• Live Feeds
    • Press Releases
    • Insider Trading
    • FDA Approvals
    • Analyst Ratings
    • Insider Trading
    • SEC filings
    • Market insights
  • Analyst Ratings
  • Alerts
  • Subscriptions
  • Settings
  • RSS Feeds
Quantisnow Logo
  • Live Feeds
    • Press Releases
    • Insider Trading
    • FDA Approvals
    • Analyst Ratings
    • Insider Trading
    • SEC filings
    • Market insights
  • Analyst Ratings
  • Alerts
  • Subscriptions
  • Settings
  • RSS Feeds
PublishGo to App
    Quantisnow Logo

    © 2025 quantisnow.com
    Democratizing insights since 2022

    Services
    Live news feedsRSS FeedsAlertsPublish with Us
    Company
    AboutQuantisnow PlusContactJobsAI superconnector for talent & startupsNEWLLM Arena
    Legal
    Terms of usePrivacy policyCookie policy

    SEC Form S-8 filed by Denali Therapeutics Inc.

    2/27/25 4:13:53 PM ET
    $DNLI
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care
    Get the next $DNLI alert in real time by email
    S-8 1 forms-82025.htm S-8 Document

    As filed with the Securities and Exchange Commission on February 27, 2025
    Registration No. 333-
        
    UNITED STATES
    SECURITIES AND EXCHANGE COMMISSION
    Washington, D.C. 20549
     ________________________________________
    FORM S-8
    REGISTRATION STATEMENT
    UNDER
    THE SECURITIES ACT OF 1933
     ________________________________________
    DENALI THERAPEUTICS INC.
    (Exact name of registrant as specified in its charter)
    Delaware46-3872213
    (State or other jurisdiction of
    incorporation or organization)
    (I.R.S. Employer
    Identification No.)
    161 Oyster Point Blvd.
    South San Francisco, CA, 94080
    (650) 866-8547
    (Address of principal executive offices, including zip code)
     ________________________________________
    2017 Equity Incentive Plan
    2017 Employee Stock Purchase Plan
    (Full title of the plan)
     ________________________________________ 
    Ryan J. Watts, Ph.D.
    President and Chief Executive Officer
    Denali Therapeutics Inc.
    161 Oyster Point Blvd.
    South San Francisco, California 94080
    (650) 866-8547
    (Name, address and telephone number, including area code, of agent for service)
      ________________________________________ 
    Copies to:
    Tony Jeffries
    Jennifer Knapp
    Wilson Sonsini Goodrich & Rosati, P.C.
    650 Page Mill Road
    Palo Alto, California 94304
    (650) 493-9300
    Alexander O. Schuth, M.D.
    Chief Operating and Financial Officer
    Denali Therapeutics Inc.
    161 Oyster Point Blvd.
    South San Francisco, California 94080
    (650) 866-8547
      ________________________________________  

    Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of "large accelerated filer," "accelerated filer," "smaller reporting company" and "emerging growth company" in Rule 12b-2 of the Exchange Act.
    Large accelerated filer x
    Accelerated filer ¨
    Non-accelerated filer ¨
    Smaller reporting company ¨
    Emerging growth company ¨
    If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. ¨
    ________________________________________ 

     




