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Pharma Stock Roundup: J&J's $8.9B Offer for Talc Litigation Settlement & Other Updates
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This week, J&J (JNJ - Free Report) announced an $8.9 billion settlement offer to completely resolve its talc lawsuits. AstraZeneca (AZN - Free Report) 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 (MRK - Free Report) blockbuster medicine, Keytruda, in combination with Seagen’s Padcev for a bladder cancer indication. The regulatory agency also accepted Pfizer’s (PFE - Free Report) 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.
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.
Here’s how the eight major stocks performed in the last five trading sessions.
Image Source: Zacks Investment Research
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%).
Image: Bigstock
Pharma Stock Roundup: J&J's $8.9B Offer for Talc Litigation Settlement & Other Updates
This week, J&J (JNJ - Free Report) announced an $8.9 billion settlement offer to completely resolve its talc lawsuits. AstraZeneca (AZN - Free Report) 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 (MRK - Free Report) blockbuster medicine, Keytruda, in combination with Seagen’s Padcev for a bladder cancer indication. The regulatory agency also accepted Pfizer’s (PFE - Free Report) 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.
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.
Here’s how the eight major stocks performed in the last five trading sessions.
Image Source: Zacks Investment Research
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.