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    SEC Form SC 13G/A filed by Applied Therapeutics Inc. (Amendment)

    2/22/24 2:26:36 PM ET
    $APLT
    Biotechnology: Pharmaceutical Preparations
    Health Care
    Get the next $APLT alert in real time by email
    SC 13G/A 1 applied-therapeutics_sc13ga1.htm SC 13G/A

     

     

     

    UNITED STATES

    SECURITIES AND EXCHANGE COMMISSION

    Washington, D.C. 20549

     

    SCHEDULE 13G

     

    Under the Securities Exchange Act of 1934

    (Amendment No. 1)*

     

    Applied Therapeutics, Inc.

    (Name of Issuer)

     

    Common Stock

    (Title of Class of Securities)

     

    03828A101

    (CUSIP Number)

     

    2/9/2024

    (Date of Event which Requires Filing of this Statement)

     

    Check the appropriate box to designate the rule pursuant to which this Schedule is filed:

     

    ☐ Rule 13d-1(b)
    ☒ Rule 13d-1(c)
    ☐ Rule 13d-1(d)

     

    * The remainder of this cover page shall be filled out for a reporting person’s initial filing on this form with respect to the subject class of securities, and for any subsequent amendment containing information which would alter the disclosures provided in a prior cover page.

     

    The information required in the remainder of this cover page shall not be deemed to be “filed” for the purpose of Section 18 of the Securities Exchange Act of 1934 (“Act”) or otherwise subject to the liabilities of that section of the Act but shall be subject to all other provisions of the Act (however, see the Notes).

     

     

     

     

     

     

    1.

    Names of Reporting Persons.

     

    Propel Bio Management LLC

    2.

    Check the Appropriate Box if a Member of a Group

    (a)

    (b)

     

    ☐

    ☐

    3.

    SEC Use Only

     

     

    4.

    Citizenship or Place of Organization

     

    Delaware

    Number of
    Shares
    Beneficially
    Owned by
    Each
    Reporting
    Person
    With:

    5.

    Sole Voting Power

     

    8,071,526

    6.

    Shared Voting Power

     

     

    7.

    Sole Dispositive Power

     

    8,071,526

    8.

    Shared Dispositive Power

     

     

    9.

    Aggregate Amount Beneficially Owned by Each Reporting Person

     

    8,071,526 (1)

     

    10.

    Check if the Aggregate Amount in Row (9) Excludes Certain Shares

     

     

    ☐

    11.

    Percent of Class Represented by Amount in Row (9)

     

    10.5% (1)(2)

     

    12.

    Type of Reporting Person

     

    IA

     

     

    (1) The beneficial ownership of the securities reported herein is described in item 4 of this Schedule 13G Amendment.
    (2) Calculations are based on 77,229,207 common shares outstanding as of November 8, 2023, as disclosed by the Issuer on its Form 10-Q filed with the Securities and Exchange Commission on November 9, 2023.

     

    1

     

     

    1.

    Names of Reporting Persons.

     

    Leen Kawas

    2.

    Check the Appropriate Box if a Member of a Group

    (a)

    (b)

     

    ☐

    ☐

    3.

    SEC Use Only

     

     

    4.

    Citizenship or Place of Organization

     

    United States

    Number of
    Shares
    Beneficially
    Owned by
    Each
    Reporting
    Person
    With:

    5.

    Sole Voting Power

     

    8,071,526

    6.

    Shared Voting Power

     

     

    7.

    Sole Dispositive Power

     

    8,071,526

    8.

    Shared Dispositive Power

     

     

    9.

    Aggregate Amount Beneficially Owned by Each Reporting Person

     

    8,071,526 (1)

     

    10.

    Check if the Aggregate Amount in Row (9) Excludes Certain Shares

     

     

    ☐

    11.

    Percent of Class Represented by Amount in Row (9)

     

    10.5% (1)(2)

     

    12.

    Type of Reporting Person

     

    IN

     

     

    (1) The beneficial ownership of the securities reported herein is described in item 4 of this Schedule 13G Amendment.
    (2) Calculations are based on 77,229,207 common shares outstanding as of November 8, 2023, as disclosed by the Issuer on its Form 10-Q filed with the Securities and Exchange Commission on November 9, 2023.

