0000000000-23-012787.txt : 20240223 0000000000-23-012787.hdr.sgml : 20240223 20231121213831 ACCESSION NUMBER: 0000000000-23-012787 CONFORMED SUBMISSION TYPE: UPLOAD PUBLIC DOCUMENT COUNT: 2 FILED AS OF DATE: 20231121 FILED FOR: COMPANY DATA: COMPANY CONFORMED NAME: MADRIGAL PHARMACEUTICALS, INC. CENTRAL INDEX KEY: 0001157601 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] ORGANIZATION NAME: 03 Life Sciences IRS NUMBER: 000000000 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: UPLOAD SEC FILE NUMBER: 001-33277 BUSINESS ADDRESS: STREET 1: 200 BARR HARBOR DRIVE, SUITE 400 CITY: WEST CONSHOHOCKEN STATE: PA ZIP: 19428 BUSINESS PHONE: 404-380-9263 MAIL ADDRESS: STREET 1: 200 BARR HARBOR DRIVE, SUITE 400 CITY: WEST CONSHOHOCKEN STATE: PA ZIP: 19428 FORMER COMPANY: FORMER CONFORMED NAME: SYNTA PHARMACEUTICALS CORP DATE OF NAME CHANGE: 20010815 PUBLIC REFERENCE ACCESSION NUMBER: 0001193125-23-045575 LETTER 1 filename1.pdf begin 644 filename1 M)5!$1BTQ+C4*)>+CS],*,2 P(&]B:@H\/"]#;VQO7!E+UA/8FIE8W0O5VED=&@@,30R."],96YG=&@@,S8U+T)I='-097)# M;VUP;VYE;G0@.#X^7M0Q1$1$1$1$1&3"Q\<'QA6_?__&K *98K_? 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Howarth Chief Financial Officer Madrigal Pharmaceuticals, Inc. Four Tower Bridge 200 Barr Harbor Drive, Suite 200 West Conshohocken, PA 19428 Re: Madrigal Pharmaceuticals, Inc. Form 10-K for Fiscal Year Ended December 31, 2022 File No. 001-33277 Dear Alex G. Howarth: We have reviewed your filing and have the following comments. Please respond to this letter within ten business days by providing the requested information or advise us as soon as possible when you will respond. If you do not believe a comment applies to your facts and circumstances, please tell us why in your response. After reviewing your response to this letter, we may have additional comments. Form 10-K for Fiscal Year Ended December 31, 2022 Dual Primary Endpoints (52 Weeks) and Key Secondary Endpoint (24 weeks), page 9 1. We note your disclosure on page 10 that Resmetirom was safe and well tolerated. Determinations related to safety are within the sole authority of the FDA. In future filings, please refrain from making such assessments related to product candidates that have not been approved. Additionally, please disclose all serious adverse events related to Resmetirom and disclose the number of such events. Explain how you have determined that the candidate is well tolerated when trial participants experienced serious adverse events. Research and Development Expenses, page 65 2. We note the statement that you expect your research and development expenses will increase substantially in the future. Accordingly for each period presented in future filings, please revise to provide a breakdown of the amount of research and development expense incurred for each of your lead product candidates by program. For product candidates with more than one application, provide a breakdown by indication. To the Alex G. Howarth Madrigal Pharmaceuticals, Inc. November 21, 2023 Page 2 extent that you do not track expenses by product candidate, program, or indication, please disclose that fact and explain why you do not maintain and evaluate research and development cost in this manner. For all unallocated research and development expense, provide a breakdown by type or nature of expense such that the sum reconciles to total research and development expense for the period. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Gary Newberry at 202-551-3761 or Kevin Kuhar at 202-551-3662 if you have questions regarding comments on the financial statements and related matters. FirstName LastNameAlex G. Howarth Sincerely, Comapany NameMadrigal Pharmaceuticals, Inc. Division of Corporation Finance November 21, 2023 Page 2 Office of Life Sciences FirstName LastName