We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Pharma Stock Roundup: FDA Nod to PFE, MRNA New COVID Jabs & More
Read MoreHide Full Article
This week, Eli Lilly’s (LLY - Free Report) stock hit a record high after a phase III study showed that its popular weight loss drug, tirzepatide, reduced the risk of developing type II diabetes. The FDA approved updated mRNA COVID-19 vaccines made by Pfizer (PFE - Free Report) and Moderna (MRNA - Free Report) that target the currently circulating variants. J&J (JNJ - Free Report) announced the acquisition of a private medical device company. The European Commission approved AbbVie’s (ABBV - Free Report) drug Epkinly/Tepkinly for a new indication in Europe.
Recap of the Week’s Most Important Stories
Lilly’s Tirzepatide Cuts Risk of Developing Diabetes: Lilly’s drug tirzepatide reduced the risk of developing type II diabetes by 94% in a three-year phase III study called SURMOUNT-1 in adults with pre-diabetes and obesity or overweight. Tirzepatide is approved as Mounjaro for type II diabetes and Zepbound for obesity and has seen stupendous success, generating sales of almost $6.7 billion in the first half of 2024, accounting for around 44% of the company’s total revenues.
The SURMOUNT-1 study evaluated tirzepatide once weekly for long-term weight management and delay in progression to diabetes in patients with pre-diabetes and obesity or overweight. Additionally, tirzepatide led to sustained weight loss over the three-year (176-week) treatment period. Adults given the 15 mg dose experienced an average weight loss of 22.9% compared to 2.1% for placebo at the end of the treatment period. Tirzepatide also led to a significant reduction in the risk of progression to type II diabetes, which was a key secondary endpoint.
Last year, Lilly announced data from the same study at 72 weeks. Back then, the data showed that treatment with tirzepatide led to up to 22.5% weight loss in obese or overweight adults with at least one comorbidity, who do not have diabetes. The latest data, however, is from patients with prediabetes.
FDA Approves Updated Covid Shots of Moderna & Pfizer: The FDA granted approval to Pfizer/BioNTech and Moderna’s updated COVID-19 vaccines, Comirnaty and Spikevax, respectively, for individuals 12 years of age and older. This updated vaccine targets the currently circulating KP.2 strain of the Omicron JN.1 lineage, as guided by the FDA in June.
In June, the FDA's Vaccines and Related Biological Products Advisory Committee recommended that vaccine makers make an updated COVID vaccine tailored to the KP.2 strain for use in the United States beginning in the fall of 2024. The FDA also granted Emergency Use Authorization to Pfizer and Moderna’s updated vaccines for individuals aged 6 months through 11 years of age.
Pfizer/BioNTech’s COVID-Flu Combo Jab Fails to Meet One Goal: Pfizer and BioNTech’s phase III study evaluating an mRNA-based combination vaccine candidate against influenza and COVID-19 missed one of its two primary immunogenicity objectives. The study’s two primary immunogenicity objectives were to demonstrate that the antibody responses elicited by the combination vaccine against the SARS-CoV-2 strain and influenza A and B strain were non-inferior to the standard of care. The combination vaccine demonstrated comparable responses against the SARS-CoV-2 strain versus Pfizer’s COVID-19 vaccine, Comirnaty. The vaccine also demonstrated a continued trend of higher responses against influenza A.
However, the combination vaccine failed to show non-inferiority against the influenza B strain in geometric mean titers and seroconversion. The companies are evaluating adjustments to their combination vaccine program to improve immune responses against influenza B and will discuss the next steps with health authorities.
EU Approval to AbbVie’s Tepkinly for Follicular Lymphoma: The European Commission granted conditional marketing authorization for the expanded use of AbbVie’s drug, Tepkinly (epcoritamab), for treating relapsed or refractory follicular lymphoma (FL) after two or more therapies. Epkinly/Tepkinly was approved for relapsed-refractory third-line diffuse large B-cell lymphoma (DLBCL) in 2023.
