Every 8-K that Denali Therapeutics Inc. (DNLI) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow DNLI and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full DNLI filings page.
Denali Therapeutics reported second-quarter 2026 results highlighted by its first commercial revenue and a significantly strengthened cash position. Net product revenue was $3.6 million from the U.S. launch of AVLAYAH for Hunter syndrome, with cost of goods sold of $0.1 million and a net loss of $127.6 million. Research and development expenses were $97.0 million, down from $102.7 million a year earlier, while selling, general and administrative expenses rose to $36.3 million, reflecting commercial launch investments. Intangible asset amortization reached $0.7 million following AVLAYAH’s FDA approval.
Cash, cash equivalents and marketable securities were approximately $940.0 million as of June 30, 2026; after receiving $195.0 million in gross proceeds from the sale of a Priority Review Voucher in July, pro forma balances exceeded $1.1 billion. AVLAYAH’s U.S. launch generated strong initial uptake, with projected third-quarter 2026 AVLAYAH net product revenue of $10.0 million to $12.0 million and broadening payer coverage. The pipeline advanced with Phase 3 start-up for zafinofusp alfa in Sanfilippo syndrome type A, completion of enrollment in the Phase 1/2 DNL593 FTD-GRN study, and multiple Alzheimer’s, lysosomal storage disease and Pompe programs progressing, while the DNL151 LUMA study in early-stage Parkinson’s disease did not meet endpoints and development in idiopathic disease was discontinued.
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.
Denali Therapeutics Inc. entered a definitive asset purchase agreement to sell its Rare Pediatric Disease Priority Review Voucher for $195 million in cash, with closing subject to customary conditions including expiration of the Hart-Scott-Rodino waiting period. The voucher was awarded after the FDA’s accelerated approval of AVLAYAH, an enzyme replacement therapy for Hunter syndrome, in March 2026. Denali states that proceeds are intended to support its TransportVehicle-enabled clinical portfolio for lysosomal storage disorders and neurodegenerative diseases, building on its blood-brain barrier-crossing platform and expanding programs across multiple central nervous system indications.
Denali Therapeutics Inc. reported the results of its annual stockholder meeting held on June 3, 2026. Of the 158,675,498 shares of common stock outstanding as of April 9, 2026, 137,986,127 were represented in person or by proxy, representing 86.96% of shares entitled to vote.
Stockholders elected three Class III directors to serve until the 2029 annual meeting: Jennifer Cook, David Schenkein, M.D., and Ryan Watts, Ph.D. Each received more votes “for” than “withheld,” with Ryan Watts, Ph.D. receiving 121,220,572 votes in favor.
Stockholders also ratified the appointment of Ernst & Young LLP as independent registered public accounting firm for the fiscal year ending December 31, 2026, with 137,516,267 votes for, 420,305 against, and 49,555 abstentions. In an advisory vote, stockholders approved the compensation of the named executive officers, with 117,038,745 votes for and 7,088,810 against.
Denali Therapeutics Inc. and Biogen reported topline results from the Phase 2b LUMA study of BIIB122 (DNL151) in early-stage Parkinson’s disease. The study did not meet its primary endpoint of time to confirmed worsening on the MDS-UPDRS Part II and III combined score, and secondary endpoints also showed no benefit versus placebo.
Based on these results, the companies will discontinue development of BIIB122 in idiopathic Parkinson’s disease. Denali will continue to run the separate Phase 2a BEACON study in individuals with Parkinson’s disease who carry a pathogenic LRRK2 variant, with data anticipated in the first half of 2027.
Denali Therapeutics reported first quarter 2026 results alongside a major pipeline milestone. The FDA granted accelerated approval for AVLAYAH, a TransportVehicle-enabled therapy for Hunter syndrome, and Denali has begun its U.S. commercial launch with initial patients treated and distribution, support hub, and payer engagement in place.
Net loss was $128.4 million for the quarter ended March 31, 2026, slightly improved from $133.0 million a year earlier, as research and development expenses declined to $103.8 million from $116.2 million. General and administrative expenses rose to $33.5 million, reflecting hiring to support AVLAYAH’s launch.
Denali ended the quarter with approximately $1.05 billion in cash, cash equivalents and marketable securities, helped by $200 million in gross proceeds from a synthetic royalty funding agreement with Royalty Pharma. The company also received a Rare Pediatric Disease Priority Review Voucher and continues to advance a broad neurological and lysosomal disorder pipeline with multiple mid-stage trials and key data readouts expected between 2026 and 2027.
Denali Therapeutics reports that Takeda will terminate their collaboration agreement to co-develop and co-commercialize the investigational therapy DNL593 for GRN-related frontotemporal dementia. The decision is based on strategic considerations and not on efficacy or safety data.
