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Pharma Stock Roundup: FDA Nod to AZN's Eplontersen, CRL to MRK's Cough Candidate
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This week, the FDA approved AstraZeneca (AZN - Free Report) and partner Ionis’ (IONS - Free Report) Wainua (eplontersen) for treating patients with hereditary transthyretin-mediated amyloid polyneuropathy, commonly called ATTRv-PN. The FDA also issued a complete response letter (CRL) to Merck’s (MRK - Free Report) chronic cough candidate gefapixant.
The regulatory body also approved Pfizer’s (PFE - Free Report) cancer drug Padcev, added from the recently closed Seagen acquisition, in combination with Merck’s Keytruda for adult patients with advanced bladder cancer. Sanofi (SNY - Free Report) is ending the development of the cancer program called tusamitamab ravtansine based on the outcome of a prespecified interim analysis conducted by an Independent Data Monitoring Committee.
Recap of the Week’s Most Important Stories
FDA Approves AstraZeneca/Ionis’ Wainua: The FDA approved AstraZeneca/Ionis’ eplontersen for ATTRv-PN, a debilitating disease, which leads to peripheral nerve damage and affects an estimated 40,000 people worldwide. Eplontersen will be marketed by the name of Wainua. The approval was based on data from the NEURO-TTRansform study, which showed that treatment with Wainua led to a consistent and sustained benefit, improving neuropathy impairment and quality of life. Wainua is expected to be launched in the United States in January 2024. Applications seeking approval of eplontersen for ATTRv-PN are under review in EU.
AstraZeneca and Ionis are also developing eplontersen as a treatment for cardiomyopathy caused by hereditary TTR amyloidosis in the phase III CARDIO-TTRansform study, which is on track for a data readout in first-half 2025.
FDA’s 2nd CRL to Merck’s Chronic Cough Candidate Gefapixant: The FDA issued a CRL to Merck’s new drug application (“NDA”) seeking approval of pipeline candidate, gefapixant, for treating refractory or unexplained chronic cough. This is the second CRL issued by the FDA to Merck’s NDA for gefapixant.
In January 2022, the FDA had issued a CRL to gefapixant NDA asking for more information related to the measurement of the efficacy of gefapixant. In the latest CRL, the FDA mentioned that the NDA did not demonstrate substantial evidence of the effectiveness of gefapixant for treating refractory or unexplained chronic cough as the reason for the CRL. Merck said the CRL was not related to the safety of gefapixant.
The European Commission granted approval to Keytruda for two indications in gastrointestinal cancers. The first one is for Keytruda plus gemcitabine and cisplatin as first-line treatment for locally advanced unresectable or metastatic biliary tract cancer based on data from the phase III KEYNOTE-966 study. The second one is for Keytruda plus fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma based on data from the KEYNOTE-859 study. Keytruda is now approved for seven gastrointestinal cancers in Europe.
The FDA granted priority review to Merck’s biologics license application seeking approval of V116, its 21-valent pneumococcal conjugate vaccine (“PCV”) specifically designed to protect adults. The FDA’s decision is expected on Jun 17, 2024. V116 targets 21 serotypes that account for 83% of all invasive pneumococcal disease in older adults in the United States, including eight serotypes not covered by currently licensed vaccines. If approved, V116 would become the first PCV specifically designed for adults.
Sanofi Terminates Tusamitamab Ravtansine Cancer Program: Sanofi said it is discontinuing the development of tusamitamab ravtansine, a type of an antibody-drug conjugate, after a phase III second-line non-squamous non small cell lung cancer study on the candidate failed to meet its dual primary endpoint of improving progression-free survival (PFS) compared to docetaxel. Though the CARMEN-LC03 study did show an improved overall survival (second primary endpoint) trend, it did not show any improvement in PFS.
FDA Approves Pfizer’s Padcev+Keytruda for Advanced Bladder Cancer: The FDA approved Pfizer’s Padcev in combination with Merck’s Keytruda for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC). This becomes the first approval for a combination of an ADC product plus PD-L1 inhibitor for the treatment of advanced bladder cancer, offering an alternative to platinum-containing chemotherapy, the current standard of care in first-line la/mUC for years.
Padcev was added to Pfizer’s cancer portfolio with the recently closed acquisition of Seagen. At present, Padcev, in combination with Keytruda, is approved, on an accelerated basis, for treating la/mUC in adult patients who are not eligible to receive cisplatin-containing chemotherapy.
The EV-302 study was the confirmatory study for converting this accelerated approval to full approval. With the latest approval, Padcev, in combination with Keytruda, is eligible for expanded use in patients with la/mUC who are eligible to receive cisplatin chemotherapy.
The NYSE ARCA Pharmaceutical Index rose 0.67% in the last five trading sessions.
