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AGLE

Aeglea BioTherapeutics

$7.78

0.085 (1.10%)

06:17
09/03/19
09/03
06:17
09/03/19
06:17

Aeglea BioTherapeutics presents 20-dose data from pegzilarginase trials at SSIEM

Aeglea BioTherapeutics presented 20-dose data on 14 patients from the company's completed Phase 1/2 trial and ongoing Phase 2 open-label extension, or OLE, trial for pegzilarginase in patients with Arginase 1 Deficiency, or ARG1-D, at the Symposium of the Society for the Study of Inborn Errors of Metabolism, or SSIEM. Data from all patients following 20 doses of pegzilarginase continued to demonstrate marked and sustained reductions in plasma arginine. Overall, 79% of patients were clinical responders, using mobility assessment components that correspond with the pivotal PEACE trial secondary endpoint. Pegzilarginase was well tolerated and the rates of treatment-related adverse events decreased over time. Serious adverse events included hypersensitivity and hyperammonemia, which were infrequent, managed with standard treatment and did not lead to any patient discontinuations. The company believes the improvements in arginine control and evidence of clinical benefit following pegzilarginase treatment provide further validation of the key endpoints and design elements of the pivotal Phase 3 PEACE trial and that the Phase 1/2 and OLE trials demonstrate the value of utilizing only three mobility assessment tools to capture the clinical benefit of pegzilarginase. Additionally, Aeglea announced that 10 patients have been dosed subcutaneously with pegzilarginase in the ongoing OLE trial in patients with ARG1-D. Subcutaneous administration of pegzilarginase controls plasma arginine similarly to IV administration, providing potential additional advantages such as improving compliance and/or convenience. Pegzilarginase was well tolerated subcutaneously, with only four mild injection site reactions related to pegzilarginase in more than 200 injections to date. All 10 eligible patients switched to, and remain on, pegzilarginase subcutaneous, with no patient discontinuations In June, Aeglea announced the dosing of the first patient in its pivotal PEACE trial, which is intended to further evaluate the efficacy and safety of pegzilarginase. The company expects to continue discussions with the FDA on the pegzilarginase program and our next steps in Q4 or Q1 of 2020. The company also expects to report topline data from the pivotal PEACE trial in Q1 of 2021.

  • 09

    Sep

AGLE Aeglea BioTherapeutics
$7.78

0.085 (1.10%)

09/04/18
WELS
09/04/18
DOWNGRADE
WELS
Market Perform
Aeglea BioTherapeutics downgraded to Market Perform at Wells Fargo
09/04/18
09/04/18
DOWNGRADE
Target $10

Market Perform
Aeglea downgraded to Market Perform on potential development risk at Wells Fargo
As previously reported, Wells Fargo analyst Aeglea BioTherapeutics to Market Perform from Outperform on potential increased development risk following review of updated interim phase 1/2 data for pegzilarginase in Arginase 1 Deficiency. The analyst also lowered his price target on the shares to $10 from $24.
03/21/19
JPMS
03/21/19
INITIATION
Target $14
JPMS
Overweight
Aeglea BioTherapeutics initiated with an Overweight at JPMorgan
JPMorgan analyst Anupam Rama started Aeglea BioTherapeutics with an Overweight rating and $14 price target. Aeglea is an emerging player in the rare disease space and its lead asset pegzilarginase "has multiple de-risking points" for lead indication arginase 1 deficiency, Rama tells investors in a research note. This is a disease with a clear unmet need for which there are no approved therapies to directly target cause and limited competition, the analyst adds.
05/21/19
HCWC
05/21/19
INITIATION
Target $20
HCWC
Buy
Aeglea BioTherapeutics initiated with a Buy at H.C. Wainwright
H.C. Wainwright analyst Edward White started Aeglea BioTherapeutics with a Buy rating and $20 price target. The company's capital raise in February removes the financial overhang from the stock, White tells investors in a research note. He believes Aeglea shares represent an attractive investment opportunity with several potential catalysts over the next 12 months.

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