AstraZeneca Plc (AZN) and Daiichi Sankyo Co Ltd. said Monday that their jointly developed drug Enhertu for the treatment of advanced gastric cancer has been granted Breakthrough Therapy Designation (BTD) status from the U.S. Food and Drug Administration (FDA).The BTD status will allow the companies to accelerate the development, regulatory review and market entry of Enhertu. The FDA awards the status for potential new medicines that are intended to treat a serious condition and address a significant unmet medical need. Enhertu is an antibody drug targeting HER2-positive cancer cells.“Current therapy options are limited for patients with HER2-positive metastatic gastric cancer and for those who relapse, there are no approved HER2-targeted medicines,” said José Baselga, Executive Vice President, R&D Oncology. “We look forward to working with the FDA to further explore the potential of Enhertu to become an important new treatment and the first antibody drug conjugate for this devastating disease.”Gastric cancer is the fifth most common cancer worldwide and the third leading cause of cancer mortality. In the US, it is estimated that 27,600 new cases of gastric cancer will be diagnosed in 2020 and more than 11,000 people will die from the disease. About one in five gastric cancers are considered HER2 positive.The FDA granted the BTD status based on Phase I trial and Phase II trial data. Patients treated with Enhertu demonstrated a statistically significant and clinically meaningful improvement in objective response rate (ORR), the primary endpoint, and overall survival (OS), a key secondary endpoint, versus patients treated with chemotherapy.Enhertu is already approved in the US and Japan for the treatment of adult patients with metastatic HER2-positive breast cancer. The drugmaker’s shares rose 1.1% to $53.29 on Friday after rallying 29% in the past 2 months.TipRanks data shows that Wall Street analysts have a bullish outlook on the stock as 4 have Buys adding up to a Strong Buy consensus rating. The $57.50 average price target puts the upside potential for the shares in the coming 12 months at 7.9%. (See AstraZeneca stock analysis on TipRanks).  Related News: AstraZeneca-Merck Ovarian Cancer Treatment Gets FDA Approval Seres Therapeutics Reports Weak Earnings, But Significant Upside Lies Ahead Eli Lilly Wins FDA Approval For Retevmo Lung, Thyroid Cancer Treatment More recent articles from Smarter Analyst: * AMC Pops 11% Amid Potential Acquisition Talks by Amazon * Carnival Cruises Enjoys Huge Bookings Surge- Report * Tesla’s China Model 3 Sales Tumbled 64% In April * Solid Biosciences: Keep Your Eyes On The Prize Says Top Analyst

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The U.S. Food and Drug Administration (FDA) approved a treatment developed by AstraZeneca (AZN) and Merck Co. (MRK) for advanced ovarian cancer.The FDA approved the ovarian drug Lynparza to be used in combination with bevacizumab as a first-line maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer. Patients will be selected for therapy based on an FDA-approved companion diagnostic for Lynparza.Lynparza is a first-in-class PARP inhibitor, which is a targeted treatment to potentially exploit DNA damage response (DDR) pathway deficiencies, such as so-called BRCA mutations to kill cancer cells. It is being tested in a range of tumor types. Ovarian cancer is the fifth most common cause of death from cancer in women in the U.S. This year, it is estimated that more than 21,000 women will be diagnosed with ovarian cancer and nearly 14,000 women will die of the disease.The nod by the U.S. regulator followed a biomarker subgroup study of 387 patients with positive tumors from the Phase 3 PAOLA-1 trial, which showed that the Lynparza drug in combination with bevacizumab reduced the risk of disease progression or death by 67%. It improved progression-free survival (PFS) to a median of 37.2 months vs. 17.7 months with bevacizumab alone in patients with advanced ovarian cancer.“Advances in understanding the role of biomarkers and PARP inhibition have fundamentally changed how physicians treat this aggressive type of cancer,” said Dr. Roy Baynes, senior vice president and chief medical officer at Merck Research Laboratories. “Today’s approval based on the PAOLA-1 trial highlights the importance of homologous recombination deficiency (HRD) testing at diagnosis to identify those who may benefit from Lynparza in combination with bevacizumab as a first-line maintenance treatment.”AstraZeneca and Merck said they are also seeking to get approval by the European Union, Japan and other countries for Lynparza’s use in combination with bevacizumab as a first-line maintenance treatment for patients with advanced ovarian cancer.Mara Goldstein, analyst at Mizuho Securities reiterated Merck’s Buy rating with a $100 price target.“The likelihood that MRK's business rebounds in 2H20 with the easing of stay-at-home restrictions is high, in our view, and drives our support of the shares,” Goldstein wrote in a note to investors.TipRanks data shows that 9 out of the 11 Wall Street analysts covering the stock in the past three months have a Buy on the stock. The remainder say Hold adding up to Strong Buy consensus rating. The $92.10 average price target suggests 21% upside potential in the shares in the coming 12 months. (See Merck stock analysis on TipRanks). Related News: Quidel’s Rapid Covid-19 Antigen Test Scores Emergency FDA Approval GM Ramps Up Coffers With $4 Billion Debt Sale, Plans New $2 Billion Credit Line Weekly Market Review: Stocks Back to Winning Ways More recent articles from Smarter Analyst: * AMC Pops 11% Amid Potential Acquisition Talks by Amazon * Carnival Cruises Enjoys Huge Bookings Surge- Report * AstraZeneca, Daiichi Get FDA Breakthrough Status For Gastro Cancer Drug * Tesla’s China Model 3 Sales Tumbled 64% In April

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Top news and what to watch in the markets on Monday, May 11, 2020.

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