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    Amendment: SEC Form SCHEDULE 13G/A filed by enGene Holdings Inc.

    1/29/25 5:09:02 PM ET
    $ENGN
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care
    Get the next $ENGN alert in real time by email



    SECURITIES AND EXCHANGE COMMISSION
    Washington, D.C. 20549


    SCHEDULE 13G


    UNDER THE SECURITIES EXCHANGE ACT OF 1934
    (Amendment No. 2)


    enGene Holdings Inc.

    (Name of Issuer)


    Common Shares, no par value per share

    (Title of Class of Securities)


    29286M105

    (CUSIP Number)


    12/31/2024

    (Date of Event Which Requires Filing of this Statement)


    Check the appropriate box to designate the rule pursuant to which this Schedule is filed:
    Checkbox not checked   Rule 13d-1(b)
    Checkbox checked   Rule 13d-1(c)
    Checkbox not checked   Rule 13d-1(d)






    SCHEDULE 13G

    CUSIP No.
    29286M105


    1Names of Reporting Persons

    BIOTECHNOLOGY VALUE FUND L P
    2Check the appropriate box if a member of a Group (see instructions)

    Checkbox checked  (a)
    Checkbox not checked  (b)
    3Sec Use Only
    4Citizenship or Place of Organization

    DELAWARE
    Number of Shares Beneficially Owned by Each Reporting Person With:
    5Sole Voting Power

    0.00
    6Shared Voting Power

    1,597,986.00
    7Sole Dispositive Power

    0.00
    8Shared Dispositive Power

    1,597,986.00
    9Aggregate Amount Beneficially Owned by Each Reporting Person

    1,597,986.00
    10Check box if the aggregate amount in row (9) excludes certain shares (See Instructions)

    Checkbox not checked
    11Percent of class represented by amount in row (9)

    3.1 %
    12Type of Reporting Person (See Instructions)

    PN


    SCHEDULE 13G

    CUSIP No.
    29286M105


    1Names of Reporting Persons

    BVF I GP LLC
    2Check the appropriate box if a member of a Group (see instructions)

    Checkbox checked  (a)
    Checkbox not checked  (b)
    3Sec Use Only
    4Citizenship or Place of Organization

    DELAWARE
    Number of Shares Beneficially Owned by Each Reporting Person With:
    5Sole Voting Power

    0.00
    6Shared Voting Power

    1,597,986.00
    7Sole Dispositive Power

    0.00
    8Shared Dispositive Power

    1,597,986.00
    9Aggregate Amount Beneficially Owned by Each Reporting Person

    1,597,986.00
    10Check box if the aggregate amount in row (9) excludes certain shares (See Instructions)

    Checkbox not checked
    11Percent of class represented by amount in row (9)

    3.1 %
    12Type of Reporting Person (See Instructions)

    OO


    SCHEDULE 13G

    CUSIP No.
    29286M105


    1Names of Reporting Persons

    BIOTECHNOLOGY VALUE FUND II LP
    2Check the appropriate box if a member of a Group (see instructions)

    Checkbox checked  (a)
    Checkbox not checked  (b)
    3Sec Use Only
    4Citizenship or Place of Organization

    DELAWARE
    Number of Shares Beneficially Owned by Each Reporting Person With:
    5Sole Voting Power

    0.00
    6Shared Voting Power

    1,263,389.00
    7Sole Dispositive Power

    0.00
    8Shared Dispositive Power

    1,263,389.00
    9Aggregate Amount Beneficially Owned by Each Reporting Person

    1,263,389.00
    10Check box if the aggregate amount in row (9) excludes certain shares (See Instructions)

    Checkbox not checked
    11Percent of class represented by amount in row (9)

    2.5 %
    12Type of Reporting Person (See Instructions)

    PN


    SCHEDULE 13G

    CUSIP No.
    29286M105


    1Names of Reporting Persons

    BVF II GP LLC
    2Check the appropriate box if a member of a Group (see instructions)

