Wired News – Agios Pharma Submitted NDA for Ivosidenib for Treatment of Patients with Relapsed/Refractory AML and IDH1 Mutation

LONDON, UK / ACCESSWIRE / December 28, 2017 / Active-Investors.com has just released a free research report on Agios Pharma, Inc. (NASDAQ: AGIO). If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=AGIO as the Company’s latest news hit the wire. On December 26, 2017, the Company declared the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for ivosidenib (AG-120), an investigational oral treatment for patients with relapsed or refractory acute myeloid leukemia (R/R AML) and an isocitrate dehydrogenase-1 (IDH1) mutation. The Company has requested priority review for the application, which, if granted, could result in a six-month review process. Register today and get access to over 1000 Free Research Reports by joining our site below:

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Active-Investors.com is focused on giving you timely information and the inside line on companies that matter to you. This morning, Agios Pharma most recent news is on our radar and our team decided to put out a fantastic report on the company that is now available for free below:

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NDA Supported by Data from Ongoing Phase-1 Dose-Escalation Study of Ivosidenib

The NDA is supported by data from the ongoing Phase-1 dose-escalation and expansion study of ivosidenib in patients with advanced hematologic malignancies and an IDH1 mutation. Agios Pharma presented new efficacy and safety data from the ongoing Phase-1 study at the 2017 American Society of Hematology (ASH) Annual Meeting, on December 11, 2017. These data demonstrated impressive single-agent efficacy with durable responses in these high-risk relapsed or refractory AML patients, and highlighted the potential for ivosidenib to be a first-in-class therapy for patients with R/R AML and an IDH1 mutation.

FDA Completed 30-Day Safety Review of IND Application for AG-270

Agios Pharma also announced that the FDA has completed their 30-day safety review of the investigational new drug (IND) application for AG-270, the development candidate targeting MTAP-deleted tumors, and has granted IND clearance to proceed with the proposed Phase-1 dose-escalation trial in multiple tumor types carrying an MTAP deletion. The Company expects to initiate the Phase-1 trial in Q1 2018.

FDA Approved Treatments for AML in 2017

On August 01, 2017, FDA granted approval to Celgene Corporation’s IDHIFA® (enasidenib) for the treatment of adult patients with relapsed or refractory AML with an isocitrate dehydrogenase-2 (IDH2) mutation.

On August 03, 2017, FDA approved Jazz Pharmaceuticals’ Vyxeos™ (daunorubicin and cytarabine) liposome for injection for the treatment of adults with two types of AML, a rapidly progressing and life-threatening blood cancer.

On September 01, 2017, FDA granted approval to Pfizer’s Mylotarg™ (gemtuzumab ozogamicin) for adults with newly diagnosed CD33-positive acute myeloid leukemia (AML), and adults and children 2 years and older with relapsed or refractory CD33-positive AML.

About ivosidenib (AG-120)

Ivosidenib, wholly owned by Agios Pharma, is an investigational first-in-class, orally available, selective, potent inhibitor of the mutated IDH1 protein and is a highly targeted investigational medicine for the treatment of patients with cancers that harbor an IDH1 mutation. IDH1 is a metabolic enzyme that is mutated in a wide range of cancers. Targeting mutated IDH1 may have the potential to benefit the subset of patients who carry IDH1 mutation. FDA has granted ivosidenib orphan drug and fast track designations.

About Acute Myeloid Leukemia

AML is a cancer of the myeloid line of blood cells, characterized by the rapid growth of abnormal cells that build up in the bone marrow and blood and interfere with normal blood cells. Symptoms may include feeling tired, shortness of breath, easy bruising and bleeding, and increased risk of infection. Occasionally AML spread may occur to the brain, skin, or gums. As an acute leukemia, AML progresses rapidly and is typically fatal within weeks or months if left untreated.

About Agios Pharmaceuticals, Inc.

Established in 2008, Agios Pharmaceuticals is a biopharmaceutical company focused on discovering and developing novel investigational medicines to treat cancer and rare genetic diseases through scientific leadership in the field of cellular metabolism. The Company is headquartered in Cambridge, Massachusetts.

Stock Performance Snapshot

December 27, 2017 – At Wednesday’s closing bell, Agios Pharma’s stock climbed 1.09%, ending the trading session at $60.47.

Volume traded for the day: 250.60 thousand shares.

Stock performance in the previous six-month period – up 13.71%; past twelve-month period – up 39.43%; and year-to-date – up 44.91%

After yesterday’s close, Agios Pharma’s market cap was at $2.75 billion.

The stock is part of the Healthcare sector, categorized under the Biotechnology industry. This sector was up 0.3% at the end of the session.

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