Denali Q2 FY26 net loss widens to $127.6 million; revenue turns to $3.6 million

Denali posted a GAAP net loss of $127.6 million, or $0.68 per share, for the quarter ended June 30, 2026. Revenue was $3.6 million, reflecting the start of U.S. AVLAYAH sales following FDA approval in March 2026.

Research and development expense fell 5.55% to $97 million, due to lower small-molecule costs and lower tividenofusp alfa clinical spending. Selling, general and administrative expense rose 12.39% to $36.3 million on higher personnel costs tied to the AVLAYAH launch.

Cash, cash equivalents and marketable securities were about $940 million at quarter-end; a $195 million Priority Review Voucher sale lifted pro forma liquidity above $1.1 billion.