Image: Shutterstock
Pharma Stock Roundup: FDA Nod to AZN's Eplontersen, CRL to MRK's Cough Candidate
This week, the FDA approved AstraZeneca (AZN - Free Report) and partner Ionis’ (IONS - Free Report) Wainua (eplontersen) for treating patients with hereditary transthyretin-mediated amyloid polyneuropathy, commonly called ATTRv-PN. The FDA also issued a complete response letter (CRL) to Merck’s (MRK - Free Report) chronic cough candidate gefapixant.
The regulatory body also approved Pfizer’s (PFE - Free Report) cancer drug Padcev, added from the recently closed Seagen acquisition, in combination with Merck’s Keytruda for adult patients with advanced bladder cancer. Sanofi (SNY - Free Report) is ending the development of the cancer program called tusamitamab ravtansine based on the outcome of a prespecified interim analysis conducted by an Independent Data Monitoring Committee.
Recap of the Week’s Most Important Stories
FDA Approves AstraZeneca/Ionis’ Wainua: The FDA approved AstraZeneca/Ionis’ eplontersen for ATTRv-PN, a debilitating disease, which leads to peripheral nerve damage and affects an estimated 40,000 people worldwide. Eplontersen will be marketed by the name of Wainua. The approval was based on data from the NEURO-TTRansform study, which showed that treatment with Wainua led to a consistent and sustained benefit, improving neuropathy impairment and quality of life. Wainua is expected to be launched in the United States in January 2024. Applications seeking approval of eplontersen for ATTRv-PN are under review in EU.
AstraZeneca and Ionis are also developing eplontersen as a treatment for cardiomyopathy caused by hereditary TTR amyloidosis in the phase III CARDIO-TTRansform study, which is on track for a data readout in first-half 2025.
FDA’s 2nd CRL to Merck’s Chronic Cough Candidate Gefapixant: The FDA issued a CRL to Merck’s new drug application (“NDA”) seeking approval of pipeline candidate, gefapixant, for treating refractory or unexplained chronic cough. This is the second CRL issued by the FDA to Merck’s NDA for gefapixant.
In January 2022, the FDA had issued a CRL to gefapixant NDA asking for more information related to the measurement of the efficacy of gefapixant. In the latest CRL, the FDA mentioned that the NDA did not demonstrate substantial evidence of the effectiveness of gefapixant for treating refractory or unexplained chronic cough as the reason for the CRL. Merck said the CRL was not related to the safety of gefapixant.
The European Commission granted approval to Keytruda for two indications in gastrointestinal cancers. The first one is for Keytruda plus gemcitabine and cisplatin as first-line treatment for locally advanced unresectable or metastatic biliary tract cancer based on data from the phase III KEYNOTE-966 study. The second one is for Keytruda plus fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma based on data from the KEYNOTE-859 study. Keytruda is now approved for seven gastrointestinal cancers in Europe.
The FDA granted priority review to Merck’s biologics license application seeking approval of V116, its 21-valent pneumococcal conjugate vaccine (“PCV”) specifically designed to protect adults. The FDA’s decision is expected on Jun 17, 2024. V116 targets 21 serotypes that account for 83% of all invasive pneumococcal disease in older adults in the United States, including eight serotypes not covered by currently licensed vaccines. If approved, V116 would become the first PCV specifically designed for adults.
Sanofi Terminates Tusamitamab Ravtansine Cancer Program: Sanofi said it is discontinuing the development of tusamitamab ravtansine, a type of an antibody-drug conjugate, after a phase III second-line non-squamous non small cell lung cancer study on the candidate failed to meet its dual primary endpoint of improving progression-free survival (PFS) compared to docetaxel. Though the CARMEN-LC03 study did show an improved overall survival (second primary endpoint) trend, it did not show any improvement in PFS.
FDA Approves Pfizer’s Padcev+Keytruda for Advanced Bladder Cancer: The FDA approved Pfizer’s Padcev in combination with Merck’s Keytruda for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC). This becomes the first approval for a combination of an ADC product plus PD-L1 inhibitor for the treatment of advanced bladder cancer, offering an alternative to platinum-containing chemotherapy, the current standard of care in first-line la/mUC for years.
Padcev was added to Pfizer’s cancer portfolio with the recently closed acquisition of Seagen. At present, Padcev, in combination with Keytruda, is approved, on an accelerated basis, for treating la/mUC in adult patients who are not eligible to receive cisplatin-containing chemotherapy.
The EV-302 study was the confirmatory study for converting this accelerated approval to full approval. With the latest approval, Padcev, in combination with Keytruda, is eligible for expanded use in patients with la/mUC who are eligible to receive cisplatin chemotherapy.
The NYSE ARCA Pharmaceutical Index rose 0.67% 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, Pfizer rose the most (8.1%), while AbbVie declined the most (1.4%).
In the past six months, Novo Nordisk has risen the most (30.1%), while Pfizer has declined the most (26.3%).
(See the last pharma stock roundup here: PFE Issues Weak 2024 View, AZN to Buy Icosavax & More)
What's Next in the Pharma World?
Watch for pipeline and regulatory updates next week.