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Aeglea Presents Itself As Buy Opportunity After Latest Data Causes Stock To Trade Lower

Dec. 07, 2021 1:14 PM ETAeglea BioTherapeutics, Inc. (AGLE)17 Comments


  • Aeglea achieved primary endpoint in reducing arginine levels with its drug pegzilarginase for ARG1-D, which in turn reduced ammonia in the blood plasma, by an average of 80%.
  • BLA filing of pegzilarginase for patients with ARG1-D is expected to occur in first half of 2022.
  • Additional results from the phase 3 PEACE study, using pegzilarginase for patients with ARG1-D, are expected to be released at an upcoming medical meeting and in peer-reviewed medical journals.
  • The company will also submit a regulatory application for pegzilarginase for ARG1-D, with its partner Immedica Pharma, to Europe and other Middle East countries in 2022.
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Aeglea BioTherapeutics (NASDAQ:AGLE) just announced results from its phase 3 study, which is using its drug pegzilarginase for a rare disease known as Arginase 1 Deficiency (ARG1-D). The company had met on the primary endpoint of being

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Terry Chrisomalis profile picture

Terry Chrisomalis is a private investor in the Biotech sector with years of experience utilizing his Applied Science background to generate long term value from Healthcare.

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Comments (17)

@Terry Chrisomalis Second 50% drawdown this year. It feels like Baker Bros are out and I have a chunk of coal for Christmas.
UP & DOWN profile picture
@LetsBond I think Orbimed was in this too?
UP & DOWN profile picture
@LetsBond Orbimed and BB still holding.
@Terry Chrisomalis can Travere Therapeutics, Inc. buy them out?
Any news anyone? Still holding this as a lottery ticket.
UP & DOWN profile picture
Any thoughts on the FDA refuse to file letter ?
What happen in 6 months? From 3.64$ >>> to >>> 0.67$ (-81%)
With a 50% haircut today, and 80% since the article, would be interested in your assessment now. Thank you.
William Meyers profile picture
Stumbled across this, good article, appreciate your work.
UP & DOWN profile picture
@William Meyers Any thought on the FDA refuse to file letter ?
Terry Chrisomalis profile picture
@UP & DOWN CMC controls has to be resolved and then establish proof of data. That can be taken care of easy the efficacy portion is up in the air. That's because Aglea is going to have a Type A meeting with the FDA. If the FDA demands another study that could be a delay if not, then it is good news for it. It just depends outcome of the meeting.
UP & DOWN profile picture
@Terry Chrisomalis Well it will be interesting if the big boys do when they report Q2 holdings and whether Orbimed / Bakers Bros add or sell.
Duras profile picture
Excellent article, thank you. There's some serious insider buying going on with AGLE, too, so it looks like management is agreeing with your thesis.
Thanks for the timely article. Do you know of any other Bio working on this?
@Ziggy60 I'm long on AGLE and during my DD couldn't find any other development for ARG1-D.
This is an ultra rare disease... Just 32 patients in the phase 3 PEACE trial!

Note the FDA granted Rare Pediatric Disease designation to this treatment, which implies a Priority Review voucher if approved (valued ~$100M).
Terry Chrisomalis profile picture
@Ziggy60 not that I know of AGLE seems to be only one targeting ARG1-D that I see.
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