    PART I
    INFORMATION REQUIRED IN THE PROSPECTUS
    The information specified in Item 1 and Item 2 of Part I of Form S-8 is omitted from this Registration Statement on Form S-8 (the "Registration Statement") in accordance with the provisions of Rule 428 under the Securities Act and the introductory note to Part I of Form S-8. The documents containing the information specified in Part I of Form S-8 will be delivered to the participants in the equity benefit plans covered by this Registration Statement as specified by Rule 428(b)(1) under the Securities Act.
    PART II
    INFORMATION REQUIRED IN REGISTRATION STATEMENT
    Item 3.    Incorporation of Documents by Reference.
    Denali Therapeutics Inc. (the "Registrant") hereby incorporates by reference into this Registration Statement the following documents previously filed with the Securities and Exchange Commission (the "Commission"):
    (1) The Registrant’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the Commission on February 27, 2025 pursuant to Section 13(a) of the Securities Exchange Act of 1934, as amended (the "Exchange Act");
    (2) All other reports filed with the Commission pursuant to Sections 13(a) or 15(d) of the Exchange Act since the end of the fiscal year covered by the Registrant’s Annual Report referred to in (1) above; and
    (3) The description of the Registrant’s Common Stock contained in the Company’s Registration Statement on Form 8-A (File No 001-38311) filed with the Commission on November 30, 2017, pursuant to Section 12(b) of the Exchange Act, including any amendment or report filed for the purpose of updating such description.
    All documents filed by the Registrant pursuant to Sections 13(a), 13(c), 14 and 15(d) of the Exchange Act on or after the date of this Registration Statement and prior to the filing of a post-effective amendment to this Registration Statement that indicates that all securities offered have been sold or that deregisters all securities then remaining unsold shall be deemed to be incorporated by reference in this Registration Statement and to be part hereof from the date of filing of such documents; provided, however, that documents or information deemed to have been furnished and not filed in accordance with the rules of the Commission shall not be deemed incorporated by reference into this Registration Statement. Any statement contained in a document incorporated or deemed to be incorporated by reference herein shall be deemed to be modified or superseded for purposes of this Registration Statement to the extent that a statement contained herein or in any subsequently filed document which also is deemed to be incorporated by reference herein modifies or supersedes such statement. Any such statement so modified or superseded shall not be deemed, except as so modified or superseded, to constitute a part of this Registration Statement.
    Item 4.    Description of Securities.
    Not applicable.
    Item 5.    Interests of Named Experts and Counsel.
    Not applicable.



    Item 6.    Indemnification of Directors and Officers.
    Section 145 of the Delaware General Corporation Law empowers a corporation to indemnify its directors and officers and to purchase insurance with respect to liability arising out of their capacity or status as directors and officers, provided that the person acted in good faith and in a manner the person reasonably believed to be in our best interests, and, with respect to any criminal action, had no reasonable cause to believe the person’s actions were unlawful. The Delaware General Corporation Law further provides that the indemnification permitted thereunder shall not be deemed exclusive of any other rights to which the directors and officers may be entitled under the corporation’s bylaws, any agreement, a vote of stockholders or otherwise. The certificate of incorporation of the registrant to be in effect upon the completion of this offering provides for the indemnification of the registrant’s directors and officers to the fullest extent permitted under the Delaware General Corporation Law. In addition, the bylaws of the registrant to be in effect upon the completion of this offering require the registrant to fully indemnify any person who was or is a party or is threatened to be made a party to any threatened, pending or completed action, suit or proceeding (whether civil, criminal, administrative or investigative) by reason of the fact that such person is or was a director or officer of the registrant, or is or was a director or officer of the registrant serving at the registrant’s request as a director, officer, employee or agent of another corporation, partnership, joint venture, trust or other enterprise, against expenses (including attorney’s fees), judgments, fines and amounts paid in settlement actually and reasonably incurred by such person in connection with such action, suit or proceeding, to the fullest extent permitted by applicable law.
    Section 102(b)(7) of the Delaware General Corporation Law permits a corporation to provide in its certificate of incorporation that a director of the corporation shall not be personally liable to the corporation or its stockholders for monetary damages for breach of fiduciary duty as a director, except (1) for any breach of the director’s duty of loyalty to the corporation or its stockholders, (2) for acts or omissions not in good faith or which involve intentional misconduct or a knowing violation of law, (3) for payments of unlawful dividends or unlawful stock repurchases or redemptions or (4) for any transaction from which the director derived an improper personal benefit. The registrant’s certificate of incorporation to be in effect upon the completion of this offering provides that the registrant’s directors shall not be personally liable to it or its stockholders for monetary damages for breach of fiduciary duty as a director and that if the Delaware General Corporation Law is amended to authorize corporate action further eliminating or limiting the personal liability of directors, then the liability of the registrant’s directors shall be eliminated or limited to the fullest extent permitted by the Delaware General Corporation Law, as so amended.
    Section 174 of the Delaware General Corporation Law provides, among other things, that a director who willfully or negligently approves of an unlawful payment of dividends or an unlawful stock purchase or redemption may be held liable for such actions. A director who was either absent when the unlawful actions were approved, or dissented at the time, may avoid liability by causing his or her dissent to such actions to be entered in the books containing minutes of the meetings of the board of directors at the time such action occurred or immediately after such absent director receives notice of the unlawful acts.
    As permitted by the Delaware General Corporation Law, the registrant has entered into separate indemnification agreements with each of the registrant’s directors and certain of the registrant’s officers which require the registrant, among other things, to indemnify them against certain liabilities which may arise by reason of their status as directors, officers or certain other employees.
    The registrant expects to obtain and maintain insurance policies under which its directors and officers are insured, within the limits and subject to the limitations of those policies, against certain expenses in connection with the defense of, and certain liabilities which might be imposed as a result of, actions, suits or proceedings to which they are parties by reason of being or having been directors or officers. The coverage provided by these policies may apply whether or not the registrant would have the power to indemnify such person against such liability under the provisions of the Delaware General Corporation Law.
    These indemnification provisions and the indemnification agreements entered into between the registrant and the registrant’s officers and directors may be sufficiently broad to permit indemnification of the registrant’s officers and directors for liabilities (including reimbursement of expenses incurred) arising under the Securities Act of 1933, as amended.
    The underwriting agreement between the registrant and the underwriters to be filed as Exhibit 1.1 to this registration statement provides for the indemnification by the underwriters of the registrant’s directors and officers and certain controlling persons against specified liabilities, including liabilities under the Securities Act with respect to information provided by the underwriters specifically for inclusion in the registration statement.



