FDA Rejects Merck’s Gefapixant Application for Chronic Cough Treatment

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Merck ($NYSE:MRK), one of the world’s leading pharmaceutical companies, has recently been dealt a major setback with the rejection of their request to the Food and Drug Administration (FDA) to approve gefapixant for chronic cough treatment. The FDA’s decision to reject Merck’s application for the use of gefapixant for chronic cough treatment has been met with disappointment by the company. Merck had been hoping that gefapixant would be able to provide relief for those suffering from the condition, but the FDA determined that there was not enough evidence that the drug was safe and effective. Merck is now looking into potential treatments and ways to further research gefapixant in order to gain approval from the FDA in the near future.

Share Price

On Wednesday, the U.S. Food and Drug Administration (FDA) rejected Merck‘s application for its experimental drug gefapixant to treat chronic cough in adults. This news caused a drop in the company’s stock price, with shares opening at $107.1 and closing at $105.4, representing a decrease of 1.1% from the previous closing price of 106.5. In their rejection letter, the FDA cited that there were still uncertainties surrounding efficacy and safety of the drug that needed to be addressed before it could be approved. Merck has stated that they will continue to work with the FDA to address these issues and hopefully get gefapixant approved in the future. Live Quote…

About the Company

Income Snapshot

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Analysis

GoodWhale has conducted an analysis of MERCK’s fundamentals and concluded that it is classified as a ‘cow’, a type of company with the track record of paying out consistent and sustainable dividends. This type of company may be of interest to investors looking for steady returns and income from dividends. The health score of 8/10 with regard to its cashflows and debt indicates MERCK is financially secure and capable to pay off debt and fund future operations. Additionally, MERCK is strong in terms of asset, dividend, and profitability, but may not be the best option for investors looking for growth. Mercks_Gefapixant_Application_for_Chronic_Cough_Treatment”>More…

Peers

In the pharmaceutical industry, Merck & Co Inc is up against some stiff competition. Sanofi SA, Roche Holding AG, and TherapeuticsMD Inc are all major players in the industry. While each company has its own strengths and weaknesses, they all compete against each other to bring new and innovative drugs to market.

– Sanofi SA ($LTS:0O59)

As of 2022, Sanofi SA has a market capitalization of 102.29 billion euros and a return on equity of 7.56%. The company is a French multinational pharmaceutical company headquartered in Paris, France, and is one of the world’s largest pharmaceutical companies. Sanofi is a diversified company, with operations in several therapeutic areas, including diabetes, vaccines, rare diseases, multiple sclerosis, oncology, immunology, and cardiovascular.

– Roche Holding AG ($LTS:0TDF)

Roche Holding AG, a Swiss multinational healthcare company, has a market cap of 270.34B as of 2022. The company’s Return on Equity is 47.83%. Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. The company provides medicines and diagnostic tests that enable personalized health care for patients.

– TherapeuticsMD Inc ($NASDAQ:TXMD)

TherapeuticsMD Inc. is a biopharmaceutical company, which focuses on developing and commercializing products for the health and well-being of women. It offers products in various therapeutic areas, such as Menopause, Osteoporosis, Chronic Vulvar and Vaginal Atrophy, and other health conditions related to hormone deficiency and imbalances. The company was founded by Robert G. Finizio, George S. Paletta, and Douglas S. Leighton in 2010 and is headquartered in Boca Raton, FL.

Summary

Merck’s stock has been a source of interest for investors due to its recent news regarding its application for gefapixant, a new chronic cough treatment. Although the company applied for approval of the drug from the Food and Drug Administration (FDA) in the US, the application was recently denied. As a result, the stock has declined slightly, with some analysts expecting further losses as the uncertainty increases. Nevertheless, many are still positive about Merck’s long-term prospects due to its strong portfolio of drugs, with some analysts suggesting that investors should stay put and wait for opportune times to enter the market.

Merck also boasts a strong balance sheet, with solid cash flow and healthy margins, which are expected to remain steady despite the setback from FDA. With their extensive research and development capabilities, Merck remains an attractive investment opportunity and investors should keep an eye on any upcoming updates that could affect their stock price.