    Checkbox checked  (a)
    Checkbox not checked  (b)
    3Sec Use Only
    4Citizenship or Place of Organization

    DELAWARE
    Number of Shares Beneficially Owned by Each Reporting Person With:
    5Sole Voting Power

    0.00
    6Shared Voting Power

    1,263,389.00
    7Sole Dispositive Power

    0.00
    8Shared Dispositive Power

    1,263,389.00
    9Aggregate Amount Beneficially Owned by Each Reporting Person

    1,263,389.00
    10Check box if the aggregate amount in row (9) excludes certain shares (See Instructions)

    Checkbox not checked
    11Percent of class represented by amount in row (9)

    2.5 %
    12Type of Reporting Person (See Instructions)

    OO


    SCHEDULE 13G

    CUSIP No.
    29286M105


    1Names of Reporting Persons

    Biotechnology Value Trading Fund OS LP
    2Check the appropriate box if a member of a Group (see instructions)

    Checkbox checked  (a)
    Checkbox not checked  (b)
    3Sec Use Only
    4Citizenship or Place of Organization

    CAYMAN ISLANDS
    Number of Shares Beneficially Owned by Each Reporting Person With:
    5Sole Voting Power

    0.00
    6Shared Voting Power

    148,043.00
    7Sole Dispositive Power

    0.00
    8Shared Dispositive Power

    148,043.00
    9Aggregate Amount Beneficially Owned by Each Reporting Person

    148,043.00
    10Check box if the aggregate amount in row (9) excludes certain shares (See Instructions)

    Checkbox not checked
    11Percent of class represented by amount in row (9)

    0.3 %
    12Type of Reporting Person (See Instructions)

    PN


    SCHEDULE 13G

    CUSIP No.
    29286M105


    1Names of Reporting Persons

    BVF Partners OS Ltd.
    2Check the appropriate box if a member of a Group (see instructions)

    Checkbox checked  (a)
    Checkbox not checked  (b)
    3Sec Use Only
    4Citizenship or Place of Organization

    CAYMAN ISLANDS
    Number of Shares Beneficially Owned by Each Reporting Person With:
    5Sole Voting Power

    0.00
    6Shared Voting Power

    148,043.00
    7Sole Dispositive Power

    0.00
    8Shared Dispositive Power

    148,043.00
    9Aggregate Amount Beneficially Owned by Each Reporting Person

    148,043.00
    10Check box if the aggregate amount in row (9) excludes certain shares (See Instructions)

    Checkbox not checked
    11Percent of class represented by amount in row (9)

    0.3 %
    12Type of Reporting Person (See Instructions)

    CO


    SCHEDULE 13G

    CUSIP No.
    29286M105


    1Names of Reporting Persons

    BVF GP HOLDINGS LLC
    2Check the appropriate box if a member of a Group (see instructions)

    Checkbox checked  (a)
    Checkbox not checked  (b)
    3Sec Use Only
    4Citizenship or Place of Organization

    DELAWARE
    Number of Shares Beneficially Owned by Each Reporting Person With:
    5Sole Voting Power

    0.00
    6Shared Voting Power

    2,861,375.00
    7Sole Dispositive Power

    0.00
    8Shared Dispositive Power

    2,861,375.00
    9Aggregate Amount Beneficially Owned by Each Reporting Person

    2,861,375.00
    10Check box if the aggregate amount in row (9) excludes certain shares (See Instructions)

    Checkbox not checked
    11Percent of class represented by amount in row (9)

    5.5 %
    12Type of Reporting Person (See Instructions)

    OO


    SCHEDULE 13G

    CUSIP No.
    29286M105


    1Names of Reporting Persons

    BVF PARTNERS L P/IL
    2Check the appropriate box if a member of a Group (see instructions)

