The Zacks Analyst Blog Highlights AbbVie, Lilly, Sanofi, Merck and J&J announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include: AbbVie ABBV, Lilly LLY, Sanofi SNY, Merck MRK and J&J JNJ.

Here are highlights from Friday’s Analyst Blog:

Pharma Stock Roundup: Regulatory Updates for Key Drugs

This week, the European Commission granted marketing approval to AbbVie’s Tepkinly (epcoritamab) to treat relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). The FDA approved Lilly’s diabetes drug, Jardiance (empagliflozin), for expanded use in chronic kidney disease (“CKD”).

The FDA also accepted Sanofi’s application seeking approval of its blockbuster medicine, Dupixent, for the use of eosinophilic esophagitis in kids and accepted and granted priority review to Merck’s application seeking approval of pulmonary arterial hypertension (PAH) candidate, sotatercept. J&J’s study, evaluating a chemotherapy-free regimen of its drug Rybrevant in first-line lung cancer, met its primary endpoint.

Recap of the Week’s Most Important Stories

European Commission Approves AbbVie’s Epcoritamab: The European Commission granted conditional marketing authorization to AbbVie’s epcoritamab, to be marketed as Tepkinly, for treating R/R DLBCL. The approval was based on the response rate and durability of response data from the expansion cohort of the phase I/II study, EPCORE NHL-1.Epcoritamab was approved (accelerated approval) as Epkinly for certain patients with R/R DLBCL in the United States in May.

FDA Approves Lilly’s Jardiance for CKD: Lilly and partner Boehringer Ingelheim announced that the FDA has approved its diabetes medicine, Jardiance (empagliflozin), for the CKD indication.

Jardiance 10 mg tablets are now approved to reduce the risk of kidney disease progression and cardiovascular death in adults with CKD based on data from the EMPA-KIDNEY phase III study. Data from the study showed that treatment with Jardiance, on top of the standard of care, led to a significant reduction in the risk of kidney disease progression and cardiovascular death in adults with CKD compared with placebo in addition to standard of care.

Jardiance is already approved for use in certain patients with heart failure and type II diabetes in the United States and some other countries.

FDA’s Priority Tag to Sanofi’s Dupixent sBLA for Eosinophilic Esophagitis in Kids: The FDA accepted and granted priority reviewto Sanofi’s supplemental biologics license application (sBLA) seeking approval of Dupixent for the treatment of eosinophilic esophagitis, a chronic inflammatory disease, in children (aged 1 to 11 years). The FDA is expected to give its decision on the sBLA on Jan 31, 2024.

The sBLA was supported by data from the phase III EoE KIDS study. Dupixent was approved by the FDA for eosinophilic esophagitis in patients aged 12 years and above in May 2022. Dupixent is now approved to treat five type II inflammatory diseases, namely severe chronic rhinosinusitis with nasal polyposis, severe asthma, moderate-to-severe atopic dermatitis, eosinophilic esophagitis and prurigo nodularis, in both Europe and the United States.

Sanofi’s Altuviiio (efanesoctocog alfa), a once-weekly new class of factor VIII therapy for hemophilia A, was granted marketing authorization for hemophilia A in Japan. Altuviiio was approved in the United States in February 2023 and launched at the end of March.

FDA Grants Priority Review to Merck’s Sotatercept BLA: The FDA accepted and granted priority review to Merck’s BLA seeking approval of sotatercept for treating adult patients with pulmonary arterial hypertension  (WHO Group 1).  The FDA’s decision is expected on Mar 26, 2024. The BLA was based on data from the STELLAR study. In the study, sotatercept plus background therapy significantly improved exercise capacity, increasing the six-minute walk distance by 40.8 meters from baseline at week 24, the study’s primary endpoint. Moreover, sotatercept demonstrated statistically significant improvements in eight of nine secondary outcome measures, including a reduction in risk of clinical worsening or death.

Merck and its partner Eisai announced results from two late-stage clinical studies evaluating Merck’s Keytruda plus Eisai’s Lenvima in patients with certain types of metastatic NSCLC. Both studies, LEAP-006 and LEAP-008, failed to achieve their dual primary endpoints of overall survival (“OS”) and progression-free survival (“PFS”). The LEAP-006 and LEAP-008 studies also did not demonstrate a statistically significant improvement in objective response rate, a key secondary endpoint in both studies.

At present, the combination of Keytruda plus Lenvima is approved for the treatment of advanced renal cell carcinoma and certain types of advanced endometrial carcinoma. We remind investors that last month, Merck and Eisai, announced that they are closing a study evaluating a combination of Keytruda plus Lenvima for first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma.

J&J’s Rybrevant First-Line NSCLC Study Meets Goal: J&J announced positive top-line data from the phase III MARIPOSA study evaluating Rybrevant (amivantamab) in combination with lazertinib, an oral third-generation EGFR tyrosine kinase inhibitor (TKI), versus osimertinib as a first-line treatment in EGFR-mutated NSCLC. The study met its primary endpoint by showing a statistically significant and clinically meaningful improvement in PFS in the Rybrevant plus lazertinib arm compared to osimertinib. As far as OS data is concerned, a planned interim analysis showed a trend favoring the Rybrevant and lazertinib combination compared to osimertinib.

At present, Rybrevant is approved for locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.

The NYSE ARCA Pharmaceutical Index declined 1.09% in the last five trading sessions.

In the last five trading sessions, while AstraZeneca rose the most (0.6%), J&J declined the most (3%).

In the past six months, Lilly has risen the most (59.8%), while Pfizer has declined the most (20.5%).

What’s Next in the Pharma World?

Watch out for regular pipeline and regulatory updates next week.
Sanofi (SNY): Free Stock Analysis Report

Johnson & Johnson (JNJ): Free Stock Analysis Report

Merck & Co., Inc. (MRK): Free Stock Analysis Report

Eli Lilly and Company (LLY): Free Stock Analysis Report

AbbVie Inc. (ABBV): Free Stock Analysis Report

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