The termination becomes effective 60 days after the April 3, 2026 notice, at which point all rights in the DNL593 program and its intellectual property will revert to Denali, and Denali will have no further financial obligations to Takeda. Denali plans to continue independent clinical development of DNL593 and expects results from an ongoing Phase 1/2 study by the end of 2026.
Denali Therapeutics Inc. reported that on March 27, 2026 it received $200.0 million in gross proceeds at the closing of its previously disclosed synthetic royalty funding agreement with Royalty Pharma. The closing occurred after the U.S. Food and Drug Administration granted accelerated approval to tividenofusp alfa on March 24, 2026.
Denali Therapeutics reported that the U.S. FDA granted accelerated approval for AVLAYAH™ (tividenofusp alfa-eknm), an enzyme replacement therapy for neurologic manifestations of Hunter syndrome (MPS II) in pediatric patients weighing at least 5 kg prior to advanced neurologic impairment.
The drug is specifically engineered to cross the blood-brain barrier using Denali’s TransportVehicle platform and showed a 91% reduction in cerebrospinal fluid heparan sulfate by week 24 in a Phase 1/2 trial, with most treated patients reaching levels seen in individuals without Hunter syndrome. Continued approval may depend on confirmatory benefit in the ongoing Phase 2/3 COMPASS study, and the FDA granted Denali a Rare Pediatric Disease Priority Review Voucher in connection with the approval.
Denali Therapeutics reported a wider net loss of $128.5 million for the fourth quarter and $512.5 million for full-year 2025, compared with losses of $114.8 million and $422.8 million in 2024. Net loss per share was $0.73 for the quarter and $2.97 for the year.
Research and development expenses were $97.9 million in the quarter and $418.8 million for the year, while general and administrative costs rose to $39.5 million and $136.6 million, mainly to prepare for the potential launch of tividenofusp alfa for Hunter syndrome. Denali ended 2025 with $966.2 million in cash, cash equivalents and marketable securities, helped by a $275.0 million synthetic royalty funding deal with Royalty Pharma and approximately $200.0 million in net proceeds from a public offering.
The company highlighted launch readiness for tividenofusp alfa ahead of the April 5, 2026 PDUFA decision and encouraging biomarker data for DNL126 in Sanfilippo syndrome type A. Multiple additional programs advanced across Alzheimer’s disease, Pompe disease, frontotemporal dementia, Parkinson’s disease and ulcerative colitis, with several key clinical readouts expected in 2026.
Denali Therapeutics Inc. filed a current report to share that it has issued a press release outlining an update on its programs and expected milestones for 2026, and its planned participation in the 44th Annual J.P. Morgan Healthcare Conference. The press release is provided as Exhibit 99.1 and is incorporated by reference. The company notes that the information under Regulation FD in this report, including Exhibit 99.1, is being furnished rather than filed, which limits how it is treated under securities law.
Denali Therapeutics (DNLI) reported that it issued a press release announcing financial results for the third quarter ended September 30, 2025. The company disclosed this under Item 2.02 and furnished the full press release as Exhibit 99.1.
The materials in Item 2.02 and Item 9.01 (including Exhibit 99.1) are designated as furnished, not filed, under the Exchange Act. The filing also lists the Inline XBRL cover page as Exhibit 104.
Denali Therapeutics (DNLI) reported that the FDA has extended the PDUFA action date for its Biologics License Application seeking accelerated approval of tividenofusp alfa to treat MPS II (Hunter syndrome). The decision date moved from January 5, 2026 to April 5, 2026.
According to the company, the FDA granted the extension to allow review of updated clinical pharmacological information, which was classified as a Major Amendment to the BLA. The update was furnished under Regulation FD, and a related press release was included as an exhibit.
Denali Therapeutics Inc. furnished a Form 8-K reporting that on August 11, 2025 the company issued a press release announcing its financial results for the quarter ended June 30, 2025. The press release is attached as Exhibit 99.1 and the filing includes an Inline XBRL cover page as Exhibit 104. The filing states that the information is furnished and not deemed to be "filed" for purposes of Section 18 of the Exchange Act and is not incorporated by reference except by specific reference. The report identifies the registrant as Denali Therapeutics Inc. (DNLI), incorporated in Delaware and listed on the Nasdaq Global Select Market.
Denali Therapeutics Inc. (Nasdaq: DNLI) filed a Form 8-K to disclose a material regulatory milestone. On July 7, 2025, the company announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to Denali’s Biologics License Application (BLA) for tividenofusp alfa, its investigational therapy for Hunter syndrome (MPS II). The news was released via a press release attached as Exhibit 99.1. No financial figures, earnings data, or transactions were included in the filing. The Priority Review designation signals that the agency will evaluate the submission under an expedited pathway, underscoring the product’s potential importance for an underserved patient population. Other than routine exhibit listings and signature blocks, the 8-K contains no additional disclosures.