    Checkbox checked  (a)
    Checkbox not checked  (b)
    3Sec Use Only
    4Citizenship or Place of Organization

    DELAWARE
    Number of Shares Beneficially Owned by Each Reporting Person With:
    5Sole Voting Power

    0.00
    6Shared Voting Power

    3,051,439.00
    7Sole Dispositive Power

    0.00
    8Shared Dispositive Power

    3,051,439.00
    9Aggregate Amount Beneficially Owned by Each Reporting Person

    3,051,439.00
    10Check box if the aggregate amount in row (9) excludes certain shares (See Instructions)

    Checkbox not checked
    11Percent of class represented by amount in row (9)

    5.9 %
    12Type of Reporting Person (See Instructions)

    IA, PN


    SCHEDULE 13G

    CUSIP No.
    29286M105


    1Names of Reporting Persons

    BVF INC/IL
    2Check the appropriate box if a member of a Group (see instructions)

    Checkbox checked  (a)
    Checkbox not checked  (b)
    3Sec Use Only
    4Citizenship or Place of Organization

    DELAWARE
    Number of Shares Beneficially Owned by Each Reporting Person With:
    5Sole Voting Power

    0.00
    6Shared Voting Power

    3,051,439.00
    7Sole Dispositive Power

    0.00
    8Shared Dispositive Power

    3,051,439.00
    9Aggregate Amount Beneficially Owned by Each Reporting Person

    3,051,439.00
    10Check box if the aggregate amount in row (9) excludes certain shares (See Instructions)

    Checkbox not checked
    11Percent of class represented by amount in row (9)

    5.9 %
    12Type of Reporting Person (See Instructions)

    CO


    SCHEDULE 13G

    CUSIP No.
    29286M105


    1Names of Reporting Persons

    LAMPERT MARK N
    2Check the appropriate box if a member of a Group (see instructions)

    Checkbox checked  (a)
    Checkbox not checked  (b)
    3Sec Use Only
    4Citizenship or Place of Organization

    UNITED STATES
    Number of Shares Beneficially Owned by Each Reporting Person With:
    5Sole Voting Power

    0.00
    6Shared Voting Power

    3,051,439.00
    7Sole Dispositive Power

    0.00
    8Shared Dispositive Power

    3,051,439.00
    9Aggregate Amount Beneficially Owned by Each Reporting Person

    3,051,439.00
    10Check box if the aggregate amount in row (9) excludes certain shares (See Instructions)

    Checkbox not checked
    11Percent of class represented by amount in row (9)

    5.9 %
    12Type of Reporting Person (See Instructions)

    IN


    SCHEDULE 13G

    Item 1. 
    (a)Name of issuer:

    enGene Holdings Inc.
    (b)Address of issuer's principal executive offices:

    4868 Rue Levy, Suite 220, Saint-Laurent, QC, Canada H4R 2P1
    Item 2. 
    (a)Name of person filing:

    Biotechnology Value Fund, L.P. ("BVF") BVF I GP LLC ("BVF GP") Biotechnology Value Fund II, L.P. ("BVF2") BVF II GP LLC ("BVF2 GP") Biotechnology Value Trading Fund OS LP ("Trading Fund OS") BVF Partners OS Ltd. ("Partners OS") BVF GP Holdings LLC ("BVF GPH") BVF Partners L.P. ("Partners") BVF Inc. Mark N. Lampert ("Mr. Lampert") Each of the foregoing is referred to as a "Reporting Person" and collectively as the "Reporting Persons."
    (b)Address or principal business office or, if none, residence:

