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    Amendment: SEC Form SCHEDULE 13G/A filed by Palvella Therapeutics Inc.

    11/14/25 4:19:50 PM ET
    $PVLA
    Biotechnology: Pharmaceutical Preparations
    Health Care
    Get the next $PVLA 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)


    PALVELLA THERAPEUTICS, INC.

    (Name of Issuer)


    Common Stock, $0.001 par value per share

    (Title of Class of Securities)


    697947109

    (CUSIP Number)


    09/30/2025

    (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.
    697947109


    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

    634,307.00
    7Sole Dispositive Power

    0.00
    8Shared Dispositive Power

    634,307.00
    9Aggregate Amount Beneficially Owned by Each Reporting Person

    634,307.00
    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)

    5.4 %
    12Type of Reporting Person (See Instructions)

    PN


    SCHEDULE 13G

    CUSIP No.
    697947109


    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

    634,307.00
    7Sole Dispositive Power

    0.00
    8Shared Dispositive Power

    634,307.00
    9Aggregate Amount Beneficially Owned by Each Reporting Person

    634,307.00
    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)

    5.4 %
    12Type of Reporting Person (See Instructions)

    OO


    SCHEDULE 13G

    CUSIP No.
    697947109


    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

    474,740.00
    7Sole Dispositive Power

    0.00
    8Shared Dispositive Power

    474,740.00
    9Aggregate Amount Beneficially Owned by Each Reporting Person

    474,740.00
    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)

    4.0 %
    12Type of Reporting Person (See Instructions)

    PN


    SCHEDULE 13G

    CUSIP No.
    697947109


    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

    474,740.00
    7Sole Dispositive Power

    0.00
    8Shared Dispositive Power

    474,740.00
    9Aggregate Amount Beneficially Owned by Each Reporting Person

    474,740.00
    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)

    4.0 %
    12Type of Reporting Person (See Instructions)

    OO


    SCHEDULE 13G

    CUSIP No.
    697947109


    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

    54,840.00
    7Sole Dispositive Power

    0.00
    8Shared Dispositive Power

    54,840.00
    9Aggregate Amount Beneficially Owned by Each Reporting Person

    54,840.00
    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)

    0.5 %
    12Type of Reporting Person (See Instructions)

    PN


    SCHEDULE 13G

    CUSIP No.
    697947109


    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

    54,840.00
    7Sole Dispositive Power

    0.00
    8Shared Dispositive Power

    54,840.00
    9Aggregate Amount Beneficially Owned by Each Reporting Person

    54,840.00
    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)

    0.5 %
    12Type of Reporting Person (See Instructions)

    CO


    SCHEDULE 13G

    CUSIP No.
    697947109


    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

    1,109,047.00
    7Sole Dispositive Power

    0.00
    8Shared Dispositive Power

    1,109,047.00
    9Aggregate Amount Beneficially Owned by Each Reporting Person

    1,109,047.00
    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)

    9.4 %
    12Type of Reporting Person (See Instructions)

    OO


    SCHEDULE 13G

    CUSIP No.
    697947109


    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

    1,181,194.00
    7Sole Dispositive Power

    0.00
    8Shared Dispositive Power

    1,181,194.00
    9Aggregate Amount Beneficially Owned by Each Reporting Person

    1,181,194.00
    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)

    9.99 %
    12Type of Reporting Person (See Instructions)

    IA, PN


    SCHEDULE 13G

    CUSIP No.
    697947109


    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

    1,181,194.00
    7Sole Dispositive Power

    0.00
    8Shared Dispositive Power

    1,181,194.00
    9Aggregate Amount Beneficially Owned by Each Reporting Person

    1,181,194.00
    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)

    9.99 %
    12Type of Reporting Person (See Instructions)

    CO


    SCHEDULE 13G

    CUSIP No.
    697947109


    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

    1,181,194.00
    7Sole Dispositive Power

    0.00
    8Shared Dispositive Power

    1,181,194.00
    9Aggregate Amount Beneficially Owned by Each Reporting Person

    1,181,194.00
    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)

    9.99 %
    12Type of Reporting Person (See Instructions)

    IN


    SCHEDULE 13G

    Item 1. 
    (a)Name of issuer:

    PALVELLA THERAPEUTICS, INC.
    (b)Address of issuer's principal executive offices:

    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 Stock, $0.001 par value per share
    (e)CUSIP No.:

