Seeking Alpha
01 Jun 2026, 09:39 UTC · 2h ago
Source · https://seekingalpha.com/article/4910547-grace-therapeutics-stock-manufacturing-setback-priced-as-a-death-sentence
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3 claims · impact-rated
The FDA's CRL for GTx-104 was based solely on Chemistry, Manufacturing, and Controls (CMC) issues, with no objections to efficacy or safety. — CMC issues are generally considered 'fixable' technical hurdles rather than fundamental failures of the drug's therapeutic value.
+0.60A scenario-weighted DCF model assigns a 75% probability of approval for GTx-104. — A high probability of eventual approval supports a bullish long-term valuation despite the current regulatory delay.
+0.40Grace Therapeutics has a $4 price target, implying a 57% upside from current levels. — A significant implied upside suggests the market has overreacted to the CRL, creating a value opportunity.
+0.30Ticker attribution
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The company is rated as a Speculative Buy with significant implied upside and a high probability of FDA approval for GTx-104.
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