UPDATE: Citi Starts Amylyx Pharmaceuticals inc. (AMLX) at Buy

Citi analyst Neena Bitritto-Garg initiates coverage on Amylyx Pharmaceuticals inc. (NASDAQ: AMLX) with a Buy rating and a price target of $21.00.

The analyst comments "Based on FDA’s position at the AdCom around validity of the primary analysis in AMX0035’s Ph2 CENTAUR study in ALS, lack of dissension between Neuro Office/Division, and the negative vote, approval by the June 29th PDUFA will likely require championing from a high-level advocate at FDA (e.g., CDER Director Patrizia Cavazzoni) to challenge validity of Neuro’s statistical arguments on rigor of the primary analysis and leverage regulatory flexibility to approve the application. Due to lack of visibility into whether this will occur, we assign 45% US PoS. In Europe, PoS may be higher (50%) as EMA’s preferred statistical methodologies in ALS and ability to leverage a conditional approval differ vs. FDA. At the current trading range, we estimate US approval is priced in at <25% PoS with minimal value to EU. As such, risk/reward is highly favorable (-$5/+$20 or more/share) into regulatory decisions between June-1Q23. Initiate Buy/High Risk, PT $21."

For an analyst ratings summary and ratings history on Amylyx Pharmaceuticals inc. click here. For more ratings news on Amylyx Pharmaceuticals inc. click here.

Shares of Amylyx Pharmaceuticals inc. closed at $8.45 yesterday.

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