     

    2

     

     

    1.

    Names of Reporting Persons.

     

    Richard Kayne and Suzanne Kayne Living Trust dtd 01/14/1999

    2.

    Check the Appropriate Box if a Member of a Group

    (a)

    (b)

     

    ☐

    ☐

    3.

    SEC Use Only

     

     

    4.

    Citizenship or Place of Organization

     

    California

    Number of
    Shares
    Beneficially
    Owned by
    Each
    Reporting
    Person
    With:

    5.

    Sole Voting Power

     

    8,071,526

    6.

    Shared Voting Power

     

     

    7.

    Sole Dispositive Power

     

    8,071,526

    8.

    Shared Dispositive Power

     

     

    9.

    Aggregate Amount Beneficially Owned by Each Reporting Person

     

    8,071,526 (1)

     

    10.

    Check if the Aggregate Amount in Row (9) Excludes Certain Shares

     

     

    ☐

    11.

    Percent of Class Represented by Amount in Row (9)

     

    10.5% (1)(2)

     

    12.

    Type of Reporting Person

     

    OO

     

     

    (1) The beneficial ownership of the securities reported herein is described in item 4 of this Schedule 13G Amendment.
    (2) Calculations are based on 77,229,207 common shares outstanding as of November 8, 2023, as disclosed by the Issuer on its Form 10-Q filed with the Securities and Exchange Commission on November 9, 2023.

     

    3

     

     

    1.

    Names of Reporting Persons.

     

    Richard Kayne

    2.

    Check the Appropriate Box if a Member of a Group

    (a)

    (b)

     

    ☐

    ☐

    3.

    SEC Use Only

     

     

    4.

    Citizenship or Place of Organization

     

    United States

    Number of
    Shares
    Beneficially
    Owned by
    Each
    Reporting
    Person
    With:

    5.

    Sole Voting Power

     

    8,071,526

    6.

    Shared Voting Power

     

     

    7.

    Sole Dispositive Power

     

    8,071,526

    8.

    Shared Dispositive Power

     

     

    9.

    Aggregate Amount Beneficially Owned by Each Reporting Person

     

    8,071,526 (1)

     

    10.

    Check if the Aggregate Amount in Row (9) Excludes Certain Shares

     

     

    ☐

    11.

    Percent of Class Represented by Amount in Row (9)

     

    10.5% (1)(2)

     

    12.

    Type of Reporting Person

     

    IN

     

     

    (1) The beneficial ownership of the securities reported herein is described in item 4 of this Schedule 13G Amendment.
    (2) Calculations are based on 77,229,207 common shares outstanding as of November 8, 2023, as disclosed by the Issuer on its Form 10-Q filed with the Securities and Exchange Commission on November 9, 2023.

     

    4

     

     

    1.

    Names of Reporting Persons.

     

    Propel Bio Partners LLC

    2.

    Check the Appropriate Box if a Member of a Group

    (a)

    (b)

     

    ☐

    ☐

    3.

    SEC Use Only

     

     

    4.

    Citizenship or Place of Organization

     

    Delaware

    Number of
    Shares
    Beneficially
    Owned by
    Each
    Reporting
    Person
    With:

    5.

    Sole Voting Power

     

    8,071,526

    6.

    Shared Voting Power

     

     

    7.

    Sole Dispositive Power

     

    8,071,526

    8.

    Shared Dispositive Power

     

     

    9.

    Aggregate Amount Beneficially Owned by Each Reporting Person

     

    8,071,526 (1)

     

    10.

    Check if the Aggregate Amount in Row (9) Excludes Certain Shares

     

     

    ☐

    11.

    Percent of Class Represented by Amount in Row (9)

     

    10.5% (1)(2)

     

    12.

    Type of Reporting Person

     

    OO

     

     

    (1) The beneficial ownership of the securities reported herein is described in item 4 of this Schedule 13G Amendment.
    (2) Calculations are based on 77,229,207 common shares outstanding as of November 8, 2023, as disclosed by the Issuer on its Form 10-Q filed with the Securities and Exchange Commission on November 9, 2023.

     

    5

     

     

    ITEM 1.

     

      (a) Name of Issuer: Applied Therapeutics, Inc.

