FDA blocks AMT-130 approval pathway; UK filing planned Q3 2026 as securities suit filed

Filed May 5, 2026 · Period ending March 31, 2026 · Compared to 10-Q May 9, 2025 · ~1 min read

Key Changes

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  FDA reversed prior agreement on accelerated approval for AMT-130, now requiring multi-year randomized controlled trial with sham surgery. Company pivoting to UK marketing application in Q3 2026 as alternative pathway.

  MD&A: AMT-130 Regulatory Strategy verify on EDGAR →
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  Securities class action filed February 2026 alleging false statements about AMT-130 study results and BLA timing during September-October 2025. Company cannot estimate potential loss range.

  Legal Proceedings verify on EDGAR →
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  Cash runway extended to H2 2029 from H2 2027, reflecting September 2025 equity raise, AMT-162 discontinuation savings, and restructured Hercules debt now maturing October 2030 instead of January 2027.

  MD&A: Liquidity verify on EDGAR →