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.
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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.
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.
Prothena Reports 2025 Results as Partners Advance Phase 3 Trials in Parkinson's, ATTR-CM
Mar 22, 2026
Prothena reported Q4 and full year 2025 financial results with $308.4 million in cash as partners Roche and Novo Nordisk initiated Phase 3 trials for prasinezumab and coramitug, both expected to complete in 2029.
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.
FDA Clears First-in-Human Trial of Allogeneic Cell Therapy for Drug-Resistant Epilepsy
Mar 14, 2026
The FDA has authorized the first human trial of an allogeneic stem cell therapy for epilepsy, developed by Shanghai-based Unixell Biotechnology. The therapy uses donor-derived stem cells to produce GABA and suppress seizures in drug-resistant patients.
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.
NeuraLight to Unveil Neuroprogression Biomarker for Parkinson's Disease at AD/PD 2026
Feb 26, 2026
NeuraLight will present a neuroprogression biomarker that outperforms the current gold standard for tracking Parkinson's disease progression at the AD/PD 2026 conference in Copenhagen beginning March 17.
Neurofilament Light Chain Identified as Cross-Species Biomarker for Aging and Mortality Risk
Feb 21, 2026
Researchers at DZNE and the University of Tübingen have identified neurofilament light chain (NfL) as a blood biomarker detectable across animal species, with levels increasing with age and predicting lifespan in mice.
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.
Prothena Q4 2025 Earnings: Two Partnered Programs Enter Phase III, Cash Position Exceeds Guidance
Feb 21, 2026
Prothena reported Q4 2025 adjusted loss of 45 cents per share, meeting estimates, while ending the year with $308.4 million in cash. Roche and Novo Nordisk advanced partnered programs prasinezumab and coramitug into Phase III trials.
BioArctic Reports Record Q4 2025 Results as Leqembi Expands Globally
Feb 18, 2026
BioArctic reported net revenues of SEK 184.0 M for Q4 2025, driven by Leqembi royalties and Novartis partnership income. Leqembi received multiple regulatory approvals and submissions across global markets during the quarter.
Drug Discovery Patent Filings Span Protein Degradation, Ion Channels, and Emerging Targets
Feb 25, 2025
Monthly patent reviews from April through December 2025 highlight notable drug discovery IP disclosures across targeted protein degradation, small molecule modulators, and emerging therapeutic targets in oncology, immunology, and neurology.
FDA Issues Complete Response Letter for Corcept's Relacorilant in Hypercortisolism
Sep 11, 2025
The FDA issued a Complete Response Letter for Corcept's relacorilant as a treatment for hypertension secondary to hypercortisolism, requesting additional evidence of effectiveness despite acknowledging positive trial results.