Gilead Sciences (NASDAQ:GILD) Reveals CDA Has Approved Epclusa for Treatment of Adults with Genotype 1-6 Chronic HCV- Akers Biosciences (AKER)


Gilead Sciences, Inc. (NASDAQ:GILD) try to make new thrust in street and making different trends, stocks trading ended with -0.07% to $67.33. Gilead Sciences, Inc. (GILD) revealed that the China Drug Administration (CDA) has approved Epclusa (sofosbuvir 400 mg/velpatasvir 100 mg) for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection. The CDA also approved Epclusa in combination with ribavirin (RBV) for adults with HCV and decompensated cirrhosis. Epclusa is the first pan-genotypic HCV single tablet regimen (STR) approved in China.

The approval of Epclusa in China is supported by five international Phase 3 studies, ASTRAL-1, ASTRAL-2, ASTRAL-3, ASTRAL-4 and ASTRAL-5. High overall rates of SVR12 (defined as undetectable HCV RNA 12 weeks after completing therapy), ranging from 92-100 percent, were achieved across difficult-to-cure patient populations including treatment-experienced patients and those with compensated or decompensated cirrhosis.

“The safety and efficacy profile of Epclusa are supported by large clinical and real-world global datasets,” said Professor Lai Wei, Peking University People’s Hospital and Institute of Hepatology, Peking University. “With high cure rates across all HCV genotypes, Epclusa could increase HCV treatment in China by potentially eliminating the need for genotype testing, which can be a barrier to treatment in many settings.”

In the ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies, 1,035 treatment-naïve and treatment-experienced patients with genotype 1-6 HCV infection, without cirrhosis or with compensated cirrhosis, received 12

weeks of Epclusa. Ninety-eight percent (1,015/1,035) of patients achieved SVR12. In the ASTRAL-5 study, 106 treatment-naïve and treatment-experienced patients with genotype 1-6 HCV infection, without cirrhosis or with compensated cirrhosis, who were coinfected with HIV and on a stable antiretroviral therapy, received 12 weeks of Epclusa. Ninety-five percent (101/106) of patients achieved SVR12. The share price of GILD attracts active investors, as stock price of week volatility recorded 1.55%. The stock is going forward to its 52-week low with 5.60% and lagging behind from its 52-week high price with -24.80%.

Akers Biosciences, Inc. (NASDAQ:AKER) moved down reacts as active mover, shares a decrease -33.58% to traded at $0.39 and the percentage gap between open changing to regular change was -18.51%. Akers Biosciences, Inc. (AKER), proclaims that, upon a recommendation from the US Food and Drug Administration (FDA), the Company has decided to withdraw its initial 510(k) application for PIFA Chlamydia in order to re-evaluate its options with regards to this product development opportunity.

John J. Gormally, Chief Executive Officer of Akers Bio, commented: “The setback to the desired commercialization timeline for this product is disappointing, however, PIFA Chlamydia continues to be a priority for the Company, and the board believes this course of action will allow the board and management to better evaluate all options.

At the same time, we remain focused on driving sales growth of our currently commercialized products and, in particular, PIFA Heparin/PF4 Rapid Assay, through expanded distribution and a strategic focus on clinical end-users and integrated delivery network customers.” The firm’s current ratio calculated as 5.30 for the most recent quarter. The firm past twelve months price to sales ratio was 9.03 and price to cash ratio remained 6.52. As far as the returns are concern, the return on equity was recorded as -104.80% and return on investment was -69.20% while its return on asset stayed at -77.20%. The firm has total debt to equity ratio measured as 0.00.


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