United States securities and exchange commission logo

                             June 2, 2021

       Timothy Noyes
       Chief Executive Officer
       Aerovate Therapeutics, Inc.
       200 Berkeley Street, Floor 18
       Boston, MA 02116

                                                        Re: Aerovate
Therapeutics, Inc.
                                                            Draft Registration
Statement on Form S-1
                                                            Submitted May 6,
                                                            CIK No. 0001798749

       Dear Mr. Noyes:

              We have reviewed your draft registration statement and have the
following comments. In
       some of our comments, we may ask you to provide us with information so
we may better
       understand your disclosure.

              Please respond to this letter by providing the requested
information and either submitting
       an amended draft registration statement or publicly filing your
registration statement on
       EDGAR. If you do not believe our comments apply to your facts and
circumstances or do not
       believe an amendment is appropriate, please tell us why in your

             After reviewing the information you provide in response to these
comments and your
       amended draft registration statement or filed registration statement, we
may have additional

       Draft Registration Statement on Form S-1

       Prospectus Summary
       Overview, page 1

   1.                                                   We note your statement
that "oral imatinib also demonstrated statistically significant and
                                                        clinically meaningful
benefit in PAH patients in an international Phase 3 trial conducted
                                                        by Novartis" and
similar statements throughout the registration statement. Since findings
                                                        of safety or efficacy
are solely within the authority of the FDA or similar foreign
                                                        regulators, and oral
imatinib has not been approved for the treatment of PAH, please
                                                        revise to remove any
statements that suggest the safety and efficacy of this product
                                                        candidate. Where you
deem appropriate, you may present objective data without
                                                        including your
conclusions related to safety or efficacy.
 Timothy Noyes
FirstName  LastNameTimothy
Aerovate Therapeutics, Inc. Noyes
June 2, 2021NameAerovate Therapeutics, Inc.
June 2,
Page 2 2021 Page 2
FirstName LastName
2.       We note your comparison of the results of your Phase 1 trial of AV-101
to the results
         observed in the Phase 3 IMPRES clinical trial of oral imatinib. Given
that it appears you
         have not conducted head-to-head trials, and the significant variables
across clinical
         trials, please tell us why you believe it is appropriate to include
this comparison. Include
         in your response whether you expect to be able to rely on this data to
support an
         application for marketing approval from the FDA or comparable
regulatory body for
         commercialization of AV-101.
3.       Please describe the    systemic" adverse events that were observed
during the Phase 3 trial
         conducted by Novartis and whether these were categorized as serious
adverse events.
4.       We note your use of the term    high unmet medical need    here and
elsewhere in the
         document. Such a term might imply that your products are eligible for
fast track
         designation or priority review granted by the FDA for products that
treat certain serious
         unmet medical needs. Please remove your use of this term throughout or
otherwise please
         explain why you believe use of this term is appropriate.
5.       We note your statement that you have received regulatory guidance from
the FDA that
         your clinical program could support a NDA submission. Please revise to
provide context
         for such statement and balance your disclosure by stating that the
process of clinical
         development is inherently uncertain and there can be no guarantee that
you will obtain
         marketing approval. We also note your statements that your "focus on
developing AV-
         101 is driven by promising historical results from the Phase 3 IMPRES
clinical trial of
         oral imatinib," that you are "pursuing an efficient clinical
development program utilizing
         established endpoints for development and approval of previous PAH
drugs" and similar
         statements throughout the registration statement. These statements
could imply that the
         FDA has approved, or will more easily approve, your product candidate.
As your drug is
         distinct from prior drugs that have been approved by the FDA, please
revise your
         disclosure to remove any implication that your product candidate is
more likely to receive
         FDA approval than others. Additionally, revise your statements on page
79 that you
         intend to pursue a "rapid development path" that "employs a seamless
adaptive design to
         streamline the development timeline to a potential NDA filing" and
similar disclosure
         throughout the prospectus to remove any implication that you will be
successful in
         obtaining regulatory approval or commercializing your product
candidate in a rapid or
         accelerated manner as such statements are speculative.
Risks Associated with Our Business, page 3

