Key Developments: Agios Pharmaceuticals Inc (AGIO.O)

AGIO.O on Nasdaq

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Latest Key Developments (Source: Significant Developments)

Agios Pharmaceuticals announces orphan drug designation of AG-348 for treatment of Pyruvate Kinase Deficiency
Tuesday, 24 Mar 2015 03:04pm EDT 

Agios Pharmaceuticals:Says United States Food and Drug Administration (FDA) has granted the company orphan drug designation for its investigational medicine AG-348 for the treatment of pyruvate kinase (PK) deficiency, a rare form of hemolytic anemia.AG-348, a first-in-class, orally available activator of pyruvate kinase-R (PKR) enzymes, met its primary endpoints in two Phase 1 healthy volunteer studies - a single ascending dose study and multiple ascending dose study.Says in addition, data presented in Dec. 2014 at the 54(th)Annual Meeting of the American Society of Hematology (ASH) provided early proof-of-mechanism for AG-348.Based on these findings, Agios plans to initiate a Phase 2 clinical trial in patients with PK deficiency in the first half of 2015.  Full Article

Agios Pharmaceuticals Inc announces closing of public offering and full exercise of over-allotment option
Tuesday, 16 Dec 2014 04:05pm EST 

Agios Pharmaceuticals Inc:Says closing of previously announced underwritten public offering of common stock, including exercise in full by the underwriters of their option to purchase an additional 297,968 shares at public offering price of $110.75 per share.Exercise of over-allotment option brought total number of shares of common stock sold by Agios to 2,284,423 shares.Increased amount of gross proceeds raised in offering, before underwriting discounts and estimated expenses of the offering, to about $253 million.J.P. Morgan Securities LLC and Goldman, Sachs & Co. acted as joint book-running managers for the offering.Cowen and Company, LLC and Leerink Partners LLC served as co-managers.  Full Article

Agios Pharmaceuticals announces pricing of $220 mln public offering of common stock
Wednesday, 10 Dec 2014 08:45pm EST 

Agios Pharmaceuticals Inc:Prices an underwritten public offering of 1,986,455 shares of common stock at a price to the public of $110.75 per share, before underwriting discounts, which would result in aggregate gross proceeds of about $220 mln.Grants the underwriters a 30-day option to purchase up to an additional 297,968 shares of common stock on the same terms and conditions.Closing of the offering is expected to occur on or about Dec. 16.J.P. Morgan Securities LLC and Goldman, Sachs & Co. are acting as joint book-running managers for the offering. Cowen and Company, LLC and Leerink Partners LLC are serving as co-managers.  Full Article

Agios Pharmaceuticals announces proposed offering of common stock
Tuesday, 9 Dec 2014 04:22pm EST 

Agios Pharmaceuticals:Says that it is offering to sell, subject to market and other conditions, up to $175 mln of its common stock in an underwritten public offering.Agios also intends to grant the underwriters a 30-day option to purchase from it up to an additional $26.3 mln of shares.All of the shares in the offering are to be sold by Agios.Proceeds of the offering are expected to be used to fund the company's clinical and research development activities.J.P. Morgan Securities LLC and Goldman, Sachs & Co. are acting as joint book-running managers for the offering.Cowen and Company, LLC and Leerink Partners LLC are serving as co-managers.  Full Article

Agios Pharmaceuticals reports positive phase 1 data in healthy volunteers for AG-348
Monday, 8 Dec 2014 01:00pm EST 

Agios Pharmaceuticals, Inc:Presents the first clinical data from its Phase 1 single (SAD) and multiple ascending dose (MAD) clinical trials of AG-348 in healthy volunteers.Results provide early proof-of-mechanism for AG-348, oral activator of both wild type (normal) and mutated pyruvate kinase-R (PKR) enzymes.Says in these Phase 1 studies, dosing of AG-348 over 14-days in healthy volunteers resulted in a dose-dependent increase in the pyruvate kinase-R pathway as evidenced by increase in ATP and decrease in 2,3-DPG levels, which are key biomarkers of PKR activity and primary indicators of PK deficiency.Says these data support the hypothesis that AG-348 treatment may similarly enhance PKR activity in patients with PK deficiency and thus correct the underlying defect of the disease.  Full Article

Agios Pharmaceuticals Inc announces new data from Ongoing Phase 1 Trial of AG-221
Sunday, 7 Dec 2014 12:30pm EST 

Agios Pharmaceuticals Inc:Announces new data from the ongoing Phase one dose escalation study of AG-221 as a single agent in patients with IDH2-mutant positive advanced hematologic malignancies.Announces the achievement of proof-of-concept for two distinct IDH inhibitors, AG-221 and AG-120.  Full Article

Agios Pharmaceuticals Inc announces early phase 1 data showing clinical activity of AG-120 as a single agent in Advanced Acute Myeloid Leukemia
Tuesday, 18 Nov 2014 06:01pm EST 

Agios Pharmaceuticals Inc:Announces the first reported safety and clinical activity for AG-120 from the ongoing Phase 1 dose escalation study in patients with IDH1-mutant positive advanced hematologic malignancies, including acute myeloid leukemia.Agios has exclusive U.S. development and commercial rights to AG-120, a first-in-class, oral, selective, potent inhibitor of the mutant IDH1 enzyme.The initial data showed investigator assessed objective responses in seven out of 14 evaluable patients, including four complete remissions, with responses observed across the four dose levels tested, and early evidence of durability.Says one additional patient remains stable on study.  Full Article

Agios Pharmaceuticals announces initiation of Phase 1/2 Clinical Trial
Tuesday, 21 Oct 2014 08:30am EDT 

Agios Pharmaceuticals Inc:Says the initiation of a Phase 1/2 multicenter study of AG-221 in patients with advanced solid tumors, including gliomas, as well as angioimmunoblastic T-cell lymphoma (AITL) that carry an isocitrate dehydrogenase-2 (IDH2) mutation.The study will enroll patients who have recurred or progressed following standard therapy or have not responded to prior standard therapy.This is the second trial to be initiated in patients with cancer as part of AG-221's clinical development program, which includes the ongoing Phase 1 trial with four expansion cohorts in patients with hematologic malignancies.  Full Article

Agios Pharmaceuticals announces initiation of four expansion cohorts in phase 1 study of AG-221
Wednesday, 15 Oct 2014 07:30am EDT 

Agios Pharmaceuticals Inc:Says initiation of four expansion cohorts in its ongoing Phase 1 study of AG-221, a first-in-class, selective, potent IDH2 mutant inhibitor.Phase 1 expansion cohorts will assess the safety and tolerability of AG-221 at 100 mg once daily in about 100 patients with IDH2-mutant hematologic malignancies, including acute myelogenous leukemia.  Full Article

Agios Pharmaceuticals announces U.S. FDA grants fast track designation to AG-221 for treatment of patients with Acute Myelogenous Leukemia That Harbor an IDH2 Mutation
Wednesday, 13 Aug 2014 08:30am EDT 

Agios Pharmaceuticals Inc:Says U.S. Food and Drug Administration (FDA) has granted Fast Track designation to AG-221 for treatment of patients with acute myelogenous leukemia (AML) that harbor an isocitrate dehydrogenase-2 (IDH2) mutation.AG-221 is first-in-class, oral, selective, potent IDH2 mutant inhibitor being evaluated in Phase 1 clinical trial in patients with advanced hematologic malignancies.  Full Article

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