Denali Therapeutics (NASDAQ:DNLI) Issues Earnings Results, Beats Estimates By $0.64 EPS

Denali Therapeutics (NASDAQ:DNLI – Get Free Report) posted its earnings results on Tuesday. The company reported $0.37 earnings per share (EPS) for the quarter, beating analysts’ consensus estimates of ($0.27) by $0.64, FiscalAI reports. The business had revenue of $17.78 million for the quarter, compared to analyst estimates of $12.67 million. During the same quarter in the prior year, the firm earned ($0.74) earnings per share.

Here are the key takeaways from Denali Therapeutics’ conference call:

  • AVLAYAH net product revenue reached $17.8 million in Q3, nearly five times the first full-quarter result and above the company’s $10 million–$12 million guidance. Denali expects Q4 revenue of $30 million–$32 million, supported by expanding payer coverage, patient starts, and a new permanent J-code.
  • AVLAYAH commercial access expanded to more than 70% of covered commercial lives, while 20 state Medicaid programs now list the treatment. Denali said physician engagement and patient persistence are strong and expects the therapy to become the leading U.S. Hunter syndrome treatment.
  • Denali reported progress across its pipeline, including completion of the primary treatment period in the Sanfilippo syndrome type A study and plans for a potential accelerated-approval BLA filing for zafinofusp alfa in 2027. Initial data from Alzheimer’s programs DNL628 and DNL921 are also expected in 2027.
  • The company cautioned that the sharp Q3-to-Q4 revenue increase is not a steady-state run rate because some clinical-trial patients transitioned to commercial therapy earlier than expected. COMPASS is not expected to complete until around the end of 2027, with data anticipated in the first half of 2028.
  • Denali ended September with approximately $1.01 billion in cash, cash equivalents, and marketable securities, while operating expenses remained essentially flat year over year. Q3 net income of $70.1 million was primarily driven by the one-time $195 million gross proceeds from selling a priority review voucher.

Denali Therapeutics Trading Up 7.8%

DNLI stock opened at $20.96 on Thursday. The company’s 50-day simple moving average is $20.35 and its 200-day simple moving average is $21.25. The company has a quick ratio of 8.32, a current ratio of 8.37 and a debt-to-equity ratio of 0.01. Denali Therapeutics has a 52-week low of $13.75 and a 52-week high of $27.30. The firm has a market cap of $3.35 billion, a P/E ratio of -12.12 and a beta of 1.08.

Insider Buying and Selling at Denali Therapeutics

In related news, insider Alexander O. Schuth sold 2,857 shares of Denali Therapeutics stock in a transaction dated Tuesday, August 11th. The stock was sold at an average price of $25.07, for a total value of $71,624.99. Following the completion of the transaction, the insider owned 281,763 shares in the company, valued at $7,063,798.41. The trade was a 1.00% decrease in their position. The sale was disclosed in a document filed with the Securities & Exchange Commission, which is available at the SEC website. 9.70% of the stock is currently owned by corporate insiders.

Analyst Ratings Changes

Several equities research analysts have weighed in on the company. Wedbush increased their price target on Denali Therapeutics from $23.00 to $24.00 and gave the stock an “outperform” rating in a research report on Wednesday. Deutsche Bank Aktiengesellschaft boosted their price objective on Denali Therapeutics from $31.00 to $35.00 and gave the company a “buy” rating in a report on Thursday, July 16th. B. Riley Financial upped their target price on Denali Therapeutics from $30.00 to $35.00 and gave the stock a “buy” rating in a research note on Tuesday, August 25th. UBS Group upped their target price on Denali Therapeutics from $25.00 to $34.00 and gave the stock a “buy” rating in a research note on Friday, August 7th. Finally, JPMorgan Chase & Co. started coverage on Denali Therapeutics in a report on Monday, July 13th. They set an “overweight” rating and a $29.00 target price on the stock. Thirteen equities research analysts have rated the stock with a Buy rating, two have given a Hold rating and one has assigned a Sell rating to the company’s stock. According to data from MarketBeat, the company presently has an average rating of “Moderate Buy” and an average target price of $36.15.

Get Our Latest Analysis on DNLI

Trending Headlines about Denali Therapeutics

Here are the key news stories impacting Denali Therapeutics this week:

  • Positive Sentiment: AVLAYAH generated $17.8 million in net product revenue in its second full commercial quarter. Denali expects Q4 revenue of $30 million to $32 million, signaling a sharp sequential increase. Denali Q3 2026 results and business highlights
  • Positive Sentiment: Analyst actions were supportive: Morgan Stanley raised its target to $42 and maintained an Overweight rating; Wedbush raised its target to $24 and maintained Outperform; BTIG reaffirmed Buy with a $39 target. These views indicate optimism, though targets are not guarantees. Morgan Stanley research ratings
  • Neutral Sentiment: Denali reported $70.1 million in Q3 net income, but that figure included a $194 million one-time gain from the voucher sale. The company ended the quarter with $1.0 billion in cash, cash equivalents and marketable securities. Denali Q3 2026 results and business highlights
  • Neutral Sentiment: The company has several potential catalysts ahead, including a planned 2027 BLA submission for zafinofusp and data expected in 2027 from five TransportVehicle programs. These remain development-stage opportunities and carry execution risk. Denali Q3 2026 results and business highlights
  • Negative Sentiment: HC Wainwright’s 2027 quarterly forecasts still project losses, ranging from $0.60 per share in Q1 to $0.53 in Q4, underscoring continued costs and the need for sustained product growth. Denali Therapeutics analyst coverage

About Denali Therapeutics

(Get Free Report)

Denali Therapeutics Inc is a biopharmaceutical company focused on discovering and developing therapies for patients with neurodegenerative diseases. The company’s research programs target conditions including Parkinson’s disease, Alzheimer’s disease, amyotrophic lateral sclerosis, and lysosomal storage disorders.

Denali uses its blood-brain barrier transport technology, known as the Transport Vehicle platform, to design medicines intended to deliver therapeutic proteins and other biologic treatments into the central nervous system.

See Also

Earnings History for Denali Therapeutics (NASDAQ:DNLI)

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