Breakthroughs in MASH

Survodutide US FDA Breakthrough Therapy phase 3 trials MASH

Boehringer announced the initiation of two Phase III clinical trials for survodutide for the treatment of adults living with MASH and fibrosis (scarring).

Sagimet Receives FDA Breakthrough Therapy Designation for ...

FASCINATE-2, a Phase 2b clinical trial of denifanstat in MASH with liver biopsy-based primary endpoints, was successfully completed with ...

Boehringer kickstarts two Phase III trials as MASH therapy wins ...

Boehringer Ingelheim has received a breakthrough therapy designation from the US Food and Drug Administration (FDA) for survodutide as a treatment for non- ...

FDA gives denifanstat for MASH breakthrough therapy status

Denifanstat works by blocking a fat-producing protein in the liver. “The FDA's Breakthrough Therapy designation for denifanstat underscores the ...

FDA Grants Survodutide Breakthrough Therapy Designation for ...

Survodutide showed significant efficacy in improving MASH and reducing liver fat content in a phase 2 trial, with varying doses outperforming ...

Breakthroughs in MASH: Highlights from EASL 2024

Breakthroughs in MASH: Highlights from EASL 2024 · Efruxifermin shows sustained efficacy in treating metabolic dysfunction-associated ...

FDA grants breakthrough designation to survodutide for treatment of ...

“Notably, the program's innovative design, which specifically targets advanced fibrosis, including patients living with cirrhosis due to MASH — ...

Boehringer receives U.S. FDA Breakthrough Therapy

In addition, Boehringer announced the initiation of two Phase III clinical trials for survodutide for the treatment of adults living with MASH ...

New MASH drug development could reshape the treatment paradigm

... breakthrough therapy designation, are crucial advancements for GLP-1 dual receptor agonists in MASH, which are poised to become a ...

FDA Grants Breakthrough Therapy Designation to Survodutide for ...

In addition to the Breakthrough Therapy Designation, Boehringer Ingelheim announced the initiation of 2 phase 3 trials in adults with MASH ...

FDA grants breakthrough status to Sagimet's denifanstat to treat ...

The FDA approved the first drug for MASH in March 2024, and many other therapies are being developed, with a few in phase 2 clinical trials. The ...

Zealand Pharma announces that Boehringer receives U.S. FDA ...

... Breakthrough Therapy designation and initiates two Phase III trials in MASH for survodutide. The U.S. FDA Breakthrough Therapy designation is ...

Breakthrough Phase 2 survodutide data liver fibrosis MASH

Boehringer Ingelheim's survodutide shows breakthrough improvement in liver fibrosis with no worsening of MASH in 64.5% of patients with F2 ...

FDA Grants Denifanstat Breakthrough Therapy Designation for ...

“As the only fat synthesis inhibitor that directly targets the three main drivers of MASH—fat accumulation, inflammation, and fibrosis—we ...

Boehringer, Zealand Pharma receive FDA breakthrough therapy ...

Boehringer, Zealand Pharma receive FDA breakthrough therapy status for MASH therapy. Copenhagen, Denmark, October 8, 2024 – Zealand Pharma ...

A Breakthrough in MASH Treatment: FDA Approval of Rezdiffra ...

What is NASH—Now Known as MASH? Non-Alcoholic Steatohepatitis (NASH), recently renamed as Metabolic Dysfunction Associated Steatohepatitis ...

Sagimet Receives FDA Breakthrough Therapy Designation for

Supported by positive data from Phase 2b FASCINATE-2 trial of denifanstat in patients with MASH Preparations are ongoing to initiate Phase 3 ...

Breakthroughs in MASH, with 89 — The Pharma Letter Podcast ...

Breakthroughs in MASH, with 89bio CEO ... This week we're focusing on an area of clinical research that has been of great interest for a number of years, that is ...

Navigating the Latest Advances in MASH: Diagnostic Approaches ...

This Learning Lab features an interactive Clinical Case Challenge, two expert-led videos, and a downloadable, action-based patient checklist.

Boehringer's Survodutide Shows Breakthrough Improvement In ...

Boehringer's Survodutide Shows Breakthrough Improvement in MASH Trial ... Builds on previously announced primary endpoint, which showed up to 83% ...