     

      (b) Address of Issuer’s Principal Executive Offices:

     

    340 Madison Avenue, 19th Floor

    New York, New York 10173

     

    ITEM 2.

     

    Propel Bio Management, LLC

     

      (a) Name of Person Filing: Propel Bio Management, LLC

     

      (b) Address of Principal Business Office, or if None, Residence:

     

    1900 Avenue of the Stars, #1000

    Los Angeles, CA 90067

     

      (c) Citizenship: Delaware

     

      (d) Title of Class of Securities: Common Stock, $0.0001 par value per share

     

    (e)

    CUSIP Number: 03828A101

         
      Leen Kawas
         
      (a) Name of Person Filing: Leen Kawas

     

      (b) Address of Principal Business Office, or if None, Residence:

     

    1900 Avenue of the Stars, #1000

    Los Angeles, CA 90067

     

      (c) Citizenship: United States

     

      (d) Title of Class of Securities: Common Stock, $0.0001 par value per share

     

      (e) CUSIP Number: 03828A101

     

    Richard Kayne

     

      (a) Name of Person Filing: Richard Kayne

     

      (b) Address of Principal Business Office, or if None, Residence:

     

    1900 Avenue of the Stars, #1000

    Los Angeles, CA 90067

     

      (c) Citizenship: United States

     

      (d) Title of Class of Securities: Common Stock, $0.001 par value per share
         
      (e) CUSIP Number: 03828A101

     

    6

     

     

    Richard Kayne and Suzanne Kayne Living Trust dtd 01/14/1999

     

      (a) Name of Person Filing: Richard Kayne and Suzanne Kayne Living Trust dtd 01/14/1999

     

      (b) Address of Principal Business Office, or if None, Residence:

     

    C/O RMZ, LLC

    1900 Avenue of the Stars, #1000

    Los Angeles, CA 90067

     

      (c) Citizenship: California

     

      (d) Title of Class of Securities: Common Stock, $0.001 par value per share
         
      (e) CUSIP Number: 03828A101

     

    Propel Bio Partners LLC

     

      (a) Name of Person Filing: Propel Bio Partners LLC

     

      (b) Address of Principal Business Office, or if None, Residence:

     

    1900 Avenue of the Stars, #1000

    Los Angeles, CA 90067

     

      (c) Citizenship: California

     

      (d) Title of Class of Securities: Common Stock, $0.001 par value per share
         
      (e) CUSIP Number: 03828A101

     

    ITEM 3. IF THIS STATEMENT IS FILED PURSUANT TO SS.240.13d-1(b) OR 240.13d-2(b) OR (c), CHECK WHETHER THE PERSON FILING IS A:

     

      (a) ☐ Broker or dealer registered under Section 15 of the Act (15 U.S.C. 78o).
           
      (b) ☐ Bank as defined in Section 3(a)(6) of the Act (15 U.S.C. 78c).
           
      (c) ☐ Insurance company as defined in Section 3(a)(19) of the Act (15 U.S.C. 78c).
           
      (d) ☐ Investment company registered under Section 8 of the Investment Company Act of 1940 (15 U.S.C. 80a-8).
           
      (e) ☐ An investment adviser in accordance with ss.240.13d-1(b)(1)(ii)(E);
           
      (f) ☐ An employee benefit plan or endowment fund in accordance with ss.240.13d-1(b)(1)(ii)(F);
           
      (g) ☐ A parent holding company or control person in accordance with ss.240.13d-1(b)(1)(ii)(G);
           
      (h) ☐ A savings associations as defined in Section 3(b) of the Federal Deposit Insurance Act (12 U.S.C. 1813);
           
      (i) ☐ A church plan that is excluded from the definition of an investment company under section 3(c)(14) of the Investment Company Act of 1940 (15 U.S.C. 80a-3);
           
      (j) ☐ Group, in accordance with ss.240.13d-1(b)(1)(ii)(J).

     

    7

     

     

    ITEM 4. OWNERSHIP.

