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Pharma Stock Roundup: EU Nod for Expanded Use of MRK's Keytruda & More
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This week, the European Commission (“EC”) granted approval to Merck’s (MRK - Free Report) Keytruda in combination with Pfizer’s (PFE - Free Report) Padcev for expanded use in bladder cancer. Sanofi (SNY - Free Report) announced mixed data from a phase III study on its investigational oral BTK inhibitor, tolebrutinib. Eli Lilly (LLY - Free Report) announced data from two phase III studies, which showed that its once-weekly insulin efsitora alfa delivered non-inferior A1C reduction compared to daily insulin in people with type II diabetes.
Recap of the Week’s Most Important Stories
Merck’s Keytruda Combo for Urothelial Carcinoma Gets EU Approval: The European Commission granted approval to Merck’s Keytruda in combination with Astellas/Pfizer’s antibody-drug conjugate Padcev for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma. The approval is based on data from the phase III KEYNOTE-A39 study. This becomes the third bladder cancer indication approval for Keytruda in the EU. The approval of the Keytruda+Padcev combination offers a new standard-of-care treatment in first-line metastatic urothelial carcinoma. Keytruda+Padcev was approved for treating locally advanced or metastatic urothelial cancer in December 2023.
Merck’s subsidiary EyeBio announced that a phase IIb/III study called BRUNELLO has been initiated on pipeline candidate Restoret (MK-3000) for the treatment of diabetic macular edema (DME). Merck closed the acquisition of EyeBio in July, which added Restoret, a novel Wnt agonist antibody being developed for treating retinal diseases, to its pipeline. The initiation of the phase IIb/III study was based on positive data from the phase I/II study called AMARONE of MK-3000 in patients with DME and neovascular age-related macular degeneration (NVAMD).
Lilly’s Two-Phase III Studies on Weekly Insulin Meet Goal: Lilly announced positive top-line results from the QWINT-1 and QWINT-3 phase III studies evaluating once-weekly insulin efsitora alfa in adults with type II diabetes. The QWINT-1 study was conducted in adults with type II diabetes using basal insulin for the first time (insulin naïve) while the QWINT-3 study was conducted in those who were already using daily basal insulin injections.
In the studies, efsitora alfa led to non-inferior reductions in A1C compared to the most commonly used daily basal insulins globally. A1C is a test that measures the average blood sugar levels over the past three months. While the QWINT-1 study met its primary endpoint of non-inferior A1C reduction at 52 weeks, the QWINT-3 study met the same at 26 weeks.
In the QWINT-1 study, efsitora reduced A1C by 1.31% compared to 1.27% for insulin glargine, resulting in an A1C of 6.92% and 6.96%, respectively. In the second study, QWINT-3, efsitora reduced A1C by 0.86% compared to 0.75% for insulin degludec, resulting in an A1C of 6.93% and 7.03%, respectively. The data from the QWINT-1 and QWINT-3 studies add to that from two other studies, QWINT-2 and QWINT-4, released in May.
Sanofi Reports Data from Multiple Sclerosis Study on Tolebrutinib: A phase III study evaluating Sanofi’s tolebrutinib in patients with non-relapsing secondary progressive multiple sclerosis (nrSPMS) met its primary endpoint. The study showed an improvement over placebo in delaying the time to onset of confirmed disability progression, thereby meeting its primary endpoint. Two other phase III studies evaluating tolebrutinib in people with relapsing multiple sclerosis (RMS), GEMINI 1 and 2, failed to show significance in the primary endpoint of reducing an annualized relapse rate over another Sanofi MS drug, Aubagio. However, when a key secondary endpoint of pooled 6-month confirmed disability worsening was analyzed, data showed a considerable delay in time to onset, in line with data from the HERCULES phase III study.
The NYSE ARCA Pharmaceutical Index declined 1.85% in the last five trading sessions.
