30 May

How Is Gilead Sciences Revamping Its NASH Strategy in 2019?

WRITTEN BY Margaret Patrick

NASH failed trials

On February 11, Gilead Sciences (GILD) issued a press release announcing the top line results from its Phase 3 STELLAR-4 study evaluating the investigational oral therapy selonsertib in the treatment of NASH (nonalcoholic steatohepatitis) patients suffering from F4 compensated cirrhosis. On April 25, the company issued a press release announcing the top line results from its Phase 3 STELLAR-3 study evaluating selonsertib in the treatment of NASH patients with F3 bridging fibrosis. The drug failed to meet its prespecified primary endpoints in both trials.

Gilead Sciences hasn’t changed its SG&A (selling, general, and administrative) and R&D (research and development) expense guidance for 2019, but it plans to update them if required during its second-quarter earnings call. In its first-quarter earnings investor presentation, the company reaffirmed its 2019 SG&A expense guidance of $3.90 billion–$4.10 billion and its R&D expense guidance of $3.60 billion–$3.80 billion. The company expects to save on SG&A expenses that would have been required to support commercial launch activities for selonsertib. In the absence of such spending, the company expects to invest some of these funds in improving the launch readiness of its investigational rheumatoid arthritis therapy, filgotinib.

How Is Gilead Sciences Revamping Its NASH Strategy in 2019?

NASH strategy

Gilead Sciences is currently evaluating its investigational compounds selonsertib, firsocostat, and cilofexor in various combinations in the treatment of patients suffering from bridging fibrosis or compensated cirrhosis due to NASH in its Phase 2 ATLAS trial. According to its first-quarter earnings conference call, the company expects to release data from this trial in the fourth quarter of 2019.

As Gilead pointed out on its first quarter earnings conference call, it presented more than 35 abstracts related to NASH, primary sclerosing cholangitis, and viral hepatitis at the International Liver Congress in Vienna in April 2019. The company presented novel data to highlight the potential in evaluating combination therapies for NASH as well as the noninvasive diagnostic test for the disease.

On April 12, Gilead Sciences issued a press release announcing its intent to commence collaboration with Novo Nordisk (NVO) for the development of combination regimens targeting NASH. The companies plan to initiate a proof-of-concept study evaluating the combination of Gilead Sciences’ FXR agonist, cilofexor, and ACC inhibitor, firsocostat, with Novo Nordisk’s GLP-1 analogue, semaglutide, in NASH indications.

On April 16, Gilead Sciences issued a press release announcing a three-year collaboration with insitro to leverage insitro’s proprietary platform for the discovery of novel drug targets in NASH indications.

Latest articles

On November 14, The George Soros Fund Management LLC filed 13F. The firm's total market value was around $3.6 billion at the end of Q3 2019.

Tesla (TSLA) stock short sellers seem to be getting exasperated. Notably, Tesla stock has been the short sellers’ favorite.

In the week that ended on November 15, natural gas prices fell 3.5% and settled at 2.688 per MMBtu (million British thermal units).

The Dow Jones Index (DIA) and S&P 500 (SPY) are trading at record highs and on Friday the Dow Jones crossed the 28,000 level for the first time.

Goldman Sachs (GS) settled a lawsuit that alleged it rigged bond prices. Also, Deutsche Bank agreed to pay a fine of $15 million to settle a lawsuit.

In the November 15 premarket trading session, Amarin Corporation (AMRN) stock rose more than 7%, caused by the FDA positive decision for Vascepa.