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

    2/12/24 5:23:05 PM ET
    $ABEO
    Biotechnology: Pharmaceutical Preparations
    Health Care
    Get the next $ABEO alert in real time by email
    SC 13G/A 1 e619238_sc13ga-at.htm

     

    SECURITIES AND EXCHANGE COMMISSION 

    WASHINGTON, DC 20549

     

    SCHEDULE 13G

    (Rule 13d-102)

     

    INFORMATION TO BE INCLUDED IN STATEMENTS FILED PURSUANT

    TO RULES 13d-1(b)(c), AND (d) AND AMENDMENTS THERETO FILED

    PURSUANT TO RULE 13d-2(b)

     

    (Amendment No. 2) *

     

    Abeona Therapeutics, Inc.

    (Name of Issuer)

     

    Common Stock

    (Title of Class of Securities)

     

    00289Y206

    (CUSIP Number)

     

    December 31, 2023

    (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)

     

    (Page 1 of 9 Pages)

     

    ----------

    * 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 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).

        

     

    CUSIP No. 00289Y206 13G Page 2 of 9

     

    1.

    NAME OF REPORTING PERSONS

    I.R.S. IDENTIFICATION NO. OF ABOVE PERSONS (ENTITIES ONLY)

     

    Deerfield Mgmt, L.P.

    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

     

    0

     
    6.

    SHARED VOTING POWER

     

    869,565 (1)

     

    7.

     

    SOLE DISPOSITIVE POWER

     

    0

     

    8.

     

    SHARED DISPOSITIVE POWER

     

    869,565 (1)

     

    9.

     

    AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON

     

    869,565 (1)

    10.

    CHECK BOX IF THE AGGREGATE AMOUNT IN ROW (9) EXCLUDES CERTAIN SHARES*

     

     

    ☐

    11.

    PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW 9

     

    3.39%

    12.

    TYPE OF REPORTING PERSON*

     

    PN

       

    __________________ 

    (1) Comprised of 869,565 shares of common stock issuable upon exercise of warrants (subject to any further adjustments that may be applicable) held by Deerfield Partners, L.P., of which Deerfield Mgmt, L.P. is the general partner. The provisions of the warrants beneficially owned by the reporting person restrict the exercise of such securities to the extent that after such exercise the holder and its Attribution Parties (as defined in the warrants) would beneficially own in excess of 4.99% of the total number of shares of the Issuer then outstanding (the “Ownership Cap”). Accordingly, notwithstanding the number of shares reported, the reporting person disclaims beneficial ownership of the shares of common stock issuable upon exercise of such warrants to the extent that upon such exercise the number of shares beneficially owned by all reporting persons hereunder, in the aggregate, would exceed the Ownership Cap.

     

     

    CUSIP No. 00289Y206 13G Page 3 of 9

     

    1.

    NAME OF REPORTING PERSONS

    I.R.S. IDENTIFICATION NO. OF ABOVE PERSONS (ENTITIES ONLY)

     

    Deerfield Management Company, L.P.

    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

     

    0

     
    6.

    SHARED VOTING POWER

     

    869,565 (2)

     

    7.

     

    SOLE DISPOSITIVE POWER

     

    0

     

    8.

     

    SHARED DISPOSITIVE POWER

     

    869,565 (2)

     

    9.

     

    AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON

     

    869,565 (2)

    10.

    CHECK BOX IF THE AGGREGATE AMOUNT IN ROW (9) EXCLUDES CERTAIN SHARES*

     

     

    ☐

    11.

    PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW 9

     

    3.39%

    12.

    TYPE OF REPORTING PERSON*

     

    PN

      

    __________________

    (2) Comprised of 869,565 shares of common stock issuable upon exercise of warrants (subject to any further adjustments that may be applicable) held by Deerfield Partners, L.P., of which Deerfield Management Company, L.P. is the investment advisor. The provisions of the warrants beneficially owned by the reporting person restrict the exercise of such securities to the extent that after such exercise the holder and its Attribution Parties (as defined in the warrants) would beneficially own in excess of 4.99% of the total number of shares of the Issuer then outstanding (the “Ownership Cap”). Accordingly, notwithstanding the number of shares reported, the reporting person disclaims beneficial ownership of the shares of common stock issuable upon exercise of such warrants to the extent that upon such exercise the number of shares beneficially owned by all reporting persons hereunder, in the aggregate, would exceed the Ownership Cap.

