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Denali reports $17.8M Avlayah sales in Q3 and guides Q4 revenue to $30-32M

🇺🇸 Denali Therapeutics Inc. (DNLI) · Tue 03 Nov 2026

Denali's Hunter syndrome therapy Avlayah, approved in March, has gained commercial coverage for over 70% of US lives, and a permanent J-code took effect on 1 October.

Denali Therapeutics reported third-quarter 2026 results on 3 November, citing net revenue of $17.8 million from Avlayah (tividenofusp alfa-eknm). The product is the first for which the company has reported sales since the US Food and Drug Administration approved it in March 2026 for the neurologic manifestations of Hunter syndrome (mucopolysaccharidosis type II, or MPS II).

The company said commercial coverage now exceeds 70% of US lives. It also noted that a permanent J-code, a billing code used for physician-administered drugs, took effect on 1 October. Its headline title indicates that Denali expects fourth-quarter revenue of $30 million to $32 million.

Beyond Avlayah, Denali said its biologics licence application (BLA) for zafinofusp alfa in Sanfilippo syndrome type A (MPS IIIA) remains on track for 2027. In August, the FDA granted Orphan Drug Designation to DNL593 for frontotemporal dementia with progranulin mutations (FTD-GRN).

The available information does not include further detail on the revenue split, patient numbers or the terms of payer coverage.

What it means for your team

  • Market-access teams can note that coverage of more than 70% of US lives was reported within about eight months of Avlayah's approval.
  • The permanent J-code effective 1 October removes a billing hurdle for a physician-administered product; teams should track how it affects claims processing.
  • Regulatory watchers should note the planned 2027 BLA for zafinofusp alfa in MPS IIIA and the August Orphan Drug Designation for DNL593 in FTD-GRN.

Company's press release (SEC filing): Denali Therapeutics Inc. ↗

Article written by VigiEye from the official source (Denali Therapeutics Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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