Denali Therapeutics Inc. 8-K

What Happened Denali Therapeutics (DNLI) announced on June 18, 2026 that it entered into an asset purchase agreement to sell a Rare Pediatric Disease Priority Review Voucher (PRV) it received when AVLAYAH™ (tividenofusp alfa) was approved by the FDA in March 2026 for Hunter syndrome (MPS II). The buyer agreed to pay $195 million in cash at closing.

Key Details

• The PRV sale is governed by a PRV Transfer Agreement containing customary representations, warranties, covenants and indemnification provisions.
• Purchase price: $195 million, payable in cash upon closing.
• Closing remains subject to customary conditions, including expiration/termination of the Hart‑Scott‑Rodino (HSR) antitrust waiting period.
• The company attached a press release (Exhibit 99.1) to the Form 8‑K; the full PRV Transfer Agreement will be filed as an exhibit in a subsequent SEC filing.

Why It Matters The transaction would convert Denali’s FDA‑awarded PRV into immediate cash consideration of $195 million upon closing, potentially boosting liquidity if and when the deal closes. Timing and completion depend on satisfaction of closing conditions, notably the HSR waiting period, so investors should watch for a follow‑on filing with the definitive agreement and closing update.