    Item 7.    Exemption from Registration Claimed.
    Not applicable.
    Item 8.    Exhibits.
                  
     
     
    Incorporated by Reference 
    Exhibit
    Number 
    Description 
    Form
    File No. 
    Exhibit
    Filing Date 
    4.1
    Specimen Common Stock Certificate of the Registrant
    S-1/A333-2215224.211/27/2017
    4.2
    2017 Equity Incentive Plan and forms of agreements thereunder
    S-1/A333-22152210.311/27/2017
    4.3
    2017 Employee Stock Purchase Plan and form of agreement thereunder
    S-1/A333-22152210.412/7/2017
    5.1
    Opinion of Wilson Sonsini Goodrich & Rosati, Professional Corporation
    ———Filed herewith
    23.1
    Consent of Independent Registered Public Accounting Firm
    ———Filed herewith
    23.2
    Consent of Wilson Sonsini Goodrich & Rosati, Professional Corporation (contained in Exhibit 5.1 hereto)
    ———Filed herewith
    24.1
    Power of Attorney (contained on signature page hereto)
    107.1
    Filing Fee Table
    ———Filed herewith
    Item 9.    Undertakings.
    A.    The undersigned Registrant hereby undertakes that:
    (1)    It will file, during any period in which offers or sales are being made, a post-effective amendment to this Registration Statement:
    (i)    To include any prospectus required by Section 10(a)(3) of the Securities Act;
    (ii)    To reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than a 20 percent change in the maximum aggregate offering price set forth in the "Calculation of Registration Fee" table in the effective registration statement; and
     
    (iii)    To include any material information with respect to the plan of distribution not previously disclosed in the Registration Statement or any material change to such information in the Registration Statement.
    Provided, however, that paragraphs (A)(1)(i) and (A)(1)(ii) do not apply if the information required to be included in a post-effective amendment by those paragraphs is contained in periodic reports filed with or furnished to the Commission by the Registrant pursuant to Section 13 or Section 15(d) of the Exchange Act that are incorporated by reference in this Registration Statement.
    (2)    For the purpose of determining any liability under the Securities Act, each such post-effective amendment shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.
    (3)    It will remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering.



    B.    The undersigned Registrant hereby undertakes that, for purposes of determining any liability under the Securities Act, each filing of the Registrant’s annual report pursuant to Section 13(a) or Section 15(d) of the Exchange Act (and, where applicable, each filing of an employee benefit plan’s annual report pursuant to Section 15(d) of the Exchange Act) that is incorporated by reference in the Registration Statement shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.
    C.    Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of the Registrant pursuant to the foregoing provisions, or otherwise, the Registrant has been advised that in the opinion of the Commission such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the Registrant of expenses incurred or paid by a director, officer or controlling person of the Registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the Registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue.
     




    SIGNATURES
    Pursuant to the requirements of the Securities Act of 1933, as amended, the Registrant certifies that it has reasonable grounds to believe that it meets all of the requirements for filing on Form S-8 and has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of South San Francisco, State of California, on the 27th day of February 2025.
    DENALI THERAPEUTICS INC.
    By:/s/ Ryan J. Watts 
     Ryan J. Watts, Ph.D.
     President and Chief Executive Officer
    POWER OF ATTORNEY
    KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below hereby constitutes and appoints Ryan J. Watts, Ph.D. and Alexander O. Schuth, M.D., and each of them, as such individual's true and lawful attorney-in-fact and agent with full power of substitution, for such individual in any and all capacities, to sign any and all amendments to this registration statement on Form S-8 (including post-effective amendments), and to file the same, with all exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorney-in-fact, proxy and agent full power and authority to do and perform each and every act and thing requisite and necessary to be done in connection therewith, as fully for all intents and purposes as such individual might or could do in person, hereby ratifying and confirming all that said attorney-in-fact, proxy and agent, or the individual's substitute, may lawfully do or cause to be done by virtue hereof.
    Pursuant to the requirements of the Securities Act of 1933, this registration statement on Form S-8 has been signed by the following persons in the capacities and on the dates indicated.  