    Biotechnology Value Fund, L.P. 44 Montgomery St., 40th Floor San Francisco, California 94104 BVF I GP LLC 44 Montgomery St., 40th Floor San Francisco, California 94104 Biotechnology Value Fund II, L.P. 44 Montgomery St., 40th Floor San Francisco, California 94104 BVF II GP LLC 44 Montgomery St., 40th Floor San Francisco, California 94104 Biotechnology Value Trading Fund OS LP PO Box 309 Ugland House Grand Cayman, KY1-1104 Cayman Islands BVF Partners OS Ltd. PO Box 309 Ugland House Grand Cayman, KY1-1104 Cayman Islands BVF GP Holdings LLC 44 Montgomery St., 40th Floor San Francisco, California 94104 BVF Partners L.P. 44 Montgomery St., 40th Floor San Francisco, California 94104 BVF Inc. 44 Montgomery St., 40th Floor San Francisco, California 94104 Mark N. Lampert 44 Montgomery St., 40th Floor San Francisco, California 94104
    (c)Citizenship:

    Biotechnology Value Fund, L.P. Delaware BVF I GP LLC Delaware Biotechnology Value Fund II, L.P. Delaware BVF II GP LLC Delaware Biotechnology Value Trading Fund OS LP Cayman Islands BVF Partners OS Ltd. Cayman Islands BVF GP Holdings LLC Delaware BVF Partners L.P. Delaware BVF Inc. Delaware Mark N. Lampert United States
    (d)Title of class of securities:

    Common Shares, no par value per share
    (e)CUSIP No.:

    29286M105
    Item 3.If this statement is filed pursuant to §§ 240.13d-1(b) or 240.13d-2(b) or (c), check whether the person filing is a:
    (a)Checkbox not checked   Broker or dealer registered under section 15 of the Act (15 U.S.C. 78o);
    (b)Checkbox not checked   Bank as defined in section 3(a)(6) of the Act (15 U.S.C. 78c);
    (c)Checkbox not checked   Insurance company as defined in section 3(a)(19) of the Act (15 U.S.C. 78c);
    (d)Checkbox not checked   Investment company registered under section 8 of the Investment Company Act of 1940 (15 U.S.C. 80a-8);
    (e)Checkbox not checked   An investment adviser in accordance with § 240.13d-1(b)(1)(ii)(E);
    (f)Checkbox not checked   An employee benefit plan or endowment fund in accordance with § 240.13d-1(b)(1)(ii)(F);
    (g)Checkbox not checked   A parent holding company or control person in accordance with § 240.13d-1(b)(1)(ii)(G);
    (h)Checkbox not checked   A savings associations as defined in Section 3(b) of the Federal Deposit Insurance Act (12 U.S.C. 1813);
    (i)Checkbox not checked   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)Checkbox not checked   A non-U.S. institution in accordance with § 240.13d-1(b)(1)(ii)(J). If filing as a non-U.S. institution in accordance with § 240.13d-1(b)(1)(ii)(J),
           please specify the type of institution:
    (k)Checkbox not checked   Group, in accordance with Rule 240.13d-1(b)(1)(ii)(K).
     
    Item 4.Ownership
    (a)Amount beneficially owned:

