Craig-Hallum lowered the firm’s price target on Grace Therapeutics (GRCE) to $4 from $11 and keeps a Buy rating on the shares following the CRL to GTx-104. FDA cited CMC issues, specifically calling out deficiencies at the company’s CDMO, as well as some non-clinical concerns related to leachables characterization for final packaging, and toxicology risk assessments, the firm notes. Craig-Hallum believes Grace has enough runway to address the deficiencies and resubmission, though shares are unlikely to move higher until further visibility is provided.
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Read More on GRCE:
- Grace Therapeutics price target lowered to $8 from $12 at TD Cowen
- Grace Therapeutics: Buy Rating Maintained as Addressable CMC Setback Delays but Does Not Derail GTx‑104 Value Thesis
- Grace Therapeutics Receives FDA Complete Response for GTx-104
- Grace Therapeutics down 48% after receipt of CRL from FDA for GTx-104
- Grace Therapeutics, Inc trading resumes
