Company: DNLI
Filing Date: 2025-12-04
Form Type: 8-K
Source: 0001714899-25-000209
Chunk: 2

Company: Denali Therapeutics Inc.
Filing Date: 2025-12-04
Form: 8-K
Item: Item 8.01
Chunk 2
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 rare diseases in children. Under Section 529, the FDA administers the RPDD and PRV programs.

DNL952 (ETV:GAA) - Pompe Disease

The Investigational New Drug ("IND") application for the Phase 1 study of DNL952 has been placed on clinical hold. The FDA requested a protocol amendment to include a lower starting dose, revised inclusion criteria, certain safety monitoring commitments, and stopping rules. These requests are related to preclinical hypersensitivity reactions observed in GAA mouse models, which are commonly observed across all GAA enzyme replacement therapies in mice. The FDA did not request additional nonclinical studies. Denali has submitted a response to the FDA, and pending FDA feedback, anticipates minimal delays in the initiation of the Phase 1 study. As part of our global development strategy for DNL952, Denali is on track to submit a Clinical Trial Application (“ CTA”) in Europe in the first half of 2026.

DNL628 (OTV:MAPT) - Alzheimer’s Disease

A CTA for DNL628 has been submitted, and a Phase 1b study in patients with Alzheimer’s disease is expected to begin in the first half of 2026.

DNL921 (ATV:Abeta) - Alzheimer’s Disease

A regulatory submission for DNL921 is planned for the first half of 2026 to initiate clinical studies.

BIIB122 (LRRK2 Inhibitor, partnered with Biogen)

The Phase 2b LUMA study for BIIB122 in patients with early-stage Parkinson’s disease is expected to read out in 2026. The BEACON study in patients with LRRK2-associated Parkinson's disease continues to enroll.

Eclitasertib (SAR443122, RIPK1 Inhibitor, partnered with Sanofi)

Phase 2 data in ulcerative colitis are expected in 1H 2026. Development is led solely by Sanofi.

Forward-Looking Statements

Certain of the statements made in this report are forward looking, such as those relating to; the progress, success costs and anticipated timing of our development activities, preclinical studies and clinical trials; the timing or likelihood of regulatory filings and approvals; and our ability to obtain and maintain regulatory approval of our product candidates, and any related restrictions and limitations. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. More information about the risks and uncertainties faced by Denali may be found in Den