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Pharma Stock Roundup: LLY Meets IBD Study Goal, PFE, MRK Give Cancer Pipeline Updates
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This week, Eli Lilly’s (LLY - Free Report) pipeline candidate, mirikizumab, met the main goals in a late-stage study evaluating it for Crohn's disease (“CD”), a form of inflammatory bowel disease (“IBD”). The FDA approved Pfizer’s (PFE - Free Report) Braftovi + Mektovi combination for a lung cancer indication. Novo Nordisk (NVO - Free Report) announced plans to stop a kidney outcomes study on Ozempic earlier than planned for efficacy. J&J (JNJ - Free Report) and Merck (MRK - Free Report) provided pipeline and regulatory updates on their cancer drugs.
Recap of the Week’s Most Important Stories
Lilly’s CD Study on Mirikizumab Meets Goals: Lilly’s phase III study (VIVID-1) evaluating its pipeline candidate, mirikizumab, for treating moderately to severely active CD, achieved the co-primary endpoints and all major secondary endpoints versus placebo. Data from the study showed that 45.4% of patients in the mirikizumab arm achieved clinical response at Week 12 and clinical remission at Week 52, statistically higher than 19.6% for placebo.
For the other primary endpoint, 38.0% of patients in the mirikizumab arm achieved clinical response at Week 12 and endoscopic response at Week 52, statistically higher than 19.6% for placebo. Overall, in the study, mirikizumab demonstrated clinical remission and endoscopic response in CD patients over the long term. Based on data from the study, Lilly plans to file regulatory applications seeking approval of mirikizumab for the CD indication in 2024.
A biologic license application (“BLA”) seeking approval of mirikizumab for ulcerative colitis (“UC”) is under review with the FDA. In April, the FDA issued a complete response letter to the BLA. The FDA did not mention any concerns related to the clinical data package, safety, or label of the drug. It rather raised issues related to the proposed manufacturing of mirikizumab. The drug is already available as Omvoh in Japan and the EU for the UC indication.
FDA Approves Pfizer’s Braftovi + Mektovi in NSCLC Indication: The FDA approved Pfizer’s cancer drugs Braftovi + Mektovi for BRAF V600E-mutant metastatic non-small cell lung cancer (“NSCLC”). At present, Braftovi + Mektovi is approved for BRAF-mutated metastatic melanoma, while Braftovi, as a monotherapy, is approved for BRAF-mutated metastatic colorectal cancer.
The FDA approval for the BRAF V600E-mutant NSCLC indication was based on data from the PHAROS study, which showed that patients with BRAF V600E-mutant metastatic NSCLC could benefit from Braftovi + Mektovi targeted therapy regardless of their prior treatment history.
Novo Nordisk’s Kidney Outcomes Study on Ozempic Stopped Early for Efficacy: An independent data monitoring committee recommended that a kidney outcomes study evaluating once-weekly injectable Ozempic be stopped earlier than planned based on an interim analysis. The data from the interim analysis showed that certain pre-specified criteria for stopping the study early for efficacy were met.
Once-weekly subcutaneous Ozempic is currently approved in the United States in 0.5 mg, 1.0 mg and 2.0 mg doses for the treatment of type II diabetes as well as for reducing the risk of major adverse cardiovascular events in adults with type II diabetes mellitus and established cardiovascular disease. The company’s FLOW study is evaluating the efficacy of Ozempic for the prevention of the progression of renal impairment in people with type II diabetes and chronic kidney disease compared to placebo.
J&J Seeks EU Approval for Expanded Use of Rybrevant: J&J filed a Type II indication application extension to the European Medicines Agency seeking expanded approval for its cancer drug, Rybrevant (amivantamab). The application, which is based on data from the phase III PAPILLON study, seeks approval of Rybrevant in combination with chemotherapy (carboplatin and pemetrexed) for the first-line treatment of patients with advanced NSCLC with EGFR exon 20 insertion mutations. A supplemental biologics license application seeking approval from the FDA for a similar first-line use of Rybrevant in NSCLC is also under review in the United States.
Rybrevant is presently approved in the United States and Europe for patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations whose disease progressed after platinum-based chemotherapy.
Merck’s Keytruda Early-Stage NSCLC Study Meets Overall Survival Goal: Merck’s pivotal phase III study, KEYNOTE-671, evaluating Keytruda as a perioperative treatment regimen for patients with resectable stage II, IIIA or IIIB NSCLC met its second of the dual primary endpoint of overall survival.
In the study, Keytruda showed a statistically significant overall survival benefitfor patients with stage II, IIIA or IIIB NSCLC. In a pivotal study, Keytruda was given in combination with chemotherapy before surgery (neoadjuvant), followed by resection and Keytruda as monotherapy after surgery (adjuvant).
Data from this new interim analysis of the study demonstrated that the Keytruda-based regimen led to a statistically significant improvement in overall survival versus pre-operative chemotherapy. We remind investors that in March KEYNOTE-671 had met the first of its dual primary endpoints, event-free survival, as well as key secondary endpoints of pathological complete response and major pathological response.
The NYSE ARCA Pharmaceutical Index rose 3.82% in the last five trading sessions.
