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Pharma Stock Roundup: JNJ's 3rd Talc-Related Bankruptcy Filing & More
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This week, J&J (JNJ - Free Report) filed for voluntary bankruptcy for the third time in an attempt to bring an end to thousands of lawsuits related to its talc products. Pfizer (PFE - Free Report) said it is withdrawing its sickle-cell drug (“SCD”) drug, Oxbryta from worldwide markets. Merck’s (MRK - Free Report) Keytruda combination study in colorectal cancer failed to meet its primary goal. Eli Lilly’s (LLY - Free Report) Alzheimer’s drug, Kisunla, got approval in Japan. AstraZeneca’s (AZN - Free Report) Daiichi Sankyo-partnered datopotamab deruxtecan failed to show overall survival benefits in a breast cancer study.
Here is a recap of the week's most important stories.
J&J Seeks 3rd Talc-Related Bankruptcy
J&J filed for voluntary bankruptcy (Chapter 11 bankruptcy) in a bankruptcy court in Texas via a subsidiary called Red River Talc. Earlier, J&J failed twice in its attempts to seek bankruptcy to fully resolve thousands of lawsuits related to its talc products.
J&J’s subsidiary, LTL Management, which was established to manage claims in the cosmetic talc litigation, filed for voluntary bankruptcy twice in New Jersey. However, both the bankruptcy filings were rejected by courts stating that J&J was not in enough financial stress to qualify for bankruptcy. In May 2024, LTL Management proposed a new plan committing to pay claimants a present value of approximately $6.5 billion to be paid over 25 years, which could resolve 99.75% of all pending talc lawsuits against the company.
J&J said that Red River filed the bankruptcy case after it received support from around 83% of current claimants for the proposed bankruptcy plan. This exceeds the 75% approval threshold required by the U.S. Bankruptcy Code to secure confirmation of the proposed plan. Red River also increased its settlement commitment by $1.75 billion to approximately $8 billion.
Pfizer Withdraws Oxbryta From Global Markets
Pfizer announced that it is voluntarily withdrawing all lots of its sickle cell disease drug, Oxbryta (voxelotor) in all markets where it is approved. Pfizer also said it is discontinuing all clinical studies evaluating the drug for expanded use. Pfizer took the decision based on clinical data, which shows that Oxbryta’s overall benefit no longer outweighs the risk for the approved SCD indication. Pfizer also added that there is an imbalance in vaso-occlusive crises, a complication associated with the disease, and fatal events. Oxbryta was added to Pfizer’s portfolio with the acquisition of Global Blood Therapeutics in 2022.
Lilly’s Alzheimer’s Drug Kisunla Gets Approval in Japan
Lilly’s Kisunla (donanemab) was approved for treating early symptomatic Alzheimer's disease (“AD”) in Japan by the Ministry of Health, Labour and Welfare. Patients with early symptomatic AD include those with mild cognitive impairment (MCI) as well as those with the mild dementia stage of AD with confirmed amyloid pathology. Japan is the second market where Kisunla, an amyloid-targeting treatment, has been approved. Kisunla was approved in the United States in July, while regulatory applications are under review in the EU. Kisunla’s approval was based on data from the TRAILBLAZER-ALZ 2 phase III study, which included participants from Japan.
AstraZeneca/Daiichi’s Dato-DXd Misses OS Goal in Breast Cancer Study
AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate, datopotamab deruxtecan (Dato-DXd), failed to achieve statistical significance in the final overall survival (OS) analysis in a study for a metastatic breast cancer indication. The TROPION-Breast01 phase III study evaluated Dato-DXd, a TROP2-directed ADC for treating inoperable or metastatic hormone receptor (HR)-positive, HER2-low or negative breast cancer previously treated with endocrine-based therapy and at least one systemic therapy. The study compared Dato-DXd to the investigator’s choice of chemotherapy. The study had previously met the dual primary endpoint of progression-free survival (PFS), demonstrating a statistically significant and clinically meaningful improvement in PFS.
AstraZeneca/Daiichi’s biologics license application (BLA) seeking approval of Dato-DXd for treating unresectable or metastatic HR+ HER2- breast cancer is already under review in the United States based on PFS data from the TROPION-Breast01 phase III study. The FDA is expected to give its decision on the BLA in the first quarter of 2025. The overall survival miss lowers the drug’s chances for approval in the breast cancer indication.
