Keros to Start Rinvatercept DMD Trial in Q1 2026, Plans ALS Regulatory Talks
Keros Therapeutics plans a phase II DMD trial of rinvatercept in Q1 2026 and regulatory talks for ALS in H2 2026. Cash stands at $383 million with runway into H1 2028.
Amyotrophic lateral sclerosis (ALS) is a rare, progressive neurodegenerative disorder caused by loss of upper and lower motor neurons, leading to weakness, muscle wasting, and eventually respiratory failure. It is the most common motor neuron disease.
Keros Therapeutics plans a phase II DMD trial of rinvatercept in Q1 2026 and regulatory talks for ALS in H2 2026. Cash stands at $383 million with runway into H1 2028.
Prothena Corporation plc will report its second quarter and first six months of 2026 financial results on August 6, 2026, after U.S. market close. No conference call will be held, consistent with past practice. The company focuses on neurodegenerative and rare amyloid diseases.
Actor Eric Dane died of ALS at age 53 in February 2026, less than a year after announcing his diagnosis. Former NFL star Chris Johnson also revealed his ALS diagnosis at age 39. The cases highlight the neurodegenerative disease, which affects about 33,000 people in the U.S. and has no cure.
Biotech companies announced new financings: HMNC closed a $50M Series B, Cartesian secured a $150M credit facility, Waiv raised $33M, and Brainstorm raised $1M. KET01 showed early efficacy but missed its primary endpoint.
Two experimental ALS therapies showed promise in recent clinical developments. Interim Phase 1/2 data suggest the antisense oligonucleotide QRL-201 restores a critical nerve protein and may slow disease decline, with a Phase 3 trial planned for 2027. Meanwhile, the oral therapy neflamapimod has been selected for testing in the UK's EXPERTS-ALS platform study, with first results expected this spring.
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.
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.
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.
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.
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.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07674667 |
FUNCtion ALS: Aiming to Restore UNC13A Function in People Living With ALS |
RECRUITING | PHASE1/PHASE2 |
| NCT07660614 |
A Study of LTX-002 in Adult Participants With Amyotrophic Lateral Sclerosis |
RECRUITING | PHASE1/PHASE2 |
| NCT07656714 |
HFCWO Vest Plus Mechanical Cough Assist Versus Cough Assist Alone on Respiratory Infections in ALS: a Pilot Trial |
COMPLETED | NA |
| NCT07636538 |
Auto-calibrating System for Upper Limb Disability Assessment, Neurological and Occupational Rehabilitation |
NOT_YET_RECRUITING | NA |
| NCT07616050 |
Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients |
NOT_YET_RECRUITING | NA |
| NCT07572838 |
Alter-Ego as an Assistive Robotic Device. |
NOT_YET_RECRUITING | |
| NCT07571486 |
Therapeutic Approach of Repeated Transient Blood-brain Barrier Opening in Amyotrophic Lateral Sclerosis. |
RECRUITING | PHASE1/PHASE2 |
| NCT07571200 |
A Master Protocol (OLMP): A Study of LY4256984 in Participants With Amyotrophic Lateral Sclerosis (ALS) |
RECRUITING | PHASE1 |
| NCT07571174 |
A Substudy of LY4256984 in Participants With Sporadic Amyotrophic Lateral Sclerosis |
RECRUITING | PHASE1 |
| NCT07502677 |
Diagnostic Accuracy of SleepImage Technology for Detecting Respiratory Failure in Patients With Amyotrophic Lateral Sclerosis |
RECRUITING |