    697947109
    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 September 30, 2025, the Reporting Persons and one of the Partners managed accounts (the "Partners Managed Accounts") held certain Pre-Funded Warrants (the "Pre-Funded Warrants") exercisable for an aggregate of 1,071,695 Shares. The Pre-Funded Warrants are exercisable at any time at an exercise price of $0.001 per Share and do not expire. A holder of Pre-Funded Warrants may not exercise such Pre-Funded Warrants if the holder, together with its affiliates, would beneficially own more than 9.99% of the number of Shares outstanding immediately after giving effect to such exercise (the "Pre-Funded Warrants Blocker"). As of the close of business on the date hereof, the Pre-Funded Warrants Blocker limits the exercise of the Pre-Funded Warrants held by the Reporting Persons and one of the Partners Managed Accounts to 19,945 Shares underlying the Pre-Funded Warrants held by them. As of the close of business on September 30, 2025, (i) BVF beneficially owned 634,307 Shares, including 19,945 Shares underlying certain Pre-Funded Warrants held by it and excluding 541,549 Shares underlying certain Pre-Funded Warrants held by it, (ii) BVF2 beneficially owned 474,740 Shares, excluding 445,782 Shares underlying the Pre-Funded Warrants held by it, and (iii) Trading Fund OS beneficially owned 54,840 Shares, excluding 44,770 Shares underlying the Pre-Funded Warrants held by it. BVF GP, as the general partner of BVF, may be deemed to beneficially own the 634,307 Shares beneficially owned by BVF. BVF2 GP, as the general partner of BVF2, may be deemed to beneficially own the 474,740 Shares beneficially owned by BVF2. Partners OS, as the general partner of Trading Fund OS, may be deemed to beneficially own the 54,840 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 1,109,047 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 1,181,194 Shares beneficially owned in the aggregate by BVF, BVF2 and Trading Fund OS and held in the Partners Managed Accounts, including 17,307 Shares held in the Partners Managed Accounts, which excludes 19,649 Shares underlying the Pre-Funded Warrants held in one of the Partners Managed Accounts. BVF Inc., as the general partner of Partners, may be deemed to beneficially own the 1,181,194 Shares beneficially owned by Partners. Mr. Lampert, as a director and officer of BVF Inc., may be deemed to beneficially own the 1,181,194 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 Accounts, 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 a denominator that is the sum of: (i) 11,059,665 Shares outstanding as of August 8, 2025, which is the total number of Shares outstanding as reported in the Issuer's Current Report on Form 8-K filed with the Securities and Exchange Commission on August 14, 2024, (ii) 744,161 Shares issued to the Reporting Persons and the Partners Managed Accounts upon conversion of the Series A Preferred Stock, Series B Preferred Stock, Series C Preferred Stock, Series D Preferred Stock, and Series E Preferred Stock previously held by the Reporting Persons, and (iii) 19,945 Shares underlying certain Pre-Funded Warrants held by the Reporting Persons, as applicable. As of the close of business on the date hereof, (i) BVF beneficially owned approximately 5.4% of the outstanding Shares, (ii) BVF2 beneficially owned approximately 4.0% 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 5.4% of the outstanding Shares, (v) BVF2 GP may be deemed to beneficially own approximately 4.0% 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 9.4% of the outstanding Shares, and (viii) each of Partners, BVF Inc. and Mr. Lampert may be deemed to beneficially own approximately 9.99% of the outstanding Shares (less than 1% of the outstanding Shares are held in the Partners Managed Accounts).
    (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 GP, BVF GPH, Partners, BVF Inc. and Mr. Lampert share voting and dispositive power over the Shares beneficially owned by BVF. BVF GPH, Partners, BVF Inc. and Mr. Lampert share voting and dispositive power over the Shares beneficially owned by 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 Accounts.
    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 by the Reporting Persons with the Securities and Exchange Commission on May 17, 2024.
    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:11/14/2025
     
    BVF I GP LLC
     
    Signature:/s/ Mark N. Lampert
    Name/Title:Mark N. Lampert, Authorized Signatory
    Date:11/14/2025
     
    BIOTECHNOLOGY VALUE FUND II LP
     
    Signature:/s/ Mark N. Lampert
    Name/Title:Mark N. Lampert, Authorized Signatory
    Date:11/14/2025
     
    BVF II GP LLC
     
    Signature:/s/ Mark N. Lampert
    Name/Title:Mark N. Lampert, Authorized Signatory
    Date:11/14/2025
     
    Biotechnology Value Trading Fund OS LP
     
    Signature:/s/ Mark N. Lampert
    Name/Title:Mark N. Lampert, Authorized Signatory
    Date:11/14/2025
     
    BVF Partners OS Ltd.
     
