Amylyx Slumps as FDA Panel Against OK to Neurodegenerative Drug -Breaking
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By Dhirendra Tripathi
Investing.com – Amylyx Pharmaceuticals Stock plunged over 21% on Thursday as a result of an FDA panel voting against the recommendation to approve an experimental drug that treats amyotrophiclateral sclerosis.
Motor neuron loss in the brain and spine causes ALS. This is a deadly and relentlessly progressing neurodegenerative condition. In ALS, motor neuron death causes deterioration in muscle function, inability to speak and move, paralysis and ultimately, death.
AMX0035, a combination of 2 small molecules and an oral fixed-dose formulation is the AMX0035.
Panel members stated that study data did not prove the effectiveness of the drug in combating the disease. The Phase-2 trial involved 137 patients.
Although the recommendations of the panel were not binding, the FDA is expected to make the final determination regarding the approval or denial of any pending drug application by June 29.
Amylyx, a company that develops novel therapies for ALS and neurodegenerative conditions in the clinical stages of biopharmaceutical development is known as Amylyx.
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