     

    Propel Bio Management, LLC

     

      (a) Amount beneficially owned: 8,071,526 (1)(2)(5)

     

      (b) Percent of class: 10.5% (1)(2)(5)

     

      (c) Number of shares as to which the person has:

     

      (i) Sole power to vote or to direct the vote: 8,071,526

     

      (ii) Shared power to vote or to direct the vote: 0

     

      (iii) Sole power to dispose or to direct the disposition of: 8,071,526

     

      (iv) Shared power to dispose or to direct the disposition of: 0

     

    Leen Kawas

     

      (a) Amount beneficially owned: 8,071,526 (1)(2)(5)

     

      (b) Percent of class: 10.5% (1)(2)(5)

     

      (c) Number of shares as to which the person has:

     

      (i) Sole power to vote or to direct the vote: 8,071,526

     

      (ii) Shared power to vote or to direct the vote: 0

     

      (iii) Sole power to dispose or to direct the disposition of: 8,071,526

     

      (iv) Shared power to dispose or to direct the disposition of: 0

     

    Richard Kayne

     

      (a) Amount beneficially owned: 8,071,526 (2)(3)(5)

     

      (b) Percent of class: 10.5% (2)(3)(5)

     

      (c) Number of shares as to which the person has:

     

      (i) Sole power to vote or to direct the vote: 8,071,526

     

      (ii) Shared power to vote or to direct the vote: 0

     

      (iii) Sole power to dispose or to direct the disposition of: 8,071,526

     

      (iv) Shared power to dispose or to direct the disposition of: 0

     

    Richard Kayne and Suzanne Kayne Living Trust dtd 01/14/1999

     

      (a) Amount beneficially owned: 8,071,526 (2)(3)(5)

     

      (b) Percent of class: 10.5% (2)(3)(5)

     

    8

     

     

      (c) Number of shares as to which the person has:

     

      (i) Sole power to vote or to direct the vote: 8,071,526

     

      (ii) Shared power to vote or to direct the vote: 0

     

      (iii) Sole power to dispose or to direct the disposition of: 8,071,526

     

      (iv) Shared power to dispose or to direct the disposition of: 0

     

    Propel Bio Partners LLC

     

      (a) Amount beneficially owned: 8,071,526 (2)(4)(5)

     

      (b) Percent of class: 10.5% (2)(4)(5)

     

      (c) Number of shares as to which the person has:

     

      (i) Sole power to vote or to direct the vote: 8,071,526

     

      (ii) Shared power to vote or to direct the vote: 0

     

      (iii) Sole power to dispose or to direct the disposition of: 8,071,526

     

      (iv) Shared power to dispose or to direct the disposition of: 0

     

    FOOTNOTES

     

    (1) 6,516,475 Shares are directly owned by a private investment fund and an investment company registered under the Investment Company Act of 1940, as amended, for which Propel Bio Management LLC (“Propel”) and Ms. Kawas provide discretionary advisory services. Ms. Kawas is the sole owner of Propel, and possesses voting control and/or the power to direct the disposition of the Shares. Accordingly, for purposes of Rule 13d-3, Propel and Ms. Kawas may be deemed to beneficially own the Shares. In addition, Ms. Kawas and Propel may be considered to form part of a group and therefore, beneficial ownership of all Shares held by group members may be deemed to be attributed to the entire group. In accordance with Rule 13d-4, Propel and Ms. Kawas expressly disclaim beneficial ownership of the Shares.
    (2) Calculations are based on 77,229,207 common shares outstanding as of November 8, 2023, as disclosed by the Issuer on its Form 10-Q filed with the Securities and Exchange Commission on November 9, 2023.
    (3) 901,907 Shares are directly owned by the Richard and Suzanne Kayne Living Trust dtd 01/14/1999, a family trust (the “Family Trust”), of which Richard Kayne is the sole trustee. Mr. Kayne, as trustee, possesses voting control and/or power to direct the disposition of the Shares held by the Family Trust. Accordingly, for purposes of Rule 13d-3, Family Trust and Mr. Kayne may be deemed to beneficially own the Shares. In addition, Mr. Kayne and the Family Trust may be considered to form part of a group and therefore, beneficial ownership of all Shares held by group members may be deemed to be attributed to the entire group. In accordance with Rule 13d-4, Mr. Kayne expressly disclaims beneficial ownership of the Shares.
    (4) Propel Bio Partners LLC (“General Partner”) serves as the manager to a special purpose vehicle (“SPV”) and general partner to a private investment fund managed by Propel. 653,144 Shares are directly owned by the SPV. Ms. Kawas and Mr. Kayne are control persons of the General Partner. For purposes of Rule 13d-3, the General Partner possesses voting control and/or power to direct the disposition of the Shares held by the private fund and SPV. In accordance with Rule 13d-4, Ms. Kawas, Mr. Kayne, and the General Partner each expressly disclaim beneficial ownership of the Shares.
    (5) Ms. Kawas, Mr. Kayne, the Family Trust, Propel, and the General Partner may be deemed to form a group and therefore, beneficial ownership of all reported Shares may be attributed to the entire group. In accordance with Rule 13d-4, Ms. Kawas, Mr. Kayne, and the General Partner each expressly disclaim beneficial ownership of the Shares.

