Denali Therapeutics (DNLI) reported $3.6 million in second-quarter revenue from AVLAYAH (tividenofusp alfa), the first full commercial quarter following its FDA approval for pediatric Hunter syndrome patients with neurologic manifestations.
The company raised its third-quarter revenue guidance to $10 million to $12 million from prior estimates, signaling accelerating uptake of the enzyme replacement therapy against Elaprase, which currently holds approximately 90% to 95% market share among eligible U.S. patients.
At the 12th Annual Cantor Fitzgerald Global Healthcare Conference on September 9, 2026, Denali CEO Ryan Watts highlighted the company's strong balance sheet: roughly $1.1 billion in cash, a current ratio of 8.37, and more cash than debt. The liquidity position is expected to fund operations through 2029.
Denali also provided an updated outlook on its broader enzyme replacement therapy franchise, estimating a $7 billion to $9 billion peak sales opportunity across rare diseases including Sanfilippo, Pompe, Gaucher, and Hurler syndromes.
The company's Zafi (DNL921/DNL593) program for Sanfilippo syndrome is advancing toward a BLA filing planned for 2027, with data to be presented at WORLDSymposium 2027. For its frontotemporal dementia (FTD-GRN) program, mid-2027 data readouts are expected for the high-dose cohort with over a year of follow-up.
Clinical data from the Phase III COMPASS trial showed approximately a 75% reduction and normalization in neurofilament light chain (NfL) levels. The trial, which enrolls neuronopathic Hunter syndrome patients aged 2 to 6 years, is expected to complete by end of 2027, with data readout anticipated by mid-2028.
Denali noted that Medicaid payer access is now in place across 14 states. The company also disclosed that its internal manufacturing facility—built to reduce cost of goods using Fc-fusion technology—is set to launch Zafi as its first product.
Eleven analysts revised earnings estimates upward following the conference, with price targets ranging from $27 to $42. Denali's market capitalization stands at approximately $3.43 billion.
Five additional clinical-stage programs and Alzheimer's-related programs are expected to generate major data readouts in 2027.
