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Form 8-K Denali Therapeutics Inc. For: Jun 12

Thu, 18 Jun 2026 08:02:00 -0400

si-local-file:///var/storage/secattach/20260618/26663145.html

Form 8-K Denali Therapeutics Inc. For: Jun 12

Thu, 18 Jun 2026 08:02:00 -0400

si-local-file:///var/storage/secattach/20260618/26663145.html

Denali Therapeutics to sell priority review voucher for $195M

Thu, 18 Jun 2026 08:00:11 -0400

Denali Therapeutics Inc. (Nasdaq: DNLI) has entered into a definitive agreement to sell its Rare Pediatric Disease Priority Review Voucher for gross proceeds of $195 million, the company said in a press release.

The U.S. Food and Drug Administration awarded the voucher to Denali following its accelerated approval in March 2026 of AVLAYAH (tividenofusp alfa-eknm), an enzyme replacement therapy for Hunter syndrome, also known as mucopolysaccharidosis type II. Denali describes AVLAYAH as the first FDA-approved medicine designed to cross the blood-brain barrier via transferrin receptor-mediated transport.

The company said proceeds from the sale will support the advancement of its clinical pipeline, which

Denali Therapeutics Enters Agreement to Sell Rare Pediatric Disease Priority Review Voucher for $195 Million

Thu, 18 Jun 2026 08:00:00 -0400

Proceeds from transaction to support advancement of Denali’s broad TransportVehicle™-enabled clinical portfolio for lysosomal storage disorders and neurodegenerative diseases
Denali was awarded Priority Review Voucher following FDA approval of AVLAYAH™, the first FDA-approved biologic specifically designed to cross blood-brain barrier

SOUTH SAN FRANCISCO, Calif., June 18, 2026 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today announced it has entered into a definitive agreement to sell its Rare Pediatric Disease Priority Review Voucher (PRV) for gross proceeds of $195 million. The U.S. Food and Drug Administration (FDA) awarded the PRV to Denali

Denali Therapeutics Enters Agreement to Sell Rare Pediatric Disease Priority Review Voucher for $195 Million

Thu, 18 Jun 2026 08:00:00 -0400

Proceeds from transaction to support advancement of Denali’s broad TransportVehicle™-enabled clinical portfolio for lysosomal storage disorders and neurodegenerative diseases
Denali was awarded Priority Review Voucher following FDA approval of AVLAYAH™, the first FDA-approved biologic specifically designed to cross blood-brain barrier

UBS Reiterates Buy Rating on Denali Therapeutics Inc. (DNLI)

Tue, 16 Jun 2026 09:27:15 -0400

UBS analyst Michael Yee reiterated a Buy rating and $25.00 price target on Denali Therapeutics Inc. (NASDAQ: DNLI).

The analyst commented, "The early launch of Avlayah is progressing with positive signals on early launch indicators. Commercial product was in the channels 2 weeks from the March 24 approval with the earliest Hunter patients on drug in 3.5 weeks in the commercial setting and co is working through getting policies in place with positive receptivity from payers who recognise this is a premium product vs. standard of care Elaprase and thus priced at a ~60% premium to Elaprase which does not treat

Form 4 Denali Therapeutics Inc. For: Jun 03 Filed by: Krognes Steve E.