     

    9

     

     

    ITEM 5. OWNERSHIP OF FIVE PERCENT OR LESS OF A CLASS.

     

    If this statement is being filed to report the fact that as of the date hereof the reporting person has ceased to be the beneficial owner of more than five percent of the class of securities, check the following ☐.

     

    ITEM 6. OWNERSHIP OF MORE THAN FIVE PERCENT ON BEHALF OF ANOTHER PERSON.

     

    Reporting persons are holding 10.5% of the shares in the aggregate on behalf of other persons who have the right to receive or the power to direct the receipt of dividends from, or proceeds from the sale of, such securities.

     

    ITEM 7. IDENTIFICATION AND CLASSIFICATION OF THE SUBSIDIARY WHICH ACQUIRED THE SECURITY BEING REPORTED ON BY THE PARENT HOLDING COMPANY.

     

    Not Applicable.

     

    ITEM 8. IDENTIFICATION AND CLASSIFICATION OF MEMBERS OF THE GROUP.

     

    Not Applicable.

     

    ITEM 9. NOTICE OF DISSOLUTION OF GROUP.

     

    Not Applicable.

     

    ITEM 10. CERTIFICATION.

     

    By signing below I certify that, to the best of my knowledge and belief, the securities referred to above were not acquired and are not held for the purpose of or with the effect of changing or influencing the control of the issuer of the securities and were not acquired and are not held in connection with or as a participant in any transaction having such purpose or effect.

     

    10

     

     

    SIGNATURE

     

    After reasonable inquiry and to the best of my knowledge and belief, I certify that the information set forth in this statement is true, complete and correct.

     

      February 22, 2024
      Date
       
      /s/ Leen Kawas/Managing Member
      Signature
       
      Leen Kawas/Managing Member
      Name/Title

     

     

    11

     

     

    Joint Filing Agreement

     

    The undersigned hereby agree that they are filing this statement jointly pursuant to Rule 13d-1(k)(1). Each of them is responsible for the timely filing of such Schedule 13G, and for the completeness and accuracy of the information concerning such person contained therein; but none of them is responsible for the completeness or accuracy of the information concerning the other persons making the filing, unless such person knows or has reason to believe that such information is inaccurate.

     

    In accordance with Rule 13d-1(k)(1) promulgated under the Securities and Exchange Act of 1934, as amended, the undersigned hereby agree to the joint filing with each other on behalf of each of them of such Schedule 13G with respect to the Common Stock of the Issuer, beneficially owned by each of them. This Joint Filing Agreement shall be included as an exhibit to such Schedule 13G.

     

     

    [Signature Page Follows]

     

    12

     

     

    IN WITNESS WHEREOF, the undersigned hereby execute this Agreement as of February 22, 2024.

     

    PROPEL BIO MANAGEMENT LLC   LEEN KAWAS
         
    By: /s/ Leen Kawas   By: /s/ Leen Kawas
      Name: Leen Kawas     Name: Leen Kawas
      Title: Managing Member     Title:  

     

    PROPEL BIO PARTNERS LLC   RICHARD KAYNE
         
    By: /s/ Leen Kawas   By: /s/ Richard Kayne
      Name: Leen Kawas     Name: Richard Kayne
      Title: Managing Member     Title:  

     

    RICHARD AND SUZANNE KAYNE LIVING

    TRUST DTD 01/14/1999

       
         
