Merck's Gardasil Gets FDA Approval for Head and Neck Cancers

Merck & Co., Inc. MRK announced that the FDA has granted accelerated approval to a supplemental biologics license application seeking label expansion of Gardasil 9 vaccine for the prevention of oropharyngeal and other head and neck cancers caused by human papillomavirus (“HPV”) types 16, 18, 31, 33, 45, 52, and 58 in females and males 9 through 45 years of age.

Continued approval of the vaccine in these indications may be contingent upon verification and description of clinical benefit in a confirmatory study. The company is currently conducting a similar study to support the vaccine’s continued approval.

Gardasil 9 is already approved as a prevention for cervical, vaginal, vulvar and anal cancers caused by certain HPV types in patients aged 9 through 45 years.

Merck’s shares have declined 16.1% this year so far compared with the industry’s increase of 5.1%.

Vaccine is an important therapeutic area for Merck. The human papillomavirus vaccine, Gardasil/Gardasil 9 is a key top-line driver forthe company, recording sales of more than $1.1 billion in the first quarter of 2020 and representing year-over-year growth of more than 30%. The current label expansion of the vaccine will further boost its sales going forward. Apart from Gardasil, the company has several marketed vaccines in its portfolio like ProQuad/M-M-R II/Varivax, RotaTeq, Pneumovax 23 and Zostavax.

The company received approval for an Ebola vaccine, Ervebo, in December last year. Merck is studying an investigational 15-valent pneumococcal conjugate vaccine candidate, V114, in late-stage studies. The candidate is being developed as a preventive treatment for invasive pneumococcal disease in pediatric as well as adult patients.

Merck Co., Inc. Price

 

Merck Co., Inc. Price

Merck Co., Inc. price | Merck Co., Inc. Quote

Zacks Rank and Stocks to Consider

Merck currently has a Zacks Rank #3 (Hold). Some better-ranked stocks in the large-cap pharma sector include Eli Lilly and Company LLY, AbbVie Inc. ABBV and AstraZeneca AZN. While Eli Lilly currently sports a Zacks Rank #1 (Strong Buy), AbbVie and AstraZeneca presently hold a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Lilly’s earnings estimates have moved up from $6.77 to $6.81 for 2020 and from $7.92 to $8.02 for 2021 over the past 60 days. The company delivered a positive earnings surprise in all the trailing four quarters, with average beat of 8.24%. Its shares have risen9.2% so far this year.

AbbVie’s earnings estimates have moved up from $9.81 to $10.54 for 2020 and from $11.28 to $12.03 for 2021 over the past 60 days. The company delivered a positive earnings surprise in all the trailing four quarters, with the average being 2.77%. Shares have gained4.4% so far this year.

AstraZeneca’s earnings estimates have moved up from $2.01 to $2.03 for 2020 and from $2.57 to $2.61 for 2021 over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with the average beat being6.11%. Shares have risen3.2% so far this year.

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