Welcome to our dedicated page for Athira Pharma news (Ticker: ATHA), a resource for investors and traders seeking the latest updates and insights on Athira Pharma stock.
About Athira Pharma, Inc.
Athira Pharma, Inc. (NASDAQ: ATHA), headquartered in Bothell, Washington, is a clinical-stage biopharmaceutical company dedicated to advancing innovative therapies for neurodegenerative diseases. Leveraging its proprietary platform targeting the neurotrophic hepatocyte growth factor (HGF) system, Athira aims to restore neuronal health, mitigate neurodegeneration, and alter disease progression. By focusing on disease-modifying approaches, the company seeks to address the underlying mechanisms of conditions such as Alzheimer's disease, Parkinson's disease, and amyotrophic lateral sclerosis (ALS).
Therapeutic Focus and Pipeline
Athira's therapeutic pipeline is built around small-molecule drug candidates that modulate the HGF system to activate neuroprotective, neurotrophic, and anti-inflammatory pathways. Key programs include:
- ATH-1105: A next-generation, orally administered small molecule designed to treat ALS and other neurodegenerative diseases. Preclinical studies have demonstrated its ability to reduce neurofilament light chain (NfL) levels, a biomarker for neurodegeneration, while improving motor function and neuronal survival.
- Fosgonimeton (ATH-1017): A subcutaneously administered drug candidate targeting mild-to-moderate Alzheimer's disease. Despite mixed results in clinical trials, it showed promising biomarker improvements, suggesting potential neuroprotective effects.
Scientific Innovation
Athira's unique approach centers on the HGF system, an endogenous repair mechanism critical for neuronal health. By enhancing this pathway, the company targets the root causes of neurodegeneration, such as mitochondrial dysfunction, protein aggregation, and inflammation. This differentiates Athira from competitors focusing primarily on symptomatic relief.
Market Position and Challenges
Operating in the highly competitive biopharmaceutical industry, Athira faces challenges such as regulatory hurdles, clinical trial risks, and competition from established players. However, its focus on a novel therapeutic pathway and its shift toward ALS with ATH-1105 position it as a potential leader in addressing unmet needs in neurodegenerative disease therapeutics.
Strategic Outlook
Following the mixed outcomes of its LIFT-AD trial for Alzheimer's, Athira has prioritized ATH-1105 for ALS, supported by robust preclinical data. The company is conducting a Phase 1 trial and plans to initiate ALS patient dosing in 2025. Additionally, Athira is exploring strategic alternatives, including partnerships, to extend its financial runway and advance its pipeline.
Through its innovative platform, focused pipeline, and commitment to addressing unmet medical needs, Athira Pharma is poised to make significant contributions to the treatment landscape for neurodegenerative diseases.
Athira Pharma (ATHA) presented results from its ACT-AD trial for fosgonimeton, a treatment for mild-to-moderate Alzheimer's disease, at the AAIC 2022. While the primary endpoint was not statistically significant, secondary analyses showed numerical improvements in daily living activities and cognitive measures. Notably, a significant reduction in neurofilament light chain (NfL), a biomarker of neurodegeneration, was observed in a subgroup receiving fosgonimeton monotherapy. The positive tolerability profile and ongoing LIFT-AD study offer further exploration into its therapeutic potential.
Athira Pharma (ATHA) showcased preclinical data on its lead candidate, fosgonimeton (ATH-1017), at the AAIC 2022. The active metabolite, fosgo-AM, demonstrated neuroprotective effects in neuron cultures, enhancing neuron survival and neurite growth while mitigating neurotoxic impacts. Furthermore, novel orally bioavailable small molecules were shown to reverse memory deficits in animal models, promising for Alzheimer's treatment. These developments underline Athira's commitment to advancing its innovative therapies targeting neurodegenerative disorders.