With the approval for the FL indication, Tepkinly has become the first and only bispecific antibody conditionally approved as a monotherapy in the EU to treat both R/R FL and R/R DLBCL after two or more lines of prior therapy. Tepkinly, which is marketed as Epkinly in the United States, was approved by the FDA on an accelerated basis for the FL indication in June. The approval was based on data from the FL cohort of the phase I/II EPCORE NHL study. AbbVie has developed Epkinly/Tepkinly in partnership with Genmab.
J&J to Acquire Private MedTech Company: J&J announced a definitive agreement to acquire V-Wave Ltd, a private medical device company that makes treatments for cardiovascular disease. V-Wave’s Ventura Interatrial Shunt (IAS) is a novel implantable device designed to treat heart failure. J&J will make an upfront payment of $600 million to V-Wave with the latter also being entitled to milestone payments of up to approximately $1.1 billion. The transaction is expected to close before the end of 2024.
The FDA approved J&J’s Rybrevant in combination with Lazcluze (lazertinib), an oral third-generation EGFR tyrosine kinase inhibitor (TKI), for the first-line treatment of certain patients with EGFR-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC). Rybrevant plus Lazcluze became the first and only chemotherapy-free regimen to be approved for EGFR-mutated advanced NSCLC. The approval was based on data from the phase III MARIPOSA study in which Rybrevant plus Lazcluze showed significant clinical benefits over osimertinib.
A regulatory application seeking approval of Rybrevant plus Lazcluze for similar expanded use based on the MARIPOSA study is under review in the EU. At present, Rybrevant is approved as monotherapy for the treatment of EGFR-mutated locally advanced or metastatic NSCLC. It is also approved in combination with chemotherapy (carboplatin and pemetrexed) in the United States for EGFR-mutated advanced NSCLC.
The NYSE ARCA Pharmaceutical Index rose 2.03% in the last five trading sessions.
Image: Bigstock
Pharma Stock Roundup: FDA Nod to PFE, MRNA New COVID Jabs & More
This week, Eli Lilly’s (LLY - Free Report) stock hit a record high after a phase III study showed that its popular weight loss drug, tirzepatide, reduced the risk of developing type II diabetes. The FDA approved updated mRNA COVID-19 vaccines made by Pfizer (PFE - Free Report) and Moderna (MRNA - Free Report) that target the currently circulating variants. J&J (JNJ - Free Report) announced the acquisition of a private medical device company. The European Commission approved AbbVie’s (ABBV - Free Report) drug Epkinly/Tepkinly for a new indication in Europe.
Recap of the Week’s Most Important Stories
Lilly’s Tirzepatide Cuts Risk of Developing Diabetes: Lilly’s drug tirzepatide reduced the risk of developing type II diabetes by 94% in a three-year phase III study called SURMOUNT-1 in adults with pre-diabetes and obesity or overweight. Tirzepatide is approved as Mounjaro for type II diabetes and Zepbound for obesity and has seen stupendous success, generating sales of almost $6.7 billion in the first half of 2024, accounting for around 44% of the company’s total revenues.
The SURMOUNT-1 study evaluated tirzepatide once weekly for long-term weight management and delay in progression to diabetes in patients with pre-diabetes and obesity or overweight. Additionally, tirzepatide led to sustained weight loss over the three-year (176-week) treatment period. Adults given the 15 mg dose experienced an average weight loss of 22.9% compared to 2.1% for placebo at the end of the treatment period. Tirzepatide also led to a significant reduction in the risk of progression to type II diabetes, which was a key secondary endpoint.
Last year, Lilly announced data from the same study at 72 weeks. Back then, the data showed that treatment with tirzepatide led to up to 22.5% weight loss in obese or overweight adults with at least one comorbidity, who do not have diabetes. The latest data, however, is from patients with prediabetes.
FDA Approves Updated Covid Shots of Moderna & Pfizer: The FDA granted approval to Pfizer/BioNTech and Moderna’s updated COVID-19 vaccines, Comirnaty and Spikevax, respectively, for individuals 12 years of age and older. This updated vaccine targets the currently circulating KP.2 strain of the Omicron JN.1 lineage, as guided by the FDA in June.
