Ionis Pharmaceuticals (IONS) announced last night that its subsidiary Akcea Therapeutics (AKCA) received a complete response letter for Waylivra from the FDA. JPMorgan analyst Jessica Fye says she had a chance to catch up with management but that they did not provide much in the way of details regarding the CRL. Given that Waylivra and Tegsedi are both generation 2.5 products and both have had platelet safety issues, the market will naturally question if the risk of a CRL also extends to Tegsedi, Fye tells investors in a research note. The analyst expects Ionis shares to reflect greater risk to approval for Tegsedi as well as Waylivra. She notes that Waylivra is worth $2 per share in her model for Ionis while Tegsedi contributes greater than $10 per share. The stock in premarket trading is down 12%, or $6.68, to $47.02. Fye keeps a Neutral rating on Ionis Pharmaceuticals.
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