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Merck's Dificid Gets FDA Approval in Pediatric Indication

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Merck & Co., Inc. (MRK - Free Report) announced that the FDA has granted approval to its new drug application ("NDA") and a supplemental NDA (sNDA) for its antibacterial medicine Dificid (fidaxomicin). The NDA sought approval for an oral suspension formulation of Dificid, which is presently available in tablet form. The sNDA aimed at approval for Dificid tablets to treat Clostridium difficile-associated diarrhea (“CDAD”) in children aged six months and above.

The approval for Dificid tablets and oral suspension was based on data from the phase III SUNSHINE study.

Shares of Merck have increased 17.6% in the past year compared with the industry’s rally of 14.9%.

 

The SUNSHINE study evaluated Dificid in patients aged six months to less than 18 years in comparison to antibiotic, vancomycin. Data from the SUNSHINE study showed that while CDAD clinical response was similar for both drugs, sustained clinical response was higher for patients receiving Dificid.

The company stated that there are almost 500,000 infections caused by Clostridioides difficile every year in the United States. This bacterial infection is also estimated to cause approximately 29,000 deaths within 30 days of initial diagnosis. These numbers suggest that the drug has significant potential in the targeted indication.

Merck has many pipeline candidates in advanced stages of development, targeting multiple disease areas such as oncology, cardiovascular diseases, diabetes, infectious diseases, neurosciences, respiratory and immunology diseases, and vaccines. Some of the important pipeline candidates include selumetinib, which is under review in the United States for pediatric neurofibromatosis type 1; MK-6482 in mid-stage study for renal cell carcinoma; V114 (15-valent pneumococcal conjugate vaccine) and chronic heart failure candidate, vericiguat in late-stage studies.

 

Zacks Rank & Stocks to Consider

Merck currently carries a Zacks Rank #3 (Hold).

Some better-ranked large cap pharma stocks are Pfizer (PFE - Free Report) Allergan and Eli Lilly (LLY - Free Report) . While Pfizer sports a Zacks Rank #1 (Strong Buy), Allergan and Lilly carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Pfizer’s earnings per share estimates have moved up from $2.59 to $2.62 for 2020 in the past 60 days. The company delivered a positive earnings surprise in each of the trailing four quarters with the average positive surprise being 8.73%.

Allergan’s earnings per share estimates have increased from $16.87 to $16.95 for 2020 in the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with the average beat being 2.76%. The stock has rallied 30.2% in the past year.

Lilly’s earnings per share estimates have increased from $6.56 to $6.77 for 2020 in the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with the average beat being 1.2%. The stock has risen 19.5% in the past year.

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