Company: SION
Filing Date: 2025-02-07
Form Type: 424B4
Source: 0001193125-25-022709
Chunk: 213

Company: Sionna Therapeutics, Inc.
Filing Date: 2025-02-07
Form: 424B4
Chunk 213
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 imposition of post-market studies or clinical trials to assess new safety risks; or imposition of distribution or other restrictions under a REMS program. Any of these limitations on approval or marketing could restrict the commercial promotion, distribution, prescription or dispensing of products. Other potential consequences include, among other things:

| • |     | restrictions on the marketing or manufacturing of the product, complete withdrawal of the product from the market or 
 product recalls;                                                                                                     |

| • |     | fines, warning letters or clinical holds on post-approval clinical trials; |

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| • |     | refusal of the FDA to approve pending NDAs or supplements to approved NDAs, or suspension or withdrawal of product 
 approvals;                                                                                                         |

| • |     | product seizure or detention, or refusal to permit the import or export of products; |

| • |     | consent decrees, corporate integrity agreements, debarment or exclusion from federal healthcare programs; |

| • |     | mandated modification of promotional materials and labeling and the issuance of corrective information; |

| • |     | issuance of safety alerts, Dear Healthcare Provider letters, press releases and other communications containing warnings or 
 other safety information about the product; and                                                                             |

| • |     | injunctions or the imposition of civil or criminal penalties. |

The FDA strictly regulates marketing, labeling, advertising and promotion of products that are placed on the market. Drugs may be promoted by a manufacturer and any third parties acting on behalf of a manufacturer only for the approved indications and in a manner consistent with the approved label for the product. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-labeluses, and a company that is found to have improperly promoted off-labeluses may be subject to significant liability. In addition, the distribution of prescription pharmaceutical products is subject to the Prescription Drug Marketing Act (“PDMA”), which regulates the distribution of drugs and drug samples at the federal level and sets minimum standards for the registration and regulation of drug distributors by the states. Both the PDMA and state laws limit the distribution of prescription pharmaceutical product samples and impose requirements to ensure accountability in distribution. Failure to comply with any of these requirements can result in, among other things, adverse publicity, warning letters, corrective advertising and potential civil and criminal penalties. Physicians may prescribe, in their independent professional medical judgment, legally available products for uses that are not described in the product’s labeling and that differ from those evaluated by us and approved by the FDA. Physicians may believe that such off-labeluses are the best treatment