In June, the FDA's Vaccines and Related Biological Products Advisory Committee recommended that vaccine makers make an updated COVID vaccine tailored to the KP.2 strain for use in the United States beginning in the fall of 2024. The FDA also granted Emergency Use Authorization to Pfizer and Moderna’s updated vaccines for individuals aged 6 months through 11 years of age.
Pfizer/BioNTech’s COVID-Flu Combo Jab Fails to Meet One Goal: Pfizer and BioNTech’s phase III study evaluating an mRNA-based combination vaccine candidate against influenza and COVID-19 missed one of its two primary immunogenicity objectives. The study’s two primary immunogenicity objectives were to demonstrate that the antibody responses elicited by the combination vaccine against the SARS-CoV-2 strain and influenza A and B strain were non-inferior to the standard of care. The combination vaccine demonstrated comparable responses against the SARS-CoV-2 strain versus Pfizer’s COVID-19 vaccine, Comirnaty. The vaccine also demonstrated a continued trend of higher responses against influenza A.
However, the combination vaccine failed to show non-inferiority against the influenza B strain in geometric mean titers and seroconversion. The companies are evaluating adjustments to their combination vaccine program to improve immune responses against influenza B and will discuss the next steps with health authorities.
EU Approval to AbbVie’s Tepkinly for Follicular Lymphoma: The European Commission granted conditional marketing authorization for the expanded use of AbbVie’s drug, Tepkinly (epcoritamab), for treating relapsed or refractory follicular lymphoma (FL) after two or more therapies. Epkinly/Tepkinly was approved for relapsed-refractory third-line diffuse large B-cell lymphoma (DLBCL) in 2023.
With the approval for the FL indication, Tepkinly has become the first and only bispecific antibody conditionally approved as a monotherapy in the EU to treat both R/R FL and R/R DLBCL after two or more lines of prior therapy. Tepkinly, which is marketed as Epkinly in the United States, was approved by the FDA on an accelerated basis for the FL indication in June. The approval was based on data from the FL cohort of the phase I/II EPCORE NHL study. AbbVie has developed Epkinly/Tepkinly in partnership with Genmab.
J&J to Acquire Private MedTech Company: J&J announced a definitive agreement to acquire V-Wave Ltd, a private medical device company that makes treatments for cardiovascular disease. V-Wave’s Ventura Interatrial Shunt (IAS) is a novel implantable device designed to treat heart failure. J&J will make an upfront payment of $600 million to V-Wave with the latter also being entitled to milestone payments of up to approximately $1.1 billion. The transaction is expected to close before the end of 2024.
The FDA approved J&J’s Rybrevant in combination with Lazcluze (lazertinib), an oral third-generation EGFR tyrosine kinase inhibitor (TKI), for the first-line treatment of certain patients with EGFR-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC). Rybrevant plus Lazcluze became the first and only chemotherapy-free regimen to be approved for EGFR-mutated advanced NSCLC. The approval was based on data from the phase III MARIPOSA study in which Rybrevant plus Lazcluze showed significant clinical benefits over osimertinib.
A regulatory application seeking approval of Rybrevant plus Lazcluze for similar expanded use based on the MARIPOSA study is under review in the EU. At present, Rybrevant is approved as monotherapy for the treatment of EGFR-mutated locally advanced or metastatic NSCLC. It is also approved in combination with chemotherapy (carboplatin and pemetrexed) in the United States for EGFR-mutated advanced NSCLC.
The NYSE ARCA Pharmaceutical Index rose 2.03% 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 green except Novo Nordisk, which declined 0.5%. Novartis rose the most (4.0%).
In the past six months, while AstraZeneca rose the most (30.3%) Merck declined the most (9.5%).
(See the last pharma stock roundup here: AZN Gets Approvals for Imfinzi Expanded Use, MRK Inks New Deal)
What's Next in the Pharma World?
Watch this space for regular pipeline and regulatory updates next week.
Eli Lilly has a Zacks Rank #2 (Buy). Pfizer and AbbVie have a Zacks Rank #3 (Hold) each and J&J has a Zacks Rank of 4 (Sell).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.