresponsive non-muscle invasive bladder cancer patients with papillary-only tumors. The expanded label now covers all BCG-unresponsive NMIBC patients. Clinical data showed a 62% complete response rate, with 58% of responders maintaining the response for at least 12 months. The safety profile was consistent with BCG instillation.

ImmunityBio, Inc. (IBRX) filed an SEC Form 8-K — Regulation FD Disclosure. Exhibit 99.1 NEWS RELEASE FDA Expands ANKTIVA ® Approval for BCG-Unresponsive Non-Muscle- Invasive Bladder Cancer to Cover Both Papillary and CIS Disease • Expanded indication extends ANKTIVA plus BCG to patients with BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC), i

ImmunityBio (IBRX) received FDA approval to expand ANKTIVA plus BCG treatment to all BCG-unresponsive NMIBC, including papillary-only tumors. This follows the April 2024 approval for CIS and broadens the U.S. patient population.