    As of the close of business on December 31, 2024, the Reporting Persons and a certain Partners managed account (the "Partners Managed Account") held exchange-traded warrants of the Issuer (the "Warrants") exercisable for an aggregate of 945,402 Shares. The Warrants are exercisable at a price of $11.50 per Share and first became exercisable 30 days after the consummation of the combination between the Issuer and Forbion European Acquisition Corp., which occurred on October 31, 2023, subject to certain conditions. The Warrants expire on October 31, 2028. As of the close of business on December 31, 2024, (i) BVF beneficially owned 1,597,986 Shares, including 505,835 Shares underlying the Warrants held by it, (ii) BVF2 beneficially owned 1,263,389 Shares, including 383,352 Shares underlying the Warrants held by it, and (iii) Trading Fund OS beneficially owned 148,043 Shares, including 43,786 Shares underlying the Warrants held by it. BVF GP, as the general partner of BVF, may be deemed to beneficially own the 1,597,986 Shares beneficially owned by BVF. BVF2 GP, as the general partner of BVF2, may be deemed to beneficially own the 1,263,389 Shares beneficially owned by BVF2. Partners OS, as the general partner of Trading Fund OS, may be deemed to beneficially own the 148,043 Shares beneficially owned by Trading Fund OS. BVF GPH, as the sole member of each of BVF GP and BVF2 GP, may be deemed to beneficially own the 2,861,375 Shares beneficially owned in the aggregate by BVF and BVF2. Partners, as the investment manager of BVF, BVF2 and Trading Fund OS, and the sole member of Partners OS, may be deemed to beneficially own the 3,051,439 Shares beneficially owned in the aggregate by BVF, BVF2 and Trading Fund OS and held in the Partners Managed Account, including 42,021 Shares held in the Partners Managed Account, including 12,429 Shares underlying the Warrants held in the Partners Managed Account. BVF Inc., as the general partner of Partners, may be deemed to beneficially own the 3,051,439 Shares beneficially owned by Partners. Mr. Lampert, as a director and officer of BVF Inc., may be deemed to beneficially own the 3,051,439 Shares beneficially owned by BVF Inc. The foregoing should not be construed in and of itself as an admission by any Reporting Person as to beneficial ownership of any Shares owned by another Reporting Person. BVF GP disclaims beneficial ownership of the Shares beneficially owned by BVF. BVF2 GP disclaims beneficial ownership of the Shares beneficially owned by BVF2. Partners OS disclaims beneficial ownership of the Shares beneficially owned by Trading Fund OS. BVF GPH disclaims beneficial ownership of the Shares beneficially owned by BVF and BVF2. Each of Partners, BVF Inc. and Mr. Lampert disclaims beneficial ownership of the Shares beneficially owned by BVF, BVF2 and Trading Fund OS and held in the Partners Managed Account, and the filing of this statement shall not be construed as an admission that any such person or entity is the beneficial owner of any such securities.
    (b)Percent of class:

    The following percentages are based upon 51,922,078 Shares outstanding, which is the sum of: (i) 50,976,676 Shares outstanding as of December 16, 2024, which is the total number of Shares outstanding as disclosed in the Issuer's Annual Report on Form 10-K filed with the Securities and Exchange Commission on December 19, 2024, and (ii) certain or all of the 945,402 Shares underlying the Warrants held by the Reporting Persons and the Partners Managed Account, as applicable. As of the close of business on December 31, 2024, (i) BVF beneficially owned approximately 3.1% of the outstanding Shares, (ii) BVF2 beneficially owned approximately 2.5% of the outstanding Shares, (iii) Trading Fund OS beneficially owned less than 1% of the outstanding Shares, (iv) BVF GP may be deemed to beneficially own approximately 3.1% of the outstanding Shares, (v) BVF2 GP may be deemed to beneficially own approximately 2.5% of the outstanding Shares, (vi) Partners OS may be deemed to beneficially own less than 1% of the outstanding Shares, (vii) BVF GPH may be deemed to beneficially own approximately 5.5% of the outstanding Shares and (viii) each of Partners, BVF Inc. and Mr. Lampert may be deemed to beneficially own approximately 5.9% of the outstanding Shares (less than 1% of the outstanding Shares are held in the Partners Managed Account).
    (c)Number of shares as to which the person has:
     (i) Sole power to vote or to direct the vote:

    See Cover Pages Items 5-9.

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

    See Cover Pages Items 5-9.

     (iii) Sole power to dispose or to direct the disposition of:

    See Cover Pages Items 5-9.

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

    See Cover Pages Items 5-9.

    Item 5.Ownership of 5 Percent or Less of a Class.
     
    Item 6.Ownership of more than 5 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 5 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.


    BVF GPH, Partners, BVF Inc. and Mr. Lampert share voting and dispositive power over the Shares beneficially owned by BVF and BVF2. Partners, BVF Inc. and Mr. Lampert share voting and dispositive power over the Shares beneficially owned by Trading Fund OS and held in the Partners Managed Account.
    Item 7.Identification and Classification of the Subsidiary Which Acquired the Security Being Reported on by the Parent Holding Company or Control Person.
     
