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Aeglea Plunges On Updated Data For Arginase 1 Deficiency Candidate, Wells Fargo Downgrade

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Aeglea Plunges On Updated Data For Arginase 1 Deficiency Candidate, Wells Fargo Downgrade
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BMO: Aeglea Has A Potentially Market-Conquering Arginase Deficiency Candidate, Oncology Opportunity

Shares of Aeglea Bio Therapeutics Inc (NASDAQ: AGLE) were slumping Tuesday following the release of data from an early-to-mid- stage trial of its lead product candidate pegzilarginase for treating Arginase 1 deficiency, or ARG1-D.

ARG1-D is a debilitating urea cycle disorder caused by deficiency of a key arginine metabolizing enzyme, leading to neurological abnormalities, hyperammonemia and early mortality.

Wells Fargo Securities downgraded shares of Aeglea from Outperform to Market Perform following the data release.

The stock was down 14.36 percent to $9.36 at time of publication Tuesday afternoon.

What Happened

Aeglea presented Phase 1/2 data for pegzilarginase, which showed that the pipeline candidate led to marked reductions in plasma arginine and related guanidine compounds. The presentation was made at the 2018 Society for the Study of Inborn Errors of Metabolism Annual Symposium in Athens, Greece.

The candidate brought about clinical improvements in one or more instruments of neuromotor functions in all three patients who completed eight weeks of repeat dose administration, according to Aeglea.

The therapy was found to be safe and well-tolerated.

Why It's Important

Patient enrollment in the trial exceeded its target by five patients, the biotech company said.

"Given the challenges of lowering arginine levels with current approaches, it is very encouraging to see the marked reductions in plasma arginine in our patient following treatment with pegzilarginase," said George Diaz, professor and chief in the divsion of medical genetics at the Icahn School of Medicine at Mount Sinai. Diaz was the presentation's co-author.

What's Next

Aeglea said it plans to present additional interim data from the Phase 1/2 trial at the 2018 American Society of Human Genetics Conference in October.

The company reaffirmed its previous expectations of announcing the design of the first pivotal clinical trial for patients with ARG1-D in the fourth quarter and initiating the trial in the first half of 2019.

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