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Another Alzheimer’s candidate failed in clinical studies this week. An independent data monitoring committee (“IDMC”) recommended Lilly (LLY - Free Report) and AstraZeneca (AZN - Free Report) to discontinue two studies on lanabecestat. Shares of Israel-based small biotech, Galmed Pharmaceuticals Ltd. (GLMD - Free Report) rose after it announced positive data from a mid-stage study on its NASH candidate Aramchol. Merck (MRK - Free Report) gained FDA approval for two new indications of its blockbuster anti-PD-1 therapy, Keytruda. While Glaxo’s (GSK - Free Report) late-stage HIV studies met the primary endpoint, AbbVie (ABBV - Free Report) , Roche (RHHBY - Free Report) and AstraZeneca gained regulatory nods for label expansion of their key cancer drugs.
Recap of the Week’s Most Important Stories
Lilly/AstraZeneca’s Alzheimer’s Candidate Fails: Lilly and AstraZeneca are discontinuing two late-stage studies on their Alzheimer disease candidate, lanabecestat, on recommendation of the IDMC.
The IDMC said that the two studies — one in early Alzheimer's disease and the other in mild Alzheimer's disease dementia — were unlikely to meet the primary endpoints upon completion, leading to a decision to discontinue these studies on the oral beta secretase cleaving enzyme (BACE) inhibitor. The latest setback adds to a long list of failed treatment options for this deadly brain disease. (Read more: Lilly & AstraZeneca Scrap Studies on Alzheimer's Candidate)
Merck’s Keytruda Gets FDA Nod for Two New Indications: Merck gained FDA’s accelerated approval for two new indications for its blockbuster anti-PD-1 therapy, Keytruda this week. These include third-line treatment of adult as well as pediatric patients with primary mediastinal B-cell lymphoma (PMBCL), a type of non-Hodgkin lymphoma and second-line treatment of recurrent or metastatic cervical cancer. These label expansion approvals should drive sales of Keytruda in the future quarters.
Also, Merck’s regulatory application seeking approval for an expanded age indication of its HPV vaccine Gardasil was granted priority review by the FDA. Merck is looking to get Gardasil approved for women and men aged 27 to 45. The HPV vaccine is presently approved for men and women aged 9 to 26. (Read more: Merck's Keytruda Gets FDA Nod for 2nd Lymphoma Indication)
Glaxo’s GEMINI Studies on Two-Drug HIV Regimen Succeed: Glaxo’s two late-stage studies testing its two-drug HIV regimen of dolutegravir (Tivicay) and lamivudine showed non-inferiority in HIV control to a standard three-drug regimen regimen of dolutegravir plus tenofovir alafenamide fumarate and emtricitabine. The studies were conducted on treatment naïve HIV-1 infected adults — those who have not received prior antiviral therapy. Regulatory application to get the two-drug regimen of dolutegravir and lamivudine approved is expected to be filed later this year.
In another positive news for Glaxo, Mylan's generic version of Glaxo’s blockbuster respiratory drug, Advair was delayed again with a second complete response letter from the FDA.
Galmed Shares Hit the Roof as NASH Candidate Succeeds in Study: Galmed announced positive top-line results from a mid-stage study on its lead candidate, Aramchol, for the treatment of non-alcoholic steatohepatitis (NASH). The study demonstrated that Aramchol was effective at reaching its primary endpoints.
Importantly, reduction in liver fat, as measured by magnetic resonance spectroscopy, was demonstrated in patients who had completed 52 weeks of treatment with Aramchol 400mg compared to placebo. These results strongly support the advancement of Aramchol to pivotal phase III studies. Shares of the company skyrocketed around 150% after this news was announced. (Read more: Galmed Soars on Positive NASH Data on Aramchol)
Allergan’s Anti-CGRP Drug Meets Goal in Study: Allergan announced that its second anti-CGRP candidate, atogepant, met the primary endpoint in a mid-stage study. The CGP-MD-01 study evaluated 5 doses of atogepant for the prevention of episodic migraine over 12 weeks. Atogepant achieved a reduction of statistical significance in monthly migraine/probable migraine (“MPM”) headache days from baseline for all doses.
Allergan’s another oral anti-CGRP acute migraine treatment, ubrogepant, has already shown positive results in two phase III studies.
Separately, Allergan announced positive top-line data from a phase III study on its pipeline candidate Bimatoprost SR, an investigational implant developed as the first sustained-release drop-free treatment option for lowering intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Data from the study showed that Bimatoprost SR reduced IOP by approximately 30% over the 12-week primary efficacy period, thereby demonstrating non-inferiority to the study comparator, timolol eye drops.