     

     

    CUSIP No. 00289Y206 13G Page 4 of 9

     

    1.

    NAME OF REPORTING PERSONS

    I.R.S. IDENTIFICATION NO. OF ABOVE PERSONS (ENTITIES ONLY)

     

    Deerfield Partners, L.P.

    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

     

    0

     
    6.

    SHARED VOTING POWER

     

    869,565 (3)

     

    7.

     

    SOLE DISPOSITIVE POWER

     

    0

     

    8.

     

    SHARED DISPOSITIVE POWER

     

    869,565 (3)

     

    9.

     

    AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON

     

    869,565 (3)

    10.

    CHECK BOX IF THE AGGREGATE AMOUNT IN ROW (9) EXCLUDES CERTAIN SHARES*

     

     

    ☐

    11.

    PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW 9

     

    3.39%

    12.

    TYPE OF REPORTING PERSON*

     

    PN 

     

    _________________

    (3) Comprised of 869,565 shares of common stock issuable upon exercise of warrants (subject to any further adjustments that may be applicable). The provisions of the warrants beneficially owned by the reporting person restrict the exercise of such securities to the extent that after such exercise the holder and its Attribution Parties (as defined in the warrants) would beneficially own in excess of 4.99% of the total number of shares of the Issuer then outstanding (the “Ownership Cap”). Accordingly, notwithstanding the number of shares reported, the reporting person disclaims beneficial ownership of the shares of common stock issuable upon exercise of such warrants to the extent that upon such exercise the number of shares beneficially owned by all reporting persons hereunder, in the aggregate, would exceed the Ownership Cap.

     

     

    CUSIP No. 00289Y206 13G Page 5 of 9

     

    1.

    NAME OF REPORTING PERSONS

    I.R.S. IDENTIFICATION NO. OF ABOVE PERSONS (ENTITIES ONLY)

     

    James E. Flynn

    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

     

    0

     
    6.

    SHARED VOTING POWER

     

    869,565 (4)

     

    7.

     

    SOLE DISPOSITIVE POWER

     

    0

     

    8.

     

    SHARED DISPOSITIVE POWER

     

    869,565 (4)

     

    9.

     

    AGGREGATE AMOUNT BENEFICIALLY OWNED BY EACH REPORTING PERSON

     

    869,565 (4)

    10.

    CHECK BOX IF THE AGGREGATE AMOUNT IN ROW (9) EXCLUDES CERTAIN SHARES*

     

     

    ☐

    11.

    PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW 9

     

    3.39%

    12.

    TYPE OF REPORTING PERSON*

     

    IN

      

    __________________

    (4) Comprised of 869,565 shares of common stock issuable upon exercise of warrants (subject to any further adjustments that may be applicable) held by Deerfield Partners, L.P. The provisions of the warrants beneficially owned by the reporting person restrict the exercise of such securities to the extent that after such exercise the holder and its Attribution Parties (as defined in the warrants) would beneficially own in excess of 4.99% of the total number of shares of the Issuer then outstanding (the “Ownership Cap”). Accordingly, notwithstanding the number of shares reported, the reporting person disclaims beneficial ownership of the shares of common stock issuable upon exercise of such warrants to the extent that upon such exercise the number of shares beneficially owned by all reporting persons hereunder, in the aggregate, would exceed the Ownership Cap.

     

     

    CUSIP No. 00289Y206 13G Page 6 of 9

     

    Item 1(a). Name of Issuer:
       
     

    Abeona Therapeutics, Inc.

       
    Item 1(b). Address of Issuer's Principal Executive Offices:
       
     

    6555 Carnegie Avenue, 4th Floor,

    Cleveland, OH 44103 

       
    Item 2(a). Name of Person Filing:
       
     

    James E. Flynn, Deerfield Mgmt, L.P., Deerfield Management Company, L.P. and Deerfield Partners, L.P.

