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Agios' IDH Inhibitors Show Their Mettle At ASH

 
• By Alexandra Shimmings

Updates for key products from Agios bring comfort for analysts as it forges ahead with a filing and new studies in AML. Another of its investigational products is also showing first-in-class potential in pyruvate kinase deficiency.

Agios Pharmaceuticals Inc. is tilting at a year-end US approval filing for its first-in-class, oral, targeted inhibitor of the mutant IDH1 enzyme, ivosidenib, for acute myeloid leukemia (AML) as it presented new data at the American Society of Hematology meeting.

Buoyed by the recent early approval of its and partner Celgene Corp.'s oral, targeted inhibitor of isocitrate dehydrogenase-2 (IDH2),...

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BeBetter, Trinomab Advance IPOs On China’s STAR Market In Firsts Since Policy Easing

 
• By Dexter Jie Yan

BeBetter becomes first unprofitable innovative drug maker to have application for an IPO on Shanghai's STAR Market cleared by China’s top securities regulator, while Trinomab becomes first among peers to have IPO filing accepted.

Genmab/AbbVie’s Epkinly Likely To See Label Expansion After Phase III Win

 
• By Alaric DeArment

The FDA is expected to rule on the anti-CD20xCD3 bispecific combined with rituximab/lenalidomide in second-line follicular lymphoma in November.

Novartis’s ‘Pipeline-In-A-Product’ Assets Progressing Well

 
• By Kevin Grogan

CMO Shreeram Aradhye talks to Scrip about the promise shown by ianalumab, remibrutinib and a next-generation CAR-T for immunological disorders.

Vertex’s Pain Drug Failure Adds To Investor Doubts

 
• By Andrew McConaghie

A Phase II trial to develop a second NaV1.8 pain signal inhibitor for acute pain has failed and the US FDA has given a thumbs down on Journavx’s path to broader use in peripheral neuropathic pain.

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Aurigene Oncology CEO On Biotech Valuations, CAR-Ts And Reimbursement Models

 
• By Anju Ghangurde

Aurigene Oncology CEO talks in this audio interview about the tough biotech funding environment, pipeline assets including a CAR-T therapy in Phase II, "hybrid" manufacturing, outcome-based reimbursement and the promise of bispecifics and multispecifics, including Akeso's PD-1/VEGF bispecific.

Allogene Sticks With Standard Lymphodepletion In CAR-T Trial After Patient Death

 
• By Alaric DeArment

The company said it will no longer use ALLO-647 after a patient developed a fatal adenovirus infection, and it will pursue further development of its Dagger technology to minimize or eliminate the need for lymphodepletion.

BioNTech Outlines Development Plan For PD-L1xVEGF-Targeting BNT-327

 
• By Jessica Merrill

The company, with partner Bristol Myers Squibb, has a three-wave development strategy for BNT-327: “establish, combine, broaden.”