    Pursuant to the requirements of the Securities Act of 1933, this registration statement on Form S-8 has been signed by the following persons in the capacities and on the dates indicated.
    SignatureTitleDate
      /s/ Ryan J. Watts
    President, Chief Executive Officer and Director
    (Principal Executive Officer)
    February 27, 2025
    Ryan J. Watts, Ph.D.
     /s/ Alexander O. Schuth
    Chief Operating and Financial Officer
    (Principal Financial and Accounting Officer)
    February 27, 2025
    Alexander O. Schuth, M.D.
     /s/ Vicki SatoChairperson of our Board of DirectorsFebruary 27, 2025
    Vicki Sato, Ph.D.
    /s/ Jennifer CookDirectorFebruary 27, 2025
    Jennifer Cook
    /s/ Jay FlatleyDirectorFebruary 27, 2025
    Jay Flatley
    /s/ Erik HarrisDirectorFebruary 27, 2025
    Erik Harris
    /s/ Peter KleinDirectorFebruary 27, 2025
    Peter Klein
     /s/ Steve E. KrognesDirectorFebruary 27, 2025
    Steve E. Krognes
    /s/ David SchenkeinDirectorFebruary 27, 2025
    David Schenkein, M.D.
    /s/ Marc Tessier-LavigneDirectorFebruary 27, 2025
    Marc Tessier-Lavigne, Ph.D.
    /s/ Nancy A. Thornberry
    DirectorFebruary 27, 2025
    Nancy A. Thornberry


    Get the next $DNLI alert in real time by email

    Crush Q1 2026 with the Best AI Superconnector

    Stay ahead of the competition with Standout.work - your AI-powered talent-to-startup matching platform.

    AI-Powered Inbox
    Context-aware email replies
    Strategic Decision Support
    Get Started with Standout.work

    Recent Analyst Ratings for
    $DNLI

    DatePrice TargetRatingAnalyst
    4/10/2025Neutral → Overweight
    Cantor Fitzgerald
    3/7/2025$41.00 → $33.00Overweight
    Morgan Stanley
    2/11/2025$31.00Buy
    Deutsche Bank
    1/7/2025$31.00Outperform
    Robert W. Baird
    1/3/2025Outperform
    William Blair
    12/16/2024$37.00Hold → Buy
    Stifel
    10/10/2024Mkt Perform
    Raymond James
    10/7/2024Overweight → Neutral
    Cantor Fitzgerald
    More analyst ratings

    $DNLI
    Insider Trading

    Insider transactions reveal critical sentiment about the company from key stakeholders. See them live in this feed.

    View All

    Director Van Hauwermeiren Timothy was granted 10,632 shares (SEC Form 4)

    4 - Denali Therapeutics Inc. (0001714899) (Issuer)

    11/6/25 8:16:39 PM ET
    $DNLI
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care

    SEC Form 3 filed by new insider Van Hauwermeiren Timothy

    3 - Denali Therapeutics Inc. (0001714899) (Issuer)

    11/6/25 8:15:55 PM ET
    $DNLI
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care

    President and CEO Watts Ryan J. gifted 50,000 shares (SEC Form 4)

    4 - Denali Therapeutics Inc. (0001714899) (Issuer)

    9/5/25 4:43:51 PM ET
    $DNLI
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care

    $DNLI
    Press Releases

    Fastest customizable press release news feed in the world

    View All

    Denali Therapeutics Announces Pricing of Public Offering of Common Stock and Pre-Funded Warrants

    SOUTH SAN FRANCISCO, Calif., Dec. 10, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ:DNLI) today announced the pricing of its underwritten public offering of 9,142,857 shares of its common stock at a price to the public of $17.50 per share and, in lieu of common stock to certain investors, pre-funded warrants to purchase 2,285,714 shares of common stock at a price of $17.49 per pre-funded warrant, which represents the per share public offering price of each share of common stock less the $0.01 per share exercise price for each pre-funded warrant. All of the shares and pre-funded warrants are to be sold by Denali Therapeutics. In addition, Denali Therapeutics has granted the unde

