2022-09-13 08:49:09 ACAD Acadia Pharmaceuticals
09/13/22 09/1308:49 09/13/2208:49 | FDA not planning trofinetide AdCom a positive sign for Acadia, says GuggenheimAfter Acadia announced that the FDA has accepted the NDA of trofinetide for the treatment of Rett syndrome, granted the application priority review and said that at this time the agency is not planning to hold an Advisory Committee meeting, Guggenheim analyst Yatin Suneja said the lack of an AdCom is "a positive sign for the likelihood of approval." The impact of trofinetide's tolerability profile may affect the overall addressable market for the drug, but Suneja doesn't think it will impact potential approval given the significant unmet need and the analyst currently models $675M in peak sales for trofinetide. Suneja has a Neutral rating on Acadia Pharmaceuticals shares with no price target. |
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