Denali Therapeutics Inc. SEC Filings

Denali Therapeutics Inc. officer Alexander O. Schuth reported selling 2,857 shares of common stock on 2026-08-11 at $25.07 per share, with a footnote stating the shares were sold to satisfy tax obligations related to previously vested RSUs. Following this transaction, he directly holds 281,763 shares, including 135,475 unvested RSUs and 1,792 shares acquired under the ESPP on June 1, 2026, and indirectly holds 523,749 shares through The Schuth Family Trust, where he serves as trustee. The filing indicates the transaction was not made under a Rule 10b5-1 trading plan.

A holder of Denali Therapeutics Inc. common stock submitted a notice to sell 2,857 shares through Morgan Stanley Smith Barney LLC Executive Financial Services on the NASDAQ market. The shares relate to a restricted stock lapse dated 08/10/2026 and are tied to equity compensation, with an indicated aggregate value of $71,623.51 as of 08/11/2026.

Denali Therapeutics reported Q2 2026 results as it transitioned to commercialization. Net product revenue from AVLAYAH, its first approved therapy for Hunter syndrome, was $3.6 million for both the quarter and first half, following FDA accelerated approval in March and U.S. launch in April.

Net loss was $127.6 million for the quarter and $256.0 million for the first six months of 2026. Research and development expense fell to $97.0 million in the quarter and $200.9 million year to date, down 6% and 8% versus 2025, while selling, general and administrative expense rose with commercialization efforts. Cash and cash equivalents were $201.5 million at June 30, 2026, with short- and long-term marketable securities of $508.9 million and $229.5 million, respectively.

Denali strengthened its balance sheet through a $200.0 million synthetic royalty funding with Royalty Pharma tied to a 9.25% revenue participation right on AVLAYAH and, subsequent to quarter end, a $195.0 million sale of a Rare Pediatric Disease Priority Review Voucher. Pipeline updates included Takeda’s termination of the DNL593 collaboration, with full rights reverting to Denali, and discontinuation of Biogen-partnered BIIB122/DNL151 development in idiopathic Parkinson’s disease after the Phase 2b LUMA study did not meet its endpoints.

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. is reported to have significant ownership by investment adviser Baillie Gifford & Co, according to this amended Schedule 13G filing. Baillie Gifford & Co beneficially owns 11,960,230 shares of Denali Therapeutics common stock, representing 7.54% of the class as of June 30, 2026. The firm has sole voting power over 11,915,890 shares and sole dispositive power over 11,960,230 shares, with no shared voting or dispositive power reported. These securities are held by Baillie Gifford & Co and/or its investment adviser subsidiaries on behalf of various investment advisory clients, including institutional accounts.

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 Schedule 13G/A reports that T. Rowe Price Investment Management, Inc. beneficially owns 16,178,963 shares of common stock, representing 10.2% of the class as stated in the filing. The filing lists CUSIP 24823R105 and identifies the reporting person as a Maryland entity. The report shows 15,639,355 shares for which the filer has sole voting power and 16,178,963 shares for which it has sole dispositive power. The filing is signed by Ellen York, Vice President, dated 07/08/2026.

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. director Jay T. Flatley reported new equity awards in the form of common stock and stock options. He received 6,408 Restricted Stock Units (RSUs), each representing a contingent right to one share of common stock, with 100% of the RSUs vesting on the earlier of the one-year anniversary of the grant date or the day before the next annual stockholder meeting.

Flatley was also granted a stock option for 19,226 shares of common stock at an exercise price of $19.66 per share, vesting on the same schedule and expiring on June 3, 2036. Following these grants, he holds 22,628 shares directly, including 6,408 unvested RSUs, and 336,313 shares indirectly through The Flatley Family Trust, for which he serves as trustee. The filing does not show any open-market purchases or sales.