Athira Pharma (NASDAQ: ATHA) announced its participation in the Alzheimer’s Association International Conference (AAIC) 2022, taking place from July 31 to August 4, 2022. Chief Medical Officer Hans Moebius will present results from the ACT-AD Phase 2 proof-of-concept study on fosgonimeton (ATH-1017) targeting mild-to-moderate Alzheimer’s patients. The conference will include discussions on novel Alzheimer’s treatments, with Athira presenting data on its small molecule HGF/MET platform aimed at neuroprotection and cognitive improvement.
Athira Pharma (ATHA) announced topline results from its ACT-AD Phase 2 study of fosgonimeton in patients with mild-to-moderate Alzheimer’s disease. The primary endpoint of statistically significant change in ERP P300 latency was not met, suggesting diminished effect when combined with standard-of-care AChEIs. However, a subgroup analysis indicated improved ERP P300 latency and cognitive performance in patients on fosgonimeton monotherapy compared to placebo. Fosgonimeton demonstrated a favorable safety profile, and insights gained will inform the ongoing LIFT-AD study.
Athira Pharma, Inc. (NASDAQ: ATHA) has established a Scientific Advisory Board (SAB) comprising leading experts in neurology and neurodegenerative diseases. The board, chaired by Athira's Chief Medical Officer, Dr. Hans Moebius, aims to provide strategic guidance for the development of Athira's novel small molecule compounds targeting conditions like Alzheimer’s and Parkinson’s disease. SAB members include prominent researchers from esteemed institutions, enhancing Athira’s capability in advancing its pipeline for neurological treatments.
Athira Pharma (NASDAQ: ATHA) announced that its shareholders have approved the election of three new independent directors: Joseph Edelman, John M. Fluke, Jr., and Grant Pickering. CEO Mark Litton expressed gratitude for shareholder support, emphasizing the directors' contributions during a crucial phase for the company. Athira will continue to advance its clinical trials, focusing on its lead drug candidate, fosgonimeton (ATH-1017), aiming to enhance shareholder value. The final voting results will be disclosed in a Form 8-K filing with the SEC.
Athira Pharma (NASDAQ: ATHA) has announced that its board recommends shareholders vote 'FOR' its three qualified director nominees on the WHITE proxy card. As Richard A. Kayne suspends his proxy contest, the board expresses gratitude for shareholder support and emphasizes its commitment to advancing Athira's strategy, especially with topline results from the Phase 2 ACT-AD study expected soon. The board believes it is well-equipped to drive company success, focusing on its developments in neurodegenerative diseases like Alzheimer’s and Parkinson’s.
On May 16, 2022, Ric Kayne, a shareholder of Athira Pharma (NASDAQ: ATHA), announced the suspension of his campaign for board election amid concerns about the company's future leadership and strategy for ATH-1017. Despite expressing optimism about the drug's potential, Kayne acknowledged that a close vote could lead to a contentious board dynamic. He emphasized shareholder engagement, urging them to voice their opinions, while asserting the need for enhanced clinical management in light of upcoming trial results.
Athira Pharma (NASDAQ: ATHA) announced promising preclinical findings for its small molecules, ATH-1018 and ATH-1019, targeting the HGF/MET signaling pathway. Presented at the 2022 Peripheral Nerve Society Annual Meeting, results showed significant improvement in pain-related behaviors in a diabetic neuropathy model. Notably, the effects persisted even after the compounds were cleared from plasma, suggesting long-lasting benefits. Athira aims to further evaluate these candidates to enhance its pipeline for treating diabetic neuropathy and other neurodegenerative conditions.
Athira Pharma (NASDAQ: ATHA) reported its Q1 2022 financial results and discussed progress in clinical studies, including the ACT-AD Phase 2 Alzheimer's study set to release topline data by the end of Q2 2022. The company increased R&D expenses to $14.5 million, up from $7.4 million in Q1 2021, and general and administrative costs surged to $8.9 million due to headcount growth. The net loss also widened to $21.0 million, or $0.56 per share, compared to $8.9 million, or $0.25 per share, in the same period last year.
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