    12/10/25 12:14:26 AM ET
    $DNLI
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care

    Denali Therapeutics Announces Proposed Offering of Common Stock and Pre-Funded Warrants

    SOUTH SAN FRANCISCO, Calif., Dec. 09, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ:DNLI) today announced that it intends to offer and sell $200 million of shares of its common stock and, in lieu of common stock to certain investors, pre-funded warrants to purchase shares of its common stock in an underwritten public offering. In addition, Denali Therapeutics intends to grant the underwriters a 30-day option to purchase up to an additional $30 million of shares of common stock. All of the shares of common stock and pre-funded warrants to be sold in the proposed offering will be sold by Denali Therapeutics. The proposed offering is subject to market and other conditions, and the

    12/9/25 4:01:00 PM ET
    $DNLI
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care

    Royalty Pharma and Denali Therapeutics Announce $275 Million Royalty Funding Agreement

    NEW YORK and SOUTH SAN FRANCISCO, Calif., Dec. 04, 2025 (GLOBE NEWSWIRE) -- Royalty Pharma plc (NASDAQ:RPRX) and Denali Therapeutics, Inc. (NASDAQ:DNLI) today announced a $275 million synthetic royalty funding agreement based on future net sales of tividenofusp alfa. Tividenofusp alfa is Denali's lead investigational TransportVehicleTM-enabled enzyme replacement therapy for the treatment of mucopolysaccharidosis type II (MPS II, or Hunter syndrome). A Biologics License Application (BLA) for accelerated approval of tividenofusp alfa is under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target date of April 5, 2026. "We are delighted t

    12/4/25 7:10:00 AM ET
    $DNLI
    $RPRX
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care
    Biotechnology: Pharmaceutical Preparations

    $DNLI
    Analyst Ratings

    Analyst ratings in real time. Analyst ratings have a very high impact on the underlying stock. See them live in this feed.

    View All

    Denali Therapeutics upgraded by Cantor Fitzgerald

    Cantor Fitzgerald upgraded Denali Therapeutics from Neutral to Overweight

    4/10/25 8:28:39 AM ET
    $DNLI
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care

    Morgan Stanley resumed coverage on Denali Therapeutics with a new price target

    Morgan Stanley resumed coverage of Denali Therapeutics with a rating of Overweight and set a new price target of $33.00 from $41.00 previously

    3/7/25 8:22:55 AM ET
    $DNLI
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care

    Deutsche Bank initiated coverage on Denali Therapeutics with a new price target

    Deutsche Bank initiated coverage of Denali Therapeutics with a rating of Buy and set a new price target of $31.00

    2/11/25 7:04:19 AM ET
    $DNLI
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care

    $DNLI
    SEC Filings

    View All

    Denali Therapeutics Inc. filed SEC Form 8-K: Entry into a Material Definitive Agreement, Other Events, Financial Statements and Exhibits

    8-K - Denali Therapeutics Inc. (0001714899) (Filer)

    12/10/25 5:21:33 PM ET
    $DNLI
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care

    SEC Form 424B5 filed by Denali Therapeutics Inc.

    424B5 - Denali Therapeutics Inc. (0001714899) (Filer)

    12/10/25 5:20:33 PM ET
    $DNLI
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care

    SEC Form 424B5 filed by Denali Therapeutics Inc.

    424B5 - Denali Therapeutics Inc. (0001714899) (Filer)

    12/9/25 4:22:26 PM ET
    $DNLI
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care

    $DNLI
    Large Ownership Changes

    This live feed shows all institutional transactions in real time.

    View All

    SEC Form SC 13G filed by Denali Therapeutics Inc.

    SC 13G - Denali Therapeutics Inc. (0001714899) (Subject)

    11/12/24 12:52:28 PM ET
    $DNLI
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care

    Amendment: SEC Form SC 13G/A filed by Denali Therapeutics Inc.

    SC 13G/A - Denali Therapeutics Inc. (0001714899) (Subject)

    11/12/24 9:55:15 AM ET
    $DNLI
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care

    Amendment: SEC Form SC 13G/A filed by Denali Therapeutics Inc.

