Company: WHWK
Filing Date: 2025-01-21
Form Type: PREM14A
Source: 0001193125-25-009599
Chunk: 312

Company: Whitehawk Therapeutics, Inc.
Filing Date: 2025-01-21
Form: PREM14A
Chunk 312
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 of problems with a drug after approval may result in restrictions on a drug, manufacturer, or holder of an approved NDA, including, among other things, recall or withdrawal of the drug from the market, and may require substantial resources to correct. The FDA also may require post-approval testing, sometimes referred to as Phase 4 testing, risk minimization action plans, and post- marketing surveillance to monitor the effects of an approved drug or place conditions on an approval that could restrict the distribution or use of the drug. Discovery of previously unknown problems with a drug or the failure to comply with applicable FDA requirements can have negative consequences, including adverse publicity, judicial, or administrative enforcement actions. 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 untitled letters; |

| • |     | clinical holds on post-approval or Phase 4 clinical studies, if applicable; |

| • |     | refusal of the FDA to approve pending applications or supplements to approved applications, or suspension or 
 revocation of product license 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; |

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

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

The FDA may withdraw approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market. Newly discovered or developed safety or effectiveness data may require changes to a drug’s approved labeling, including the addition of new warnings and contraindications, and also may require the implementation of other risk management measures, including a REMS or the conduct of post-marketing studies to assess a newly discovered safety issue. Also, new government requirements, including those resulting from new legislation, may be established, or the FDA’s policies may change, which could delay or prevent regulatory approval of our drugs under development. As a condition of the approval of the NDA for FYARRO, we are required to conduct