Upcoming AWS Coverage on Retrophin Post-Earnings Results
LONDON, UK / ACCESSWIRE / May 25, 2017 / Active Wall St. blog coverage looks at the headline from Merck & Co., Inc. (NASDAQ: MRK) as the Company announced that the US Food and Drug Administration (FDA) has granted accelerated approval to a treatment for patients whose cancers have a specific genetic feature (biomarker). This is the first time the agency has approved a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated. Register with us now for your free membership and blog access at:
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One of Merck & Co.'s competitors within the Drug Manufacturers - Major space, Retrophin, Inc. (NASDAQ: RTRX), posted on May 04, 2017, its financial results for Q1 2017 and also provided a corporate update. AWS will be initiating a research report on Retrophin in the coming days.
Today, AWS is promoting its blog coverage on MRK; touching on RTRX. Get all of our free blog coverage and more by clicking on the link below:
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The Approval
Keytruda (pembrolizumab) is indicated for the treatment of adult and pediatric patients with unresectable or metastatic solid tumors that have been identified as having a biomarker referred to as microsatellite instability-high (MSI-H), or mismatch repair deficient (dMMR). This indication covers patients with solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options and patients with colorectal cancer that has progressed following treatment with certain chemotherapy drugs.
Keytruda works by targeting the cellular pathway known as PD-1/PD-L1. By blocking this pathway, Keytruda may help the body's immune system fight the cancer cells. The FDA previously approved Keytruda for the treatment of certain patients with metastatic melanoma, metastatic non-small cell lung cancer, recurrent or metastatic head and neck cancer, refractory classical Hodgkin lymphoma, and urothelial carcinoma.
"This is an important first for the cancer community," said Richard Pazdur, M.D., acting director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research and director of the FDA's Oncology Center of Excellence, "Until now, the FDA has approved cancer treatments based on where in the body the cancer started - for example, lung or breast cancers. We have now approved a drug based on a tumor's biomarker without regard to the tumor's original location."
The safety and efficacy of Keytruda for this indication were studied in patients with MSI-H or dMMR solid tumors enrolled in one of five uncontrolled, single-arm clinical trials. In some trials, patients were required to have MSI-H or dMMR cancers, while in other trials, a subgroup of patients were identified as having MSI-H or dMMR cancers by testing tumor samples after treatment began. The review of Keytruda for this indication was based on the percentage of patients who experienced complete or partial shrinkage of their tumors (overall response rate) and for how long (durability of response). Of the 149 patients who received Keytruda in the trials, 39.6% had a complete or partial response. For 78% of those patients, the response lasted for six months or more.
The FDA granted this application Priority Review designation, under which the FDA's goal is to take action on an application within six months where the agency determines that the drug, if approved, would significantly improve the safety or effectiveness of treating, diagnosing or preventing a serious condition.
Dividend Declared
Merck also announced that its Board of Directors has declared a quarterly dividend of $0.47 per share of the Company's common stock for Q3 2017. Payment will be made on July 10, 2017, to shareholders of record at the close of business on June 15, 2017.
Stock Performance
On Wednesday, May 24, 2017, the stock closed the trading session at $64.93, slightly up by 0.59% from its previous closing price of $64.55 with a total volume of 7.04 million shares traded. Merck's stock price surged 4.22% in the last month, 4.22% in the past six months, and 16.78% in the previous twelve months. Furthermore, since the start of the year, shares of the Company have gained 10.29%. The Company's shares are trading at a PE ratio of 41.60 and have a dividend yield of 2.90%. At Wednesday's closing price, the stock's net capitalization stands at $177.90 billion.
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