    By: /s/ Richard Kayne      
      Name: Richard Kayne        
      Title: Trustee        

     

    13

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    Biotechnology: Pharmaceutical Preparations
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    Cycle Pharmaceuticals to Acquire Applied Therapeutics

    NEW YORK, Dec. 11, 2025 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (NASDAQ:APLT, "Applied")), a clinical-stage biopharmaceutical company dedicated to creating transformative treatments for rare diseases, today announced a definitive agreement for Cycle Group Holdings Limited ("Cycle") to acquire Applied Therapeutics. Applied Therapeutics is a clinical-stage biopharmaceutical company committed to the development of novel drug candidates against validated molecular targets in rare diseases. Applied's lead drug candidate, govorestat, is a novel central nervous system (CNS) penetrant Aldose Reductase Inhibitor (ARI) for the treatment of CNS rare metabolic diseases, including Classic Gala

    12/11/25 5:25:00 PM ET
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    $APLT
    Insider Trading

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    Director Kanter Stacy J. returned 22,500 shares to the company, closing all direct ownership in the company (SEC Form 4)

    4 - Applied Therapeutics, Inc. (0001697532) (Issuer)

    2/4/26 11:17:54 AM ET
    $APLT
    Biotechnology: Pharmaceutical Preparations
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    Chief Commercial Officer Hooks Corwin Dale was granted 312,500 shares and returned 862,500 shares to the company, closing all direct ownership in the company (SEC Form 4)

    4 - Applied Therapeutics, Inc. (0001697532) (Issuer)

    2/3/26 7:16:05 PM ET
    $APLT
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    Officer Chinoporos Constantine was granted 437,500 shares and returned 1,000,000 shares to the company, closing all direct ownership in the company (SEC Form 4)

    4 - Applied Therapeutics, Inc. (0001697532) (Issuer)

    2/3/26 7:03:25 PM ET
    $APLT
    Biotechnology: Pharmaceutical Preparations
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    $APLT
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    Applied Therapeutics downgraded by Robert W. Baird

    Robert W. Baird downgraded Applied Therapeutics from Outperform to Neutral

    12/12/25 9:22:39 AM ET
    $APLT
    Biotechnology: Pharmaceutical Preparations
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    Applied Therapeutics downgraded by Leerink Partners with a new price target

    Leerink Partners downgraded Applied Therapeutics from Outperform to Market Perform and set a new price target of $1.00

    12/3/25 8:27:30 AM ET
    $APLT
    Biotechnology: Pharmaceutical Preparations
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    Applied Therapeutics downgraded by William Blair

    William Blair downgraded Applied Therapeutics from Outperform to Mkt Perform

    12/23/24 7:22:04 AM ET
    $APLT
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    $APLT
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    Applied Therapeutics Reports Third Quarter 2025 Financial Results

    –   Update on regulatory strategy for govorestat for the treatment of CMT-SORD following receipt of Type C meeting minutes –   Meeting scheduled with the FDA in 4Q 2025 to discuss govorestat for the treatment of Classic Galactosemia –   New data on govorestat for the treatment of PMM2-CDG published in JIMD and presented at the 2025 ASHG Annual Meeting –   Announces Board of Directors Leadership Transition NEW YORK, Nov. 13, 2025 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (NASDAQ:APLT) (the "Company"), a clinical-stage biopharmaceutical company dedicated to creating transformative treatments for rare diseases, today reported financial results for the third quarter ended September 30

    11/13/25 7:00:00 AM ET
    $APLT
    Biotechnology: Pharmaceutical Preparations
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    Applied Therapeutics Appoints Todd F. Baumgartner, MD, MPH as Chief Regulatory Officer

    NEW YORK, March 19, 2025 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (NASDAQ:APLT), a biopharmaceutical company dedicated to creating transformative treatments for rare disease, today announced the appointment of Todd F. Baumgartner, MD, MPH as Chief Regulatory Officer. Dr. Baumgartner will serve as part of the Company's executive leadership team and will be responsible for leading Applied's global regulatory strategy. Dr. Baumgartner joins Applied as an accomplished global drug development leader with over 35 years of experience in senior regulatory, clinical development, and medical affairs roles. He has held a diverse set of leadership roles over the course of his career, notably

