Item
8.01. Other Events.
As previously disclosed, on June, 15, 2020,
Applied Therapeutics, Inc. (the “Company”) announced the initiation of the ACTION-Galactosemia Kids pediatric registrational
study of AT-007 for treatment of galactosemia (the “ACTION-Kids Study”) to evaluate safety, pharmacokinetics, and reduction
in the toxic biomarker, galactitol. The study is comprised of two parts: a placebo-controlled dose range finding segment
evaluating up to seven days of consecutive dosing to determine the optimal dose in children, followed by a placebo-controlled 90
day study evaluating safety and biomarker efficacy.
On August 14, 2020, the Company received a
letter from the U.S. Food and Drug Administration (the “FDA”) that placed a partial clinical hold on the ACTION-Kids
Study and requested that the Company provide the FDA additional technical information relating to ensuring that every patient in
the study has access to the prospect of direct benefit of the drug. The partial clinical hold does not relate to concerns regarding
the safety profile of AT-007. The study is currently in the dose range finding segment, and the partial clinical hold does not
introduce any disruption to ongoing treatment. The adult ACTION-Galactosemia study, which is in the long-term extension phase,
is not affected by the partial clinical hold.
The Company will work closely with FDA to
resume the study as soon as possible and plans to submit the supporting technical information requested by the FDA promptly. The
FDA has 30 days thereafter to review the information and to notify the Company if the ACTION-Kids Study may be resumed.
Based on this anticipated pediatric study
delay, the Company plans to submit a new drug application in the first quarter of 2021.
This
Form 8-K contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the
safe harbor provided by the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical
fact, included herein regarding strategy, future operations, prospects, plans and objectives of management, including words such
as “may,” “will,” “expect,” “anticipate,” “plan,” “intend,”
and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are forward-looking
statements. These include, without limitation, statements regarding (i) the timing of the initiation and completion, including
with respect to any disruptions or delays, of our clinical trials, (ii) the likelihood of obtaining regulatory approval of our
product candidates, including the length of the partial clinical hold on the ACTION-Kids Study, (iii) our plan to submit a new
drug application in the first quarter of 2021 and (iii) the overall timing of our clinical development plan. Forward-looking statements
in this Form 8-K involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed
or implied by the forward-looking statements, and we, therefore cannot assure you that our plans, intentions, expectations or strategies
will be attained or achieved. Such risks and uncertainties include, without limitation, the uncertainties inherent in the initiation,
execution and completion of clinical trials, in the timing of availability of trial data, in the results of the clinical trials,
in the actions of regulatory agencies, in the commercialization and acceptance of new therapies as well as the impact of the COVID-19
pandemic on these plans and expectations. Factors that may cause actual results to differ from those expressed or implied in the
forward-looking statements in this Form 8-K are discussed in our filings with the U.S. Securities and Exchange Commission, including
the “Risk Factors” contained therein. Except as otherwise required by law, we disclaim any intention or obligation
to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new
information, future events or circumstances or otherwise.