# FDA Approves Denali Therapeutics' AVLAYAH, Expanding Its Neurology Portfolio Denali Therapeutics Inc. received FDA approval for AVLAYAH (tividenofusp alfa-eknm), an intravenous therapy that strengthens the company's position in the neurology market and diversifies its revenue streams beyond its current pipeline. The approval positions Denali to capture market share in a new therapeutic category while establishing a foundation for potential label expansions and combination therapies.