Aeglea BioTherapeutics

Aeglea Biotherapeutics, Inc. is a clinical-stage biotechnology company, which engages in the development of next-generation human enzyme therapeutics as disruptive solutions for rare and other high-burden diseases. Its product Pegzilarginase, is in a Phase 3 pivotal trial for the treatment of Arginase 1 Deficiency. The company was founded by George Georgiou and David G. Lowe in December 2013 and is headquartered in Austin, TX.

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Spyre Therapeutics, Inc. is a clinical-stage biotechnology company, which engages in the development of next-generation human enzyme therapeutics as disruptive solutions for rare and other high-burden diseases. Its product, Pegzilarginase, is in a Phase 3 pivotal trial for the treatment of Arginase 1 Deficiency. The company was founded by George Georgiou and David G. Lowe on December 16, 2013 and is headquartered in Waltham, MA.

AUSTIN, Texas , Aug. 18, 2022 /PRNewswire/ -- Aeglea BioTherapeutics, Inc. (NASDAQ:AGLE), a clinical-stage biotechnology company developing a new generation of human enzyme therapeutics to benefit people with rare metabolic diseases, today announced that a Marketing Authorization Application (MAA) for pegzilarginase for the treatment of Arginase 1 Deficiency (ARG1-D) has been submitted to and successfully validated by the European Medicines Agency (EMA). The MAA was submitted by Immedica Pharma AB, Aeglea's commercialization partner in Europe and the Middle East.

Aeglea BioTherapeutics Announces European Medicines Agency Validation of Marketing Authorization Application for Pegzilarginase for the Treatment of Arginase 1 Deficiency

Aeglea (AGLE) delivered earnings and revenue surprises of -3.85% and 55.99%, respectively, for the quarter ended June 2022. Do the numbers hold clues to what lies ahead for the stock?

Aeglea Biotherapeutics (AGLE) Reports Q2 Loss, Lags Revenue Estimates

Cohort 2 Completed in Phase 1/2 Trial of AGLE-177; Data Expected in Fourth Quarter of 2022 Actively Engaged with FDA to Identify Potential Paths Forward for Pegzilarginase Gross Proceeds of $45 Million from May 2022 Registered Direct Offering Extends Cash Runway Through the Second Quarter of 2023 AUSTIN, Texas , Aug. 4, 2022 /PRNewswire/ -- Aeglea BioTherapeutics, Inc. (NASDAQ:AGLE), a clinical-stage biotechnology company developing a new generation of human enzyme therapeutics as innovative solutions for rare metabolic diseases, today announced financial results for the second quarter ended June 30, 2022 and provided program updates. "We continue to make progress with our Homocystinuria program and are encouraged by the physician and patient interest in advancing our Phase 1/2 trial.

Aeglea BioTherapeutics Reports Second Quarter 2022 Financial Results and Provides Program Updates

Aeglea (AGLE) gets a Refusal to File letter from the FDA related to the biologics license application for pegzilarginase to treat arginase 1 deficiency. Stock down.

Aeglea (AGLE) Down on RTF Letter from FDA for Rare Disease Drug

Aeglea BioTherapeutics, Inc. (NASDAQ: AGLE) announced the U.S. Food and Drug Administration (FDA) has refused to accept the company's Biologics License Application (BLA) with a Refusal to File (RTF) letter. The company filed the BLA in April for its lead drug candidate pegzilarginase for.

Aeglea BioTherapeutics Shares Plummet Following Refusal To File Letter From FDA

AUSTIN, Texas , June 2, 2022 /PRNewswire/ -- Aeglea BioTherapeutics, Inc. (NASDAQ: AGLE), a clinical-stage biotechnology company developing a new generation of human enzyme therapeutics to benefit people with rare metabolic diseases, today announced that it received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) regarding the company's Biologics License Application (BLA) for pegzilarginase for the treatment of Arginase 1 Deficiency (ARG1-D). In the RTF letter the FDA requested additional data to support effectiveness, such as evidence showing that plasma arginine and metabolite reduction predicts clinical benefit in patients with ARG1-D or clinical data demonstrating a treatment effect on clinically meaningful outcomes.

Aeglea BioTherapeutics Receives Refusal to File Letter from FDA for Pegzilarginase for the Treatment of Arginase 1 Deficiency

AUSTIN, Texas , May 5, 2022 /PRNewswire/ -- Aeglea BioTherapeutics, Inc. (NASDAQ:AGLE), a clinical-stage biotechnology company developing a new generation of human enzyme therapeutics as innovative solutions for rare metabolic diseases, today announced that it has entered into a securities purchase agreement with certain institutional investors providing for the purchase and sale of registered securities of the Company in a registered direct offering for gross proceeds to Aeglea of approximately $45 million, prior to deducting placement agent fees and estimated offering expenses. The financing includes participation from Bain Capital Life Sciences, LP, Great Point Partners, LLC, clients of Nantahala Capital Management, Sio Capital Management, LLC and other institutional investors.