    Not Applicable
    Item 8.Identification and Classification of Members of the Group.
     
    If a group has filed this schedule pursuant to §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 §240.13d-1(c) or §240.13d-1(d), attach an exhibit stating the identity of each member of the group.


    See Exhibit 99.1 to the Schedule 13G filed with the Securities and Exchange Commission on November 13, 2023.
    Item 9.Notice of Dissolution of Group.
     
    Not Applicable

    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.

        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.

     
    BIOTECHNOLOGY VALUE FUND L P
     
    Signature:/s/ Mark N. Lampert
    Name/Title:Mark N. Lampert, Authorized Signatory
    Date:01/29/2025
     
    BVF I GP LLC
     
    Signature:/s/ Mark N. Lampert
    Name/Title:Mark N. Lampert, Authorized Signatory
    Date:01/29/2025
     
    BIOTECHNOLOGY VALUE FUND II LP
     
    Signature:/s/ Mark N. Lampert
    Name/Title:Mark N. Lampert, Authorized Signatory
    Date:01/29/2025
     
    BVF II GP LLC
     
    Signature:/s/ Mark N. Lampert
    Name/Title:Mark N. Lampert, Authorized Signatory
    Date:01/29/2025
     
    Biotechnology Value Trading Fund OS LP
     
    Signature:/s/ Mark N. Lampert
    Name/Title:Mark N. Lampert, Authorized Signatory
    Date:01/29/2025
     
    BVF Partners OS Ltd.
     
    Signature:/s/ Mark N. Lampert
    Name/Title:Mark N. Lampert, Authorized Signatory
    Date:01/29/2025
     
    BVF GP HOLDINGS LLC
     
    Signature:/s/ Mark N. Lampert
    Name/Title:Mark N. Lampert, Authorized Signatory
    Date:01/29/2025
     
    BVF PARTNERS L P/IL
     
    Signature:/s/ Mark N. Lampert
    Name/Title:Mark N. Lampert, Authorized Signatory
    Date:01/29/2025
     
    BVF INC/IL
     
    Signature:/s/ Mark N. Lampert
    Name/Title:Mark N. Lampert, Authorized Signatory
    Date:01/29/2025
     
    LAMPERT MARK N
     
    Signature:/s/ Mark N. Lampert
    Name/Title:Mark N. Lampert
    Date:01/29/2025
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    Piper Sandler initiated coverage on enGene Holdings with a new price target

    Piper Sandler initiated coverage of enGene Holdings with a rating of Overweight and set a new price target of $26.00

    2/18/25 7:08:31 AM ET
    $ENGN
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care

    $ENGN
    Insider Trading

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    SEC Form 4 filed by Chief Scientific Officer Cheung Anthony Tzeyew

    4 - enGene Holdings Inc. (0001980845) (Issuer)

    2/3/26 4:13:44 PM ET
    $ENGN
    Biotechnology: Biological Products (No Diagnostic Substances)
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    SEC Form 4 filed by Chief Legal Ofc. and Corp Secy Giguere Lee

    4 - enGene Holdings Inc. (0001980845) (Issuer)

    2/3/26 4:12:56 PM ET
    $ENGN
    Biotechnology: Biological Products (No Diagnostic Substances)
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    SEC Form 4 filed by Chief Strategy & Ops. Ofc Nichols Alexander Julian

    4 - enGene Holdings Inc. (0001980845) (Issuer)

    2/3/26 4:11:10 PM ET
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    $ENGN
    Insider Purchases

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    Large owner Forbion Growth Opportunities Fund I Cooperatief U.A. bought $4,999,993 worth of shares (561,797 units at $8.90) (SEC Form 4)

