This section highlights FDA-related milestones and regulatory updates for drugs developed by Athira Pharma (ATHA).
Over the past two years, Athira Pharma has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ATH-1105 and fosgonimeton. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
ATH-1105 - FDA Regulatory Timeline and Events
ATH-1105 is a drug developed by Athira Pharma for the following indication: For Amyotrophic Lateral Sclerosis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ATH-1105
- Announced Date:
- May 13, 2025
- Indication:
- For Amyotrophic Lateral Sclerosis
Announcement
Athira Pharma, Inc. announced that the Company will present data from a Phase 1 clinical trial of ATH-1105 in healthy volunteers at the 4th Annual ALS drug Development Summit taking place from May 12-14, 2025 in Boston, Massachusetts.
AI Summary
Athira Pharma, Inc. announced that it will present key Phase 1 clinical trial data for its oral drug candidate ATH-1105 at the 4th Annual ALS Drug Development Summit, scheduled for May 12-14, 2025, in Boston, Massachusetts. The Phase 1 trial, conducted in healthy volunteers, demonstrated a favorable safety and tolerability profile, along with dose proportional pharmacokinetics and central nervous system penetration. These positive results support the continued clinical development of ATH-1105 as a potential treatment for amyotrophic lateral sclerosis (ALS).
The upcoming presentations, including both an oral talk and a poster session, will detail how ATH-1105 works to modulate the neurotrophic HGF system, potentially benefiting nerve and motor function. This development has positioned Athira Pharma on track to initiate a clinical trial in ALS patients later in 2025, marking an important step in the search for effective ALS therapies.
Read Announcement- Drug:
- ATH-1105
- Announced Date:
- May 9, 2025
- Estimated Event Date Range:
- October 1, 2025 - December 31, 2025
- Target Action Date:
- LATE 2025
- Indication:
- For Amyotrophic Lateral Sclerosis
Announcement
Athira Pharma, Inc. announced that its On-track to enable dosing ALS patients in late 2025
AI Summary
Recently, Athira Pharma announced encouraging progress in its development of ATH-1105 for treating ALS. The company successfully completed a Phase 1 clinical study in healthy volunteers, which confirmed that the drug is safe and well tolerated. Positive test results and supportive data, including improvements in nerve and motor function and key biomarkers, underline ATH-1105’s potential in managing neurodegeneration. Athira Pharma is on track to enable dosing ALS patients in late 2025, with full detailed results expected in the second half of the year. This advancement is an important milestone in the company’s commitment to developing innovative therapies for neurodegenerative diseases. The company’s next steps will involve expanding clinical evaluation and collaborating with researchers to ensure the treatment effectively reaches patients, marking a significant move toward improved outcomes for those suffering from ALS.
Read Announcement- Drug:
- ATH-1105
- Announced Date:
- May 9, 2025
- Indication:
- For Amyotrophic Lateral Sclerosis
Announcement
Athira Pharma, Inc. provided recent pipeline and business updates.
AI Summary
Athira Pharma recently provided updates on its pipeline and business progress, highlighting advancements for its experimental ALS treatment, ATH-1105. The company completed its first-in-human Phase 1 clinical trial in healthy volunteers, showing encouraging safety and tolerability results. Preclinical findings have shown statistically significant improvements in nerve and motor functions, as well as positive changes in biomarkers related to inflammation and neurodegeneration. Athira expects to release the full Phase 1 data in the second half of 2025, keeping the program on track to begin dosing ALS patients by late 2025.
Along with these clinical updates, the company shared financial results for the quarter, noting reductions in both research and development and general administrative expenses compared to earlier periods. These strategic moves reflect Athira’s focus on advancing ATH-1105 and maximizing value for its shareholders while progressing its innovative drug development pipeline.
Read Announcement
fosgonimeton - FDA Regulatory Timeline and Events
fosgonimeton is a drug developed by Athira Pharma for the following indication: For the treatment of Alzheimer's disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- fosgonimeton
- Announced Date:
- September 3, 2024
- Indication:
- For the treatment of Alzheimer's disease
Announcement
Athira Pharma, Inc announced topline results from its Phase 2/3 LIFT-AD clinical trial of fosgonimeton, a hepatocyte growth factor (HGF) positive modulator, in patients with mild-to-moderate Alzheimer's disease (AD).
AI Summary
Athira Pharma announced topline results from its Phase 2/3 LIFT-AD clinical trial, which evaluated fosgonimeton, a hepatocyte growth factor positive modulator, in patients with mild-to-moderate Alzheimer’s disease. While the trial did not meet its primary endpoint—the Global Statistical Test combining measures of cognition (ADAS-Cog11) and function (ADCS-ADL23)—or its key secondary endpoints, the results provided important insights. In pre-specified subgroups, particularly among patients with moderate Alzheimer’s disease and APOE4 carriers, fosgonimeton showed a numerically greater treatment effect, with improvements or stabilization in cognition and function compared to placebo. Additionally, favorable changes in several biomarkers linked to Alzheimer’s pathology were observed, supporting the drug’s proposed broad neuroprotective mechanism. These findings suggest that further exploration of HGF modulation could potentially benefit neuronal health and mitigate disease progression.
Read Announcement
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