U.S. Markets open in 4 hrs 27 mins

AstraZeneca's Selumetinib Gets Breakthrough Therapy Status

Zacks Equity Research

AstraZeneca Inc. AZN announced that the FDA has granted Breakthrough Therapy designation (BTD) to its investigational MEK 1/2 inhibitor, selumetinib for the treatment of neurofibromatosis type 1 (NF1) related plexiform neurofibromas (PN), an incurable genetic condition that affects newborns.

The Breakthrough Therapy designation is granted to speed up the development and review of drugs that target serious or life-threatening conditions. AstraZeneca is developing selumetinib in partnership with Merck & Co. Inc. MRK. AstraZeneca and Merck entered into a co-development and co-commercialization agreement for selumetinib in 2017.

Shares of AstraZeneca have increased 20.5% year to date compared with the industry’s growth of 20%.


The BTD was supported by phase II results from the SPRINT study, testing selumetinib as an oral monotherapy in pediatric patients aged three years or older with inoperable NF1-related PN. Results from the study have shown that selumetinib shrank tumors in children and young adults with NF1 and may improve symptoms such as pain and reduced mobility that result from tumors called, which develop in many people with NF1.

In the study, 36 of the 50 patients (72%) had a partial response to selumetinib, which means the tumor volume shrank at least 20%. Selumetinib was granted Orphan Drug designation for the treatment of NF1 by the FDA in February 2018 and the European Medicines Agency in August 2018. It is being developed as a monotherapy and in combination with other treatments in ongoing studies.

AstraZeneca boasts a strong late-stage oncology pipeline. Other than Selumetinib, the company’s oncology portfolio includes savolitinib (kidney cancer), which is also in late-stage development. An interesting candidate in the company’s immuno-oncology pipeline is Imfinzi (durvalumab), which is being evaluated for multiple cancers, either alone or in combination with other regimens. Imfinzi is presently marketed in the United States for second-line advanced bladder and early-stage lung cancer (NSCLC).

Lynparza, also marketed in partnership with Merck for advanced ovarian and breast cancers, is being evaluated in different studies for a range of tumor types, including prostate and pancreatic cancers, and earlier-line settings for ovarian cancer. Tagrisso is also being evaluated in earlier-line settings for lung cancer.

AstraZeneca PLC Price

AstraZeneca PLC Price | AstraZeneca PLC Quote


Zacks Rank & Stocks to Consider

AstraZeneca is currently a Zacks Rank #3 (Hold) stock.

Some better-ranked stocks from the same space are Johnson & Johnson JNJ and Roche Holding AG RHHBY, each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Johnson & Johnson’s earnings per share estimates have increased from $9.20 to $9.21 for 2020 in the past 60 days. The company delivered a positive earnings surprise in all the trailing four quarters, with average of 1.61%.

Roche’s earnings per share estimates have increased from $2.30 to $2.35 for 2019 and from $2.34 to $2.37 for 2020 over the past 90 days.

Zacks' Top 10 Stocks for 2019

In addition to the stocks discussed above, wouldn't you like to know about our 10 finest buy-and-holds for the year?

From more than 4,000 companies covered by the Zacks Rank, these 10 were picked by a process that consistently beats the market. Even during 2018 while the market dropped -5.2%, our Top 10s were up well into double-digits. And during bullish 2012 – 2017, they soared far above the market's +126.3%, reaching +181.9%.

This year, the portfolio features a player that thrives on volatility, an AI comer, and a dynamic tech company that helps doctors deliver better patient outcomes at lower costs.

See Stocks Today >>

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Johnson & Johnson (JNJ) : Free Stock Analysis Report
Roche Holding AG (RHHBY) : Free Stock Analysis Report
Merck & Co., Inc. (MRK) : Free Stock Analysis Report
AstraZeneca PLC (AZN) : Free Stock Analysis Report
To read this article on Zacks.com click here.
Zacks Investment Research