    SC 13G/A - Denali Therapeutics Inc. (0001714899) (Subject)

    11/8/24 10:52:39 AM ET
    $DNLI
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care

    $DNLI
    Financials

    Live finance-specific insights

    View All

    Royalty Pharma and Denali Therapeutics Announce $275 Million Royalty Funding Agreement

    NEW YORK and SOUTH SAN FRANCISCO, Calif., Dec. 04, 2025 (GLOBE NEWSWIRE) -- Royalty Pharma plc (NASDAQ:RPRX) and Denali Therapeutics, Inc. (NASDAQ:DNLI) today announced a $275 million synthetic royalty funding agreement based on future net sales of tividenofusp alfa. Tividenofusp alfa is Denali's lead investigational TransportVehicleTM-enabled enzyme replacement therapy for the treatment of mucopolysaccharidosis type II (MPS II, or Hunter syndrome). A Biologics License Application (BLA) for accelerated approval of tividenofusp alfa is under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target date of April 5, 2026. "We are delighted t

    12/4/25 7:10:00 AM ET
    $DNLI
    $RPRX
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care
    Biotechnology: Pharmaceutical Preparations

    Denali Therapeutics and Royalty Pharma Announce $275 Million Royalty Funding Agreement

    SOUTH SAN FRANCISCO, Calif. and NEW YORK, Dec. 04, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ:DNLI) and Royalty Pharma plc (NASDAQ:RPRX) today announced a $275 million synthetic royalty funding agreement based on future net sales of tividenofusp alfa. Tividenofusp alfa is Denali's lead investigational TransportVehicle™-enabled enzyme replacement therapy for the treatment of mucopolysaccharidosis type II (MPS II, or Hunter syndrome). A Biologics License Application (BLA) for accelerated approval of tividenofusp alfa is under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target date of April 5, 2026. "We are pleased t

    12/4/25 7:00:00 AM ET
    $DNLI
    $RPRX
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care
    Biotechnology: Pharmaceutical Preparations

    $DNLI
    Leadership Updates

    Live Leadership Updates

    View All

    Denali Therapeutics Reports Third Quarter 2025 Financial Results and Business Highlights

    Tividenofusp alfa BLA review process for accelerated approval for MPS II continues with productive engagement with the FDA; commercial launch preparations on trackDNL126 Phase 1/2 study enrollment completed, supporting an accelerated approval path in MPS IIIATwo new regulatory applications submitted to initiate clinical studies with DNL628 (OTV:MAPT) for Alzheimer's disease and DNL952 (ETV:GAA) for Pompe diseaseTim Van Hauwermeiren, CEO of argenx, to join Denali's Board of DirectorsCarole Ho, M.D., Chief Medical Officer, departing company; Peter Chin, M.D., assuming role of Acting CMO and Head of DevelopmentDenali to host Investor Day on December 4, 2025 SOUTH SAN FRANCISCO, Calif., Nov. 0

    11/6/25 4:01:00 PM ET
    $DNLI
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care

    Denali Therapeutics Announces Board and Executive Leadership Updates

    SOUTH SAN FRANCISCO, Calif., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (NASDAQ:DNLI) today announced updates to its Board of Directors and executive leadership team. Tim Van Hauwermeiren has been appointed to Denali's Board of Directors. Mr. Van Hauwermeiren is co-founder and Chief Executive Officer of argenx. Carole Ho, M.D., who has served as Denali's Chief Medical Officer and Head of Development since 2015, will be departing to join Eli Lilly and Company as Executive Vice President, and President of Lilly Neuroscience. Peter Chin, M.D., is assuming the role of Acting Chief Medical Officer and Head of Development at Denali. Dr. Chin is a neurologist and joined Denali in

    11/6/25 4:00:00 PM ET
    $DNLI
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care

    Flagship Appoints Amy O'Shea as CEO-Partner and Chief Executive Officer of Invaio Sciences

    O'Shea is a Seasoned Global Executive with more than 20 Years' Experience across the Agriculture, Food and Pharmaceutical Industries CAMBRIDGE, Mass., April 8, 2024 /PRNewswire/ -- Flagship Pioneering, the bioplatform innovation company, and Invaio Sciences, a bioplatform company accelerating the leap to nature-positive agriculture, today announced that Amy O'Shea has joined Flagship Pioneering as CEO-Partner and Invaio as Chief Executive Officer and Board Director. O'Shea is a seasoned global executive with more than 20 years' experience across the agriculture, food, and phar

    4/8/24 8:00:00 AM ET
    $DNLI
    $FHTX
    $MCRB
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care
    Biotechnology: Pharmaceutical Preparations