Aeglea BioTherapeutics Announces $45 Million Registered Direct Offering Priced at a Premium to Market

Aeglea (AGLE) delivered earnings and revenue surprises of -5.71% and 6.07%, respectively, for the quarter ended March 2022. Do the numbers hold clues to what lies ahead for the stock?

Aeglea Biotherapeutics (AGLE) Reports Q1 Loss, Lags Revenue Estimates

Pegzilarginase BLA submitted to the FDA; if approved, pegzilarginase would be the first FDA-approved treatment for Arginase 1 Deficiency Additional PEACE data supporting potential efficacy of pegzilarginase presented at SIMD Enrollment continues in Phase 1/2 trial of AGLE-177; IND now open for U.S. site initiation AUSTIN, Texas , May 5, 2022 /PRNewswire/ -- Aeglea BioTherapeutics, Inc. (NASDAQ:AGLE), a clinical-stage biotechnology company developing a new generation of human enzyme therapeutics as innovative solutions for rare metabolic diseases, today announced financial results for the first quarter 2022 and provided program updates. "We have started off 2022 with significant progress in both our clinical programs.

Aeglea BioTherapeutics Reports First Quarter 2022 Financial Results and Provides Program Updates

Aeglea (AGLE) files a biologics license application to the FDA for pegzilarginase to treat arginase 1 deficiency. The company has requested the FDA to grant priority review to the BLA.

Aeglea (AGLE) Submits BLA for a Rare Disease Drug to the FDA

BLA submission provides FDA with all pegzilarginase program data to review in detail; Aeglea looks forward to working collaboratively with the FDA on next steps in the review process If approved, pegzilarginase would be the first FDA-approved treatment for this devastating rare disease European marketing application on track for submission this year AUSTIN, Texas , April 12, 2022 /PRNewswire/ -- Aeglea BioTherapeutics, Inc. (Nasdaq:AGLE), a clinical-stage biotechnology company developing a new generation of human enzyme therapeutics to benefit people with rare metabolic diseases, today announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for pegzilarginase for the treatment of Arginase 1 Deficiency (ARG1-D). Aeglea requested FDA Priority Review at the time of the BLA submission.

Aeglea BioTherapeutics Submits BLA to FDA for Pegzilarginase for the Treatment of Arginase 1 Deficiency

AUSTIN, Texas , April 11, 2022 /PRNewswire/ -- Aeglea BioTherapeutics, Inc. (Nasdaq:AGLE), a clinical-stage biotechnology company developing a new generation of human enzyme therapeutics to benefit people with rare metabolic diseases, today shared additional data from the PEACE Phase 3 study during a poster presentation at the Society for Inherited Metabolic Disorders (SIMD) Annual Meeting being held in Orlando, FL from April 10-13. The poster, titled Pegzilarginase in Arginase 1 Deficiency: Results of the PEACE Pivotal Phase 3 Clinical Trial (Abstract #30), will also be available on the publications section of Aeglea's website and includes new data on patient-level outcomes, additional secondary endpoints and previously announced topline results.

Aeglea BioTherapeutics Presents Additional Data from PEACE Phase 3 Study of Pegzilarginase for the Treatment of Arginase 1 Deficiency at SIMD

AUSTIN, Texas , April 6, 2022 /PRNewswire/ -- Aeglea BioTherapeutics, Inc. (Nasdaq:AGLE), a clinical-stage biotechnology company developing a new generation of human enzyme therapeutics to benefit people with rare metabolic diseases, today announced its participation in two investor conferences as follows:  Conference: 21st Annual Needham Virtual Healthcare Conference, April 11-14, 2022 Presentation Date/Time: Wednesday, April 13 at 9:30 a.m. EDT Presenter: Anthony G.

Aeglea BioTherapeutics to Participate in the Needham Virtual Healthcare Conferences in April 2022

AUSTIN, Texas , March 29, 2022 /PRNewswire/ -- Aeglea BioTherapeutics, Inc. (Nasdaq:AGLE), a clinical-stage biotechnology company developing a new generation of human enzyme therapeutics to benefit people with rare metabolic diseases, today announced poster presentations at two upcoming medical meetings. The Company will present additional data from the PEACE Phase 3 study of pegzilarginase for the treatment of patients with Arginase 1 Deficiency (ARG1-D) at the Society for Inherited Metabolic Disorders (SIMD) Annual Meeting in Orlando, FL.

Aeglea BioTherapeutics Announces Presentation of Additional Data from PEACE Phase 3 Study of Pegzilarginase for the Treatment of Arginase 1 Deficiency at the Society for Inherited Metabolic Disorders Annual Meeting

Aeglea (AGLE) delivered earnings and revenue surprises of 3.12% and 18.70%, respectively, for the quarter ended December 2021. Do the numbers hold clues to what lies ahead for the stock?