AbbVie/Roche Cancer Drugs Get FDA Nod for Combo Use: AbbVie and Roche announced FDA approval for the combination use of their cancer drugs Venclexta and Rituxan, for previously treated chronic lymphocytic leukemia (“CLL”). The FDA approval was based on positive data from the phase III MURANO study of Venclexta plus Rituxan in relapse/refractory CLL. Venclexta is jointly marketed by AbbVie and Roche’s subsidiary Genentech in the United States and by AbbVie outside the United States.
Separately, Roche announced FDA approval for its cancer drug, Avastin in combination with chemotherapy (carboplatin and paclitaxel) for the treatment for women with advanced ovarian cancer following initial surgery. With this latest approval, Avastin is now approved for six different types of cancer in the United States.
Tagrisso Gets EU Approval in First-Line Setting: AstraZeneca’s (AZN - Free Report) lung cancer drug Tagrisso gained EU approval for the first-line treatment of adult patients with metastatic NSCLC whose tumors have EGFR mutations. A similar label expansion application was approved in the United States in April. Until now, Tagrisso was approved in the United States, European Union, Japan and China as a second-line treatment option for patients with EGFR mutation-positive NSCLC. The label expansion in the first-line setting should drive sales of Tagrisso higher in future quarters. (Read more: AstraZeneca's Tagrisso Wins EU Nod for First-Line Lung Cancer).
J&J Accepts Offer to Sell Diabetes Unit: J&J formally accepted the binding offer it received in March of approximately $2.1 billion from a private equity firm, Platinum Equity, for its LifeScan diabetes device unit. The LifeScan unit makes blood glucose monitoring products and generated revenues of $1.5 billion last year. The transaction is expected to be closed by the end of the year. (Read more: J&J Accepts Platinum Equity's Offer for LifeScan Unit)
The NYSE ARCA Pharmaceutical Index rose 0.3% in the last five trading sessions.
Watch out for FDA decisions on several pipeline drugs and line extensions of marketed products this month.
Wall Street’s Next Amazon
Zacks EVP Kevin Matras believes this familiar stock has only just begun its climb to become one of the greatest investments of all time. It’s a once-in-a-generation opportunity to invest in pure genius.
Image: Bigstock
Pharma Stock Roundup: LLY/AZN Alzheimer's Drug Fails, MRK's Keytruda Wins Approvals
Another Alzheimer’s candidate failed in clinical studies this week. An independent data monitoring committee (“IDMC”) recommended Lilly (LLY - Free Report) and AstraZeneca (AZN - Free Report) to discontinue two studies on lanabecestat. Shares of Israel-based small biotech, Galmed Pharmaceuticals Ltd. (GLMD - Free Report) rose after it announced positive data from a mid-stage study on its NASH candidate Aramchol. Merck (MRK - Free Report) gained FDA approval for two new indications of its blockbuster anti-PD-1 therapy, Keytruda. While Glaxo’s (GSK - Free Report) late-stage HIV studies met the primary endpoint, AbbVie (ABBV - Free Report) , Roche (RHHBY - Free Report) and AstraZeneca gained regulatory nods for label expansion of their key cancer drugs.
Recap of the Week’s Most Important Stories
Lilly/AstraZeneca’s Alzheimer’s Candidate Fails: Lilly and AstraZeneca are discontinuing two late-stage studies on their Alzheimer disease candidate, lanabecestat, on recommendation of the IDMC.
The IDMC said that the two studies — one in early Alzheimer's disease and the other in mild Alzheimer's disease dementia — were unlikely to meet the primary endpoints upon completion, leading to a decision to discontinue these studies on the oral beta secretase cleaving enzyme (BACE) inhibitor. The latest setback adds to a long list of failed treatment options for this deadly brain disease. (Read more: Lilly & AstraZeneca Scrap Studies on Alzheimer's Candidate)
Merck’s Keytruda Gets FDA Nod for Two New Indications: Merck gained FDA’s accelerated approval for two new indications for its blockbuster anti-PD-1 therapy, Keytruda this week. These include third-line treatment of adult as well as pediatric patients with primary mediastinal B-cell lymphoma (PMBCL), a type of non-Hodgkin lymphoma and second-line treatment of recurrent or metastatic cervical cancer. These label expansion approvals should drive sales of Keytruda in the future quarters.
Also, Merck’s regulatory application seeking approval for an expanded age indication of its HPV vaccine Gardasil was granted priority review by the FDA. Merck is looking to get Gardasil approved for women and men aged 27 to 45. The HPV vaccine is presently approved for men and women aged 9 to 26. (Read more: Merck's Keytruda Gets FDA Nod for 2nd Lymphoma Indication)
Glaxo’s GEMINI Studies on Two-Drug HIV Regimen Succeed: Glaxo’s two late-stage studies testing its two-drug HIV regimen of dolutegravir (Tivicay) and lamivudine showed non-inferiority in HIV control to a standard three-drug regimen regimen of dolutegravir plus tenofovir alafenamide fumarate and emtricitabine. The studies were conducted on treatment naïve HIV-1 infected adults — those who have not received prior antiviral therapy. Regulatory application to get the two-drug regimen of dolutegravir and lamivudine approved is expected to be filed later this year.
