For Immediate Release
Chicago, IL – October 2, 2023 – Zacks.com 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 Quick Quote ABBV - Free Report) , Lilly ( LLY Quick Quote LLY - Free Report) , Sanofi ( SNY Quick Quote SNY - Free Report) , Merck ( MRK Quick Quote MRK - Free Report) and J&J ( JNJ Quick Quote JNJ - Free Report) . 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 The European Commission European Commission Approves AbbVie’s Epcoritamab: 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. Lilly and partner Boehringer Ingelheim announced that the FDA has approved its diabetes medicine, FDA Approves Lilly’s Jardiance for CKD: 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.
The FDA’s Priority Tag to Sanofi’s Dupixent sBLA for Eosinophilic Esophagitis in Kids: 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.
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. FDA Grants Priority Review to Merck’s Sotatercept BLA:
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 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. J&J’s Rybrevant First-Line NSCLC Study Meets Goal:
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%).
(See the last pharma stock roundup here:
EU Nod to PFE’s Litfulo, FDA Priority Tag to MRK Applications.) What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.
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