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Athira Pharma, Inc. (NASDAQ: ATHA) is a late clinical-stage biopharmaceutical company based in the Seattle, Washington area, dedicated to developing small molecule therapeutics aimed at restoring neuronal health and slowing neurodegeneration. Athira's innovative pipeline includes several promising compounds, particularly targeting the neurotrophic hepatocyte growth factor (HGF) system, which plays a crucial role in nervous system maintenance and repair.
The company’s lead candidate, Fosgonimeton (ATH-1017), is a subcutaneously administered small molecule designed to positively modulate the HGF/MET system. It is currently being evaluated in the Phase 2/3 LIFT-AD clinical trial for the treatment of mild-to-moderate Alzheimer’s disease, with topline data expected in the second half of 2024. Fosgonimeton has shown potential in enhancing neuroprotective, neurotrophic, and anti-inflammatory pathways, which are critical in combating neurodegenerative diseases such as Alzheimer’s and Parkinson’s disease.
In addition to Fosgonimeton, Athira’s pipeline includes ATH-1105 and ATH-1020, both designed to be orally available treatments enhancing the HGF/MET system. ATH-1105 is particularly promising in preclinical models of amyotrophic lateral sclerosis (ALS), demonstrating significant neuroprotective effects, enhanced survival, and improved motor and nerve functions. The company plans to initiate first-in-human studies for ATH-1105 in the first half of 2024.
Athira's research is bolstered by funding from notable organizations such as the Alzheimer’s Drug Discovery Foundation, Washington’s Life Sciences Discovery Fund, and Dolby Family Ventures. This support underscores the company’s strong financial position and its capacity to advance its therapeutic candidates through key development milestones.
Recent updates highlight the therapeutic potential of Athira’s small molecules. For instance, fosgonimeton has demonstrated promising results in preclinical models of Alzheimer’s and Parkinson’s diseases, showing neuroprotective effects and improvement in cognitive and motor functions. Additionally, ATH-1105's preclinical studies have shown consistent beneficial effects in ALS models, reinforcing Athira’s approach and commitment to developing novel therapies for neurodegenerative diseases.
Athira is also active in the scientific community, regularly presenting its findings at major conferences and publishing in peer-reviewed journals. The company’s efforts are focused on leveraging its patented technologies to develop cost-effective treatments that address the root causes of neurodegenerative diseases, setting it apart from competitors that primarily target disease symptoms.
For more information about Athira Pharma, Inc., visit www.athira.com and follow the company on Facebook, LinkedIn, X (formerly known as Twitter), and Instagram.
Athira Pharma (NASDAQ: ATHA) presented preclinical data for ATH-1105 at the Motor Neurone Disease Association's 35th International Symposium on ALS/MND. The research demonstrated the drug's neuroprotective effects in human models of ALS, specifically in human iPSC-derived motor neurons expressing the SOD1-A4V mutation.
Key findings showed that ATH-1105 promoted activation of MET receptor in ALS patient-derived motor neurons, enhanced motor neuron survival, and preserved neurite networks following glutamate challenge. The drug demonstrated neuroprotective activity through the MET receptor, with effects diminishing when MET was knocked down. In a neuromuscular junction model, ATH-1105 showed protective effects on motor neuron survival and neurite networks.
Athira Pharma reported Q3 2024 financial results and provided updates on its pipeline and business. The company is advancing ATH-1105, an oral drug candidate for ALS, with Phase 1 trials in healthy volunteers expected to complete by year-end and ALS patient dosing to begin in 2025. ATH-1105 has shown promising preclinical results in ALS models. However, the LIFT-AD Phase 2/3 trial for fosgonimeton in Alzheimer's did not meet primary or key secondary endpoints. Consequently, Athira is exploring strategic alternatives and has paused further fosgonimeton development. Financially, Athira's cash position was $68.9 million, with a net loss of $28.7 million for Q3 2024. R&D expenses decreased to $17.9 million, while G&A expenses remained stable at $7.6 million. Legal expenses were $4.1 million due to a DOJ investigative demand.
Athira Pharma (NASDAQ: ATHA) announced that results from the Phase 2/3 LIFT-AD clinical trial of fosgonimeton for Alzheimer's disease will be presented at the 17th Annual Clinical Trials on Alzheimer's Disease (CTAD) meeting in Madrid, Spain. The presentation, titled "Fosgonimeton for the Treatment of Alzheimer's Disease; Efficacy and Safety Results from the LIFT-AD Trial," will be given by Dr. Anton P. Porsteinsson on October 29, 2024.
While the trial did not achieve statistical significance for its primary and key secondary endpoints, cognition and function directionally favored fosgonimeton treatment. In pre-specified subgroups with more rapid disease progression, improvements or stabilization were observed. Biomarker data showed directional changes supporting fosgonimeton's neuroprotective mechanism.
Athira is now focusing on ATH-1105, a novel oral small molecule for neurodegenerative diseases, currently in a Phase 1 trial with healthy volunteers. The company aims to begin dosing ALS patients in 2025.