The FDA approved Tagrisso (osimertinib) for treating unresectable stage III EGFR-mutated non-small cell lung cancer (NSCLC) following treatment with chemoradiotherapy in patients whose tumors have exon 19 deletions or exon 21 (L858R) mutations. The approval was based on data from the phase III LAURA study. Currently, Tagrisso is approved as a monotherapy for the first-line treatment of EFGR-mutated NSCLC, locally advanced or metastatic EGFR T790M mutation-positive NSCLC and adjuvant treatment of early-stage EGFRm NSCLC.
Merck Keytruda Combo Colorectal Cancer Study Fails
Merck’s phase III study evaluating a fixed dose combination of Keytruda and favezelimab, an anti-LAG-3 antibody for previously treated PD-L1 positive microsatellite stable (MSS) metastatic colorectal cancer (mCRC), failed to meet its primary endpoint of overall survival (OS). Data from the KEYFORM-007 study showed that the fixed-dose combination of Keytruda and favezelimab failed to show an improvement in OS compared to the standard of care. In colorectal cancer, Keytruda is presently approved for treating unresectable or metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer.
FDA Approves Sanofi’s Sarclisa in First-Line Multiple Myeloma
The FDA granted approval for the expanded use of Sanofi’s Sarclisa in multiple myeloma. The FDA approval is for Sarclisa in combination with standard-of-care bortezomib, lenalidomide and dexamethasone for first-line treatment of patients with newly diagnosed multiple myelomanot eligible for transplant. The approval is based on positive data from the IMROZ phase III study. This is the third approved indication for Sarclisa in the United States and the first one in the first-line setting. Sarclisa is approved in several countries for two indications in relapsed or refractory multiple myeloma.
The NYSE ARCA Pharmaceutical Index declined 2.1% in the last five trading sessions.
Watch this space for regular pipeline and regulatory updates next week.
Lilly has a Zacks Rank #1 (Strong Buy) currently, while Pfizer and AstraZeneca have a Zacks Rank #2 (Buy) each. J&J and Merck have a Zacks Rank #4 (Sell).
Image: Bigstock
Pharma Stock Roundup: JNJ's 3rd Talc-Related Bankruptcy Filing & More
This week, J&J (JNJ - Free Report) filed for voluntary bankruptcy for the third time in an attempt to bring an end to thousands of lawsuits related to its talc products. Pfizer (PFE - Free Report) said it is withdrawing its sickle-cell drug (“SCD”) drug, Oxbryta from worldwide markets. Merck’s (MRK - Free Report) Keytruda combination study in colorectal cancer failed to meet its primary goal. Eli Lilly’s (LLY - Free Report) Alzheimer’s drug, Kisunla, got approval in Japan. AstraZeneca’s (AZN - Free Report) Daiichi Sankyo-partnered datopotamab deruxtecan failed to show overall survival benefits in a breast cancer study.
Here is a recap of the week's most important stories.
J&J Seeks 3rd Talc-Related Bankruptcy
J&J filed for voluntary bankruptcy (Chapter 11 bankruptcy) in a bankruptcy court in Texas via a subsidiary called Red River Talc. Earlier, J&J failed twice in its attempts to seek bankruptcy to fully resolve thousands of lawsuits related to its talc products.
J&J’s subsidiary, LTL Management, which was established to manage claims in the cosmetic talc litigation, filed for voluntary bankruptcy twice in New Jersey. However, both the bankruptcy filings were rejected by courts stating that J&J was not in enough financial stress to qualify for bankruptcy. In May 2024, LTL Management proposed a new plan committing to pay claimants a present value of approximately $6.5 billion to be paid over 25 years, which could resolve 99.75% of all pending talc lawsuits against the company.
J&J said that Red River filed the bankruptcy case after it received support from around 83% of current claimants for the proposed bankruptcy plan. This exceeds the 75% approval threshold required by the U.S. Bankruptcy Code to secure confirmation of the proposed plan. Red River also increased its settlement commitment by $1.75 billion to approximately $8 billion.
Pfizer Withdraws Oxbryta From Global Markets
Pfizer announced that it is voluntarily withdrawing all lots of its sickle cell disease drug, Oxbryta (voxelotor) in all markets where it is approved. Pfizer also said it is discontinuing all clinical studies evaluating the drug for expanded use. Pfizer took the decision based on clinical data, which shows that Oxbryta’s overall benefit no longer outweighs the risk for the approved SCD indication. Pfizer also added that there is an imbalance in vaso-occlusive crises, a complication associated with the disease, and fatal events. Oxbryta was added to Pfizer’s portfolio with the acquisition of Global Blood Therapeutics in 2022.