    Signature:/s/ Mark N. Lampert
    Name/Title:Mark N. Lampert, Authorized Signatory
    Date:11/14/2025
     
    BVF GP HOLDINGS LLC
     
    Signature:/s/ Mark N. Lampert
    Name/Title:Mark N. Lampert, Authorized Signatory
    Date:11/14/2025
     
    BVF PARTNERS L P/IL
     
    Signature:/s/ Mark N. Lampert
    Name/Title:Mark N. Lampert, Authorized Signatory
    Date:11/14/2025
     
    BVF INC/IL
     
    Signature:/s/ Mark N. Lampert
    Name/Title:Mark N. Lampert, Authorized Signatory
    Date:11/14/2025
     
    LAMPERT MARK N
     
    Signature:/s/ Mark N. Lampert
    Name/Title:Mark N. Lampert
    Date:11/14/2025
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    6/11/25 8:00:08 PM ET
    $PVLA
    Biotechnology: Pharmaceutical Preparations
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    SEC Form 4 filed by Director Kiritsy Christopher P

    4 - PALVELLA THERAPEUTICS, INC. (0001583648) (Issuer)

    6/11/25 7:59:56 PM ET
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    $PVLA
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    Palvella Therapeutics upgraded by Raymond James with a new price target

    Raymond James upgraded Palvella Therapeutics from Outperform to Strong Buy and set a new price target of $143.00

    11/19/25 8:47:27 AM ET
    $PVLA
    Biotechnology: Pharmaceutical Preparations
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    Oppenheimer initiated coverage on Palvella Therapeutics with a new price target

    Oppenheimer initiated coverage of Palvella Therapeutics with a rating of Outperform and set a new price target of $85.00

    9/9/25 7:43:25 AM ET
    $PVLA
    Biotechnology: Pharmaceutical Preparations
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    Raymond James initiated coverage on Palvella Therapeutics with a new price target

    Raymond James initiated coverage of Palvella Therapeutics with a rating of Outperform and set a new price target of $54.00

    8/6/25 8:01:45 AM ET
    $PVLA
    Biotechnology: Pharmaceutical Preparations
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    Palvella Therapeutics Reports Third Quarter 2025 Financial Results and Provides Corporate Update

    Palvella's recently expanded rare disease pipeline now comprises QTORIN™-derived product candidates advancing in four serious, rare skin diseases that currently have no FDA-approved therapies Top-line results for fully enrolled Phase 2 TOIVA trial evaluating QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin) for cutaneous venous malformations remain on track for mid-December 2025 Top-line results for fully enrolled Phase 3 SELVA trial evaluating QTORIN™ rapamycin for microcystic lymphatic malformations remain on track for the first quarter of 2026 Expanded QTORIN™ rapamycin's development into clinically significant angiokeratomas, a rare and debilitating lymphatic disease with no FD

    11/11/25 7:30:00 AM ET
    $PVLA
    Biotechnology: Pharmaceutical Preparations
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    Palvella Therapeutics to Present at the Stifel 2025 Healthcare Conference

    WAYNE, Pa., Nov. 06, 2025 (GLOBE NEWSWIRE) -- (NASDAQ:PVLA) Palvella Therapeutics, Inc. (Palvella or "the Company"), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare skin diseases for which there are no U.S. Food and Drug Administration (FDA)-approved therapies, today announced that Wes Kaupinen, Founder and Chief Executive Officer of Palvella, will present at the Stifel 2025 Healthcare Conference on Wednesday, November 12, 2025, at 4:00 p.m. ET. A live webcast of the presentation will be available on the Events and Presentations section of Palvella's website at www.palvellatx.com. An archiv

    11/6/25 7:30:00 AM ET
    $PVLA
    Biotechnology: Pharmaceutical Preparations
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    Palvella Therapeutics Announces New QTORIN™ Product Candidate, QTORIN™ Pitavastatin, for the Treatment of Disseminated Superficial Actinic Porokeratosis (DSAP), a Rare, Chronic, and Pre-Cancerous Genetic Skin Disease with No FDA-Approved Therapies

    DSAP is a premalignant, progressive disease characterized by numerous expanding lesions which significantly impact quality-of-life; no FDA-approved therapies exist for the estimated more than 50,000 diagnosed U.S. patients QTORIN™ pitavastatin has the potential to be the first pathogenesis-directed therapy designed to directly inhibit the mevalonate pathway, the causal driver of DSAP, in the pathogenic skin tissue Company plans to initiate a Phase 2 trial evaluating QTORIN™ pitavastatin for DSAP in the second half of 2026 Company to host webcast conference call today, November 5, 2025 at 8:30am ET WAYNE, Pa., Nov. 05, 2025 (GLOBE NEWSWIRE) -- (NASDAQ:PVLA) Palvella Therapeutics, Inc. (

    11/5/25 6:00:00 AM ET
    $PVLA
    Biotechnology: Pharmaceutical Preparations
    Health Care

