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The Zacks Analyst Blog Highlights Sanofi, Regeneron, AbbVie, Roche and Eli Lilly
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For Immediate Release
Chicago, IL – March 27, 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: Sanofi (SNY - Free Report) , Regeneron (REGN - Free Report) , AbbVie (ABBV - Free Report) , Roche (RHHBY - Free Report) and Eli Lilly (LLY - Free Report) .
This week, Sanofi and partner Regeneron’s blockbuster medicine, Dupixent succeeded in a pivotal study for yet another new indication, chronic obstructive pulmonary disease (COPD).The FDA declined to approve AbbVie’s Parkinson’s disease (PD) therapy, ABBV-951.Roche entered into a deal with Eli Lilly for the development of its blood test for early diagnosis of Alzheimer’s disease.
Recap of the Week’s Most Important Stories
Sanofi’s Dupixent Meets Primary Endpoint in COPD study: The pivotal phase III study, BOREAS, which evaluated Sanofi/Regeneron’s Dupixent for treating COPD, met both its primary and secondary endpoints. Data from the BOREAS study demonstrated that Dupixent led to a clinically meaningful and statistically significant reduction (30%) in exacerbations compared to placebo. In fact, treatment with the drug also led to significant improvement in lung function, quality of life and respiratory symptoms.
Dupixent is currently approved in the United States and EU for five type II inflammatory diseases, namely severe chronic rhinosinusitis with nasal polyposis, severe asthma, moderate-to-severe atopic dermatitis, eosinophilic esophagitis and prurigo nodularis. The promising data from the COPD study opens up a new avenue for growth for this already highly successful medicine.
Sanofi and Regeneron are also evaluating Dupixent in the COPD indication in an ongoing second replicate phase III study (NOTUS). Data from the same is expected next year, following which the companies plan to file for approval.
The European Commission approved Dupixent for treating children six months to five years of age with severe atopic dermatitis, also called eczema, who are candidates for systemic therapy. Dupixent was approved by the FDA for atopic dermatitis in children in this age group in June 2022. In Europe, approximately 80,000 infants and young children have uncontrolled severe atopic dermatitis, which signifies the drug’s significant unmet need for kids under 5 years.
FDA Gives CRL to AbbVie NDA for Parkinson’s Candidate: The FDA issued a complete response letter (CRL) to AbbVie’s new drug application (“NDA”) seeking approval for ABBV-951 for the treatment of motor fluctuations in patients with advanced PD. ABBV-951 is a solution of carbidopa and levodopa prodrugs, which are the standard of care for PD patients. ABBV-951 has been designed to offer continuous subcutaneous delivery of CD/LD prodrugs through a pump device and offer a better patient experience. In the CRL, the FDA has asked for some extra information about the pump device used to administer the medicine. The FDA has not requested any additional efficacy/safety studies.
AbbVie’s phase II study evaluating Rinvoq (upadacitinib) for patients with moderately to severely active systemic lupus erythematosus (SLE) met the primary endpoint in the 30 mg group. The primary endpoint of the study was achieving SLE Responder Index (SRI-4) with a steroid dose less than or equal to 10 mg prednisone equivalent once daily at week 24. Based on the phase II positive data, AbbVie is advancing upadacitinib to phase III development for SLE.
AbbVie also announced positive data from a phase III induction study evaluating Skyrizi (risankizumab) to treat moderately to severely active ulcerative colitis. The data showed that a significantly higher proportion of patients, 20.3% treated with risankizumab achieved the primary endpoint of clinical remission compared to 6.2% of patients on placebo at week 12. The study also met all secondary endpoints, including clinical, endoscopic and histologic outcomes. Skyrizi is presently approved for Crohn's disease, psoriatic arthritis and psoriasis.
Roche & Lilly’s Alzheimer’s Collaboration: Roche announced a collaboration with Lilly for the development of Elecsys Amyloid Plasma Panel (EAPP), its blood test for earlier diagnosis of Alzheimer’s disease. The FDA had granted Breakthrough Device Designation to EAPP in July last year. Lilly has donanemab and remternetug in its Alzheimer’s pipeline. In January, the FDA issued a CRL to Lilly’s biologics license application for donanemab for treating early symptomatic Alzheimer's disease.
The NYSE ARCA Pharmaceutical Index declined 1.8% in the last five trading sessions.
In the last five trading sessions, AstraZeneca rose the most (1.9%), while Merck declined the most (2.9%).
In the past six months, AstraZeneca has risen the most (26.9%), while Roche has declined the most (9.5%).
Since 2000, our top stock-picking strategies have blown away the S&P's +6.2 average gain per year. Amazingly, they soared with average gains of +46.4%, +49.5% and +55.2% per year. Today you can access their live picks without cost or obligation.
Past performance is no guarantee of future results. Inherent in any investment is the potential for loss. This material is being provided for informational purposes only and nothing herein constitutes investment, legal, accounting or tax advice, or a recommendation to buy, sell or hold a security. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. It should not be assumed that any investments in securities, companies, sectors or markets identified and described were or will be profitable. All information is current as of the date of herein and is subject to change without notice. Any views or opinions expressed may not reflect those of the firm as a whole. Zacks Investment Research does not engage in investment banking, market making or asset management activities of any securities. These returns are from hypothetical portfolios consisting of stocks with Zacks Rank = 1 that were rebalanced monthly with zero transaction costs. These are not the returns of actual portfolios of stocks. The S&P 500 is an unmanaged index. Visit https://www.zacks.com/performance for information about the performance numbers displayed in this press release.
