$DNLI

Denali Therapeutics Inc. (DNLI) filed an SEC Form 8-K — Results of Operations and Financial Condition. EX-99.1 2 ex991pressreleaseq22026.htm EX-99.1 Document Exhibit 99.1 Denali Therapeutics Reports Second Quarter 2026 Financial Results and Business Highlights • Strong first full quarter of AVLAYAH™ (tividenofusp alfa-eknm) launch generated $3.6 million in net product revenue • Ad

Denali Therapeutics Inc. (DNLI) filed an SEC Form 8-K — Completion of Acquisition or Disposition of Assets. dnli-20260727 0001714899 FALSE 0001714899 2026-07-27 2026-07-27 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported):

Biogen reported at the Alzheimer’s Association International Conference that its experimental antisense drug diranersen, given via spinal injection, slowed cognitive decline in a subset of about 400 participants with mild cognitive impairment or mild Alzheimer’s. In one lowest-dose test, results showed a 26% reduction in decline versus placebo. Biogen plans a larger study; side effects included injection pain and temporary confusion.

Denali Therapeutics Inc. (DNLI) filed an SEC Form 8-K — Entry into a Material Definitive Agreement. dnli-20260612 0001714899 FALSE 0001714899 2026-06-12 2026-06-12 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported):

Oppenheimer has reiterated its Buy rating for Denali Therapeutics (DNLI.US) and increased the target price to $40. This revision reflects the firm's continued confidence in Denali Therapeutics' stock.

Denali Therapeutics (DNLI) reported a narrower-than-expected loss in Q4 2025, with a loss of 73 cents per share against an estimated 75 cents. The company is focused on the potential commercial launch of tividenofusp alfa for Hunter syndrome, with the FDA extending its review timeline to April 5, 2026. Denali also provided updates on other pipeline candidates, including DNL126 for Sanfilippo syndrome type A, and collaborations with Takeda, Biogen, and Sanofi.

Denali Therapeutics has announced the pricing of a public offering of 9.14 million shares at $17.50 each. This development follows a recent plan for a $200 million public offering and other significant events like analyst target adjustments and royalty funding agreements. The company continues to advance its clinical development programs for neurodegenerative and lysosomal storage diseases.

Denali Therapeutics (NASDAQ: DNLI) has priced an underwritten public offering of 9,142,857 common shares at $17.50 per share, alongside pre-funded warrants for 2,285,714 shares at $17.49 each. This offering is expected to generate gross proceeds of approximately $200 million and is anticipated to close around December 11, 2025. The company has also granted underwriters a 30-day option to purchase up to an additional 1,714,285 shares.

Denali's Q3 loss widens year over year as expenses rise, while the FDA delays its review of the firm???s key Hunter syndrome therapy to 2026.

The U.S. Food and Drug Administration extended on Monday Denali Therapeutics Inc.'s ( NASDAQ:DNLI ) review timeline of the Biologics License Application ( BLA ) , seeking accelerated approval of tividenofusp alfa for the treatment of mucopolysaccharidosis type II ( MPS II ) , also known as Hunter ...