In another positive news for Glaxo, Mylan's generic version of Glaxo’s blockbuster respiratory drug, Advair was delayed again with a second complete response letter from the FDA.
Galmed Shares Hit the Roof as NASH Candidate Succeeds in Study: Galmed announced positive top-line results from a mid-stage study on its lead candidate, Aramchol, for the treatment of non-alcoholic steatohepatitis (NASH). The study demonstrated that Aramchol was effective at reaching its primary endpoints.
Importantly, reduction in liver fat, as measured by magnetic resonance spectroscopy, was demonstrated in patients who had completed 52 weeks of treatment with Aramchol 400mg compared to placebo. These results strongly support the advancement of Aramchol to pivotal phase III studies. Shares of the company skyrocketed around 150% after this news was announced. (Read more: Galmed Soars on Positive NASH Data on Aramchol)
Allergan’s Anti-CGRP Drug Meets Goal in Study: Allergan announced that its second anti-CGRP candidate, atogepant, met the primary endpoint in a mid-stage study. The CGP-MD-01 study evaluated 5 doses of atogepant for the prevention of episodic migraine over 12 weeks. Atogepant achieved a reduction of statistical significance in monthly migraine/probable migraine (“MPM”) headache days from baseline for all doses.
Allergan’s another oral anti-CGRP acute migraine treatment, ubrogepant, has already shown positive results in two phase III studies.
Separately, Allergan announced positive top-line data from a phase III study on its pipeline candidate Bimatoprost SR, an investigational implant developed as the first sustained-release drop-free treatment option for lowering intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Data from the study showed that Bimatoprost SR reduced IOP by approximately 30% over the 12-week primary efficacy period, thereby demonstrating non-inferiority to the study comparator, timolol eye drops.
AbbVie/Roche Cancer Drugs Get FDA Nod for Combo Use: AbbVie and Roche announced FDA approval for the combination use of their cancer drugs Venclexta and Rituxan, for previously treated chronic lymphocytic leukemia (“CLL”). The FDA approval was based on positive data from the phase III MURANO study of Venclexta plus Rituxan in relapse/refractory CLL. Venclexta is jointly marketed by AbbVie and Roche’s subsidiary Genentech in the United States and by AbbVie outside the United States.
Separately, Roche announced FDA approval for its cancer drug, Avastin in combination with chemotherapy (carboplatin and paclitaxel) for the treatment for women with advanced ovarian cancer following initial surgery. With this latest approval, Avastin is now approved for six different types of cancer in the United States.
Tagrisso Gets EU Approval in First-Line Setting: AstraZeneca’s (AZN - Free Report) lung cancer drug Tagrisso gained EU approval for the first-line treatment of adult patients with metastatic NSCLC whose tumors have EGFR mutations. A similar label expansion application was approved in the United States in April. Until now, Tagrisso was approved in the United States, European Union, Japan and China as a second-line treatment option for patients with EGFR mutation-positive NSCLC. The label expansion in the first-line setting should drive sales of Tagrisso higher in future quarters. (Read more: AstraZeneca's Tagrisso Wins EU Nod for First-Line Lung Cancer).
J&J Accepts Offer to Sell Diabetes Unit: J&J formally accepted the binding offer it received in March of approximately $2.1 billion from a private equity firm, Platinum Equity, for its LifeScan diabetes device unit. The LifeScan unit makes blood glucose monitoring products and generated revenues of $1.5 billion last year. The transaction is expected to be closed by the end of the year. (Read more: J&J Accepts Platinum Equity's Offer for LifeScan Unit)
The NYSE ARCA Pharmaceutical Index rose 0.3% in the last five trading sessions.
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
Here is how the seven major stocks performed in the last five trading sessions:
In the last week, Pfizer declined the most (0.9%) while Glaxo generated the highest return (3%).
In the past six months too, Glaxo has been the biggest gainer (18.8%) while Bristol Myers declined the most (14.0%).
(See the last pharma stock roundup here: Pharma Stock Roundup: MRK Impresses at ASCO, LLY Gets FDA Nod for Olumiant)
What's Next in the Pharma World?
Watch out for FDA decisions on several pipeline drugs and line extensions of marketed products this month.
Wall Street’s Next Amazon
Zacks EVP Kevin Matras believes this familiar stock has only just begun its climb to become one of the greatest investments of all time. It’s a once-in-a-generation opportunity to invest in pure genius.
Click for details >>