Denali Therapeutics sells review voucher for $195M

Denali Therapeutics Inc. completed the sale of its Rare Pediatric Disease Priority Review Voucher to a large pharmaceutical company on July 27, 2026.

Rhea-AI Filing Summary

Denali Therapeutics Inc. completed the sale of its Rare Pediatric Disease Priority Review Voucher to a large pharmaceutical company on July 27, 2026. The transaction was carried out under an asset purchase agreement dated June 12, 2026.

Denali received gross proceeds of $195.0 million from the buyer upon closing of the sale. The voucher had been obtained when tividenofusp alfa was approved by the U.S. Food and Drug Administration for the treatment of Hunter syndrome (mucopolysaccharidosis type II; MPS II) in March 2026. Denali plans to file the full PRV Transfer Agreement as an exhibit in a subsequent Securities and Exchange Commission filing.

8-K Event Classification

2 items: 2.01, 9.01

2 items

Item 2.01 Completion of Acquisition or Disposition of Assets Financial

The company completed a significant acquisition or sale of business assets.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, or exhibit attachments filed with this report.

Key Figures

PRV sale gross proceeds: $195.0 million PRV Transfer Agreement date: June 12, 2026 Tividenofusp alfa approval timing: March 2026

3 metrics

PRV sale gross proceeds $195.0 million Gross proceeds received upon closing of PRV sale on July 27, 2026

PRV Transfer Agreement date June 12, 2026 Date of asset purchase agreement governing the PRV sale

Tividenofusp alfa approval timing March 2026 Month and year FDA approved tividenofusp alfa for Hunter syndrome

Key Terms

Rare Pediatric Disease Priority Review Voucher, asset purchase agreement, tividenofusp alfa

3 terms

Rare Pediatric Disease Priority Review Voucher regulatory

"completed the previously disclosed sale of its Rare Pediatric Disease Priority Review Voucher"

A rare pediatric disease priority review voucher is a transferable regulatory benefit awarded to a company that wins approval for a drug treating a serious but uncommon childhood illness. It works like a “fast-pass” with regulators: the holder can use it to get an accelerated review of a future drug application or sell the voucher to another company, often for a large sum. Investors care because it can speed time to market or generate immediate cash, boosting potential returns and lowering risk on other programs.

asset purchase agreement financial

"The Sale was completed pursuant to the terms of an asset purchase agreement"

An asset purchase agreement is a legal contract in which a buyer agrees to buy specific assets and contracts of a business rather than buying the company’s stock or ownership. It matters to investors because it determines exactly what is being bought and what liabilities stay behind — like buying the furniture and equipment from a store but not the building or past debts — which affects the deal’s value, taxes and future risk exposure.

tividenofusp alfa medical

"The Company received the PRV when (tividenofusp alfa) was approved"

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What transaction did Denali Therapeutics (DNLI) report in this Form 8-K?

Denali Therapeutics reported completing the sale of its Rare Pediatric Disease Priority Review Voucher to a large pharmaceutical company on July 27, 2026, under an asset purchase agreement dated June 12, 2026, for cash proceeds at closing.

How much did Denali Therapeutics (DNLI) receive from selling its PRV?

Denali received gross proceeds of $195.0 million from the buyer upon closing of the PRV sale. This amount was paid at closing under the PRV Transfer Agreement described in the report.

When and how did Denali Therapeutics (DNLI) obtain its Rare Pediatric Disease PRV?

Denali obtained the Rare Pediatric Disease Priority Review Voucher when tividenofusp alfa was approved by the U.S. Food and Drug Administration in March 2026 for treating Hunter syndrome, also known as mucopolysaccharidosis type II (MPS II).

Who purchased Denali Therapeutics’ (DNLI) Rare Pediatric Disease PRV and when did the sale close?

The PRV was sold to a large pharmaceutical company, which is not named in the report. The sale closed on July 27, 2026, when Denali received the agreed gross proceeds.

Will Denali Therapeutics (DNLI) disclose the full PRV Transfer Agreement terms?

Denali states that the description of the PRV Transfer Agreement is summary only and that the full agreement will be filed as an exhibit to a subsequent Securities and Exchange Commission filing for public review.

AI-generated analysis. How Rhea-AI works. Not financial advice.

Understanding 8-K Material Events →

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

Available on EDGAR 07/28/2026 - 06:03 AM Accepted by SEC EDGAR 07/27/2026 - 09:01 PM Learn about SEC filing dates

0001714899FALSE00017148992026-07-272026-07-27

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported):

July 27, 2026

Denali Therapeutics Inc.

(Exact name of registrant as specified in its charter)

Delaware

001-38311

46-3872213

(State or other jurisdiction of

(Commission

(I.R.S. Employer

incorporation)

File Number)

Identification No.)

161 Oyster Point Blvd.

South San Francisco, California 94080

(Address of principal executive offices, including zip code)

(650) 866-8547

(Registrant’s telephone number, including area code)

Not Applicable

(Former name or former address, if changed since last reports)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐			Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐			Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐			Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐			Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class			Trading Symbol			Name of each exchange on which registered
Common Stock, par value $0.01 per share			DNLI			Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

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 13(a) of the Exchange Act. ¨

Item 2.01    Completion of Acquisition or Disposition of Assets.

On July 27, 2026, Denali Therapeutics Inc. (the “Company”) completed the previously disclosed sale (the “Sale”) of its Rare Pediatric Disease Priority Review Voucher (the “PRV”) to a large pharmaceutical company. The Company received the PRV when AVLAYAHTM (tividenofusp alfa) was approved by the U.S. Food and Drug Administration for the treatment of Hunter syndrome (mucopolysaccharidosis type II; MPS II) in March 2026. The Sale was completed pursuant to the terms of an asset purchase agreement, dated June 12, 2026 (the “PRV Transfer Agreement”). Pursuant to the PRV Transfer Agreement, the Company received gross proceeds of $195.0 million from the buyer upon the closing of the Sale.

The foregoing description of the PRV Transfer Agreement does not purport to be complete and is qualified in its entirety by the full text of the PRV Transfer Agreement, which will be filed as an exhibit to a subsequent filing with the Securities and Exchange Commission.

Item 9.01    Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.						Description
104						Cover Page Interactive Data File (formatted as Inline XBRL)

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

						DENALI THERAPEUTICS INC.
Date:			July 27, 2025			By:			/s/ Alexander O. Schuth
									Alexander O. Schuth, M.D.
									Chief Operating and Financial Officer

Filing Exhibits & Attachments

4 documents

Other Documents

• EX-101 XBRL TAXONOMY EXTENSION SCHEMA DOCUMENT 2.0 KB
• EX-101 XBRL TAXONOMY EXTENSION DEFINITION LINKBASE DOCUMENT 4.2 KB
• EX-101 XBRL TAXONOMY EXTENSION LABEL LINKBASE DOCUMENT 22.9 KB
• EX-101 XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE DOCUMENT 15.4 KB