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United States securities and exchange commission logo
November 21, 2023
Alex G. 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