       
    Item 2(b). Address of Principal Business Office, or if None, Residence:
       
     

    James E. Flynn, Deerfield Mgmt, L.P., Deerfield Management Company, L.P. and Deerfield Partners, L.P., 345 Park Avenue South, 12th Floor, New York, NY 10010 

       
    Item 2(c). Citizenship:
       
     

    Deerfield Mgmt, L.P., Deerfield Management Company, L.P. and Deerfield Partners, L.P. - Delaware limited partnerships;

     

    James E. Flynn – United States citizen 

       
    Item 2(d). Title of Class of Securities:
       
     

    Common Stock, par value $0.01 per share

       
    Item 2(e). CUSIP Number:
       
     

    00289Y206

         
    Item 3.

    If This Statement is Filed Pursuant to Rule 13d-1(b), or 13d-2(b) or (c), Check Whether the Person Filing is a:

       
    (a) ☐

    Broker or dealer registered under Section 15 of the Exchange Act.

         
    (b) ☐ Bank as defined in Section 3(a)(6) of the Exchange Act.
         
    (c) ☐

    Insurance company as defined in Section 3(a)(19) of the Exchange Act.

         
    (d) ☐

    Investment company registered under Section 8 of the Investment Company Act.

         
    (e) ☐ An investment adviser in accordance with Rule 13d-1(b)(1)(ii)(E);
         
    (f) ☐

    An employee benefit plan or endowment fund in accordance with Rule 13d-1(b)(1)(ii)(F);

         
    (g) ☐

    A parent holding company or control person in accordance with Rule 13d-1(b)(1)(ii)(G);

         

    (h)

    ☐

    A savings association as defined in Section 3(b) of the Federal Deposit Insurance Act;

         
    (i) ☐

    A church plan that is excluded from the definition of an investment company under Section 3(c)(14) of the Investment Company Act;

      

     

    CUSIP No. 00289Y206 13G Page 7 of 9

      

         
    (j) ☐ A non-U.S. institution in accordance with Rule 13d-1(b)(1)(ii)(J);
         
    (k) ☐ Group, in accordance with Rule 13d-1(b)(1)(ii)(K).

     

    If filing as a non-U.S. institution in accordance with Rule 13d-1(b)(1)(ii)(J), please specify the type of institution: _________________

     

    Item 4. Ownership.
           

    Provide the following information regarding the aggregate number and percentage of the class of securities of the issuer identified in Item 1.

           
    (a) Amount beneficially owned**:  
           
     

    Deerfield Mgmt, L.P. – 869,565 shares 

    Deerfield Management Company, L.P. - 869,565 shares

    Deerfield Partners, L.P. - 869,565 shares

    James E. Flynn – 869,565 shares 

           
    (b) Percent of class**:  
           
     

    Deerfield Mgmt, L.P. – 3.39%

    Deerfield Management Company, L.P. – 3.39%

    Deerfield Partners, L.P. – 3.39%

    James E. Flynn – 3.39% 

           
    (c) Number of shares as to which such person has**:  
           
      (i) Sole power to vote or to direct the vote: All Reporting Persons - 0
           
      (ii) Shared power to vote or to direct the vote:

    Deerfield Mgmt, L.P. - 869,565

    Deerfield Management Company, L.P. - 869,565

    Deerfield Partners, L.P. - 869,565 

    James E. Flynn – 869,565

           
      (iii)

    Sole power to dispose or to direct the disposition of:

    All Reporting Persons - 0
           
      (iv)

    Shared power to dispose or to direct the disposition of:

    Deerfield Mgmt, L.P. - 869,565 

    Deerfield Management Company, L.P. - 869,565 

    Deerfield Partners, L.P. - 869,565 

    James E. Flynn – 869,565

      

    **See footnotes on cover pages which are incorporated by reference herein.

      

     

    CUSIP No. 00289Y206 13G Page 8 of 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.

       

    If any other person is known to have the right to receive or the power to direct the receipt of dividends from, or the proceeds from the sale of, such securities, a statement to that effect should be included in response to this item and, if such interest relates to more than five percent of the class, such person should be identified. A listing of the shareholders of an investment company registered under the Investment Company Act of 1940 or the beneficiaries of employee benefit plan, pension fund or endowment fund is not required

     
      N/A
       
    Item 7.

    Identification and Classification of the Subsidiary Which Acquired the Security Being Reported on by the Parent Holding Company or Control Person. 

