Company: SMNR
Filing Date: 2025-06-11
Form Type: CORRESP
Source: 0001193125-25-139135
Chunk: 5

Company: Semnur Pharmaceuticals, Inc.
Filing Date: 2025-06-11
Form: CORRESP
Chunk 5
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 the treatment of sciatica. In response to the Staff’s comment, the Company has revised the disclosure on pages 87-88, 114 and 292 of Amendment No. 2 to clarify the foregoing and to provide more detail with respect to the guidance provided by the FDA regarding the CLEAR-2trial. 4

U.S. Securities and Exchange Commission June 11, 2025

| 13. | We refer to prior comment 29 and note your disclosures on page 288 and elsewhere concerning the Type D                                                                                                                                                
 meeting that Scilex/Semnur had with FDA in February 2024. Please revise to disclose in greater detail the additional guidance provided by FDA at this meeting concerning the confirmatory trial design. Also, disclose the primary endpoints, and any 
 secondary endpoints, that have been established for the CLEAR-2 trial, or advise.                                                                                                                                                                     |

Response: The Company respectfully advises the Staff that it has revised the disclosure on pages 87-88, 114 and 292 of Amendment No. 2 in response to the Staff’s comment. Our Strategy, page 288

| 14. | We note your revisions in response to prior comment 30 as well as the disclosures on pages 309 and 311                                                                                                                                           
 concerning circumstances where FDA may approve a drug product based on the results of a single adequate and well-controlled Phase 3 trial for excellent design and which provides highly reliable and statistically strong evidence of important 
 “clinical benefit.” Given your revised disclosures on pages 289 and elsewhere concerning the “clinical benefit” and “tolerability” assessed in the CLEAR- 1 trial, please tell us, and, if applicable, revise to indicate,                       
 whether Semnur’s planned NDA application would seek approval on this particular basis. Also, please revise where appropriate to explain in greater detail the “clinical benefit” standard including how it is demonstrated.                      |

Response: The Company respectfully advises the Staff that Semnur’s planned NDA application will not seek approval based on the results of a single adequate and well-controlled Phase 3 trial for excellent design and which provides highly reliable and statistically strong evidence of important “clinical benefit.” The Company further advises the Staff that it has revised the disclosure on page 314 of Amendment No. 2 to explain the “clinical benefit” standard and how it is demonstrated. Management’s Discussion and Analysis of Financial Condition and Results of Operations of Semnur Liquidity and Capital Resources, page 329

| 15. | We note your