The shares of Amylyx Pharmaceuticals ( NASDAQ: AMLX ) slipped pre-market Friday after the company focused on neurodegenerative diseases set its new FDA-approved treatment for amyotrophic lateral sclerosis at an initial annual price of $158K.
AMLX shares surged in post-market trading Thursday as the FDA finally approved AMX0035 branded as Relyvrio following the recommendation of an expert panel of the agency, which initially rejected it in March.
The company will charge $12.5K for a 28-day supply of Relyvrio, which amounts to an annual cost of $158K for the first year when the dosing frequency is less frequent and $163K for subsequent years.
On Wall Street, Citi analyst Neena Bitritto-Garg with a Buy rating on AMLX, cited robust ALS patient advocacy and other recent launches to argue that Relyvrio could see a “substantial” demand during the rollout.
Meanwhile, SVB Securities noted that even if the company’s confirmatory trial Phoenix turns negative, Relyvrio is unlikely to be withdrawn from the market due to “significant enthusiasm and support” from patients and clinicians.
The analyst Marc Goodman who has an Outperform rating on AMLX, expects the company shares to rise in 2023 thanks to a strong launch and a relatively fast Relyvrio sales ramp in the U.S.
Before the FDA, Health Canada approved AMX0035 for ALS subject to several conditions.
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Amylyx sets annual price for new ALS therapy at $158K