Coya Therapeutics advances COYA 302 as FDA fast track status raises clinical expectations
Coya Therapeutics’ COYA 302 fast track status raises the stakes for Treg-based ALS therapy. Find out what comes next.
What Clene Inc.’s FDA feedback reveals about the future of surrogate endpoints in ALS trials
Can biomarker-driven approvals transform ALS drug development? Explore how Clene Inc.’s FDA feedback on CNM-Au8 could accelerate innovation.
A failed ALS trial still showed a stunning survival signal. Can Corcept turn it into Phase 3 proof?
A failed ALS endpoint meets a striking survival signal. Corcept now faces the harder test: proving dazucorilant in Phase 3.
What Celosia Therapeutics’ Phase 1b CTx1000 trial could reveal about TDP-43 targeting in ALS
Celosia Therapeutics has dosed the first ALS patient with CTx1000. Read why this TDP-43 gene therapy trial could reshape the ALS pipeline.
Can STATHMIN-2 restoration succeed where ALS therapies have failed? QurAlis data examined
QurAlis ANQUR trial data puts STATHMIN-2 restoration on the ALS map. Find out what changes and what risks remain.
Coya Therapeutics expands ALS trial into Canada as COYA 302 gains Health Canada clearance
Coya Therapeutics expands its ALS trial for COYA 302 to Canada after Health Canada clearance. Explore what this means for the biotech’s immunotherapy platform.
QurAlis links QRL-101 to motor nerve excitability shift in ALS: Is target validation finally here?
QurAlis confirms target engagement of QRL-101 in ALS patients. Find out what this means for epilepsy trials and Kv7-targeted drug development.
What Neurizon’s entry into the HEALEY ALS trial means for the future of NUZ-001
Neurizon Therapeutics Limited has received clearance from the United States Food and Drug Administration for its investigational therapy NUZ-001 to be included in the HEALEY ALS Platform Trial, a globally recognized adaptive trial framework for amyotrophic lateral sclerosis. The decision formally designates NUZ-001 as Regimen I in the platform, allowing clinical site activation and study […]
What makes Prilenia’s PREVAiLS trial different from past ALS failures
FDA clears Prilenia’s PREVAiLS ALS trial. Can pridopidine validate neuroprotection and shift the treatment paradigm? Read the full analysis here.