Company: KROS
Filing Date: 2025-02-26
Form Type: 10-K
Source: 0001664710-25-000018
Chunk: 135

Company: Keros Therapeutics, Inc.
Filing Date: 2025-02-26
Form: 10-K
Item: Item 1
Chunk 135
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 Service Act, and other federal, state, local and foreign statutes and regulations. We, along with third-party contractors, will be required to navigate the various preclinical, clinical and commercial approval requirements of the governing regulatory agencies of the countries in which we wish to conduct studies or seek approval or licensure of our product candidates. 

U.S. Drug and Biological Product Regulation 

Our product candidates must be approved by the FDA through either a New Drug Application, or NDA, or a Biologics License Application, or BLA. The process required by the FDA before biopharmaceutical product candidates may be marketed in the United States generally involves the following: 

▪completion of extensive preclinical laboratory tests and animal studies performed in accordance with applicable regulations, including the FDA’s Good Laboratory Practice, or GLP, requirements; 

▪submission to the FDA of an Investigational New Drug, or IND, application which must become effective before human clinical trials may begin; 

▪approval by an independent institutional review board, or IRB, or ethics committee at each clinical site before the trial may be initiated; 

▪performance of adequate and well-controlled human clinical trials in accordance with applicable IND regulations, good clinical practice, or GCP, requirements and other clinical trial-related regulations to establish the safety and efficacy of the investigational drug product for each proposed indication and to establish the safety, purity and potency of the investigational biologic product candidate for each proposed indication; 

▪preparation of and submission to the FDA of an NDA for a small molecule product candidate or a BLA for a biologic after completion of all pivotal clinical trials; 

▪payment of user fees for FDA review of the NDA or BLA; 

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▪a determination by the FDA within 60 days of its receipt of the NDA or BLA to file the application for review; 

▪satisfactory completion of one or more FDA pre-approval inspections of the manufacturing facility or facilities at which the proposed product will be produced to assess compliance with current Good Manufacturing Practice, or cGMP, requirements and to assure that the facilities, methods and controls are adequate to preserve the product’s continued identity, strength, quality and purity; 

▪potential FDA audit of the preclinical study and/or clinical trial sites that generated the data in support of the NDA or BLA; 

▪satisfactory completion of an FDA Advisory Committee review, if applicable; 

▪FDA review and approval of an NDA or