Novo drops oncology ambitions, early-stage MASH prospects in ongoing R&D shake-up

Novo Nordisk is winding down a range of early-stage programs for liver disease, oncology and stem cells as part of the Danish Pharma’s ambitious restructuring.

This morning’s third-quarter earnings results showed the company is taking a 9 billion Danish kroner ($1.4 billion) hit from a wide-ranging restructuring that has included plans to lay off about 9,000 employees worldwide and shutter the company’s cell therapy R&D work.

This axed cell therapy work encompassed programs for Parkinson’s disease and chronic heart failure as well as research aimed at reversing or curing Type 1 diabetes. 

Now, Novo’s earnings documents reveal that the company has also ruled out launching any new clinical trials for a variety of other programs. Among them were two siRNA molecules in phase 1 studies for metabolic dysfunction-associated steatohepatitis (MASH).

One of these, dubbed NN-6581, targeted the mitochondrial amidoxime reducing component 1 (MARC1) protein as a once-monthly subcutaneous treatment. The other, called NN6582, targets liver X receptor alpha.

However, Novo remains an established player in the MASH space, with its blockbuster obesity drug Wegovy gaining a label expansion in August as a weekly treatment for adults with noncirrhotic MASH and moderate to advanced fibrosis.

Meanwhile, the pharma also confirmed this morning that it has abandoned its fledgling efforts in oncology, namely a pair of GalXC-derived lipid conjugates aimed at PD-L1 and STAT3.

Also gone is an RNA-based oligonucleotide called NN4004 that was in phase 1 as a subcutaneous treatment for gout.

Even more clinical-stage programs may face the ax—Novo suggested in the document that “in addition, a number of changes to the portfolio of early-stage projects will also be implemented.”

“Novo Nordisk may pursue partnerships for some of the above projects,” the pharma added, while stressing that its “strategic focus within rare disease remains unchanged.”

On a call with journalists this morning, Novo CEO Mike Doustdar—who took on the top job in August—explained the rationale beyond the pipeline changes.

“In the past, we spread resources into areas far from our core, like stem cell research for Parkinson’s and treatments for heart failure that require different expertise,” Doustdar said. “To maximize patient impact and value creation, during this last quarter we have discontinued several non-core assets and redirected resources to areas aligned with our strength.”

On the same call, the CEO explained why the pharma remains optimistic that it can lure obesity biotech Metsera away from a planned acquisition by Pfizer. Novo’s curveball offer has ignited a bidding war and legal battle in recent days.