FDA Approves Merck’s KEYTRUDA

Merck (MRK), an American multinational pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has approved its anti-PD-1 therapy KEYTRUDA for the adjuvant treatment of adult and pediatric (12 years and older) patients with stage IIB or IIC melanoma following complete resection. Additionally, the FDA has expanded the indication for KEYTRUDA for stage III melanoma to include pediatric patients (12 years and older).

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KEYTRUDA is the first-of-its-kind anti-PD-1/L1 therapy to reflect recurrence-free survival benefit in the adjuvant setting for stage IIB and IIC melanoma (the most serious form of skin cancer). The injection increases the body’s immune system to help detect and fight tumor cells.

Supporting Data

Merck said that the approval followed data from the first interim analysis of its Phase 3 KEYNOTE-716 trial, in which KEYTRUDA showed a statistically significant improvement in recurrence-free survival (RFS), reducing the risk of disease recurrence or death by 35% compared to placebo. The trial was designed to evaluate the efficacy and safety of KEYTRUDA in adults and pediatric (12 years and older) patients.

Official Comments

Merck’s Clinical Research VP Dr. Scot Ebbinghaus said, “KEYTRUDA was the first anti-PD-1 therapy to be approved in metastatic melanoma in the U.S. seven years ago. Since then, we have built on this foundation in melanoma and have expanded the use of KEYTRUDA into earlier stages of this disease.” (See Merck stock charts on TipRanks)

“With today’s approval, we can now offer healthcare providers and patients 12 years and older the opportunity to help prevent melanoma recurrence with KEYTRUDA across resected stage IIB, stage IIC and stage III melanoma,” Ebbinghaus added.

Wall Street’s Take

Recently, Merck and Ridgeback Biotherapeutics revealed that the FDA’s Antimicrobial Drugs Advisory Committee voted in favor of the company’s COVID-19 pill by a narrow margin of three votes.

Following the update, Mizuho Securities analyst Mara Goldstein reiterated a Buy rating and a price target of $100 (36.35% upside potential) on the stock.

Goldstein said, “Given the favorable vote and the FDA’s internal review, we see EUA likely in the next few weeks. As MRK has secured/in-process government contracts we anticipate that roughly $1 billion of revenue could be recognized in 2021.”

The rest of the Street is cautiously optimistic about the stock and has a Moderate Buy consensus rating based on 5 Buys and 6 Holds. The average Merck price target stands at $93.73 and implies upside potential of 27.8% to current levels. Shares have lost 6.8% over the past year.

Smart Score

According to TipRanks’ Smart Score system, Merck gets a 5 out of 10, which indicates that the stock is likely to perform in line with market averages. (See Top Smart Score Stocks on TipRanks)