Yahoo Finance Pfizer (PFE) Gets FDA Acceptance for Braftovi + Mektovi sNDAs
Pfizer PFE announced that the FDA has accepted its supplemental new drug applications (sNDAs) seeking approval of its cancer drugs Braftovi + Mektovi in BRAF V600E-mutant metastatic non-small cell lung cancer (NSCLC).
The sNDAs were given a standard review, with the FDA’s decision expected in the fourth quarter of 2023.
At present Braftovi + Mektovi is approved for BRAF-mutated metastatic melanoma, while Braftovi, as a monotherapy, is approved for BRAF-mutated metastatic colorectal cancer.
The sNDAs were based on data from the PHAROS study, which evaluated Braftovi plus Mektovi in patients with BRAF V600E-mutant metastatic NSCLC. In the study, PHAROS met its primary endpoint of objective response rate.
In the past year, Pfizer’s stock has declined 22.6% against an increase of 2.3% for the industry.
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Braftovi and Mektovi were added to Pfizer’s oncology portfolio with the acquisition of Array Biopharma in 2019.
Pfizer’s top line is expected to decline in 2023 due to potentially steep declines in revenues from its COVID-19 products, the Comirnaty vaccine and Paxlovid oral pill, on lower demand. However, Pfizer has the largest number of new product and indication launches planned for 2023. In the next 18 months, Pfizer expects to launch up to 19 new products or indications (all non-COVID indications), which are expected to generate around $20 billion in sales by 2030. Two-thirds of these products have blockbuster potential, according to Pfizer.
Zacks Rank and Stocks to Consider
Pfizer currently has a Zacks Rank #4 (Sell).
Some better-ranked drugmakers/biotech companies are Novo Nordisk NVO, Innoviva INVA and Roche RHHBY. While Novo Nordisk has a Zacks Rank of 1 (Strong Buy), Innoviva and Roche have a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Estimates for Novo Nordisk’s 2023 earnings per share have increased from $4.20 to $4.48. Estimates for 2024 have jumped from $4.90 per share to $5.26 in the past 60 days. Novo Nordisk’s stock has surged 35.4% in the past year.
Novo Nordisk beat earnings expectations in three of the trailing four quarters. The company delivered a four-quarter earnings surprise of 3.00%, on average.
Estimates for Roche’s earnings per share have remained stable for both 2023 and 2024 at $2.59 and $2.82 per share in the past 60 days. Roche’s stock has declined 31.3% in the past year.
Estimates for Innoviva’s 2023 earnings per share have increased from $1.04 to $1.37. Estimates for 2024 have jumped from 52 cents per share to $1.25 in the past 60 days. Innoviva’s stock has declined 40.6% in the past year.
Innoviva missed earnings expectations in three of the trailing four quarters. The company delivered a four-quarter negative earnings surprise of 50.78%, on average.
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Roche Holding AG (RHHBY) : Free Stock Analysis Report
Pfizer Inc. (PFE) : Free Stock Analysis Report
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Innoviva, Inc. (INVA) : Free Stock Analysis Report
