Company: CRNX
Filing Date: 2025-02-27
Form Type: 10-K
Source: 0000950170-25-029050
Chunk: 156

Company: Crinetics Pharmaceuticals, Inc.
Filing Date: 2025-02-27
Form: 10-K
Item: Item 1A
Chunk 156
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 delay or abandon clinical development plans. For example, while we have completed two Phase 3 clinical trials of paltusotine in distinct patient populations, the FDA or comparable foreign regulatory authorities may require additional clinical trials or suggest changes to our planned clinical trials, prior to and in support of the approval of an NDA or equivalent foreign marketing application. Further, requirements regarding clinical trial data may evolve. For example, the FDA published a draft guidance, E6 (R3) Good Clinical Practice, in June 2023, and Annex 2 thereto in December 2024, which seeks to unify standards for clinical trial data for ICH member countries and regions. Changes to data requirements by the FDA or comparable foreign regulatory authorities, as the case may be, may cause the applicable regulatory authorities to require us to conduct additional preclinical 

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studies or clinical trials for our product candidates either prior to or post-approval, or may object to elements of our clinical development program. 

The FDA or comparable foreign regulatory authorities can delay, limit or deny approval of a product candidate for many reasons, including: 

•such authorities may disagree with the design or implementation of our clinical trials; 

•negative or ambiguous results from our clinical trials or results may not meet the level of statistical significance required by the FDA or comparable foreign regulatory agencies for approval; 

•serious and unexpected drug-related side effects may be experienced by participants in our clinical trials or by individuals using drugs similar to our product candidates; 

•the population studied in the clinical trial may not be sufficiently broad or representative to assure safety in the full population for which we seek approval; 

•such authorities may not accept clinical data from trials which are conducted at clinical facilities or in countries where the standard of care is potentially different from that of the United States; 

•we may be unable to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks; 

•such authorities may disagree with our interpretation of data from preclinical studies or clinical trials; such authorities may not agree that the data collected from clinical trials of our product candidates are acceptable or sufficient to support the submission of an NDA or other submission or to obtain regulatory approval in the United States or elsewhere, and such authorities may impose requirements for additional preclinical studies or clinical trials; 

•such authorities may disagree regarding the formulation, labeling and/or the specifications of our product candidates; 

•approval may be granted only for indications that are significantly more limited than what we apply for and/or with other significant restrictions on distribution and use