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Pharma Stock Roundup: FDA Approves SNY's Dupixent for COPD & More
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This week, the FDA granted approval to Sanofi (SNY - Free Report) and Regeneron’s (REGN - Free Report) blockbuster drug, Dupixent, for its sixth indication. The FDA also granted priority review designation to AstraZeneca’s (AZN - Free Report) label expansion filings for two cancer drugs. Eli Lilly (LLY - Free Report) announced that it is investing $4.5 billion to build a new manufacturing site in Indiana to advance drug production and innovation. AbbVie (ABBV - Free Report) filed a regulatory application to the FDA to seek approval for its lung cancer candidate Teliso-V.
Here's a recap of the week’s most important stories.
Sanofi’s Dupixent Gets Approval in United States for COPD
The FDA granted approval to Sanofi/Regeneron’s Dupixent as an add-on maintenance treatment for adults with inadequately controlled COPD and an eosinophilic phenotype. COPD is the sixth approved indication for Dupixent. It is currently approved in several countries, including the United States and EU, for five other type II inflammatory diseases, namely severe chronic rhinosinusitis with nasal polyposis, severe asthma, moderate-to-severe atopic dermatitis, eosinophilic esophagitis and prurigo nodularis. Dupixent was approved for treating COPD with raised blood eosinophils in the EU in July 2024. Dupixent was also approved for the COPD indication in China last week.
The approval for COPD was based on data from two studies, NOTUS and BOREAS.
LLY to Invest $4.5B to Open New Facility in Indiana
Lilly announced that it is investing $4.5 billion to establish the Lilly Medicine Foundry in Indiana to improve manufacturing and drug development. This facility will enable the development of new methods for making its drugs and also scale up the supply of medicines for clinical trials for Lilly’s growing pipeline. The facility will be opened in 2027. The Medicine Foundry will be situated in the LEAP Research and Innovation District in Lebanon, IN, which will increase Lilly’s investment in Lebanon to more than $13 billion. The new “foundry” will increase Lilly's total capital commitment in the United States to more than $23 billion since 2020.
AbbVie Seeks Approval for Lung Cancer Candidate Teliso-V
AbbVie submitted a biologics license application (BLA) to the FDA seeking accelerated approval for its investigational antibody-drug conjugate telisotuzumab vedotin or Teliso-V for previously treated EGFR wild type non-small cell lung cancer in adult patients with c-Met overexpression. The BLA was based on data from the phase II LUMINOSITY study. Data from the study showed that study participants treated with Teliso V achieved an overall response rate of 35% across c-Met high patients and 23% across c-Met intermediate patients.
FDA’s Priority Tag to AstraZeneca/Daiichi’s Enhertu sBLA
The FDA granted priority review to a supplemental biologics license application (sBLA) seeking approval for AstraZeneca’s Daiichi-partnered drug, Enhertu, for treating unresectable or metastatic HER2-low or HER2-ultralow breast cancer in adult patients who have received at least one endocrine therapy in the metastatic setting. The FDA’s decision on the sBLA is expected in the first quarter of 2025. The sBLA was based on data from the phase III DESTINY-Breast06 study. The sBLA looks to expand the currently approved indication of Enhertu in HER2-low metastatic breast cancer to include use in an earlier disease setting as well as in a broader patient population that includes HER2-ultralow.
Enhertu is presently approved for advanced or metastatic HER2-positive gastric cancer, previously treated HER2-mutant metastatic non-small cell lung cancer and metastatic HER2-positive and HER2-low breast cancer and solid tumors.
The FDA also granted priority review to a supplemental new drug application (sNDA) seeking approval of Calquence for previously untreated mantle cell lymphoma (MCL), a rare and typically aggressive form of non-Hodgkin lymphoma. The FDA’s decision is expected in the first quarter of 2025. The sNDA was based on data from the ECHO phase III study. In the MCL indication, Calquence is currently approved for treating adult patients with MCL who have received at least one prior therapy in the United States and some other countries. It is also approved for treating chronic lymphocytic leukemia and small lymphocytic lymphoma in several countries.
The NYSE ARCA Pharmaceutical Index declined 2.0% in the last five trading sessions.
