Denali Therapeutics Projects $30M-$32M Q4 Revenue for AVLAYAH Amid Hunter Syndrome Commercialization
Denali Therapeutics (DNLI) has provided revenue guidance of $30 million to $32 million for the fourth quarter, driven by the commercial launch of AVLAYAH. CEO Ryan Watts characterized the recent period as a defining quarter for the company, noting that AVLAYAH represents the first new FDA-approved therapy for Hunter syndrome in nearly two decades. While the company focuses on the initial rollout of AVLAYAH, its long-term pipeline remains intact with plans to file a Biologics License Application (BLA) for Sanfilippo syndrome in 2027. The management's outlook emphasizes both immediate product commercialization and broader validation of their underlying therapeutic platform.

Tickers: $DNLI
Topics: commercialization earnings call FDA approval Hunter syndrome
Read the full article at Seeking Alpha
Part of the story Denali expects $30M-$32M Q4 AVLAYAH net product revenue as Sanfilippo BLA filing remains planned for 2027 (2 articles)