     

    If a parent holding company or Control person has filed this schedule, pursuant to Rule 13d-1(b)(1)(ii)(G), so indicate under Item 3(g) and attach an exhibit stating the identity and the Item 3 classification of the relevant subsidiary. If a parent holding company or control person has filed this schedule pursuant to Rule 13d-1(c) or Rule 13d-1(d), attach an exhibit stating the identification of the relevant subsidiary

     
    N/A
       
    Item 8.

    Identification and Classification of Members of the Group. 

       

    If a group has filed this schedule pursuant to ss.240.13d-1(b)(1)(ii)(J), so indicate under Item 3(j) and attach an exhibit stating the identity and Item 3 classification of each member of the group. If a group has filed this schedule pursuant to ss.240.13d-1(c) or ss.240.13d-1(d), attach an exhibit stating the identity of each member of the grou

     
      See Exhibit B
       
    Item 9. Notice of Dissolution of Group.
       

    Notice of dissolution of a group may be furnished as an exhibit stating the date of the dissolution and that all further filings with respect to transactions in the security reported on will be filed, if required, by members of the group, in their individual capacity. See Item 5

     
      N/A
       
    Item 10. Certifications.
       

    "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 that purpose or effect, other than activities solely in connection with a nomination under §240.14a–11."

     

     

    CUSIP No. 00289Y206 13G Page 9 of 9

     

    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.

     

     

    DEERFIELD MGMT, L.P.

    By: J.E. Flynn Capital, LLC, General Partner

     

    By: /s/ Jonathan Isler

           Jonathan Isler, Attorney-In-Fact

     

     

    DEERFIELD MANAGEMENT COMPANY, L.P.

    By: Flynn Management LLC, General Partner

     

    By: /s/ Jonathan Isler

           Jonathan Isler, Attorney-In-Fact

     

     

    DEERFIELD PARTNERS, L.P.

    By: Deerfield Mgmt, L.P., General Partner

    By: J.E. Flynn Capital, LLC, General Partner

     

    By: /s/ Jonathan Isler

           Jonathan Isler, Attorney-In-Fact

     

     

    JAMES E. FLYNN

     

    /s/ Jonathan Isler

    Jonathan Isler, Attorney-In-Fact

     

    Date: February 12, 2024

     

     

    Exhibit List

     

    Exhibit A. Joint Filing Agreement.

     

    Exhibit B. Item 8 Statement.

     

    Exhibit C. Power of Attorney (1).

     

    (1) Power of Attorney previously filed as Exhibit 24 to a Form 4 with regard to DA32 Life Science Tech Acquisition Corp. filed with the Securities and Exchange Commission on August 3, 2021 by Deerfield Partners, L.P., Deerfield Mgmt, L.P., Deerfield Management Company, L.P. and James E. Flynn.

     

     

    Exhibit A

     

    Joint Filing Agreement

     

    The undersigned agree that this Schedule 13G, and all amendments thereto, relating to the Common Stock, par value $0.001 per share, of Abeona Therapeutics, Inc. shall be filed on behalf of the undersigned.

     

     

    DEERFIELD MGMT, L.P.

    By: J.E. Flynn Capital, LLC, General Partner

     

    By: /s/ Jonathan Isler

           Jonathan Isler, Attorney-In-Fact

     

     

    DEERFIELD MANAGEMENT COMPANY, L.P.

    By: Flynn Management LLC, General Partner

     

    By: /s/ Jonathan Isler

           Jonathan Isler, Attorney-In-Fact

     

     

    DEERFIELD PARTNERS, L.P.

    By: Deerfield Mgmt, L.P., General Partner

    By: J.E. Flynn Capital, LLC, General Partner

     

    By: /s/ Jonathan Isler

           Jonathan Isler, Attorney-In-Fact

     

    JAMES E. FLYNN

     

    /s/ Jonathan Isler

    Jonathan Isler, Attorney-In-Fact

     

     

    Exhibit B

     

    Due to the relationships between them, the reporting persons hereunder may be deemed to constitute a “group” with one another for purposes of Section 13(d)(3) of the Securities Exchange Act of 1934.