    4 - enGene Holdings Inc. (0001980845) (Issuer)

    11/1/24 4:15:08 PM ET
    $ENGN
    Biotechnology: Biological Products (No Diagnostic Substances)
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    Large owner Forbion Growth Opportunities Fund I Cooperatief U.A. bought $3,012,674 worth of shares (470,633 units at $6.40) (SEC Form 4)

    4 - enGene Holdings Inc. (0001980845) (Issuer)

    10/18/24 4:15:05 PM ET
    $ENGN
    Biotechnology: Biological Products (No Diagnostic Substances)
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    Chief Executive Officer Cooper Ronald Harold Wilfred bought $57,000 worth of shares (10,000 units at $5.70) (SEC Form 4)

    4 - enGene Holdings Inc. (0001980845) (Issuer)

    10/1/24 8:02:44 AM ET
    $ENGN
    Biotechnology: Biological Products (No Diagnostic Substances)
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    $ENGN
    SEC Filings

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    enGene Holdings Inc. filed SEC Form 8-K: Entry into a Material Definitive Agreement, Creation of a Direct Financial Obligation, Unregistered Sales of Equity Securities, Financial Statements and Exhibits

    8-K - enGene Holdings Inc. (0001980845) (Filer)

    1/21/26 4:05:39 PM ET
    $ENGN
    Biotechnology: Biological Products (No Diagnostic Substances)
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    enGene Holdings Inc. filed SEC Form 8-K: Regulation FD Disclosure, Financial Statements and Exhibits

    8-K - enGene Holdings Inc. (0001980845) (Filer)

    1/21/26 7:38:06 AM ET
    $ENGN
    Biotechnology: Biological Products (No Diagnostic Substances)
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    SEC Form 10-K filed by enGene Holdings Inc.

    10-K - enGene Holdings Inc. (0001980845) (Filer)

    12/22/25 4:11:40 PM ET
    $ENGN
    Biotechnology: Biological Products (No Diagnostic Substances)
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    $ENGN
    Financials

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    Detalimogene Demonstrates Improved Complete Response Rate of 62% at 6 Months

    Low rates of treatment-related adverse events (42%) and dose interruptions (1.6%) Emerging detalimogene profile supports potential first line use in patients with high-risk, BCG-unresponsive non-muscle invasive bladder cancer with CIS LEGEND trial pivotal cohort completed enrollment with 125 patients, exceeding target enGene to host conference call and webcast at 8:00 a.m. ET enGene Holdings Inc. (NASDAQ:ENGN), a clinical-stage, non-viral genetic medicines company, today reported additional preliminary data from the pivotal cohort of its ongoing, Phase 2 LEGEND trial of detalimogene voraplasmid (also known as detalimogene and previously EG-70) in high-risk, Bacillus Calmette-Guérin

    11/11/25 7:30:00 AM ET
    $ENGN
    Biotechnology: Biological Products (No Diagnostic Substances)
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    enGene to Host Conference Call to Provide Update on Pivotal Cohort of LEGEND Trial

    enGene Holdings Inc. (NASDAQ:ENGN), a clinical-stage, non-viral genetic medicines company, today announced that it will host a conference call and webcast tomorrow, November 11, 2025, at 8:00 a.m. ET to discuss new preliminary data from its pivotal cohort in the ongoing LEGEND trial of its novel, non-viral gene therapy candidate, detalimogene voraplasmid (also known as detalimogene, and previously EG-70) for patients with high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer with carcinoma in situ. The live call can be accessed by registering as a participant here. Upon registration, participants will receive conference dial-in information. A link to th

