ImmunityBio Advances ANKTIVA Application with FDA Meeting, Achieving 96% Survival Rate at 36 Months
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1h ago
0mins
Source: Businesswire
- Clinical Data Highlights: ImmunityBio showcased clinical data during its FDA meeting, revealing a 96% disease-specific survival rate at 36 months for ANKTIVA combined with BCG in treating BCG-unresponsive non-muscle invasive bladder cancer, indicating the therapy's long-term efficacy and potential market competitiveness.
- FDA Feedback and Next Steps: The FDA recommended that ImmunityBio submit additional information within the next 30 days to support the resubmission of its supplemental Biologics License Application (sBLA), reflecting the regulatory body's interest and the potential for approval.
- Patient Management and Treatment Options: Several leading urologists discussed real-world treatment approaches for patients with BCG-unresponsive disease, emphasizing the importance of ANKTIVA as an alternative, especially in the absence of other effective treatment options.
- Global Regulatory Progress: ANKTIVA has already been approved in multiple regions for BCG-unresponsive bladder cancer, demonstrating ImmunityBio's commitment to expanding patient access globally, and if approved in the U.S., it would become the first immunotherapy option for this indication.
Analyst Views on IBRX
Wall Street analysts forecast IBRX stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for IBRX is 7.33 USD with a low forecast of 5.00 USD and a high forecast of 9.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
3 Analyst Rating
3 Buy
0 Hold
0 Sell
Strong Buy
Current: 3.950
Low
5.00
Averages
7.33
High
9.00
Current: 3.950
Low
5.00
Averages
7.33
High
9.00
About IBRX
Immunitybio, Inc. is a vertically integrated, clinical-stage biotechnology company developing therapies and vaccines that bolster the natural immune system to defeat cancers and infectious diseases. Using its applied science and platforms to treat cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies to reduce or eliminate the need for standard high-dose chemotherapy. Its platforms and their associated product candidates are designed to attack cancer and infectious pathogens by activating both the innate immune system, including NK cells, dendritic cells, and macrophages, as well as the adaptive immune system comprising B and T cells, in an orchestrated manner. Its platforms for the development of biologic product candidates include antibody-cytokine fusion proteins, vaccine vectors, and cell therapies. Its biologic commercial product candidate, Anktiva, is an IL-15 superagonist antibody-cytokine fusion protein.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