     

     

     

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      NEW YORK and CLEVELAND, Oct. 12, 2021 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO), a fully-integrated leader in gene and cell therapy, today announced the appointment of Jon Voss as Vice President, Head of Quality. Mr. Voss, who has been advising the Company as a consultant, will now serve in a leadership role to further strengthen Abeona's quality system and oversee all quality functions. "Jon is a proven technical leader with a strong track record of successful quality oversight that includes chemistry, manufacturing and control (CMC)-related and clinical functions for gene therapies," said Dr. Vish Seshadri, Ph.D., M.B.A., Head of Research & Clinical Development and CEO-

      10/12/21 7:30:00 AM ET
      $ABEO
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Oppenheimer initiated coverage on Abeona Therapeutics with a new price target

      Oppenheimer initiated coverage of Abeona Therapeutics with a rating of Outperform and set a new price target of $16.00

      3/5/25 7:50:58 AM ET
      $ABEO
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • H.C. Wainwright initiated coverage on Abeona Therapeutics with a new price target

      H.C. Wainwright initiated coverage of Abeona Therapeutics with a rating of Buy and set a new price target of $15.00

      7/3/24 7:23:46 AM ET
      $ABEO
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Stifel initiated coverage on Abeona Therapeutics with a new price target

      Stifel initiated coverage of Abeona Therapeutics with a rating of Buy and set a new price target of $21.00

      5/30/24 7:24:37 AM ET
      $ABEO
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • SEC Form 144 filed by Abeona Therapeutics Inc.

      144 - ABEONA THERAPEUTICS INC. (0000318306) (Subject)

      5/16/25 4:07:49 PM ET
      $ABEO
      Biotechnology: Pharmaceutical Preparations
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    • SEC Form 10-Q filed by Abeona Therapeutics Inc.

      10-Q - ABEONA THERAPEUTICS INC. (0000318306) (Filer)

      5/15/25 7:35:46 AM ET
      $ABEO
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Abeona Therapeutics Inc. filed SEC Form 8-K: Results of Operations and Financial Condition, Financial Statements and Exhibits

      8-K - ABEONA THERAPEUTICS INC. (0000318306) (Filer)

      5/15/25 7:30:12 AM ET
      $ABEO
      Biotechnology: Pharmaceutical Preparations
      Health Care

    $ABEO
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    • Abeona Therapeutics® Reports First Quarter 2025 Financial Results and Corporate Updates

      - Received approval by U.S. Food and Drug Administration (FDA) for ZEVASKYN™ (prademagenezamikeracel), the first and only autologous cell-based gene therapy for the treatment of wounds in adultand pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB) - - U.S. launch of ZEVASKYN underway with activation of first qualified treatment center (QTC) - - Entered into sales agreement for priority review voucher (PRV) for $155 million - CLEVELAND, May 15, 2025 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO) today reported financial results and business highlights for the first quarter of 2025 and shared recent operational progress. "ZEVASKYN's appr

      5/15/25 7:30:00 AM ET
      $ABEO
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • U.S. FDA Approves ZEVASKYN™ (prademagene zamikeracel), the First and Only Cell-Based Gene Therapy for Patients with Recessive Dystrophic Epidermolysis Bullosa (RDEB)

      - ZEVASKYN fills a critical need for people living with RDEB, a debilitating dermatological condition with no cure - - Approval based on the pivotal Phase 3 VIITAL™ study, showing ZEVASKYN resulted in significant wound healing and pain reduction after a single treatment with a favorable safety profile - - ZEVASKYN to be available through Qualified Treatment Centers beginning in 3Q 2025 - - Abeona Assist™ patient services program offers personalized support for eligible patients and families throughout their treatment journey with ZEVASKYN - - Rare Pediatric Disease Priority Review Voucher (PRV) granted by FDA - - Abeona Therapeutics® to host conference call today, Tuesday, April 29, 20

      4/29/25 6:00:00 AM ET
      $ABEO
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Abeona Therapeutics® Reports Full Year 2024 Financial Results, Provides Pz-cel Regulatory Update and Commercial Launch Plans