Image: Bigstock
Pharma Stock Roundup: EU Nod for Expanded Use of MRK's Keytruda & More
This week, the European Commission (“EC”) granted approval to Merck’s (MRK - Free Report) Keytruda in combination with Pfizer’s (PFE - Free Report) Padcev for expanded use in bladder cancer. Sanofi (SNY - Free Report) announced mixed data from a phase III study on its investigational oral BTK inhibitor, tolebrutinib. Eli Lilly (LLY - Free Report) announced data from two phase III studies, which showed that its once-weekly insulin efsitora alfa delivered non-inferior A1C reduction compared to daily insulin in people with type II diabetes.
Recap of the Week’s Most Important Stories
Merck’s Keytruda Combo for Urothelial Carcinoma Gets EU Approval: The European Commission granted approval to Merck’s Keytruda in combination with Astellas/Pfizer’s antibody-drug conjugate Padcev for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma. The approval is based on data from the phase III KEYNOTE-A39 study. This becomes the third bladder cancer indication approval for Keytruda in the EU. The approval of the Keytruda+Padcev combination offers a new standard-of-care treatment in first-line metastatic urothelial carcinoma. Keytruda+Padcev was approved for treating locally advanced or metastatic urothelial cancer in December 2023.
Merck’s subsidiary EyeBio announced that a phase IIb/III study called BRUNELLO has been initiated on pipeline candidate Restoret (MK-3000) for the treatment of diabetic macular edema (DME). Merck closed the acquisition of EyeBio in July, which added Restoret, a novel Wnt agonist antibody being developed for treating retinal diseases, to its pipeline. The initiation of the phase IIb/III study was based on positive data from the phase I/II study called AMARONE of MK-3000 in patients with DME and neovascular age-related macular degeneration (NVAMD).
Lilly’s Two-Phase III Studies on Weekly Insulin Meet Goal: Lilly announced positive top-line results from the QWINT-1 and QWINT-3 phase III studies evaluating once-weekly insulin efsitora alfa in adults with type II diabetes. The QWINT-1 study was conducted in adults with type II diabetes using basal insulin for the first time (insulin naïve) while the QWINT-3 study was conducted in those who were already using daily basal insulin injections.
In the studies, efsitora alfa led to non-inferior reductions in A1C compared to the most commonly used daily basal insulins globally. A1C is a test that measures the average blood sugar levels over the past three months. While the QWINT-1 study met its primary endpoint of non-inferior A1C reduction at 52 weeks, the QWINT-3 study met the same at 26 weeks.
In the QWINT-1 study, efsitora reduced A1C by 1.31% compared to 1.27% for insulin glargine, resulting in an A1C of 6.92% and 6.96%, respectively. In the second study, QWINT-3, efsitora reduced A1C by 0.86% compared to 0.75% for insulin degludec, resulting in an A1C of 6.93% and 7.03%, respectively. The data from the QWINT-1 and QWINT-3 studies add to that from two other studies, QWINT-2 and QWINT-4, released in May.
Sanofi Reports Data from Multiple Sclerosis Study on Tolebrutinib: A phase III study evaluating Sanofi’s tolebrutinib in patients with non-relapsing secondary progressive multiple sclerosis (nrSPMS) met its primary endpoint. The study showed an improvement over placebo in delaying the time to onset of confirmed disability progression, thereby meeting its primary endpoint. Two other phase III studies evaluating tolebrutinib in people with relapsing multiple sclerosis (RMS), GEMINI 1 and 2, failed to show significance in the primary endpoint of reducing an annualized relapse rate over another Sanofi MS drug, Aubagio. However, when a key secondary endpoint of pooled 6-month confirmed disability worsening was analyzed, data showed a considerable delay in time to onset, in line with data from the HERCULES phase III study.
The NYSE ARCA Pharmaceutical Index declined 1.85% 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, Merck rose the most (1.0%), while AstraZeneca declined the most (4.9%).
In the past six months, while AstraZeneca rose the most (25.4%), Merck declined the most (4.4%).
(See the last pharma stock roundup here: LLY Offers Cheap Zepbound, EU Okays Some Drugs)
What's Next in the Pharma World?
Watch this space for regular pipeline and regulatory updates next week.
Merck, Sanofi and Eli Lilly have a Zacks Rank #3 (Hold) each. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.