Company: MBIO
Filing Date: 2025-04-01
Form Type: 424B3
Source: 0001104659-25-030657
Chunk: 68

Company: MUSTANG BIO, INC.
Filing Date: 2025-04-01
Form: 424B3
Chunk 68
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 associated with such approval may adversely impact our business.

A pharmaceutical product cannot be marketed in
the U.S. or other countries until we have completed a rigorous and extensive regulatory review process, including approval of a brand
name. Any brand names we intend to use for our product candidates will require approval from the FDA regardless of whether we have secured
a formal trademark registration from the USPTO. The FDA typically conducts a review of proposed product brand names, including an evaluation
of the potential for confusion with other product names. The FDA may also object to a product brand name if it believes the name inappropriately
implies medical claims. If the FDA objects to any of our proposed product brand names, we may be required to adopt an alternative brand
name for our product candidates. If we adopt an alternative brand name, we would lose the benefit of our existing trademark applications
for such product candidate and may be required to expend significant additional resources in an effort to identify a suitable product
brand name that would qualify under applicable trademark laws, not infringe the existing rights of third parties and be acceptable to
the FDA. We may be unable to build a successful brand identity for a new trademark in a timely manner or at all, which would limit our
ability to commercialize our product candidates.

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Public concern regarding the safety of drug products could delay or limit our ability to obtain regulatory approval, result in the inclusion of unfavorable information in our labeling, or require us to undertake other activities that may entail additional costs.

In light of widely publicized events concerning
the safety risk of certain drug products, the FDA, members of the U.S. Congress, the Government Accountability Office, medical professionals
and the general public have raised concerns about potential drug safety issues. These events have resulted in the withdrawal of drug products,
revisions to drug labeling that further limit use of the drug products and the establishment of risk management programs. The Food and
Drug Administration Amendments Act of 2007, (“FDAAA”), grants significant expanded authority to the FDA, much of which is
aimed at improving the safety of drug products before and after approval. In particular, the law authorizes the FDA to, among other things,
require post-approval studies and clinical trials, mandate changes to drug labeling to reflect new safety information and require risk
evaluation and mitigation strategies for certain drugs, including certain currently approved drugs. It also significantly expanded the
federal government’s clinical trial registry and results databank