      FDA priority review of pz-cel Biologics License Application (BLA) progressing with Prescription Drug User Fee Act (PDUFA) target action date of April 29, 2025 Launch preparations on track toward goal to treat first patient in 3Q 2025 CLEVELAND, March 20, 2025 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO) today reported financial results for the full year of 2024, and announced progress in the ongoing review with the U.S. Food and Drug Administration (FDA) regarding prademagene zamikeracel (pz-cel) and plans for the U.S. commercial launch of pz-cel for recessive dystrophic epidermolysis bullosa (RDEB), if approved. The Company will host a conference call and webcast today at

      3/20/25 7:30:00 AM ET
      $ABEO
      Biotechnology: Pharmaceutical Preparations
      Health Care

    $ABEO
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    • Abeona Therapeutics® Reports First Quarter 2025 Financial Results and Corporate Updates

      - Received approval by U.S. Food and Drug Administration (FDA) for ZEVASKYN™ (prademagenezamikeracel), the first and only autologous cell-based gene therapy for the treatment of wounds in adultand pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB) - - U.S. launch of ZEVASKYN underway with activation of first qualified treatment center (QTC) - - Entered into sales agreement for priority review voucher (PRV) for $155 million - CLEVELAND, May 15, 2025 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO) today reported financial results and business highlights for the first quarter of 2025 and shared recent operational progress. "ZEVASKYN's appr

      5/15/25 7:30:00 AM ET
      $ABEO
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • UPDATE -- Abeona Therapeutics® and Lurie Children's Open First Center for ZEVASKYN™ Gene Therapy to Treat Wounds in Painful Skin Disorder

      - ZEVASKYN, the first and only cell-based gene therapy for patients with recessive dystrophic epidermolysis bullosa (RDEB), now commercially available in the U.S. - - Ann & Robert H. Lurie Children's Hospital of Chicago, a top-ranked hospital, is ready to evaluate patients for ZEVASKYN treatment - - Abeona Assist™ comprehensive patient services program in place to offer personalized support for eligible patients and their families throughout ZEVASKYN treatment journey - CLEVELAND and CHICAGO, May 14, 2025 (GLOBE NEWSWIRE) -- Correction for Trademark symbol in headline - Abeona Therapeutics Inc. (NASDAQ:ABEO) and Ann & Robert H. Lurie Children's Hospital of Chicago today announced that L

      5/14/25 8:07:06 AM ET
      $ABEO
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Abeona Therapeutics® and Lurie Children's Open First Center for ZEVASKYNTM Gene Therapy to Treat Wounds in Painful Skin Disorder

      - ZEVASKYN, the first and only cell-based gene therapy for patients with recessive dystrophic epidermolysis bullosa (RDEB), now commercially available in the U.S. - - Ann & Robert H. Lurie Children's Hospital of Chicago, a top-ranked hospital, is ready to evaluate patients for ZEVASKYN treatment - - Abeona Assist™ comprehensive patient services program in place to offer personalized support for eligible patients and their families throughout ZEVASKYN treatment journey - CLEVELAND and CHICAGO, May 14, 2025 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (NASDAQ:ABEO) and Ann & Robert H. Lurie Children's Hospital of Chicago today announced that Lurie Children's is now activated as the

      5/14/25 7:30:00 AM ET
      $ABEO
      Biotechnology: Pharmaceutical Preparations
      Health Care

    $ABEO
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    • Director Alvino Mark sold $45,440 worth of shares (8,000 units at $5.68), decreasing direct ownership by 8% to 92,435 units (SEC Form 4)

      4 - ABEONA THERAPEUTICS INC. (0000318306) (Issuer)

      5/16/25 5:23:52 PM ET
      $ABEO
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Chief Executive Officer Seshadri Vishwas sold $119,500 worth of shares (25,000 units at $4.78), decreasing direct ownership by 2% to 1,355,322 units (SEC Form 4)

      4 - ABEONA THERAPEUTICS INC. (0000318306) (Issuer)

      3/31/25 7:17:50 PM ET
      $ABEO
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Chief Financial Officer Vazzano Joseph Walter covered exercise/tax liability with 685 shares, decreasing direct ownership by 0.13% to 509,041 units (SEC Form 4)

      4 - ABEONA THERAPEUTICS INC. (0000318306) (Issuer)

      3/17/25 4:30:19 PM ET
      $ABEO
      Biotechnology: Pharmaceutical Preparations
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