Lilly’s Alzheimer’s Drug Kisunla Gets Approval in Japan
Lilly’s Kisunla (donanemab) was approved for treating early symptomatic Alzheimer's disease (“AD”) in Japan by the Ministry of Health, Labour and Welfare. Patients with early symptomatic AD include those with mild cognitive impairment (MCI) as well as those with the mild dementia stage of AD with confirmed amyloid pathology. Japan is the second market where Kisunla, an amyloid-targeting treatment, has been approved. Kisunla was approved in the United States in July, while regulatory applications are under review in the EU. Kisunla’s approval was based on data from the TRAILBLAZER-ALZ 2 phase III study, which included participants from Japan.
AstraZeneca/Daiichi’s Dato-DXd Misses OS Goal in Breast Cancer Study
AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate, datopotamab deruxtecan (Dato-DXd), failed to achieve statistical significance in the final overall survival (OS) analysis in a study for a metastatic breast cancer indication. The TROPION-Breast01 phase III study evaluated Dato-DXd, a TROP2-directed ADC for treating inoperable or metastatic hormone receptor (HR)-positive, HER2-low or negative breast cancer previously treated with endocrine-based therapy and at least one systemic therapy. The study compared Dato-DXd to the investigator’s choice of chemotherapy. The study had previously met the dual primary endpoint of progression-free survival (PFS), demonstrating a statistically significant and clinically meaningful improvement in PFS.
AstraZeneca/Daiichi’s biologics license application (BLA) seeking approval of Dato-DXd for treating unresectable or metastatic HR+ HER2- breast cancer is already under review in the United States based on PFS data from the TROPION-Breast01 phase III study. The FDA is expected to give its decision on the BLA in the first quarter of 2025. The overall survival miss lowers the drug’s chances for approval in the breast cancer indication.
The FDA approved Tagrisso (osimertinib) for treating unresectable stage III EGFR-mutated non-small cell lung cancer (NSCLC) following treatment with chemoradiotherapy in patients whose tumors have exon 19 deletions or exon 21 (L858R) mutations. The approval was based on data from the phase III LAURA study. Currently, Tagrisso is approved as a monotherapy for the first-line treatment of EFGR-mutated NSCLC, locally advanced or metastatic EGFR T790M mutation-positive NSCLC and adjuvant treatment of early-stage EGFRm NSCLC.
Merck Keytruda Combo Colorectal Cancer Study Fails
Merck’s phase III study evaluating a fixed dose combination of Keytruda and favezelimab, an anti-LAG-3 antibody for previously treated PD-L1 positive microsatellite stable (MSS) metastatic colorectal cancer (mCRC), failed to meet its primary endpoint of overall survival (OS). Data from the KEYFORM-007 study showed that the fixed-dose combination of Keytruda and favezelimab failed to show an improvement in OS compared to the standard of care. In colorectal cancer, Keytruda is presently approved for treating unresectable or metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer.
FDA Approves Sanofi’s Sarclisa in First-Line Multiple Myeloma
The FDA granted approval for the expanded use of Sanofi’s Sarclisa in multiple myeloma. The FDA approval is for Sarclisa in combination with standard-of-care bortezomib, lenalidomide and dexamethasone for first-line treatment of patients with newly diagnosed multiple myelomanot eligible for transplant. The approval is based on positive data from the IMROZ phase III study. This is the third approved indication for Sarclisa in the United States and the first one in the first-line setting. Sarclisa is approved in several countries for two indications in relapsed or refractory multiple myeloma.
The NYSE ARCA Pharmaceutical Index declined 2.1% in the last five trading sessions.
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
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 red, with Novo Nordisk declining the most (7.9%).
In the past six months, while Novartis rose the most (19.5%), Merck declined the most (14.3%).
(See the last pharma stock roundup here: FDA Approvals for LLY, MRK, AZN & JNJ Drugs)
What's Next in the Pharma World?
Watch this space for regular pipeline and regulatory updates next week.
Lilly has a Zacks Rank #1 (Strong Buy) currently, while Pfizer and AstraZeneca have a Zacks Rank #2 (Buy) each. J&J and Merck have a Zacks Rank #4 (Sell).
You can see the complete list of today’s Zacks #1 Rank stocks here.