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Pharma Stock Roundup: Trump, Pharma Executives Meeting on Coronavirus, FDA Updates
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This week, executives of pharmaceutical companies working on making vaccines or treatments for the coronavirus met President Donald Trump at the White House. Trump asked them to accelerate their development efforts for the coronavirus vaccine/treatment.
Meanwhile, the FDA approved Sanofi’s (SNY - Free Report) Sarclisa (isatuximab) to treat relapsed/refractory multiple myeloma (RRMM) and Allergan’s Durysta (bimatoprost implant) for glaucoma.
Recap of the Week’s Most Important Stories:
FDA Approves Sanofi’s Sarclisa & Allergan’s Durysta: The FDA approved Sanofi’s anti-CD38 monoclonal antibody, isatuximab, in combination with standard-of-care medicines, pomalidomide and dexamethasone (pom-dex) for the treatment of patients with relapsed/refractory multiple myeloma (RRMM). The approval came almost two months ahead of the PDUFA date of Apr 30, 2020. Isatuximab will be marketed by the trade name of Sarclisa. The FDA approval is based on positive data from the phase III ICARIA-MM study, which evaluated isatuximab plus pom-dex for RRMM patients who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.
The FDA also approved Allergan’s biodegradable implant bimatoprost to reduce intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). Bimatoprost will be marketed by the trade name of Durysta and is the first sustained-release drop-free treatment option for the indication. The approval was based on data from two phase III studies, ARTEMIS, which showed that Durysta lowered IOP in the above patients by approximately 30% over the 12-week primary efficacy period, demonstrating non-inferiority to timolol eye drops.
FDA Accepts Lilly/Pfizer’s BLA for Tanezumab: The FDA accepted for review Pfizer (PFE - Free Report) & Lilly’s (LLY - Free Report) biologics license application (BLA) seeking approval for tanezumab, which has been developed to treat chronic pain due to moderate-to-severe osteoarthritis (OA). The FDA is expected to give its decision in December.
Meanwhile, at the meeting with Trump, Pfizer management said the company has identified some antiviral compounds in its pipeline, which have the potential to be developed as a treatment for coronavirus.
AbbVie Venclexta Study in AML Fails: AbbVie’s (ABBV - Free Report) late-stage combination study evaluating its cancer drug Venclexta in patients with acute myeloid leukemia (AML) failed to meet its primary endpoint of statistically significant improvement of overall survival (OS). The study compared Venclexta with low-dose cytarabine (LDAC) to LDAC plus placebo in previously untreated AML patients who are ineligible for intensive chemotherapy. The data showed that the Venclexta combination led to a 25% reduction in the risk of death compared to LDAC with placebo. At the time of the primary analysis, median OS was 7.2 months in the Venclexta arm and 4.1 months in the comparator arm. Venclexta is presently approved in combination with azacitidine, or decitabine, or LDAC to treat newly-diagnosed AML patients who are ineligible for intensive chemotherapy.
Merck’s Keytruda Meets Goal in Phase III Lymphoma Study: Merck’s (MRK - Free Report) Keytruda significantly improved progression-free survival (PFS) compared with the currently approved therapy, brentuximab vedotin in patients with relapsed or refractory classical Hodgkin Lymphoma (cHL). The study thus met one of the dual primary endpoints of PFS. However, the other dual primary endpoint of OS was not formally tested at the interim analysis, which was conducted by an independent Data Monitoring Committee (DMC). The study will continue to test OS and the company plans to file the PFS data with regulatory authorities soon.
Lilly Says Coronavirus Won’t Hurt Its Drugs Supply: Lilly announced that it does not expect shortage in supply of its medicines, including all forms of insulin, due to the novel coronavirus, as it does not source APIs of any of its marketed drugs from China. Lilly also informed that their insulin manufacturing sites in the United States and Europe have not been impacted by coronavirus.
AbbVie/Allergan Merger Clears Another Hurdle: AbbVie and Allergan announced that the European Commission (EC) has approved the divestiture of its mid-stage candidate for autoimmune disease, brazikumab to AstraZeneca. AbbVie is due to buy Allergan in a cash-and-stock deal for $63 billion. Allergan announced a definitive agreement to divest brazikumab and marketed medicine, Zenpep to AstraZeneca and Nestle, respectively in January in connection with the pending merger.
The EC had approved the merger in January, conditional on the divestiture of brazikumab. EC’s final approval clears the path in Europe for the pending merger. However, the transaction remains subject to some other customary closing conditions including Federal Trade Commission (FTC) decision, which is expected early in the second quarter of 2020.
J&J Files Marketing Application for Ponesimod in Europe: J&J (JNJ - Free Report) submitted marketing application in Europe seeking approval of its pipeline candidate ponesimod for treating adults with relapsing forms of multiple sclerosis (RMS). The regulatory filing is based on data from the head-to-head OPTIMUM phase III study comparing ponesimod to Sanofi’s MS drug, Aubagio. Ponesimod was added to J&J’s pipeline with the June 2017 $30 billion acquisition of Swiss biotech, Actelion.
FDA’s Breakthrough Therapy Tag for Roche’s Esbriet for New Indication: The FDA granted Breakthrough Therapy status to Roche’s Esbriet for a new indication, unclassifiable interstitial lung disease, which is a debilitating, severe respiratory condition. The designation was based on data from a phase II study, which suggested that Esbriet slowed disease progression in such patients. Esbriet is presently approved for the treatment of IPF.
The NYSE ARCA Pharmaceutical Index rose 3.3% in the last five trading sessions.
Watch out for regular pipeline and regulatory updates next week.
Biggest Tech Breakthrough in a Generation
Be among the early investors in the new type of device that experts say could impact society as much as the discovery of electricity. Current technology will soon be outdated and replaced by these new devices. In the process, it’s expected to create 22 million jobs and generate $12.3 trillion in activity.
