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Pharma Stock Roundup: Sanofi RA Drug Gets EU Nod, Merck CETP Inhibitor Surprises
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This week’s highlights include positive data on Merck’s (MRK - Free Report) CETP inhibitor while Sanofi (SNY - Free Report) gained EU approval for its rheumatoid arthritis (RA) drug which has blockbuster potential.
Recap of the Week’s Most Important Stories
Merck’s CETP Inhibitor Meets Endpoint in REVEAL Study: Merck provided an update on its CETP inhibitor, anacetrapib. The company said that anacetrapib met the primary endpoint in the REVEAL (Randomized EValuation of the Effects of Anacetrapib through Lipid modification) outcomes study and showed a significant reduction in major coronary events compared to placebo in patients at risk for cardiac events who are already receiving an effective LDL-C lowering regimen (Read more: Merck's CETP Inhibitor Reduces CV Risk in Phase III Study).
The news comes as a bit of a surprise considering other companies like Lilly, Roche and Pfizer have had some high profile setbacks with their CETP inhibitors and the class was more or less written off. Merck itself seems to be adopting a cautious attitude as it intends to discuss the results with external experts to see whether it should seek regulatory approval. The safety profile was found to be consistent with that seen in earlier studies.
So far in 2017, Merck has lagged the Zacks categorized Large Cap Pharmaceuticals industry with shares gaining 9.3% while the industry is up 13.5%.
Sanofi/Regeneron RA Drug Gets EU Approval: Sanofi and partner Regeneron gained EU approval for their RA drug Kevzara. Kevzara is approved for use in combination with methotrexate (MTX) for the treatment of moderately to severely active RA in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs), such as MTX.
Kevzara, an IL-6R antibody, was approved in the U.S. in May this year. While Kevzara has blockbuster potential, the RA market is highly crowded given the presence of treatments like Humira and Xeljanz among others. However, the patient population is huge with many patients spending years on different treatments without achieving their treatment goals. With RA affecting about 1.3 million Americans and 2.9 million people in Europe, Kevzara represents a new treatment option for patients (Read more: Sanofi/Regeneron's Kevzara Gets Marketing Approval in EU).
Roche’s Data on Hemophilia Drug: Roche’s (RHHBY - Free Report) experimental hemophilia treatment, emicizumab, delivered positive results in a couple of late-stage pivotal studies. A substantial and clinically meaningful reduction in bleeds was observed in the studies. The once-weekly subcutaneous treatment was evaluated for hemophilia A with inhibitors to factor VIII. However, side effects remain a concern especially given the death of a patient that was reported earlier this year in February.
Esperion Up on Regulatory Update: Lipid management company, Esperion (ESPR - Free Report) , saw it shares rising on news that the FDA has confirmed the regulatory pathway for the company’s once-daily, oral combination pill of bempedoic acid 180 mg and ezetimibe 10 mg. Esperion intends to commence a single pivotal bridging study by year end based on feedback from the agency. Top-line results from this study are expected the end of next year. Regulatory filings for bempedoic acid as well as the combination are expected in the first half of 2019.
With this development, Esperion now has two convenient, cost-effective, complementary, non-statin, once-daily, oral LDL-C lowering therapies in late-stage development with confirmed regulatory pathways (Read more: Esperion's Combo Cholesterol Candidate Enters Phase III).
Priority Review for J&J Xarelto Label Expansion: J&J got priority review for its efforts to expand Xarelto’s label to include a 10 mg once-daily dose for reducing the risk of VTE after at least six months of standard anticoagulant therapy. With the FDA granting priority review, a response should be out by Oct 28, 2017. Approval of the 10 mg dose will provide physicians with an additional dosing option apart from the currently approved 20 mg.
Teva/Xenon Drug Fails in Mid-Stage Study: Teva (TEVA - Free Report) and partner Xenon suffered a pipeline setback with their experimental post-herpetic neuralgia (PHN) treatment, topical TV-45070, failing in a mid-stage proof-of-concept study. The study failed to meet the primary as well as secondary endpoints. The data will be analyzed further to determine the path forward. We note that TV-45070 had previously failed in a mid-stage study in pain due to osteoarthritis of the knee (Read more: Teva/Xenon Nerve Pain Candidate Fails in Phase II Study).
EU Approvals for Novartis: The European Commission (EC) expanded the use of Novartis’ Zykadia (ceritinib) to include the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors are ALK-positive. Approval was expected considering a positive opinion was received from the Committee for Medicinal Products for Human Use (CHMP) in May. FDA approval for the first line indication was granted in May (Read more: Novartis Gets EC Nod for Lung Cancer Drug's Label Expansion).
The EC also gave its nod to the company’s biosimilar version of Enbrel. Sandoz, a Novartis division, got approval for the use of Erelzi for all indications of the reference medicine, Enbrel, including rheumatoid arthritis, psoriasis, and psoriatic arthritis (Read more: Novartis' Erelzi, Biosimilar of Enbrel Approved In Europe).
The NYSE ARCA Pharmaceutical Index declined 2% over the last five trading sessions. Among major stocks, AstraZeneca (AZN - Free Report) was down 3.5%. Over the last six months, AstraZeneca was up 28.9% while Bristol-Myers (BMY - Free Report) was down 3.9% (See the last pharma stock roundup here: NVS Scores with Positive Data, Shire ADHD Drug Gets FDA Nod).
What's Next in the Pharma World?
Watch out for the usual pipeline and regulatory updates.
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Pharma Stock Roundup: Sanofi RA Drug Gets EU Nod, Merck CETP Inhibitor Surprises
This week’s highlights include positive data on Merck’s (MRK - Free Report) CETP inhibitor while Sanofi (SNY - Free Report) gained EU approval for its rheumatoid arthritis (RA) drug which has blockbuster potential.
Recap of the Week’s Most Important Stories
Merck’s CETP Inhibitor Meets Endpoint in REVEAL Study: Merck provided an update on its CETP inhibitor, anacetrapib. The company said that anacetrapib met the primary endpoint in the REVEAL (Randomized EValuation of the Effects of Anacetrapib through Lipid modification) outcomes study and showed a significant reduction in major coronary events compared to placebo in patients at risk for cardiac events who are already receiving an effective LDL-C lowering regimen (Read more: Merck's CETP Inhibitor Reduces CV Risk in Phase III Study).
The news comes as a bit of a surprise considering other companies like Lilly, Roche and Pfizer have had some high profile setbacks with their CETP inhibitors and the class was more or less written off. Merck itself seems to be adopting a cautious attitude as it intends to discuss the results with external experts to see whether it should seek regulatory approval. The safety profile was found to be consistent with that seen in earlier studies.
So far in 2017, Merck has lagged the Zacks categorized Large Cap Pharmaceuticals industry with shares gaining 9.3% while the industry is up 13.5%.
Sanofi/Regeneron RA Drug Gets EU Approval: Sanofi and partner Regeneron gained EU approval for their RA drug Kevzara. Kevzara is approved for use in combination with methotrexate (MTX) for the treatment of moderately to severely active RA in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs), such as MTX.
Kevzara, an IL-6R antibody, was approved in the U.S. in May this year. While Kevzara has blockbuster potential, the RA market is highly crowded given the presence of treatments like Humira and Xeljanz among others. However, the patient population is huge with many patients spending years on different treatments without achieving their treatment goals. With RA affecting about 1.3 million Americans and 2.9 million people in Europe, Kevzara represents a new treatment option for patients (Read more: Sanofi/Regeneron's Kevzara Gets Marketing Approval in EU).
Sanofi is a Zacks Rank #2 (Buy) stock. The company has outperformed the Zacks categorized Large Cap Pharmaceuticals industry year-to-date with the company gaining 19.1%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Roche’s Data on Hemophilia Drug: Roche’s (RHHBY - Free Report) experimental hemophilia treatment, emicizumab, delivered positive results in a couple of late-stage pivotal studies. A substantial and clinically meaningful reduction in bleeds was observed in the studies. The once-weekly subcutaneous treatment was evaluated for hemophilia A with inhibitors to factor VIII. However, side effects remain a concern especially given the death of a patient that was reported earlier this year in February.
Esperion Up on Regulatory Update: Lipid management company, Esperion (ESPR - Free Report) , saw it shares rising on news that the FDA has confirmed the regulatory pathway for the company’s once-daily, oral combination pill of bempedoic acid 180 mg and ezetimibe 10 mg. Esperion intends to commence a single pivotal bridging study by year end based on feedback from the agency. Top-line results from this study are expected the end of next year. Regulatory filings for bempedoic acid as well as the combination are expected in the first half of 2019.
With this development, Esperion now has two convenient, cost-effective, complementary, non-statin, once-daily, oral LDL-C lowering therapies in late-stage development with confirmed regulatory pathways (Read more: Esperion's Combo Cholesterol Candidate Enters Phase III).
Priority Review for J&J Xarelto Label Expansion: J&J got priority review for its efforts to expand Xarelto’s label to include a 10 mg once-daily dose for reducing the risk of VTE after at least six months of standard anticoagulant therapy. With the FDA granting priority review, a response should be out by Oct 28, 2017. Approval of the 10 mg dose will provide physicians with an additional dosing option apart from the currently approved 20 mg.
Teva/Xenon Drug Fails in Mid-Stage Study: Teva (TEVA - Free Report) and partner Xenon suffered a pipeline setback with their experimental post-herpetic neuralgia (PHN) treatment, topical TV-45070, failing in a mid-stage proof-of-concept study. The study failed to meet the primary as well as secondary endpoints. The data will be analyzed further to determine the path forward. We note that TV-45070 had previously failed in a mid-stage study in pain due to osteoarthritis of the knee (Read more: Teva/Xenon Nerve Pain Candidate Fails in Phase II Study).
EU Approvals for Novartis: The European Commission (EC) expanded the use of Novartis’ Zykadia (ceritinib) to include the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors are ALK-positive. Approval was expected considering a positive opinion was received from the Committee for Medicinal Products for Human Use (CHMP) in May. FDA approval for the first line indication was granted in May (Read more: Novartis Gets EC Nod for Lung Cancer Drug's Label Expansion).
The EC also gave its nod to the company’s biosimilar version of Enbrel. Sandoz, a Novartis division, got approval for the use of Erelzi for all indications of the reference medicine, Enbrel, including rheumatoid arthritis, psoriasis, and psoriatic arthritis (Read more: Novartis' Erelzi, Biosimilar of Enbrel Approved In Europe).
Performance
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
The NYSE ARCA Pharmaceutical Index declined 2% over the last five trading sessions. Among major stocks, AstraZeneca (AZN - Free Report) was down 3.5%. Over the last six months, AstraZeneca was up 28.9% while Bristol-Myers (BMY - Free Report) was down 3.9% (See the last pharma stock roundup here: NVS Scores with Positive Data, Shire ADHD Drug Gets FDA Nod).
What's Next in the Pharma World?
Watch out for the usual pipeline and regulatory updates.
5 Trades Could Profit "Big-League" from Trump Policies
If the stocks above spark your interest, wait until you look into companies primed to make substantial gains from Washington's changing course.
Today Zacks reveals 5 tickers that could benefit from new trends like streamlined drug approvals, tariffs, lower taxes, higher interest rates, and spending surges in defense and infrastructure. See these buy recommendations now >>