4D Molecular Shares Fall After Filing For Fabry Disease Trial Amendment

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  • 4D Molecular Therapeutics Inc FDMT said that in June, the company filed a protocol amendment with the FDA for the ongoing Phase 1/2 trial of 4D-310 for Fabry disease.
  • The protocol amendment is intended to expand the eligible patient population, including the addition of female Fabry patients with symptomatic disease.
  • SVB Securities cuts 4D Molecular to Market Perform from Outperform with a price target of $12, down from $28 after the Fabry update.
  • The analyst feels this decision is an "unforced error," as it "introduces additional complexity into a population with an already small N and high inter-patient variability." 
  • Fabry disease is a rare inherited condition that affects enzymes that metabolize fat. Fat deposits then clog blood vessels and tissue.
  • The inclusion of female patients in the phase 1/2 clinical trial was supported by clinical experience and a GLP toxicology study in female mice models.
  • Related: 4D Molecular Shares Updated Data From Fabry Disease Trial.
  • The company continues to expect to provide a clinical data update on 4D-310 in 1H of 2023.
  • Cash, cash equivalents, and marketable securities were $261.6 million as of June 30, 2022. sufficient to fund operations into 1H of 2025.
  • Five clinical-stage product candidates are on track for multiple clinical data updates in 2023.
  • Price Action: FDMT shares are down 11.5% at $9.20 during the market session on the last check Friday.
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