Gilead Sciences Reports Market-Moving News

Gilead Sciences Reports Market-Moving News,

(NASDAQ: GILD) investors are probably breathing a little easier. On Tuesday, the company reported positive results from a late-stage study of its most advanced drug, filgotinib. The win is particularly important because Gilead Sciences needs new drugs targeting blockbuster indications to offset sliding sales for its hepatitis C drugs. Does filgotinib’s latest data make this biotech giant a stock worth buying? ” data-reactid=”11″>Gilead Sciences (NASDAQ: GILD) investors are probably breathing a little easier. On Tuesday, the company reported positive results from a late-stage study of its most advanced drug, filgotinib. The win is particularly important because Gilead Sciences needs new drugs targeting blockbuster indications to offset sliding sales for its hepatitis C drugs. Does filgotinib’s latest data make this biotech giant a stock worth buying? 

Delivering the goods

An inhibitor that’s highly selective for the JAK1 enzyme, which plays a key role in signaling cytokines that control cell growth and immune responses, filgotinib has had its progress watched closely since it delivered positive phase 2 results in rheumatoid arthritis, a multibillion-dollar treatment market.

On Tuesday, investors got their first look at phase 3 data, and overall it appears impressive. In the 200 mg arm, 69% of patients achieved a 20% improvement on the American College of Rheumatology scoring system, 46% achieved a 50% improvement, and 32% achieved a 70% improvement. These results were statistically significant, with a p-value on each that was less than 0.001. 

Importantly, there weren’t any cases of deep venous thrombosis or pulmonary embolism, nor were there any “deaths, malignancies, gastrointestinal perforations, or opportunistic infections, including active tuberculosis.” The drug was generally well tolerated, and adverse events were “mostly mild or moderate in severity.” In the placebo group, 3.4% of patients suffered a serious adverse event. In the 100 mg and 200 mg arm, it was 5.2% and 4.1% of patients, respectively.

A large opportunity

The trial results are positive, but it will need to be confirmed in two other ongoing phase 3 rheumatoid arthritis studies, data from which are expected in the first half of 2019.

The remaining two trials are designed differently from this first trial, though. This first study was a 24-week randomized, double-blind, placebo-controlled study of filgotinib alongside disease-modifying anti-rheumatic drugs in moderately to-severely active rheumatoid arthritis patients who inadequately respond to treatment. 

One of the two remaining studies is evaluating filgotinib versus placebo in rheumatoid arthritis sufferers who have an inadequate response to methotrexate, a commonly used first-line rheumatoid arthritis treatment, and the other study is evaluating it as a monotherapy or in combination with methotrexate in patients who haven’t yet taken methotrexate.

An eventual filgotinib approval wouldn’t derail the use of anti-TNFs, but anti-TNFs aren’t necessarily ideal therapies. Some people don’t respond well to them, they can interact with other medications, and patients can suffer from infections on them. Also, unlike filgotinib, which is taken orally, biologics are injected or infused, which is another disadvantage that could make it smart to buy Gilead Sciences and Galapagos shares because of filgotinib.

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