Longeveron Inc. (LGVN) has disclosed a new risk, in the Manufacturing category.
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Longeveron Inc. faces significant business risks related to its CMC readiness and manufacturing capabilities for commercialization, which may experience delays or be unsuccessful. The complexity of BLA-enabling activities, such as comparability protocols and process validation, coupled with regulatory scrutiny, poses challenges that could impede the company’s ability to meet regulatory and investor expectations for product approval and launch. The FDA’s discretionary power and the uncertain, costly approval process further exacerbate these risks, potentially affecting the clinical and commercial success of Longeveron’s product candidates. Consequently, any setbacks in completing CMC readiness and BLA-enabling activities could materially harm Longeveron’s financial condition.
The average LGVN stock price target is $5.00, implying 562.08% upside potential.
To learn more about Longeveron Inc.’s risk factors, click here.