Why Did Aeglea BioTherapeutics Shares Nosedived To 52-Week Low On Monday Premarket?

Loading...
Loading...

Aeglea BioTherapeutics Inc AGLE has announced data from the Phase 3 study of pegzilarginase in Arginase 1 Deficiency (ARG1-D) patients aged two years and older. ARG1-D is a rare disease characterized by high levels of the amino acid arginine. The disease manifestations include spasticity, developmental delay, intellectual disability, and seizures.

  • The study met the primary endpoint with a statistically significant reduction in plasma arginine from baseline after 24 weeks.
  • At six months, 21 patients dosed with pegzilarginase posted an 80% reduction in mean plasma arginine over placebo. 
  • Meanwhile, 90.5% of patients receiving pegzilarginase reached normal plasma arginine levels compared with no patients in the control arm.
  • So what resulted in shares plunging to a 52-week low?
  • On two key secondary endpoints, including improvements in a two-minute walk test and a catch-all mobility test known as GMFM-E, peglizarginase failed to best placebo.
  • For the two-minute walk test, patients dosed with peglizarginase posted a mean increase in distance walked from a baseline of 7.4 meters compared with an increase of 1.9 meters in control patients, far below the bar for statistical significance.
  • On the GMFM-E test, patients dosed with pegzilarginase showed a 4.2-unit increase over baseline compared with a 0.4-unit decline for placebo patients.
  • Aeglea said it didn’t flag any new safety concerns in the study and no patients dropping out due to dosing.
  • The Company plans to submit a marketing application to the FDA in 1H of 2022.
  • Price Action: AGLE shares are down 30.7% at $4.16 during the premarket session on the last check Monday.
Market News and Data brought to you by Benzinga APIs
Comments
Loading...
Posted In: BiotechNewsShort IdeasHealth CareMoversTrading IdeasGeneralBriefsPhase 3 Trialwhy it's moving
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!

Loading...