DNL343

DNL343, an investigational eIF2B agonist for ALS, did not meet its primary endpoint in the HEALEY-ALS trial, showing no significant difference from placebo in overall function, survival, muscle strength, or respiratory function at 24 weeks. Further analyses are expected by late 2025. The treatment was safe and well-tolerated.

Denali Therapeutics' Phase II/III HEALEY ALS trial for DNL343 did not meet its primary endpoint, showing no significant difference in disease severity or survival rates between therapy and placebo groups at 24 weeks. The therapy was safe and well-tolerated. Further analyses, including neurofilament light and other biomarkers, are anticipated later this year.

Denali Therapeutics' DNL343 for ALS failed its Phase II/III trial primary endpoint, showing no significant difference in disease severity or survival rates vs. placebo at 24 weeks. Secondary endpoints also showed no significant differences. The therapy was safe and well-tolerated. Further analyses, including biomarker and subgroup data, are anticipated later this year.

Jefferies maintains a Buy rating on Denali Therapeutics with a $45 target, despite ALS trial miss. Stock at $19.82, seen undervalued. Denali's DNL310 for Hunter Syndrome aims for 2025 approval. Positive data for DNL126 for Sanfilippo Syndrome noted. Financials strong, with 9.98 current ratio, minimal debt.

Denali Therapeutics' phase 2/3 trial for ALS drug DNL343 did not meet its primary goal of slowing disease progression. Despite being safe and well-tolerated, DNL343 showed no significant impact on disease severity, muscle strength, or respiratory function compared to placebo. Further analysis of data, including biomarkers and subgroup effects, is expected.

Denali Therapeutics' drug DNL343 failed to meet primary and secondary endpoints in a Phase II/III ALS study, not significantly slowing disease progression or improving respiratory function and muscle strength. Despite the setback, analysts remain optimistic about Denali's future, citing the high-risk nature of ALS drug development.

AbbVie, Calico, and Denali Therapeutics' ALS treatments targeting eIF2B, fosigotifator and DNL343, failed to significantly slow disease progression in Mass General's HEALEY ALS Platform trial. Despite missing primary endpoints, exploratory data suggest potential benefits. Denali plans further analysis, while AbbVie remains silent on fosigotifator's future.

DNL343, evaluated in the HEALEY ALS Platform Trial, did not meet primary or key secondary endpoints at 24 weeks but was safe and well-tolerated. Further analyses, including biomarkers and subgroup data, are expected in 2025. ALS affects ~30,000 in the U.S., highlighting the urgent need for effective therapies.

Denali Therapeutics' DNL343 for ALS did not meet primary efficacy endpoints in a Phase 2/3 trial, showing no significant difference from placebo in disease progression or secondary endpoints. Despite the setback, the drug was safe and well-tolerated, with further analyses expected in 2025. Analysts remain hopeful, citing the disease's complexity and historical trial challenges.

BofA Securities lowered Denali Therapeutics' price target to $30 from $34, maintaining a Buy rating, after DNL343 failed phase 2/3 ALS trial endpoints. Despite this, optimism remains for Denali's brain delivery platform and financial health, with a pivotal 2025 expected for its Hunter syndrome treatment. Denali's stock is seen as undervalued, offering a potential buying opportunity.