    $PVLA
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    Palvella Therapeutics Reports Third Quarter 2025 Financial Results and Provides Corporate Update

    Palvella's recently expanded rare disease pipeline now comprises QTORIN™-derived product candidates advancing in four serious, rare skin diseases that currently have no FDA-approved therapies Top-line results for fully enrolled Phase 2 TOIVA trial evaluating QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin) for cutaneous venous malformations remain on track for mid-December 2025 Top-line results for fully enrolled Phase 3 SELVA trial evaluating QTORIN™ rapamycin for microcystic lymphatic malformations remain on track for the first quarter of 2026 Expanded QTORIN™ rapamycin's development into clinically significant angiokeratomas, a rare and debilitating lymphatic disease with no FD

    11/11/25 7:30:00 AM ET
    $PVLA
    Biotechnology: Pharmaceutical Preparations
    Health Care

    Palvella Therapeutics Announces New QTORIN™ Product Candidate, QTORIN™ Pitavastatin, for the Treatment of Disseminated Superficial Actinic Porokeratosis (DSAP), a Rare, Chronic, and Pre-Cancerous Genetic Skin Disease with No FDA-Approved Therapies

    DSAP is a premalignant, progressive disease characterized by numerous expanding lesions which significantly impact quality-of-life; no FDA-approved therapies exist for the estimated more than 50,000 diagnosed U.S. patients QTORIN™ pitavastatin has the potential to be the first pathogenesis-directed therapy designed to directly inhibit the mevalonate pathway, the causal driver of DSAP, in the pathogenic skin tissue Company plans to initiate a Phase 2 trial evaluating QTORIN™ pitavastatin for DSAP in the second half of 2026 Company to host webcast conference call today, November 5, 2025 at 8:30am ET WAYNE, Pa., Nov. 05, 2025 (GLOBE NEWSWIRE) -- (NASDAQ:PVLA) Palvella Therapeutics, Inc. (

    11/5/25 6:00:00 AM ET
    $PVLA
    Biotechnology: Pharmaceutical Preparations
    Health Care

    Palvella Therapeutics to Host Third Quarter 2025 Financial Results and Corporate Update Conference Call on November 11, 2025

    WAYNE, Pa., Nov. 04, 2025 (GLOBE NEWSWIRE) -- (NASDAQ:PVLA) Palvella Therapeutics, Inc. (Palvella), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare skin diseases for which there are no FDA-approved therapies, today announced that it will report its third quarter 2025 financial results before market open on Tuesday, November 11, 2025. Palvella management will host a conference call for investors at 8:30 a.m. ET on that same day to discuss the results and provide a corporate update. To access the live webcast of the call with slides, please click here or visit the "Events & Presentations" sec

    11/4/25 7:30:00 AM ET
    $PVLA
    Biotechnology: Pharmaceutical Preparations
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    $PVLA
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    Palvella Therapeutics Strengthens Leadership with Appointment of Accomplished Scientist and Biopharmaceutical Executive David W. Osborne, Ph.D. as Chief Innovation Officer

    Co-Founder and former Chief Technical Officer of Arcutis Biotherapeutics brings extensive topical product development experience, including track record of translating science into commercially available therapies Dr. Osborne to guide expansion of QTORIN™ platform, including second QTORIN™ product candidate on track to be announced by year-end 2025 WAYNE, Pa., Sept. 03, 2025 (GLOBE NEWSWIRE) -- (NASDAQ:PVLA) Palvella Therapeutics, Inc. (Palvella or "the Company"), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare genetic skin diseases for which there are no U.S. Food and Drug Administration

    9/3/25 7:30:00 AM ET
    $ARQT
    $PVLA
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    Palvella Therapeutics Strengthens Executive Leadership Team with Appointment of Rare Disease Commercial Veteran Ashley Kline as Chief Commercial Officer

    Ms. Kline to lead Palvella's commercial buildout for planned standalone U.S. launch of QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin) for microcystic lymphatic malformations, a serious, rare, and lifelong genetic disease affecting an estimated more than 30,0000 patients in the U.S., if approved Under Kline's leadership at Dompé, Oxervate®, a first-in-disease topical therapy for rare disease neurotrophic keratitis, scaled to over $500 million in annual U.S. sales while achieving early profitability WAYNE, Pa., May 27, 2025 (GLOBE NEWSWIRE) -- (NASDAQ:PVLA) Palvella Therapeutics, Inc. (Palvella or "the Company"), a clinical-stage biopharmaceutical company focused on developing an

    5/27/25 8:00:00 AM ET
    $PVLA
    Biotechnology: Pharmaceutical Preparations
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