ImmunityBio’s ANKTIVA Approval Lifts Shares In PreMarket

ImmunityBio, Inc. (NASDAQ: IBRX) watched its stock fall 12.20% in yesterdays trading, but it is already on the climb in the pre-market, lifting 8.30% so far.

In spite of this downwards trajectory reported yesterday, in the last 6 months, the share price has a fair few green days, with it propelling itself 205.06%. The U.S. Food and Drug Administration's (FDA) has given the nod of approval for its novel bladder cancer treatment. The mixed market response yesterday has the medical and financial communities poised to pounce with this fantastic news about the company's innovative approach to combating cancer.

The FDA sanctioned ANKTIVA (N-803), an interleukin-15 (IL-15) superagonist, for use in conjunction with Bacillus Calmette-Guérin (BCG) in treating patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) that includes carcinoma in situ (CIS). The combination therapy promises a new lease on life for patients battling this specific, challenging form of cancer, and the approval reflects confidence in its therapeutic potential.

Patrick Soon-Shiong, ImmunityBio's Executive Chairman and Global Chief Scientific and Medical Officer, heralded the FDA's decision, deeming ANKTIVA a “next-generation immunotherapy” that transcends traditional checkpoint inhibitors. This enthusiasm stems from ANKTIVA's demonstrated ability to invoke a robust response from the immune system, targeting cancer with precision and potency.

The FDA's approval of ANKTIVA was predicated on its “Breakthrough Therapy” status—indicative of the treatment's unprecedented safety and efficacy profile. These conclusions were drawn from a compelling single-arm, multicenter trial involving 77 patients, which reported a complete response (CR) rate of 62% and a remarkable duration of complete response (DOR) exceeding 47 months for some patients. Moreover, 58% of patients experiencing a complete response witnessed a DOR for a minimum of 12 months, with 40% surpassing the 24-month mark, signifying a sustained reprieve from the disease for many involved in the trial.

Given these formidable figures, optimism runs high regarding ANKTIVA's market release, scheduled for mid-May 2024. This timeline allows ImmunityBio ample opportunity to prepare for distribution and to ensure the therapy is accessible to those in need across the United States.

The favourable verdict reverberated through Wall Street, with IBRX's stock value ascending to $5.22 at premarket. ImmunityBio's price target from Piper Sandler has been raised from $4 to $5 and are keeping a Neutral Rating on the shares. This flurry of financial activity emphasises investor confidence in both ImmunityBio's direction and the therapeutic promise ANKTIVA holds.

The FDA's endorsement of ANKTIVA marks a significant milestone for ImmunityBio and for cancer treatment innovation. The capacity of this therapy to significantly impact patient outcomes has invigorated the biopharmaceutical industry and illustrated the untapped potential within novel immunotherapies.