Image: Bigstock
Pharma Stock Roundup: LLY Meets IBD Study Goal, PFE, MRK Give Cancer Pipeline Updates
This week, Eli Lilly’s (LLY - Free Report) pipeline candidate, mirikizumab, met the main goals in a late-stage study evaluating it for Crohn's disease (“CD”), a form of inflammatory bowel disease (“IBD”). The FDA approved Pfizer’s (PFE - Free Report) Braftovi + Mektovi combination for a lung cancer indication. Novo Nordisk (NVO - Free Report) announced plans to stop a kidney outcomes study on Ozempic earlier than planned for efficacy. J&J (JNJ - Free Report) and Merck (MRK - Free Report) provided pipeline and regulatory updates on their cancer drugs.
Recap of the Week’s Most Important Stories
Lilly’s CD Study on Mirikizumab Meets Goals: Lilly’s phase III study (VIVID-1) evaluating its pipeline candidate, mirikizumab, for treating moderately to severely active CD, achieved the co-primary endpoints and all major secondary endpoints versus placebo. Data from the study showed that 45.4% of patients in the mirikizumab arm achieved clinical response at Week 12 and clinical remission at Week 52, statistically higher than 19.6% for placebo.
For the other primary endpoint, 38.0% of patients in the mirikizumab arm achieved clinical response at Week 12 and endoscopic response at Week 52, statistically higher than 19.6% for placebo. Overall, in the study, mirikizumab demonstrated clinical remission and endoscopic response in CD patients over the long term. Based on data from the study, Lilly plans to file regulatory applications seeking approval of mirikizumab for the CD indication in 2024.
A biologic license application (“BLA”) seeking approval of mirikizumab for ulcerative colitis (“UC”) is under review with the FDA. In April, the FDA issued a complete response letter to the BLA. The FDA did not mention any concerns related to the clinical data package, safety, or label of the drug. It rather raised issues related to the proposed manufacturing of mirikizumab. The drug is already available as Omvoh in Japan and the EU for the UC indication.
FDA Approves Pfizer’s Braftovi + Mektovi in NSCLC Indication: The FDA approved Pfizer’s cancer drugs Braftovi + Mektovi for BRAF V600E-mutant metastatic non-small cell lung cancer (“NSCLC”). At present, Braftovi + Mektovi is approved for BRAF-mutated metastatic melanoma, while Braftovi, as a monotherapy, is approved for BRAF-mutated metastatic colorectal cancer.
The FDA approval for the BRAF V600E-mutant NSCLC indication was based on data from the PHAROS study, which showed that patients with BRAF V600E-mutant metastatic NSCLC could benefit from Braftovi + Mektovi targeted therapy regardless of their prior treatment history.
Novo Nordisk’s Kidney Outcomes Study on Ozempic Stopped Early for Efficacy: An independent data monitoring committee recommended that a kidney outcomes study evaluating once-weekly injectable Ozempic be stopped earlier than planned based on an interim analysis. The data from the interim analysis showed that certain pre-specified criteria for stopping the study early for efficacy were met.
Once-weekly subcutaneous Ozempic is currently approved in the United States in 0.5 mg, 1.0 mg and 2.0 mg doses for the treatment of type II diabetes as well as for reducing the risk of major adverse cardiovascular events in adults with type II diabetes mellitus and established cardiovascular disease. The company’s FLOW study is evaluating the efficacy of Ozempic for the prevention of the progression of renal impairment in people with type II diabetes and chronic kidney disease compared to placebo.
J&J Seeks EU Approval for Expanded Use of Rybrevant: J&J filed a Type II indication application extension to the European Medicines Agency seeking expanded approval for its cancer drug, Rybrevant (amivantamab). The application, which is based on data from the phase III PAPILLON study, seeks approval of Rybrevant in combination with chemotherapy (carboplatin and pemetrexed) for the first-line treatment of patients with advanced NSCLC with EGFR exon 20 insertion mutations. A supplemental biologics license application seeking approval from the FDA for a similar first-line use of Rybrevant in NSCLC is also under review in the United States.
Rybrevant is presently approved in the United States and Europe for patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations whose disease progressed after platinum-based chemotherapy.
Merck’s Keytruda Early-Stage NSCLC Study Meets Overall Survival Goal: Merck’s pivotal phase III study, KEYNOTE-671, evaluating Keytruda as a perioperative treatment regimen for patients with resectable stage II, IIIA or IIIB NSCLC met its second of the dual primary endpoint of overall survival.
In the study, Keytruda showed a statistically significant overall survival benefitfor patients with stage II, IIIA or IIIB NSCLC. In a pivotal study, Keytruda was given in combination with chemotherapy before surgery (neoadjuvant), followed by resection and Keytruda as monotherapy after surgery (adjuvant).
Data from this new interim analysis of the study demonstrated that the Keytruda-based regimen led to a statistically significant improvement in overall survival versus pre-operative chemotherapy. We remind investors that in March KEYNOTE-671 had met the first of its dual primary endpoints, event-free survival, as well as key secondary endpoints of pathological complete response and major pathological response.
The NYSE ARCA Pharmaceutical Index rose 3.82% 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, while Lilly rose the most (12.9%), Pfizer declined the most (1.5%).
In the past six months, Lilly has risen the most (63%), while Pfizer has declined the most (20%).
(See the last pharma stock roundup here:LLY Offers to Buy POINT Biopharma & Other Updates.)
What's Next in the Pharma World?
Watch out for J&J's Q3 earnings and regular pipeline and regulatory updates next week.