Shares of Denali Therapeutics DNLI gained 11.8% on Wednesday after the company announced that it has initiated a rolling submission of a biologics license application (BLA) for accelerated approval of tividenofusp alfa for the treatment of Hunter syndrome (MPS II). The same has also been received by the Center for Drug Evaluation and Research (CDER) of the FDA.

DNLI reported ongoing collaborative and productive engagement with CDER, aligning with the same on the content of the BLA data package, including the use of CSF HS as a surrogate endpoint for accelerated approval and the path to full approval.

Denali expects to complete its BLA submission by mid-May 2025 and is preparing for a potential U.S. commercial launch in late 2025 or early 2026. Tividenofusp alfa, an Enzyme Transport Vehicle-enabled iduronate-2-sulfatase (IDS) replacement therapy, enjoys the FDA’s Fast Track and Breakthrough Therapy designations in the United States for MPS II. In the EU, the candidate enjoys the Priority Medicines designation for the same indication.

Year to date, shares of DNLI have lost 32.6% against the industry’s 1.2% growth.Zacks Investment Research

Image Source: Zacks Investment Research

Updates Regarding DNLI’s Key Pipeline Candidates

Denali continues to enroll patients in the global phase II/III COMPASS study of tividenofusp alfa, which aims to support global regulatory approvals. In January 2025, it expanded target enrollment for neuronopathic participants (Cohort A) to 42 patients, reflecting steady progress in recruitment and data collection. The candidate has not yet been approved for therapeutic use by any health authority.

MPS II is a rare genetic disorder affecting more than 2,000 people worldwide, mostly males, and causes physical, cognitive, and behavioral symptoms.

Denali is also evaluating DNL126 for the treatment of Sanfilippo syndrome type A (MPS IIIA) in a phase I/II study. The candidate enjoys the FDA’s Orphan Disease designation and Fast Track status for this indication.

DNL126 has been selected for the FDA’s Support for Clinical Trials Advancing Rare Disease Therapeutics (START) program. This pilot initiative aims to accelerate the development of rare disease treatments.

Based on initial positive phase I/II results demonstrating proof of concept for MPS IIIA, Denali is engaging in productive collaboration with the FDA, under START, to align on a pathway for accelerated development and approval of DNL126 in the United States. This candidate has also not yet been approved for therapeutic use by any health authority.

Denali Therapeutics Inc. Price and ConsensusDenali Therapeutics Inc. Price and Consensus

Denali Therapeutics Inc. price-consensus-chart | Denali Therapeutics Inc. Quote

Story Continues

DNLI’s Zacks Rank & Stocks to Consider

Denali currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks from the sector are Bayer BAYRY, Dynavax Technologies Corporation DVAX and Corcept Therapeutics CORT, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.

In the past 30 days, estimates for Bayer’s earnings per share have increased from $1.14 to $1.19 for 2025. During the same time, earnings per share have increased from $1.23 to $1.28 for 2026. Year to date, shares of Bayer have gained 19.5%.

BAYRY’s earnings matched estimates in two of the trailing three quarters while missing the same on the remaining occasion, the average negative surprise being 19.61%.

In the past 30 days, estimates for Dynavax’s earnings per share have remained constant at 33 cents for 2025. During the same time, earnings per share have remained constant at 57 cents for 2026. Year to date, shares of DVAX have gained 0.8%.

DVAX’s earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 9.58%.

In the past 30 days, the estimate for Corcept Therapeutics’ 2025 earnings per share has increased from $1.84 to $1.87. The estimate for 2026 earnings per share has increased from $3.05 to $3.11. Year to date, shares of Corcept Therapeutics have gained 66.3%.

CORT’s earnings beat estimates in three of the trailing four quarters and missed once, delivering an average surprise of 20.08%.

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

Dynavax Technologies Corporation (DVAX):Free Stock Analysis Report

Bayer Aktiengesellschaft (BAYRY):Free Stock Analysis Report

Corcept Therapeutics Incorporated (CORT):Free Stock Analysis Report

Denali Therapeutics Inc. (DNLI):Free Stock Analysis Report

This article originally published on Zacks Investment Research (zacks.com).

Zacks Investment Research

View Comments