Company: LIMN
Filing Date: 2025-08-13
Form Type: 424B3
Source: 0001410578-25-001746
Chunk: 43

Company: Liminatus Pharma, Inc.
Filing Date: 2025-08-13
Form: 424B3
Chunk 43
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 of Liminatus’s product candidates receives marketing approval, and Liminatus or others later identify undesirable side effects or adverse events caused by such products, a number of potentially significant negative consequences could result, including:

| ● | regulatory authorities may withdraw approvals of such product and cause Liminatus to recall its products; |

| ● | regulatory authorities may require additional warnings on the label or impose a more restrictive, narrower indication for use of the agent; |

| ● | Liminatus may be required to change the way the product is administered or conduct additional clinical trials or post-approval studies; |

| ● | Liminatus may be required to create a REMS plan, which could include a medication guide outlining the risks of such side effects for distribution to patients, a communication plan for healthcare providers, and/or other elements, such as boxed warning on the packaging, to assure safe use; |

| ● | Liminatus could be sued and held liable for harm caused to patients; and |

| ● | Liminatus’s reputation may suffer. |

Any of these events could prevent Liminatus from achieving or maintaining market acceptance of the particular product candidate, if approved, and could significantly harm Liminatus’s business, financial condition, results of operations, and growth prospects. For any current and future clinical trials for Liminatus’s product candidates outside the United States, the FDA, EMA, and applicable foreign regulatory authorities may not accept data from such trials. Liminatus conducts clinical trials outside the United States, and may choose to conduct future clinical trials outside the United States. The acceptance of study data from clinical trials conducted outside the United States or another jurisdiction by the FDA, EMA, or applicable foreign regulatory authority may be subject to certain conditions. In cases where data from foreign clinical trials are intended to serve as the basis for marketing approval in the United States, the FDA will generally not approve the application on the basis of foreign data alone unless the data are applicable to the United States population and United States medical practice, and the trials were performed by clinical investigators of recognized competence and pursuant to Good Clinical Practice (“GCP”) regulations. Additionally, the FDA’s clinical trial requirements, including sufficient size of patient populations and statistical powering, must be met. Many foreign regulatory bodies have comparable approval requirements, including appropriate examination of the product in the country-specific population. In addition, such foreign trials would be subject to the applicable local laws of the foreign jurisdictions where the trials are conducted. There can be no assurance that the FDA, EMA, or