Amylyx Pharmaceuticals Inc. said on Tuesday that a European regulatory panel had taken a negative view on its amyotrophic lateral sclerosis (ALS) treatment, stalling the company’s plans on introducing its first commercial drug in the region.
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Amylyx is dipping back into the well to raise funds to launch its recently approved ALS drug Relyvrio. The company plans to offer 6 million shares in a public offering to bring in between $167 to $192.2 million.
Say what you will about the $158,000 price tag on Amylyx’s newly minted Relyvrio or the worthiness of the CENTAUR trial, the FDA’s approval of its third-ever ALS drug has ignited the growing momentum in the space.
The biopharma world – and markets – spent Thursday evening reacting as the FDA gave the green light to only its third-ever drug for ALS, Amylyx’s AMX0035.
Amylyx Pharmaceuticals Inc. said on Friday it has set the list price of its newly approved drug to slow the progression of amyotrophic lateral sclerosis (ALS) at about $158,000 per year in the United States.
Following a favorable vote from an FDA advisory committee, Amylyx is one step closer to seeing its amyotrophic lateral sclerosis (ALS) treatment approved for use in the United States.
Wednesday offers a rare opportunity for Amylyx Pharmaceuticals, which will go before the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee in a second attempt to win recommendation for its amyotrophic lateral sclerosis (ALS) drug, AMX0035.
Amylyx Pharmaceuticals Inc.’s experimental drug for the neurodegenerative disease amyotrophic lateral sclerosis (ALS) would be more cost effective than other U.S.-approved treatments if priced around $170,000, an independent U.S. pricing watchdog said on Tuesday.