    11/10/25 4:05:00 PM ET
    $ENGN
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care

    enGene Reports Third Quarter 2025 Financial Results and Provides Business Update

    Achieved target enrollment milestone for LEGEND trial pivotal cohort in high-risk BCG unresponsive NMIBC with carcinoma in situ LEGEND's pivotal cohort data update planned for 4Q 2025 Detalimogene granted Regenerative Medicine Advanced Therapy (RMAT) designation by FDA Biologic License Application (BLA) submission planned for 2H 2026 Cash and marketable securities of $224.9 million expected to provide runway into 2027 enGene Holdings Inc. (NASDAQ:ENGN, "enGene" or the "Company")), a clinical-stage, non-viral gene therapy company, today announced its financial results for the third quarter ended July 31, 2025, and provided a business update. "Reaching target enrollment in LEGEND'

    9/11/25 4:03:00 PM ET
    $ENGN
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    $ENGN
    Leadership Updates

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    enGene Appoints Hussein Sweiti, M.D., MSc, as Chief Medical Officer

    Bladder cancer development leader who helped drive recent FDA product approval in NMIBC joins to lead research and development strategy Appointment strengthens enGene's clinical development and regulatory capabilities ahead of planned 2H 2026 BLA submission for detalimogene enGene Holdings Inc. (NASDAQ:ENGN, "enGene" or the "Company")), a clinical-stage, non-viral genetic medicine company, today announced that Hussein Sweiti, M.D., MSc, was appointed Chief Medical Officer, effective September 29, 2025. Dr. Sweiti is a surgical oncologist and physician-scientist with more than 15 years of experience spanning clinical practice, oncology clinical research, global drug development, regula

    9/30/25 7:30:00 AM ET
    $ENGN
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care

    enGene Announces Board and Leadership Appointments to Support Commercial Readiness

    Philip Astley-Sparke, William Grossman and Michael Heffernan join the Board Management promotions strengthen clinical and regulatory operations Matthew Boyd named Chief Regulatory Officer, Jill Buck Chief Development Officer, and Katherine Chan Executive Director, Urology Clinical Lead enGene Holdings Inc. (NASDAQ:ENGN), a clinical-stage, non-viral gene-based immunotherapy company, today announced the appointment of three new members to its Board of Directors: Philip Astley-Sparke, William Grossman, M.D., Ph.D., and Michael Heffernan, R.Ph. Their combined experience across gene therapy, oncology, clinical development, and global product launches will support enGene's strategic transit

    7/8/25 8:00:00 AM ET
    $ENGN
    Biotechnology: Biological Products (No Diagnostic Substances)
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    enGene Names Amy Pott as Chief Global Commercialization Officer

    enGene Holdings Inc. (NASDAQ:ENGN), a clinical-stage, non-viral genetic medicines company, today announced the appointment of Amy Pott as Chief Global Commercialization Officer. In this role, Ms. Pott will serve as the Company's first dedicated executive for commercialization planning and execution, reporting to enGene's Chief Executive Officer, Ron Cooper. This appointment marks a significant milestone, as the Company expects to file a Biologics License Application (BLA) with the FDA in mid-2026 for detalimogene voraplasmid, its lead investigational agent in Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC), following the completion of the pivotal co

    5/28/25 7:30:00 AM ET
    $ENGN
    Biotechnology: Biological Products (No Diagnostic Substances)
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    $ENGN
    Large Ownership Changes

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    Amendment: SEC Form SC 13G/A filed by enGene Holdings Inc.

    SC 13G/A - enGene Holdings Inc. (0001980845) (Subject)

    11/14/24 5:48:15 PM ET
    $ENGN
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    Amendment: SEC Form SC 13G/A filed by enGene Holdings Inc.

    SC 13G/A - enGene Holdings Inc. (0001980845) (Subject)

    11/14/24 5:05:21 PM ET
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    Biotechnology: Biological Products (No Diagnostic Substances)
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    Amendment: SEC Form SC 13G/A filed by enGene Holdings Inc.

    SC 13G/A - enGene Holdings Inc. (0001980845) (Subject)

    11/14/24 7:53:57 AM ET
    $ENGN
    Biotechnology: Biological Products (No Diagnostic Substances)
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