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Pharma Stock Roundup: Label Expansion for Merck Drug, Aerie Up On Eye Data
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This week, there were quite a few regulatory updates with Merck (MRK - Free Report) getting FDA approval for yet another indication for Keytruda while Bristol-Myers (BMY - Free Report) got priority review for a regulatory application for Opdivo.
Recap of the Week’s Most Important Stories
Aerie Soars on Positive Eye Data: Aerie’s shares shot up almost 34% to a new 52-week high on positive late-stage data on its fixed-dose combination candidate, Roclatan. Aerie intends to file for FDA approval in the first half of 2018 if 12-month safety results, due in the third quarter of 2017, are positive. Meanwhile, the company expects to submit for European approval in the second half of 2019 with a late-stage study scheduled to commence in mid-2017 (Read more: Aerie's Ophthalmic Candidate Positive in Registration Trial). Aerie is a Zacks Rank #2 (Buy) stock -- you can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Aerie is up 42.4% year-to-date (YTD), outperforming the Zacks-categorized Medical-Drugs industry which is up 7.3% so far in 2017.
Another Approval for Merck’s Keytruda: Merck’s anti-PD-1 therapy Keytruda is on a roll with the drug now gaining FDA approval for use in adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options or colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This makes Keytruda the first cancer therapy approved for use based on a biomarker regardless of tumor type. This approval comes shortly after the company got approval for the first- as well as second-line treatment of certain patients with locally advanced or metastatic urothelial carcinoma, a type of bladder cancer.
Moreover, Keytruda got priority review in the U.S. for the treatment of recurrent or advanced gastric or gastroesophageal junction adenocarcinoma in patients who have already received two or more lines of chemotherapy. A response from the FDA should be out by Sep 22, 2017 (Read more: Merck's Keytruda Gets FDA Nod for Solid Tumor Cancers).
Merck also announced an exclusive worldwide license agreement with Teijin Pharma for an experimental Alzheimer’s disease candidate, an anti-tau antibody in preclinical stage. Merck has been working on developing treatments for Alzheimer’s though the company suffered a setback earlier this year when verubecestat was halted in a phase II/III study.
Pfizer Biosimilar Gets Advisory Panel Support: Pfizer’s (PFE - Free Report) biosimilar version of Epogen and Procrit (epoetin alfa) was recommended for approval by the FDA’s Oncologic Drugs Advisory Committee (ODAC) across all indications. This is the first time a biosimilar erythropoiesis-stimulating agent (ESA) has been recommended for approval by an FDA advisory panel. While the FDA is not required to do so, it usually follows the recommendation of its advisory panels.
GW Pharma Epilepsy Data Published: GW Pharma announced the publication of phase III data on Epidiolex (cannabidiol) for children with Dravet syndrome in The New England Journal of Medicine. Epidiolex, a liquid formulation of purified, plant-derived cannabidiol (CBD), is being evaluated for the treatment of several rare and severe pediatric-onset epilepsy disorders. Results from the Dravet syndrome study showed that Epidiolex significantly reduced monthly convulsive seizure frequency compared to placebo in highly treatment-resistant children when added to existing treatment. GW Pharma remains on track to file for FDA approval in mid-2017.
Bristol-Myers Drug Gets Priority Review: Bristol-Myers got priority review status for its regulatory application for the label expansion of Opdivo for use in hepatocellular carcinoma (HCC) patients who have been on Nexavar (sorafenib). With the FDA granting priority review, a response should be out by Sep 24, 2017 (Read more: Bristol-Myers' Opdivo Gets Priority Review for Liver Cancer).
Sanofi, Regeneron RA Drug Gets FDA Nod on Second Attempt: It proved to be second time lucky for Sanofi (SNY - Free Report) and partner Regeneron with the companies gaining FDA approval for their rheumatoid arthritis (RA) treatment, Kevzara. The companies had got a complete response letter (CRL) for the IL-6R antibody in Oct 2016 due to manufacturing issues. While Kevzara has blockbuster potential, the RA market is highly crowded given the presence of treatments like Humira and Xeljanz among others. Sanofi and Regeneron have priced Kevzara at $39,000/year, a discount of about 30% to the U.S. wholesale acquisition cost for the two most widely used TNF-alpha inhibitors. Moreover, 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, Kevzara represents a new treatment option for patients (Read more: Sanofi/Regeneron's Kevzara Gets FDA Approval for Arthritis).
Sanofi has outperformed the Zacks categorized Large Cap Pharmaceuticals industry YTD with shares gaining 21.2% while the industry is up 10.6%.
The NYSE ARCA Pharmaceutical Index was up slightly (0.7%) over the last five trading sessions. Merck was up 1.8% while Glaxo slipped 1.6%. Over the last six months, AstraZeneca was up 26.7% while Bristol-Myers was down 4.6% (See the last pharma stock roundup here: J&J's Pharma Pipeline Update, Shire's HAE Data & More).
What's Next in the Pharma World?
Companies like Pfizer, Lilly (LLY - Free Report) , AstraZeneca, Bristol-Myers, Merck KGaA and Merck will all be at the annual meeting of the American Society of Clinical Oncology (ASCO) showcasing data on approved and pipeline candidates targeting cancer.
Meanwhile, a response from the FDA regarding a once-daily formulation of Isentress (for use in combination with other antiretroviral therapies for the treatment of HIV-1 in treatment-naïve patients or patients whose virus remains suppressed after treatment with an initial regimen of 400 mg of Isentress twice-daily), is expected by May 27, 2017.
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Pharma Stock Roundup: Label Expansion for Merck Drug, Aerie Up On Eye Data
This week, there were quite a few regulatory updates with Merck (MRK - Free Report) getting FDA approval for yet another indication for Keytruda while Bristol-Myers (BMY - Free Report) got priority review for a regulatory application for Opdivo.
Recap of the Week’s Most Important Stories
Aerie Soars on Positive Eye Data: Aerie’s shares shot up almost 34% to a new 52-week high on positive late-stage data on its fixed-dose combination candidate, Roclatan. Aerie intends to file for FDA approval in the first half of 2018 if 12-month safety results, due in the third quarter of 2017, are positive. Meanwhile, the company expects to submit for European approval in the second half of 2019 with a late-stage study scheduled to commence in mid-2017 (Read more: Aerie's Ophthalmic Candidate Positive in Registration Trial). Aerie is a Zacks Rank #2 (Buy) stock -- you can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Aerie is up 42.4% year-to-date (YTD), outperforming the Zacks-categorized Medical-Drugs industry which is up 7.3% so far in 2017.
Another Approval for Merck’s Keytruda: Merck’s anti-PD-1 therapy Keytruda is on a roll with the drug now gaining FDA approval for use in adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options or colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This makes Keytruda the first cancer therapy approved for use based on a biomarker regardless of tumor type. This approval comes shortly after the company got approval for the first- as well as second-line treatment of certain patients with locally advanced or metastatic urothelial carcinoma, a type of bladder cancer.
Moreover, Keytruda got priority review in the U.S. for the treatment of recurrent or advanced gastric or gastroesophageal junction adenocarcinoma in patients who have already received two or more lines of chemotherapy. A response from the FDA should be out by Sep 22, 2017 (Read more: Merck's Keytruda Gets FDA Nod for Solid Tumor Cancers).
Merck also announced an exclusive worldwide license agreement with Teijin Pharma for an experimental Alzheimer’s disease candidate, an anti-tau antibody in preclinical stage. Merck has been working on developing treatments for Alzheimer’s though the company suffered a setback earlier this year when verubecestat was halted in a phase II/III study.
Pfizer Biosimilar Gets Advisory Panel Support: Pfizer’s (PFE - Free Report) biosimilar version of Epogen and Procrit (epoetin alfa) was recommended for approval by the FDA’s Oncologic Drugs Advisory Committee (ODAC) across all indications. This is the first time a biosimilar erythropoiesis-stimulating agent (ESA) has been recommended for approval by an FDA advisory panel. While the FDA is not required to do so, it usually follows the recommendation of its advisory panels.
GW Pharma Epilepsy Data Published: GW Pharma announced the publication of phase III data on Epidiolex (cannabidiol) for children with Dravet syndrome in The New England Journal of Medicine. Epidiolex, a liquid formulation of purified, plant-derived cannabidiol (CBD), is being evaluated for the treatment of several rare and severe pediatric-onset epilepsy disorders. Results from the Dravet syndrome study showed that Epidiolex significantly reduced monthly convulsive seizure frequency compared to placebo in highly treatment-resistant children when added to existing treatment. GW Pharma remains on track to file for FDA approval in mid-2017.
Bristol-Myers Drug Gets Priority Review: Bristol-Myers got priority review status for its regulatory application for the label expansion of Opdivo for use in hepatocellular carcinoma (HCC) patients who have been on Nexavar (sorafenib). With the FDA granting priority review, a response should be out by Sep 24, 2017 (Read more: Bristol-Myers' Opdivo Gets Priority Review for Liver Cancer).
Sanofi, Regeneron RA Drug Gets FDA Nod on Second Attempt: It proved to be second time lucky for Sanofi (SNY - Free Report) and partner Regeneron with the companies gaining FDA approval for their rheumatoid arthritis (RA) treatment, Kevzara. The companies had got a complete response letter (CRL) for the IL-6R antibody in Oct 2016 due to manufacturing issues. While Kevzara has blockbuster potential, the RA market is highly crowded given the presence of treatments like Humira and Xeljanz among others. Sanofi and Regeneron have priced Kevzara at $39,000/year, a discount of about 30% to the U.S. wholesale acquisition cost for the two most widely used TNF-alpha inhibitors. Moreover, 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, Kevzara represents a new treatment option for patients (Read more: Sanofi/Regeneron's Kevzara Gets FDA Approval for Arthritis).
Sanofi has outperformed the Zacks categorized Large Cap Pharmaceuticals industry YTD with shares gaining 21.2% while the industry is up 10.6%.
Performance
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
The NYSE ARCA Pharmaceutical Index was up slightly (0.7%) over the last five trading sessions. Merck was up 1.8% while Glaxo slipped 1.6%. Over the last six months, AstraZeneca was up 26.7% while Bristol-Myers was down 4.6% (See the last pharma stock roundup here: J&J's Pharma Pipeline Update, Shire's HAE Data & More).
What's Next in the Pharma World?
Companies like Pfizer, Lilly (LLY - Free Report) , AstraZeneca, Bristol-Myers, Merck KGaA and Merck will all be at the annual meeting of the American Society of Clinical Oncology (ASCO) showcasing data on approved and pipeline candidates targeting cancer.
Meanwhile, a response from the FDA regarding a once-daily formulation of Isentress (for use in combination with other antiretroviral therapies for the treatment of HIV-1 in treatment-naïve patients or patients whose virus remains suppressed after treatment with an initial regimen of 400 mg of Isentress twice-daily), is expected by May 27, 2017.
Looking for Ideas with Even Greater Upside?
Most of Zacks’ investment ideas are short-term, directly based on our proven 1 to 3 month indicator. In addition, I invite you to consider our long-term opportunities. These rare trades look to start fast with strong Zacks Ranks, but carry through with double and triple-digit profit potential. Starting now, you can look inside our home run, value, and stocks under $10 portfolios, plus more. Click here for a peek at this private information>>