A select few stocks could skyrocket the most as rollout accelerates for this new tech. Early investors could see gains similar to buying Microsoft in the 1990s. Zacks’ just-released special report reveals 8 stocks to watch. The report is only available for a limited time.
Image: Bigstock
Pharma Stock Roundup: Trump, Pharma Executives Meeting on Coronavirus, FDA Updates
This week, executives of pharmaceutical companies working on making vaccines or treatments for the coronavirus met President Donald Trump at the White House. Trump asked them to accelerate their development efforts for the coronavirus vaccine/treatment.
Meanwhile, the FDA approved Sanofi’s (SNY - Free Report) Sarclisa (isatuximab) to treat relapsed/refractory multiple myeloma (RRMM) and Allergan’s Durysta (bimatoprost implant) for glaucoma.
Recap of the Week’s Most Important Stories:
FDA Approves Sanofi’s Sarclisa & Allergan’s Durysta: The FDA approved Sanofi’s anti-CD38 monoclonal antibody, isatuximab, in combination with standard-of-care medicines, pomalidomide and dexamethasone (pom-dex) for the treatment of patients with relapsed/refractory multiple myeloma (RRMM). The approval came almost two months ahead of the PDUFA date of Apr 30, 2020. Isatuximab will be marketed by the trade name of Sarclisa. The FDA approval is based on positive data from the phase III ICARIA-MM study, which evaluated isatuximab plus pom-dex for RRMM patients who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.
The FDA also approved Allergan’s biodegradable implant bimatoprost to reduce intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). Bimatoprost will be marketed by the trade name of Durysta and is the first sustained-release drop-free treatment option for the indication. The approval was based on data from two phase III studies, ARTEMIS, which showed that Durysta lowered IOP in the above patients by approximately 30% over the 12-week primary efficacy period, demonstrating non-inferiority to timolol eye drops.
FDA Accepts Lilly/Pfizer’s BLA for Tanezumab: The FDA accepted for review Pfizer (PFE - Free Report) & Lilly’s (LLY - Free Report) biologics license application (BLA) seeking approval for tanezumab, which has been developed to treat chronic pain due to moderate-to-severe osteoarthritis (OA). The FDA is expected to give its decision in December.
Meanwhile, at the meeting with Trump, Pfizer management said the company has identified some antiviral compounds in its pipeline, which have the potential to be developed as a treatment for coronavirus.
AbbVie Venclexta Study in AML Fails: AbbVie’s (ABBV - Free Report) late-stage combination study evaluating its cancer drug Venclexta in patients with acute myeloid leukemia (AML) failed to meet its primary endpoint of statistically significant improvement of overall survival (OS). The study compared Venclexta with low-dose cytarabine (LDAC) to LDAC plus placebo in previously untreated AML patients who are ineligible for intensive chemotherapy. The data showed that the Venclexta combination led to a 25% reduction in the risk of death compared to LDAC with placebo. At the time of the primary analysis, median OS was 7.2 months in the Venclexta arm and 4.1 months in the comparator arm. Venclexta is presently approved in combination with azacitidine, or decitabine, or LDAC to treat newly-diagnosed AML patients who are ineligible for intensive chemotherapy.
Merck’s Keytruda Meets Goal in Phase III Lymphoma Study: Merck’s (MRK - Free Report) Keytruda significantly improved progression-free survival (PFS) compared with the currently approved therapy, brentuximab vedotin in patients with relapsed or refractory classical Hodgkin Lymphoma (cHL). The study thus met one of the dual primary endpoints of PFS. However, the other dual primary endpoint of OS was not formally tested at the interim analysis, which was conducted by an independent Data Monitoring Committee (DMC). The study will continue to test OS and the company plans to file the PFS data with regulatory authorities soon.
Lilly Says Coronavirus Won’t Hurt Its Drugs Supply: Lilly announced that it does not expect shortage in supply of its medicines, including all forms of insulin, due to the novel coronavirus, as it does not source APIs of any of its marketed drugs from China. Lilly also informed that their insulin manufacturing sites in the United States and Europe have not been impacted by coronavirus.
AbbVie/Allergan Merger Clears Another Hurdle: AbbVie and Allergan announced that the European Commission (EC) has approved the divestiture of its mid-stage candidate for autoimmune disease, brazikumab to AstraZeneca. AbbVie is due to buy Allergan in a cash-and-stock deal for $63 billion. Allergan announced a definitive agreement to divest brazikumab and marketed medicine, Zenpep to AstraZeneca and Nestle, respectively in January in connection with the pending merger.
The EC had approved the merger in January, conditional on the divestiture of brazikumab. EC’s final approval clears the path in Europe for the pending merger. However, the transaction remains subject to some other customary closing conditions including Federal Trade Commission (FTC) decision, which is expected early in the second quarter of 2020.
J&J Files Marketing Application for Ponesimod in Europe: J&J (JNJ - Free Report) submitted marketing application in Europe seeking approval of its pipeline candidate ponesimod for treating adults with relapsing forms of multiple sclerosis (RMS). The regulatory filing is based on data from the head-to-head OPTIMUM phase III study comparing ponesimod to Sanofi’s MS drug, Aubagio. Ponesimod was added to J&J’s pipeline with the June 2017 $30 billion acquisition of Swiss biotech, Actelion.
FDA’s Breakthrough Therapy Tag for Roche’s Esbriet for New Indication: The FDA granted Breakthrough Therapy status to Roche’s Esbriet for a new indication, unclassifiable interstitial lung disease, which is a debilitating, severe respiratory condition. The designation was based on data from a phase II study, which suggested that Esbriet slowed disease progression in such patients. