Here's How Citi Views Amylyx Pharma

  • Citi Research has raised the price target on Amylyx Pharmaceuticals Inc's AMLX to $33 from $32, with a Buy rating.
  • It says the small market opportunity for the newly approved amyotrophic lateral sclerosis (ALS) drug in Canada (~$100 million peak) bodes well for ongoing FDA review. 
  • Availability in Canada and using ALSFRS-R data as the primary basis for approval could pressure the FDA.
  • The analyst cites the political implications of an FDA rejection (CDER Director Cavazzoni's congressional testimony last year on ALS), weaknesses in the FDA's arguments on ALSFRS-R analyses in CENTAUR, and potential concerns around Canadian importation. 
  • The Institute for Clinical and Economic Review (ICER) has released a new analysis to determine the ALS drug's cost-effectiveness.
  • Current analysis suggests no — for now.
  • Though Amylyx has not disclosed the price for AMX0035, branded as Albrioza in Canada, ICER pegged $169,000 per year, similar to an older ALS medicine, edaravone. 
  • ICER says that the drug would not be cost-effective to the U.S. healthcare system at the above price point and far from it.
  • It notes that the price will be finalized after a public comment period in early August.
  • Price Action: AMLX shares are up 17.38% at $15.26 during the market session on the last check Tuesday.

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