FDA grants Fast Track designation to Coya Therapeutics' COYA 302 for ALS
May 19, 2026
The FDA granted Fast Track designation to COYA 302 for ALS. Phase 1 data showed tolerability and biomarker effects, and the phase 2 ALSTARS trial is underway.
News Related to Amyotrophic Lateral Sclerosis
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Amylyx Awaits Phase 3 Avexitide Data and Pipeline Updates
May 05, 2026
Amylyx is approaching key catalysts ahead of its May 7 earnings report, led by Phase 3 LUCIDITY data for avexitide in post-bariatric hypoglycemia due in the third quarter. The company is also expected to provide updates on AMX0035 in Wolfram syndrome and AMX0114 biomarker data in ALS.
Experts prioritize Zostavax, sildenafil and riluzole for Alzheimer disease trials
Apr 10, 2026
A Delphi consensus of 23 experts identified Zostavax, sildenafil and riluzole as high-priority candidates for Alzheimer disease clinical trials. Caregivers ranked the herpes zoster vaccine highest for acceptability and perceived benefit–risk balance.
NeuroTherapia Completes Phase 2a Alzheimer's Trial with Positive Safety and Biomarker Results
Apr 07, 2026
NeuroTherapia has completed a Phase 2a trial of NTRX-07 in Alzheimer's patients, meeting safety objectives with no treatment-related serious adverse events. Preliminary biomarker analysis shows encouraging results, including MRI findings trending toward stabilization. The oral small molecule targets neuroinflammation and showed positive effects in animal models.
CervoMed's Neflamapimod Advances in DLB and ALS Clinical Programs
Apr 07, 2026
CervoMed presents new MRI data showing neflamapimod may reduce basal forebrain atrophy in dementia with Lewy bodies and finalizes Phase 3 trial design. The drug has also been selected for a UK-funded ALS platform trial, with first dosing expected by end of 2026.
Phase 3 ALS Trial Launches for Pridopidine as AI Identifies Potential Drug Candidates
Apr 03, 2026
A phase 3 clinical trial has launched for pridopidine as a potential ALS treatment, while AI research identified 18 FDA-approved drugs that may extend survival. Separate studies found a promising three-drug combination for sporadic ALS using new cell models.
Two Experimental ALS Therapies Report Positive Safety Data from Early-Stage Trials
Mar 16, 2026
PrimeC, an oral combination therapy, showed safety and signals of clinical benefit in a phase 2b trial, while PLL001, a gut-targeting therapy, demonstrated positive safety and tolerability in a phase I/II study for amyotrophic lateral sclerosis.
FDA-Approved Compound Shows Neuroprotective Effects in Parkinson's Disease Models
Mar 16, 2026
Northwestern Medicine scientists discovered that N-acetyl-L-leucine (NALL), an FDA-approved compound, promotes neuroprotective effects in experimental Parkinson's disease models by targeting multiple molecular pathways simultaneously.
Brainstorm Cell Therapeutics Secures $1M Financing for ALS Phase IIIb Trial
Mar 12, 2026
Brainstorm Cell Therapeutics announced a $1 million private placement at a premium to market price to support its upcoming Phase IIIb trial of NurOwn stem cell therapy for amyotrophic lateral sclerosis.
Coya Therapeutics Advances ALS Combo Immunotherapy Into Phase 2 Trial
Mar 04, 2026
Coya Therapeutics detailed plans for a Phase 2 trial of combination immunotherapy targeting neuroinflammation in ALS, following a four-patient study showing biomarker improvements and reported slowing of disease progression.
Insmed Reports Strong 2025 Results, FDA Grants Orphan Drug Status to Treprostinil Palmitil
Feb 28, 2026
Insmed reported total revenues of $606.4 million for 2025, with ARIKAYCE growing 19% annually. The FDA granted orphan drug designation to treprostinil palmitil for pulmonary arterial hypertension treatment in January 2026.
New Approaches Target Underexplored Pathways in Alzheimer's Disease Research
Feb 26, 2026
Research initiatives are identifying novel therapeutic targets for Alzheimer's disease beyond traditional approaches, with focus on TREM2 agonists, metabolic interventions, and multi-omic data integration to diversify treatment strategies.