Aeglea Biotherapeutics (AGLE) Reports Q4 Loss, Tops Revenue Estimates

AUSTIN, Texas, Feb. 10, 2022 /PRNewswire/ -- Aeglea BioTherapeutics, Inc. (Nasdaq:AGLE), a clinical-stage biotechnology company developing a new generation of human enzyme therapeutics as innovative solutions for rare metabolic diseases, announced today the withdrawal of the previously announced, proposed public offering. We are well capitalized, with cash and cash equivalents of $95.0 million as of December 31, 2021, which we believe will be sufficient to fund our operations into the first quarter of 2023.

Aeglea BioTherapeutics Withdraws Public Offering

AUSTIN, Texas , Feb. 9, 2022 /PRNewswire/ -- Aeglea BioTherapeutics, Inc. (Nasdaq:AGLE), a clinical-stage biotechnology company developing a new generation of human enzyme therapeutics as innovative solutions for rare metabolic diseases, today announced a proposed underwritten public offering in which it intends to offer and sell shares of its common stock and, in lieu of common stock, to offer and sell to certain investors pre-funded warrants to purchase shares of its common stock. Aeglea expects to grant the underwriters a 30-day option to purchase additional shares of common stock.

Aeglea BioTherapeutics Announces Proposed Public Offering

AUSTIN, Texas, Jan. 25, 2022 /PRNewswire/ -- Aeglea BioTherapeutics, Inc. (Nasdaq:AGLE), a clinical-stage biotechnology company developing a new generation of human enzyme therapeutics to benefit people with rare metabolic diseases, today announced that it will host a Key Opinion Leader (KOL) and Patient Caregiver Webinar on Arginase 1 Deficiency on Thursday, February 3, 2022, at 2:30pm EST. The webinar will include presentations from: Barbara Burton, M.D.

Aeglea BioTherapeutics Announces Upcoming KOL and Patient Caregiver Webinar on Arginase 1 Deficiency

AUSTIN, Texas , Jan. 5, 2022 /PRNewswire/ -- Aeglea BioTherapeutics, Inc. (Nasdaq:AGLE), a clinical-stage biotechnology company developing a new generation of human enzyme therapeutics to benefit people with rare metabolic diseases, today announced its participation in two investor conferences as follows:  Conference: 40th Annual J.P. Morgan Health Care Conference, January 10-13, 2022 Live Presentation Date/Time: Wednesday, January 12 at 10:30 a.m.

Aeglea BioTherapeutics to Participate in Two Investor Conferences in January 2022

Bolt Biotherapeutics

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At least one of the three could be in store for better news in the future.

3 Biotech Stocks That Sank: Are Any a Bad-News Buy?

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 1st half of 2022.

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

MIxed phase 3 clinical trial results are making investors nervous.

Why Aeglea BioTherapeutics Stock Is Way Down Today

AUSTIN, Texas, Dec. 6, 2021 /PRNewswire/ -- Aeglea BioTherapeutics, Inc. (NASDAQ: AGLE), a clinical-stage biotechnology company developing a new generation of human enzyme therapeutics as innovative solutions for rare metabolic diseases, today announced that the pivotal Phase 3 study, PEACE (Pegzilarginase Effect on Arginase 1 Deficiency Clinical Endpoints), met the primary endpoint with a statistically significant reduction in plasma arginine from baseline after 24 weeks of treatment with pegzilarginase (p

Aeglea BioTherapeutics Announces Achievement of Primary Endpoint in Phase 3 Study of Pegzilarginase in Patients with Arginase 1 Deficiency

AUSTIN, Texas, Dec. 5, 2021 /PRNewswire/ -- Aeglea BioTherapeutics, Inc. (NASDAQ: AGLE), a clinical-stage biotechnology company developing a new generation of human enzyme therapeutics as innovative solutions for rare metabolic diseases, today announced that it will host an investor conference call and webcast tomorrow morning to discuss the topline results from the PEACE Phase 3 clinical trial of pegzilarginase in patients with Arginase 1 Deficiency (ARG1-D). Investors and the public are invited to listen to a live audio webcast of the conference call on December 6, 2021, at 8:00am ET, which can be accessed prior to the start of the call by dialing 1-877-425-9470 (U.S.) or 1-201-389-0878 (International) Conference ID 13725511 or through the Events & Presentations section of the Company's website.

Aeglea BioTherapeutics to Host Conference Call to Report Phase 3 Topline Results of Pegzilarginase in Patients with Arginase 1 Deficiency

AUSTIN, Texas, Nov. 16, 2021 /PRNewswire/ -- Aeglea BioTherapeutics, Inc. (Nasdaq: AGLE), a clinical-stage biotechnology company developing a new generation of human enzyme therapeutics as innovative solutions for rare metabolic diseases, today announced the appointment of Hunter C. Smith to its board of directors.

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