NASH

5th Antifibrotic Drug Development Summit -AFDD-

The 5th Antifibrotic Drug Development Summit (AFDD) will provide you with a deeper understanding of how to progress early-stage candidates and avoid late-stage failures, know the studies that show early signs of efficacy and surrogate indication opportunities, and evaluate interacting mechanisms for new targets and biomarkers. This unique cross-organ, cross-disease discussion forum will host the transferrable insights …

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Boehringer Ingelheim to Develop Dicerna’s GalXC RNAi Candidate for NASH

Shots: Boehringer Ingelheim has accepted a GalXC RNAi candidate (DCR-LIV2) for advancement under the existing agreement b/w the companies for the discovery and development of novel therapies for chronic liver diseases Dicerna will receive $170M as development and commercial milestones related to DCR-LIV2 and is eligible to receive royalties on net sales of the therapy …

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NGM craters after dropping mid-stage NASH candidate aldafermin

Shares in NGM Biopharma have plummeted after the US biotech said it would abandon development of aldafermin in non-alcoholic steatohepatitis (NASH), adding to a lengthening list of failed candidates for the fatty liver disease.  The decision was taken after a phase 2b trial of NGM’s lead drug candidate missed its primary target of showing an …

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Gilead Expands its Collaboration with Novo Nordisk to Evaluate Triple Combination Regimen for Compensated Cirrhosis (F4) due to NASH

Shots: The companies plan to initiate a P-IIb study assessing NovoNordisk’s semaglutide and FD combination of Gilead’s cilofexor + firsocostat vs PBO in ~440 patients with compensated cirrhosis (F4) due to NASH The trial will evaluate the therapeutic effect on liver fibrosis improvement and NASH resolution and expected to initiate recruitment in H2’21 The new …

Gilead Expands its Collaboration with Novo Nordisk to Evaluate Triple Combination Regimen for Compensated Cirrhosis (F4) due to NASH Read More »

Gilead Expands its Collaboration with Novo Nordisk to Evaluate Triple Combination Regimen for Compensated Cirrhosis (F4) due to NASH

Shots: The companies plan to initiate a P-IIb study assessing NovoNordisk’s semaglutide and FD combination of Gilead’s cilofexor + firsocostat vs PBO in ~440 patients with compensated cirrhosis (F4) due to NASH The trial will evaluate the therapeutic effect on liver fibrosis improvement and NASH resolution and expected to initiate recruitment in H2’21 The new …

Gilead Expands its Collaboration with Novo Nordisk to Evaluate Triple Combination Regimen for Compensated Cirrhosis (F4) due to NASH Read More »

High hopes as Inventiva takes NASH contender into phase 3

Analysts are continuing to back Inventiva’s lanifibranor as a potential “best-in-class” drug for the fatty liver disease NASH, as the company prepares for the launch of a phase 3 trial in spring. A team of analysts from Jefferies led by Lucy Codrington noted the design of the trial, which will have a dual goal measuring …

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Novo Nordisk’s gene silencing alliance with Dicerna bears first fruit

Two years after starting to work together, Novo Nordisk and Dicerna have selected the first candidate from a joint project to find new, gene-silencing drugs for liver-related cardiometabolic diseases. Danish drugmaker Novo Nordisk signed a deal with the US biotech in 2019 valued at up to $675.5 million – including $175 million upfront and an …

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FTA for Gannex’s ASC4; Disappointment for Incyte’s Ruxolitinib; Historic win for Pfizer, BioNTech’s COVID Vaccine; Alexion buyout; the debut of InnoSkel

Gannex received US FDA fast track designation for its NASH drug, ASC42 an FXR Agonist Gannex Pharma has received Fast Track designation approval from FDA for its drug candidate ASC42 for non-alcoholic steatohepatitis (NASH). The FTA designation will help the pharma company to advance its research and development in the NASH landscape and help its …

FTA for Gannex’s ASC4; Disappointment for Incyte’s Ruxolitinib; Historic win for Pfizer, BioNTech’s COVID Vaccine; Alexion buyout; the debut of InnoSkel Read More »

Gilead and Novo Nordisk plot next steps after encouraging data from NASH combo

Gilead and Novo Nordisk have announced drug combinations for the fatty liver disease known as NASH involving the GLP-1 class drug semaglutide have checked out in a mid-stage proof-of-concept study. The companies said that the trial met its primary safety goal in people with non-alcoholic steatohepatitis (NASH) but stopped short of announcing any further plans …

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Merck & Co to repurpose failed obesity drug for NASH

Merck & Co is to pay $10 million to Hanmi to repurpose an obesity drug discarded by Johnson & Johnson, into a therapy for the fatty liver disease known as NASH. Non-alcoholic steatohepatitis, as the disease is also known, has been a target for pharma for years but is proving a tough nut to crack …

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Merck and Hanmi Collaborate to Develop Efinopegdutide for NASH

Shots: Hanmi to receive $10M up front, $860M as development, regulatory approval, and commercialization of efinopegdutide along with royalties on sales of the approved product Merck to receive an exclusive license to develop, manufacture and commercialize efinopegdutide in the US and globally while Hanmi to retain an option to commercialize the therapy in Korea Efinopegdutide …

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Genfit abandons late-stage trial of NASH drug elafibranor

France’s Genfit has said its elafibranor drug as a treatment for non-alcoholic steatohepatitis (NASH) was unable to improve patient outcomes in a phase 3 study, which has now been terminated. Genfit took the “highly disappointing” decision after taking a look at interim data from the RESOLVE-IT study, said the company’s chief executive Pascal Prigent. Those …

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Glympse Bio raises more than $46M in Series B round for biosensor technology

The company is developing biosensors, initially for NASH, that could be used in place of liver biopsy and have applicability in development of drugs for the disease.