Gilead Sciences should be having an incredible day in the market today after announcing topline results from four international Phase III clinical studies designed to evaluate a once-daily, fixed-dose combination treatment. However, thanks to comments made by Hillary Clinton, the stock is currently down. Today, we’ll talk about the top-line results released today, the comments made by Hillary Clinton, how the market is reacting, and what we can expect to see moving forward.
GILD Announces Positive Results!
The results announced today by GILD pertain to four Phase III clinical studies known as ASTRAL-1, ASTRAL-2, ASTRAL-3 and ASTRAL-4. The studies were designed to evaluate a once-daily, fixed-dose combination of the nucleotide analog polymerase inhibitor, sofosbuvir with velpatasvir, an investigational pangenotypic NS5 inhibitor, for the treatment of genotype 1-6 chronic hepatitis C virus (HCV) infection.
During the first three of the studies, 1,035 patients with genotype 1-6 HCV infection received 12 weeks of the treatment. Out of the 1,035 patients, 21% had compensated cirrhosis and 28% had failed prior treatments. In the case of ASTRAL-4, the randomized study treated 267 patients with decompensated cirrhosis who were to receive 12 weeks of the combination treatment with or without ribavirin, or 24 weeks of the combination treatment alone.
Out of the 1,035 patients in the first 3 studies, 1,015 (98%) achieved the primary efficacy endpoint of SVR12. Of the 20 patients who did not, 13 patients experienced virologic failure and seven did not complete a follow up visit. Following the release of the data, Norbert Bischofberger, Ph.D., Executive Vice President of Research and Developement and Chief Scientific Officer at GILD had the following to say…
“The ASTRAL study results demonstrated that a 12-week course of therapy with the first fixed-dose combination of two pan-genotypic compounds can provide high cure rates for patients with all HCV genotypes… We are pleased to have now brought forward our second single tablet regimen for HCV infection that complements Harvoni, our first single tablet regimen approved specifically for patients with genotype 1 infection and which could eliminate the need for HCV genotype testing. We look forward to advancing the regulatory submissions for the SOF/VEL fixed-dose combination.”
How The Market Reacted & Hillary Clinton’s Comments
While Gilead Sciences should be having an exceptional day in the market today following the good news, that’s not exactly the case. Unfortunately, Hillary Clinton made comments with regard to the pricing of specialty treatments that brought many biotech stocks down. Ultimately, Clinton said that she will be proposing a plan to take on specialty drug “price gouging” if she takes office. While she would have to take office first, investors still reacted. Currently (1:28), GILD is trading at $105.87 per share after a decline of 2.37%.
What We Can Expect To See Moving Forward
First and foremost, I’m not concerned about Clinton’s comments. She would have to take office first and I don’t think that’s going to happen… Sorry Hillary! Nonetheless, that’s a big topic in and of itself. Sticking to predictions on GILD, I think that we’re going to see great things moving forward. I’m expecting that we are likely to see the positive reaction one would expect from such positive news to come by the end of the week. While Clinton’s comments are a drag at the moment, I don’t think they will drag the stock down for very long! All in all, GILD is a great company and has provided exceptional data. This is what investors should be focusing on… not a political candidate that has already shot herself in the foot during her campaign!
What Do You Think?
Where do you think GILD is headed and why? Let us know in the comments below.
[Image Courtesy of Mercury News]