Athira Pharma (NASDAQ: ATHA) announced a strategic shift to focus on advancing ATH-1105, an oral, next-generation small molecule positive modulator of the HGF system, for treating neurodegenerative diseases like ALS and Alzheimer's. This decision follows the topline data readout from the Phase 2/3 LIFT-AD trial of fosgonimeton. The company is implementing cost containment measures, including a 70% workforce reduction, expecting one-time costs of $2.8 million and annual savings of $13.4 million. These measures aim to extend Athira's cash runway into Q1 2026.
Athira is currently conducting a Phase 1 trial of ATH-1105, expecting completion by year-end 2024 and plans to begin dosing ALS patients in 2025. The company is encouraged by ATH-1105's potential, citing its enhanced blood-brain-barrier penetration and improved pharmacokinetic properties. Preclinical data has shown neuroprotective effects, including consistent reduction in plasma neurofilament light chain (NfL) levels, a marker of disease progression in ALS.
Athira Pharma ATHA announced topline results from its Phase 2/3 LIFT-AD clinical trial of fosgonimeton for mild-to-moderate Alzheimer's disease. The trial did not meet its primary endpoint of Global Statistical Test (GST) or key secondary endpoints of cognition (ADAS-Cog11) and function (ADCS-ADL23) at 26 weeks. However, in pre-specified subgroups of patients with moderate Alzheimer's or APOE4 carriers, fosgonimeton showed a numerically greater treatment effect. Biomarkers associated with Alzheimer's pathology showed changes consistent with fosgonimeton's neuroprotective mechanism. The drug was generally well-tolerated with a favorable safety profile. Athira continues to evaluate ATH-1105, a next-generation oral drug candidate for neurodegenerative diseases, with a Phase 1 trial expected to complete by year-end 2024.
Athira Pharma (NASDAQ: ATHA) reported Q2 2024 financial results and provided pipeline updates. Key highlights include:
1. Topline data from Phase 2/3 LIFT-AD trial of fosgonimeton for Alzheimer's disease expected in September 2024.
2. Phase 1 trial of ATH-1105 for ALS underway.
3. Cash position of $91.8 million as of June 30, 2024.
4. Net loss of $26.9 million ($0.70 per share) for Q2 2024.
5. R&D expenses increased to $22.2 million, while G&A expenses decreased to $5.9 million.
The company remains focused on developing small molecules to restore neuronal health and slow neurodegeneration, with fosgonimeton showing potential as a first-in-class therapy for Alzheimer's disease.
Athira Pharma (NASDAQ: ATHA) presented new preclinical data on fosgonimeton at the Alzheimer's Association International Conference (AAIC) 2024. The data demonstrated fosgonimeton's ability to mitigate amyloid-β-induced toxicity, lower pTau levels, and reduce disruption of protein clearance mechanisms in Alzheimer's disease models. Notably, fosgonimeton showed neuroprotective effects against amyloid-β toxicity in primary neurons, both alone and in combination with lecanemab. The research suggests that fosgonimeton may attenuate pTau pathology by improving autophagy, a cellular process impaired in Alzheimer's. These findings support Athira's approach of targeting the neurotrophic HGF system as a potential Alzheimer's treatment and suggest potential benefits of combining fosgonimeton with amyloid-β-targeting monoclonal antibodies.
Athira Pharma announced the completion of dosing for the last patient in their Phase 2/3 LIFT-AD clinical trial of fosgonimeton, aimed at treating mild-to-moderate Alzheimer's disease (AD). The trial involved approximately 315 patients, assessing the efficacy and safety of fosgonimeton through once-daily subcutaneous injections over a 26-week period. Athira plans to release topline results by the end of Q3 2024 and will present detailed data at the CTAD conference on October 29, 2024, in Madrid. The primary endpoint, the GST, evaluates changes in cognition and function using the ADAS-Cog11 and ADCS-ADL23 tests. The trial also includes serum biomarker analysis to explore the neuroprotective effects of fosgonimeton. Additionally, a significant portion of participants have enrolled in an open-label extension study, with over 70 patients continuing treatment beyond 18 months.
Athira Pharma will host a webinar on June 18, 2024, to discuss the potential of fosgonimeton for treating mild-to-moderate Alzheimer's disease (AD). The event will cover the ongoing Phase 2/3 LIFT-AD trial, with topline data expected in the second half of 2024. Chief Medical Officer Javier San Martin, alongside two neurodegeneration experts, will review the trial's primary endpoint, the Global Statistical Test (GST), which measures cognition and function. The webinar will provide insights into the unmet medical needs in AD and the potential benefits of fosgonimeton.
Athira Pharma has completed the first cohort in its Phase 1 clinical trial for ATH-1105, a potential treatment for ALS. This first-in-human, dose-escalation study aims to assess the safety, tolerability, and pharmacokinetics of the drug in healthy volunteers. The trial is expected to conclude by the end of 2024, with a Phase 2 study in ALS patients slated for 2025. Preclinical data indicates that ATH-1105 can improve motor function, preserve nerve health, and extend survival in ALS models. The Phase 1 trial will involve up to 80 healthy participants and will evaluate single and multiple ascending doses of the drug.
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