UPDATE: Citi Starts Amylyx Pharmaceuticals inc. (AMLX) at Buy
- World stocks in red as consumers signal recession ahead
- JPMorgan Reiterates Amazon, Booking, and Uber as Top Internet Stocks to Own
- Pinterest (PINS) CEO Silbermann Is Stepping Down, Shares Gain 8%
- Morgan Stanley Downgrades Upstart to Underweight, Price Target Cut by Nearly 80%
- Euro trims declines after Spain inflation surge
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."
Shares of Amylyx Pharmaceuticals inc. closed at $8.45 yesterday.
You May Also Be Interested In
- UPDATE: Raymond James Starts Seagen (SGEN) at Outperform
- UPDATE: Morgan Stanley Downgrades Upstart Holdings Inc (UPST) to Underweight
- Synchrony Financial (SYF) PT Lowered to $50 at Citi, Adds to Focus List
Create E-mail Alert Related CategoriesAnalyst Comments, Hot Comments, Hot New Coverage, New Coverage
Related EntitiesCiti, PDUFA, AdCom, FDA
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!