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Intercept quiet on NASH safety data disclosure concerns

 
• By Mandy Jackson

Intercept Pharmaceuticals is not commenting on reports that the company did not appropriately disclose safety information about its lead drug candidate obeticholic acid (OCA), but Intercept released a set of e-mail messages on 22 May that show the company knew about OCA's impacts on cholesterol in the investigator-sponsored FLINT trial as early as 6 January.

Intercept Pharmaceuticals is not commenting on reports that the company did not appropriately disclose safety information about its lead drug candidate obeticholic acid (OCA), but Intercept released a set of e-mail messages on 22 May that show the company knew about OCA's impacts on cholesterol in the investigator-sponsored FLINT trial as early as 6 January.

OCA's effects on lipid levels in nonalcoholic steatohepatitis (NASH) patients were not unexpected, since diabetes and cardiovascular disease are common...

More from Alimentary/Metabolic

Scholar Rock Shows Muscle-Building PoC In Obesity

 
• By Jessica Merrill

The company said it intends to maintain a focus on rare neuromuscular disease with apitegromab but could consider partnering in obesity.

Lilly Looks For Muscle-Sparing Candidates In Pact With Juvena

 
• By Joseph Haas

Deal Snapshot: Including its internal efforts with bimagrumab, Lilly has been seeking a muscle-sparing therapy to complement GLP-1 obesity drugs, such as Zepbound.

Novo Nordisk Teams With Deep Apple On Non-Incretin Obesity Approach

 
• By Joseph Haas

Novo Nordisk will partner with privately held Deep Apple to study a novel, non-incretin target that could be better suited than GLP-1s for long-term obesity treatment.

Metsera’s Amylin Analog Stars In Obesity Phase I

 
• By Joseph Haas

Intended as obesity monotherapy and for combination with the firm’s GLP-1 analog, MET-0233i showed best-in-class efficacy with placebo-like tolerability at low doses.

More from Therapy Areas

Spyre Takes Aim At Roche And J&J In Inflammatory Diseases

 
• By Andrew McConaghie

The US firm was already looking to compete in ulcerative colitis, but now expands its ambitions by moving into rheumatoid arthritis as well.

Draig Is All Fired Up To Transform Neuropsychiatric Field

 
• By Kevin Grogan

Wales-based group launches with $140m series A.

Immuneering Could Partner Atebimetinib Or Go It Alone After Phase IIa Success

 
• By Alaric DeArment

CEO Ben Zeskind said all options are on the table after atebimetinib showed impressive results in pancreatic cancer.