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The Zacks Analyst Blog Highlights J&J, AstraZeneca, Merck, Seagen and Pfizer

For Immediate Release

Chicago, IL – April 10, 2023 – Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include: J&J JNJ, AstraZeneca AZN, Merck's MRK, Seagen SGEN and Pfizer PFE.

Here are highlights from Thursday’s Analyst Blog:

Big Pharma Stock Roundup: JNJ, AZN and More

This week, J&J announced an $8.9 billion settlement offer to completely resolve its talc lawsuits. AstraZeneca said a combination of its cancer drugs, Lynparza and Imfinzi met the primary goal in an advanced ovarian cancer study. The FDA approved Merck's blockbuster medicine, Keytruda, in combination with Seagen's Padcev for a bladder cancer indication. The regulatory agency also accepted Pfizer's regulatory application seeking approval of its cancer drugs Braftovi + Mektovi in a lung cancer indication.

Recap of the Week's Most Important Stories

J&J Offers $8.96B to Settle Talc Lawsuits: J&J filed for voluntary bankruptcy through its subsidiary, LTL Management, for the second time to equitably resolve all present and future talc-related claims. J&J faces thousands of lawsuits, which allege that its baby powder and other talc products contain asbestos that causes cancer, mainly ovarian cancer and mesothelioma. To completely resolve its cosmetic talc litigation, J&J has agreed to pay $8.9 billion over a period of 25 years. This amount is much higher than the $2 billion that the company had committed alongside LTL's first bankruptcy filing in October 2021. However, in January this year, an appeals court rejected J&J's first bankruptcy filing via LTL Management LLC.

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FDA Approves Merck's Keytruda Plus Padcev in Bladder Cancer: The FDA granted accelerated approval to Merck's Keytruda plus Seagen's antibody-drug conjugate, Padcev for the treatment of locally advanced or metastatic urothelial cancer in patients who are not eligible to receive cisplatin-containing chemotherapy. The accelerated approval was based on the tumor response rate and the durability of response data from some cohorts of the phase Ib/II KEYNOTE-869 study (also known as EV-103 study), which was conducted in collaboration with Seagen and Astellas. This is the first approval for a combination of an anti-PD-1 inhibitor and an antibody-drug conjugate in the United States in this patient group.

AstraZeneca's Lynparza + Imfinzi Improve PFS in Ovarian Cancer Study: AstraZeneca and partner Merck announced interim data from the DUO-O phase III study, which evaluated a combination of Lynparza, Imfinzi plus chemotherapy and bevacizumab versus chemotherapy plus bevacizumab (control arm) in newly diagnosed patients with advanced ovarian cancer without tumor BRCA mutations. In the study, the Lynparza plus Imfinzi arm demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus the control arm.

However, another arm, which comprised Imfinzi, chemotherapy plus bevacizumab, did not reach statistical significance for PFS at the interim analysis.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) gave a positive opinion, recommending approval of AstraZeneca's rare disease drug Ultomiris for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive (Ab+). Ultomiris is also under review in the United States for the treatment of NMOSD. Ultomiris was added to AstraZeneca's portfolio with the acquisition of Alexion and is already approved to treat paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome and generalized myasthenia gravis in the United States, EU and Japan.

FDA Accepts Pfizer's Braftovi + Mektovi sNDAs in NSCLC: The FDA accepted Pfizer's supplemental new drug applications (sNDAs) seeking approval of its cancer drugs Braftovi + Mektovi in BRAF V600E-mutant metastatic non-small cell lung cancer.

The FDA's decision is expected in the fourth quarter of 2023. 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. 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 NYSE ARCA Pharmaceutical Index rose 4.43% in the last five trading sessions.

In the last five trading sessions, all the stocks were in the green, with J&J rising the most (8%).

In the past six months, AstraZeneca has risen the most (30.1%), while Roche has declined the most (8.5%).

(See the last pharma stock roundup here: SNY's COPD Study Meets Goal, ABBV Parkinson's Drug Gets CRL)

What's Next in the Pharma World?

Watch out for regular pipeline and regulatory updates next week.

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Past performance is no guarantee of future results. Inherent in any investment is the potential for loss. This material is being provided for informational purposes only and nothing herein constitutes investment, legal, accounting or tax advice, or a recommendation to buy, sell or hold a security. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. It should not be assumed that any investments in securities, companies, sectors or markets identified and described were or will be profitable. All information is current as of the date of herein and is subject to change without notice. Any views or opinions expressed may not reflect those of the firm as a whole. Zacks Investment Research does not engage in investment banking, market making or asset management activities of any securities. These returns are from hypothetical portfolios consisting of stocks with Zacks Rank = 1 that were rebalanced monthly with zero transaction costs. These are not the returns of actual portfolios of stocks. The S&P 500 is an unmanaged index. Visit https://www.zacks.com/performance for information about the performance numbers displayed in this press release.

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AstraZeneca PLC (AZN) : Free Stock Analysis Report

Johnson & Johnson (JNJ) : Free Stock Analysis Report

Pfizer Inc. (PFE) : Free Stock Analysis Report

Merck & Co., Inc. (MRK) : Free Stock Analysis Report

Seagen Inc. (SGEN) : Free Stock Analysis Report

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