Company: SION
Filing Date: 2025-01-17
Form Type: S-1
Source: 0001193125-25-008474
Chunk: 197

Company: Sionna Therapeutics, Inc.
Filing Date: 2025-01-17
Form: S-1
Chunk 197
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 process, approval process or after approval, may subject an applicant and/or sponsor to a variety of sanctions. For example, failure to comply with the applicable U.S. requirements may result in administrative or judicial
sanctions including refusal by FDA to approve pending applications, withdrawal of an approval, imposition of a clinical hold, issuance of warning letters and untitled letters, product recalls, product seizures, total or partial suspension of
production or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement or civil or criminal investigations and penalties brought by the FDA and the Department of Justice or other governmental entities.

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Review and Approval of Drugs in the United States In the U.S., the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act (“FDCA”), and its implementing regulations. Drugs are also subject to other federal, state and local statutes and regulations. The process required by the FDA before a drug may be marketed in the U.S. generally involves the following:

| • |     | completion of extensive nonclinical, or preclinical, laboratory tests, animal studies and formulation studies in compliance 
 with the FDA’s Good Laboratory Practice (“GLP”) regulations;                                                                |

| • |     | submission to the FDA of an IND, which must become effective before human clinical trials may begin and must be updated 
 annually and when certain changes are made;                                                                             |

| • |     | approval by an institutional review board (“IRB”) or independent ethics committee (“IEC”) at each 
 clinical site before each trial may be initiated at that site;                                    |

| • |     | performance of adequate and well-controlled human clinical trials in accordance with Good Clinical Practices                                                             
 (“GCP”) requirements and other clinical trial-related regulations to establish the safety and efficacy of the investigational drug product for each proposed indication; |

| • |     | preparation and submission to the FDA of an NDA after completion of all pivotal trials, together with the payment of 
 application user fees, as applicable;                                                                                |

| • |     | a determination by the FDA within 60 days of its receipt of an NDA to accept the marketing application for review; |

| • |     | satisfactory completion of an FDA advisory committee review, if applicable; |

| • |     | satisfactory completion of one or more FDA inspections of the manufacturing facility or facilities at which the product is                                                                  
 produced to assess compliance with cGMP requirements and to assure that the facilities, methods and controls are adequate to preserve the product’s identity, strength