6.       Please revise this section as follows:

                Add a bullet point highlighting that your patent portfolio is
pending and that you do
              not own any issued patents with respect to AV-101. In this
regard, we note your
              disclosure on page 30.
                Add a bullet point highlighting the risks related to the
concentration of ownership of
              your common stock, as discussed on page 49. Please include in
this bullet and in the
 Timothy Noyes
FirstName  LastNameTimothy
Aerovate Therapeutics, Inc. Noyes
June 2, 2021NameAerovate Therapeutics, Inc.
June 2,
Page 3 2021 Page 3
FirstName LastName
              corresponding risk factor on page 49 a discussion of the number
of your executive
              officers and directors who are affiliated with your principal
                Expand your disclosure in the ninth bullet point or add a new
bullet point to highlight
              that you plan to conduct clinical trials for AV-101 outside the
United States and that
              if the FDA, EMA, or any applicable foreign regulatory authority
does not accept such
              data, it would result in the need for additional trials, as
discussed on page 38. Please
              also revise the disclosure in your prospectus summary to discuss
that you plan to
              conduct your clinical trials outside the United States and
clarify where you conducted
              your Phase 1 trial.
Use of Proceeds, page 60

7.       Please revise your disclosure that you expect to use net proceeds from
this offering to fund
         further development of AV101, including the global Phase 2b/3 clinical
trial, to provide
         an estimate of how far in the clinical development process for AV101
the allocated
         proceeds of the offering will enable you to reach. For example, if you
will not complete
         the Phase 2b or Phase 3 portion of the trial, please revise to so
state. If any material
         amounts of other funds are necessary to complete your clinical trials
for this candidate,
         please revise your disclosure to state the amounts and the sources of
such other funds.
          Refer to Instruction 3 of Item 504 of Regulation S-K.
Management's Discussion and Analysis of Financial Condition and Results of
Critical Accounting Policies and Significant Judgments and Estimates
Common Stock Valuations, page 74

8.       Please disclose the fair value of your common stock for each grant
date of stock-based
         awards, as determined by your board of directors, as well as the
significant actual factors
         considered by them in their determination of fair value. As part of
the revised disclosure,
         identify the reasons for grant date-over-grant date changes in fair
Intellectual Property, page 93

9.       Please revise your intellectual property disclosure to disclose for
each material patent
         application the specific products or technologies to which such patent
applications relate.
         Also clearly describe on an individual basis the type of patent
protection sought for each
         product or technology (composition of matter, use, or process), the
expected expiration of
         each patent, and the jurisdiction, including any foreign jurisdiction,
of each pending
         patent. In this regard, it may be useful to provide this disclosure in
tabular form to support
         the narrative already included.
Competition, page 95

10.      We note your statement that AV-101 is a "potentially first-in-class
inhaled medication"
         targeting certain PAH patients. Given the stage of development, and
 Timothy Noyes
Aerovate Therapeutics, Inc.
June 2, 2021
Page 4
      acknowledgement that obtaining FDA approval is inherently uncertain, this
      would appear to be premature. Please revise this statement as
Employment Arrangements with Our Named Executive Officers, page 122

11.   We note your disclosure on page 122 that you have entered into offer
letter agreements
      with certain of your named executive officers. We also note your
disclosure on page 126
      regarding the Senior Executive Cash Incentive Bonus Plan. Please file
      offer letter agreements and the Senior Executive Cash Incentive Bonus
Plan as exhibits
      pursuant to Item 601(b)(10) of Regulation S-K.

12.   Please confirm that you will update your disclosure for any shares you
become obligated
      to issue under the Stock Purchase Agreement prior to the completion of
the initial public
13.   Please supplementally provide us with copies of all written
communications, as defined in
      Rule 405 under the Securities Act, that you, or anyone authorized to do
so on your behalf,
      present to potential investors in reliance on Section 5(d) of the
Securities Act, whether or
      not they retain copies of the communications.
       You may contact Michael Fay at 202-551-3812 or Al Pavot at 202-551-3738
if you have
questions regarding comments on the financial statements and related matters.
Please contact
Kasey Robinson at 202-551-5880 or Christopher Edwards at 202-551-6761 with any

FirstName LastNameTimothy Noyes
                                                            Division of
Corporation Finance
Comapany NameAerovate Therapeutics, Inc.
                                                            Office of Life
June 2, 2021 Page 4
cc:       Edwin O   Connor, Esq.
FirstName LastName