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The Zacks Analyst Blog Highlights Sanofi, Regeneron, AbbVie, Roche and Eli Lilly
For Immediate Release
Chicago, IL – March 27, 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: Sanofi (SNY - Free Report) , Regeneron (REGN - Free Report) , AbbVie (ABBV - Free Report) , Roche (RHHBY - Free Report) and Eli Lilly (LLY - Free Report) .
Here are highlights from Friday’s Analyst Blog:
Pharma Stock Roundup: Meeting Goals, Receiving CRLs
This week, Sanofi and partner Regeneron’s blockbuster medicine, Dupixent succeeded in a pivotal study for yet another new indication, chronic obstructive pulmonary disease (COPD).The FDA declined to approve AbbVie’s Parkinson’s disease (PD) therapy, ABBV-951.Roche entered into a deal with Eli Lilly for the development of its blood test for early diagnosis of Alzheimer’s disease.
Recap of the Week’s Most Important Stories
Sanofi’s Dupixent Meets Primary Endpoint in COPD study: The pivotal phase III study, BOREAS, which evaluated Sanofi/Regeneron’s Dupixent for treating COPD, met both its primary and secondary endpoints. Data from the BOREAS study demonstrated that Dupixent led to a clinically meaningful and statistically significant reduction (30%) in exacerbations compared to placebo. In fact, treatment with the drug also led to significant improvement in lung function, quality of life and respiratory symptoms.
Dupixent is currently approved in the United States and EU for five type II inflammatory diseases, namely severe chronic rhinosinusitis with nasal polyposis, severe asthma, moderate-to-severe atopic dermatitis, eosinophilic esophagitis and prurigo nodularis. The promising data from the COPD study opens up a new avenue for growth for this already highly successful medicine.
Sanofi and Regeneron are also evaluating Dupixent in the COPD indication in an ongoing second replicate phase III study (NOTUS). Data from the same is expected next year, following which the companies plan to file for approval.
The European Commission approved Dupixent for treating children six months to five years of age with severe atopic dermatitis, also called eczema, who are candidates for systemic therapy. Dupixent was approved by the FDA for atopic dermatitis in children in this age group in June 2022. In Europe, approximately 80,000 infants and young children have uncontrolled severe atopic dermatitis, which signifies the drug’s significant unmet need for kids under 5 years.
FDA Gives CRL to AbbVie NDA for Parkinson’s Candidate: The FDA issued a complete response letter (CRL) to AbbVie’s new drug application (“NDA”) seeking approval for ABBV-951 for the treatment of motor fluctuations in patients with advanced PD. ABBV-951 is a solution of carbidopa and levodopa prodrugs, which are the standard of care for PD patients. ABBV-951 has been designed to offer continuous subcutaneous delivery of CD/LD prodrugs through a pump device and offer a better patient experience. In the CRL, the FDA has asked for some extra information about the pump device used to administer the medicine. The FDA has not requested any additional efficacy/safety studies.
AbbVie’s phase II study evaluating Rinvoq (upadacitinib) for patients with moderately to severely active systemic lupus erythematosus (SLE) met the primary endpoint in the 30 mg group. The primary endpoint of the study was achieving SLE Responder Index (SRI-4) with a steroid dose less than or equal to 10 mg prednisone equivalent once daily at week 24. Based on the phase II positive data, AbbVie is advancing upadacitinib to phase III development for SLE.
AbbVie also announced positive data from a phase III induction study evaluating Skyrizi (risankizumab) to treat moderately to severely active ulcerative colitis. The data showed that a significantly higher proportion of patients, 20.3% treated with risankizumab achieved the primary endpoint of clinical remission compared to 6.2% of patients on placebo at week 12. The study also met all secondary endpoints, including clinical, endoscopic and histologic outcomes. Skyrizi is presently approved for Crohn's disease, psoriatic arthritis and psoriasis.
Roche & Lilly’s Alzheimer’s Collaboration: Roche announced a collaboration with Lilly for the development of Elecsys Amyloid Plasma Panel (EAPP), its blood test for earlier diagnosis of Alzheimer’s disease. The FDA had granted Breakthrough Device Designation to EAPP in July last year. Lilly has donanemab and remternetug in its Alzheimer’s pipeline. In January, the FDA issued a CRL to Lilly’s biologics license application for donanemab for treating early symptomatic Alzheimer's disease.
The NYSE ARCA Pharmaceutical Index declined 1.8% in the last five trading sessions.
In the last five trading sessions, AstraZeneca rose the most (1.9%), while Merck declined the most (2.9%).
In the past six months, AstraZeneca has risen the most (26.9%), while Roche has declined the most (9.5%).
(See the last pharma stock roundup here: M&A Boom in Drug Industry With PFE & SNY Deals, Other Updates)
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Since 2000, our top stock-picking strategies have blown away the S&P's +6.2 average gain per year. Amazingly, they soared with average gains of +46.4%, +49.5% and +55.2% per year. Today you can access their live picks without cost or obligation.
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Past performance is no guarantee of future results. Inherent in any investment is the potential for loss. This material is being provided for informational purposes only and nothing herein constitutes investment, legal, accounting or tax advice, or a recommendation to buy, sell or hold a security. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. It should not be assumed that any investments in securities, companies, sectors or markets identified and described were or will be profitable. All information is current as of the date of herein and is subject to change without notice. Any views or opinions expressed may not reflect those of the firm as a whole. Zacks Investment Research does not engage in investment banking, market making or asset management activities of any securities. These returns are from hypothetical portfolios consisting of stocks with Zacks Rank = 1 that were rebalanced monthly with zero transaction costs. These are not the returns of actual portfolios of stocks. The S&P 500 is an unmanaged index. Visit https://www.zacks.com/performance for information about the performance numbers displayed in this press release.