Company: SION
Filing Date: 2025-01-17
Form Type: S-1
Source: 0001193125-25-008474
Chunk: 79

Company: Sionna Therapeutics, Inc.
Filing Date: 2025-01-17
Form: S-1
Chunk 79
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 uses for which they do not have approval, commonly known as off-labelpromotion. Physicians, on the other hand, may prescribe products for off-labeluses. Although the FDA and other regulatory agencies do not regulate a physician’s choice of drug treatment made in the physician’s independent medical judgment, they do restrict promotional communications from companies, including their sales force, with respect to off-labeluses of products for which marketing approval has not been issued. However, companies may share truthful and not misleading information that is otherwise consistent with a product’s FDA approved labeling. The holder of an approved NDA must submit new or supplemental applications and obtain prior approval for certain changes to the approved product, product labeling, or manufacturing process. A company that is found to have improperly promoted off-labeluses of their products may be subject to significant civil, criminal and administrative penalties. In addition, drug manufacturers are subject to payment of annual fees and continual review and periodic inspections by the FDA and other regulatory authorities for compliance with cGMP requirements and adherence to commitments made in the NDA or foreign marketing application. If we, or a regulatory authority, discover previously unknown problems with any product, if approved, such as adverse experiences of unanticipated severity or frequency, or problems with the facility where the product is manufactured or if a regulatory authority disagrees with the promotion, marketing or labeling of that product, a regulatory authority may impose restrictions relative to that product, the manufacturing facility or us, including requesting revisions to the approved labeling to add new safety information, imposing of post-market studies or clinical trials to assess new safety risks or imposing distribution restrictions or other restrictions under a REMS program, requesting a recall or requiring withdrawal of the product from the market or suspension of manufacturing. If we fail to comply with applicable regulatory requirements following approval of any of our product candidates, a regulatory authority may:

| • |     | issue an untitled letter or warning letter asserting that we are in violation of the law; |

| • |     | seek an injunction or impose administrative, civil or criminal penalties or monetary fines, disgorgement or profits or 
 revenue, warning letters or adverse publicity requirements;                                                            |

| • |     | suspend or withdraw regulatory approvals; |

| • |     | restrict product distribution or use, including full or partial holds on any ongoing or planned clinical trials; |

| • |     | refuse to approve a pending NDA or comparable foreign marketing application (or any supplements thereto) submitted by us or 
 our strategic partners;                                                                                                     |

| • |     | restrict the marketing or manufacturing