Denali and Sanofi are also developing SAR443122/DNL758 (eclitasertib), a peripheralRIPK1 inhibitor, for the treatment of ulcerative colitis. The cash position is sound as well. Cash, cash equivalents and marketable securities totaled approximately $1.43 billion as of Mar 31, 2024. In February, Denali announced the completion of a private investment in public equity (PIPE) financing with gross proceeds of $500 million. Denali's pipeline potential and the successful development of any of these candidates will ...

This company is expected to post quarterly loss of $0.69 per share in its upcoming report, which represents a year-over-year change of -153.1%. Revenues are expected to be $24.23 million, down 91.8% from the year-ago quarter. The stock currently carries a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks Rank #1 (Strong Buy) stocks here >>>> Denali owns an impressive pipeline of targeted therapeutic candidates for neurodegenerative diseases and its recent pipeline progress has been encour ...

Collaboration leverages ProFound's proprietary ProFoundry™ Platform to identify potential novel protein therapeutics from the expanded human proteome Pioneering Medicines, Flagship's in house drug discovery and development unit, is responsible for leading the partnership with Pfizer, including driving the exploration process to rapidly surface potential drug development programs built on Flagship's diverse bioplatforms and modalities. Under this collaboration, ProFound will deploy its proprietary ProFoundry ...

It has been about a month since the last earnings report for Denali Therapeutics Inc. (DNLI) . Shares have added about 15.6% in that time frame, outperforming the S&P 500. Denali Q1 Earnings Miss, Pipeline Progress in Focus The year-over-year narrower loss was due to a decline in operating expenses. Quarter in Detail Research and development expenses fell 17% to $107 million in the quarter. The decrease was mainly attributable to a decrease in ETV:IDS program external expenses year. As of Mar 31, 2024, cash ...

Since DNL126 has been selected as a START participant, it can interact with the FDA frequently. The company expects the increased level of engagement from the FDA, to facilitate alignment on the most efficient development path to ultimately support a marketing application for DNL126 in MPS IIIA. Please note that Denali has another candidate in its pipeline, tividenofusp alfa (DNL310), which is engineered to cross the BBB via receptor-mediated transcytosis into the brain. The candidate is being developed as ...

START is a pilot program newly launched jointly by the FDA CDER and CBER divisions to further accelerate the development of novel drug and biological products for rare diseases DNL126 was selected as one of three CDER-regulated products based on eligibility criteria including the potential for clinical benefit for a rare neurodegenerative disease and the drug sponsor's ability to advance development towards a marketing application Participation in START is expected to facilitate and accelerate development o ...

Denali Therapeutics Inc. (NASDAQ:DNLI) is advancing a drug by the name of DNL-310 [tividenofusp alfa] for the treatment of patients with MSP II [Hunter Syndrome]. It had been able to report positive results from an ongoing phase 1/2 study, using this drug to treat these patients, at the 20th Annual WORLD Symposium. In essence, this highlights positive two-year data that patients achieved improvements in terms of both biomarkers and other clinical outcome measures. This lead program sets about two major reas ...

Denali Therapeutics (DNLI) incurred a first-quarter 2024 loss of 68 cents per share, wider than the Zacks Consensus Estimate of a loss of 67 cents but narrower than the year-ago quarter’s loss of 80 cents.The year-over-year narrower loss was due to a decline in operating expenses.In the absence of a marketed product, the company only recognizes revenues from ongoing collaborations in the top line. Denali did not generate any collaboration revenues in the reported quarter. The Zacks Consensus Estimate for re ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38311 Denali Therapeutics Inc. (Exact name of registrant as specified in its charter) (State or other jurisdi ...

Exhibit 99.1 Denali Therapeutics Reports First Quarter 2024 Financial Results and Business Highlights SOUTH SAN FRANCISCO, Calif., – May 7, 2024 – Denali Therapeutics Inc. (Nasdaq: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for the treatment of neurodegenerative diseases and lysosomal storage diseases, today reported financial results for the first quarter ended March 31, 2024, and provided business highlights. "It ...