Image: Bigstock
Pharma Stock Roundup: FDA Approves SNY's Dupixent for COPD & More
This week, the FDA granted approval to Sanofi (SNY - Free Report) and Regeneron’s (REGN - Free Report) blockbuster drug, Dupixent, for its sixth indication. The FDA also granted priority review designation to AstraZeneca’s (AZN - Free Report) label expansion filings for two cancer drugs. Eli Lilly (LLY - Free Report) announced that it is investing $4.5 billion to build a new manufacturing site in Indiana to advance drug production and innovation. AbbVie (ABBV - Free Report) filed a regulatory application to the FDA to seek approval for its lung cancer candidate Teliso-V.
Here's a recap of the week’s most important stories.
Sanofi’s Dupixent Gets Approval in United States for COPD
The FDA granted approval to Sanofi/Regeneron’s Dupixent as an add-on maintenance treatment for adults with inadequately controlled COPD and an eosinophilic phenotype. COPD is the sixth approved indication for Dupixent. It is currently approved in several countries, including the United States and EU, for five other type II inflammatory diseases, namely severe chronic rhinosinusitis with nasal polyposis, severe asthma, moderate-to-severe atopic dermatitis, eosinophilic esophagitis and prurigo nodularis. Dupixent was approved for treating COPD with raised blood eosinophils in the EU in July 2024. Dupixent was also approved for the COPD indication in China last week.
The approval for COPD was based on data from two studies, NOTUS and BOREAS.
LLY to Invest $4.5B to Open New Facility in Indiana
Lilly announced that it is investing $4.5 billion to establish the Lilly Medicine Foundry in Indiana to improve manufacturing and drug development. This facility will enable the development of new methods for making its drugs and also scale up the supply of medicines for clinical trials for Lilly’s growing pipeline. The facility will be opened in 2027. The Medicine Foundry will be situated in the LEAP Research and Innovation District in Lebanon, IN, which will increase Lilly’s investment in Lebanon to more than $13 billion. The new “foundry” will increase Lilly's total capital commitment in the United States to more than $23 billion since 2020.
AbbVie Seeks Approval for Lung Cancer Candidate Teliso-V
AbbVie submitted a biologics license application (BLA) to the FDA seeking accelerated approval for its investigational antibody-drug conjugate telisotuzumab vedotin or Teliso-V for previously treated EGFR wild type non-small cell lung cancer in adult patients with c-Met overexpression. The BLA was based on data from the phase II LUMINOSITY study. Data from the study showed that study participants treated with Teliso V achieved an overall response rate of 35% across c-Met high patients and 23% across c-Met intermediate patients.
FDA’s Priority Tag to AstraZeneca/Daiichi’s Enhertu sBLA
The FDA granted priority review to a supplemental biologics license application (sBLA) seeking approval for AstraZeneca’s Daiichi-partnered drug, Enhertu, for treating unresectable or metastatic HER2-low or HER2-ultralow breast cancer in adult patients who have received at least one endocrine therapy in the metastatic setting. The FDA’s decision on the sBLA is expected in the first quarter of 2025. The sBLA was based on data from the phase III DESTINY-Breast06 study. The sBLA looks to expand the currently approved indication of Enhertu in HER2-low metastatic breast cancer to include use in an earlier disease setting as well as in a broader patient population that includes HER2-ultralow.
Enhertu is presently approved for advanced or metastatic HER2-positive gastric cancer, previously treated HER2-mutant metastatic non-small cell lung cancer and metastatic HER2-positive and HER2-low breast cancer and solid tumors.
The FDA also granted priority review to a supplemental new drug application (sNDA) seeking approval of Calquence for previously untreated mantle cell lymphoma (MCL), a rare and typically aggressive form of non-Hodgkin lymphoma. The FDA’s decision is expected in the first quarter of 2025. The sNDA was based on data from the ECHO phase III study. In the MCL indication, Calquence is currently approved for treating adult patients with MCL who have received at least one prior therapy in the United States and some other countries. It is also approved for treating chronic lymphocytic leukemia and small lymphocytic lymphoma in several countries.
The NYSE ARCA Pharmaceutical Index declined 2.0% 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, AbbVie rose the most (1.9%), while Novo Nordisk declined the most (7.4%).
In the past six months, while Novartis rose the most (18.8%), Merck declined the most (13.9%).
(See the last pharma stock roundup here: Pharma Stock Roundup: JNJ’s 3rd Talc-Related Bankruptcy Filing & More)
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), while AstraZeneca has a Zacks Rank #2 (Buy). AbbVie and Sanofi have a Zacks Rank #3 (Hold) each. You can see the complete list of today’s Zacks #1 Rank stocks here.