    3/19/25 7:00:00 AM ET
    $APLT
    Biotechnology: Pharmaceutical Preparations
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    Applied Therapeutics Appoints Reena Thomas Colacot as Vice President and Head of Quality

    NEW YORK, Jan. 21, 2025 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (NASDAQ:APLT), a biopharmaceutical company dedicated to creating transformative treatments for rare disease, today announced the appointment of Reena Thomas Colacot as Vice President and Head of Quality. Ms. Colacot joins Applied with over 25 years of quality leadership experience across the biopharmaceutical and medical device industries. In this newly created role, she will report directly to the executive leadership team and Executive Chairman, and will be responsible for overseeing all quality matters, including Good Manufacturing Practices, Good Laboratory Practices, and Good Clinical Practices. "We are pleased to

    1/21/25 7:00:00 AM ET
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    Amendment: SEC Form SC 13G/A filed by Applied Therapeutics Inc.

    SC 13G/A - Applied Therapeutics, Inc. (0001697532) (Subject)

    11/14/24 5:47:55 PM ET
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    Amendment: SEC Form SC 13G/A filed by Applied Therapeutics Inc.

    SC 13G/A - Applied Therapeutics, Inc. (0001697532) (Subject)

    11/14/24 4:50:26 PM ET
    $APLT
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    Amendment: SEC Form SC 13G/A filed by Applied Therapeutics Inc.

    SC 13G/A - Applied Therapeutics, Inc. (0001697532) (Subject)

    11/14/24 4:38:38 PM ET
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    Cycle Pharmaceuticals Completes Acquisition of Applied Therapeutics

    Cycle Group Holdings Limited ("Cycle") is delighted to announce it has completed the acquisition of NASDAQ-listed Applied Therapeutics, Inc. (NASDAQ:APLT, "Applied")), a clinical-stage biopharmaceutical company. Applied's lead drug candidate, govorestat, is a novel central nervous system (CNS) penetrant Aldose Reductase Inhibitor (ARI) for the treatment of CNS rare metabolic diseases, including Classic Galactosemia, Charcot-Marie-Tooth Sorbitol Dehydrogenase Deficiency (CMT-SORD) and phosphomannomutase 2 congenital disorder of glycosylation (PMM2-CDG), for which there are currently no FDA approved treatment options available. "Cycle was founded with a commitment to support patients livi

    2/3/26 8:39:00 AM ET
    $APLT
    Biotechnology: Pharmaceutical Preparations
    Health Care

    Applied Therapeutics Announces Positive Results from 12-month Interim Analysis of Govorestat (AT-007) in the Ongoing INSPIRE Phase 3 Trial in Sorbitol Dehydrogenase (SORD) Deficiency

    Interim primary endpoint met; Statistically significant correlation of sorbitol with the CMT-FOM clinical outcome composite (p=0.05) Sustained, statistically significant reduction in sorbitol in govorestat-treated patients vs. placebo (p<0.001) Highly statistically significant effects on the CMT Health Index (CMT-HI) patient reported outcome measure (p=0.01), with benefit of govorestat on categories of lower limb function, mobility, fatigue, pain, sensory function, and upper limb function Company plans to request a pre-NDA meeting with the neurology division of the US FDA regarding potential approval based on current data Company to host investor conference call and webcast today at 8:3

    2/15/24 7:00:00 AM ET
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    Applied Therapeutics Announces Clinical Benefit of Govorestat (AT-007) in ACTION-Galactosemia Kids Trial; Company Plans to Meet with FDA Regarding Potential NDA Submission

    Govorestat demonstrated consistent long-term clinical outcomes benefit across a range of functional measures in the ACTION-Galactosemia Kids trial, confirming prior biomarker dataGovorestat treatment improved activities of daily living, behavior, cognition, fine motor skills, adaptive skills and tremor vs. placeboCompany plans to request a pre-NDA meeting with the FDA as soon as possible to discuss a potential NDA submission in second half of 2023; plans to submit a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) in mid-2023  NEW YORK, April 24, 2023 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (NASDAQ:APLT), a clinical-stage biopharmaceutical company

    4/24/23 7:00:00 AM ET
    $APLT
    Biotechnology: Pharmaceutical Preparations
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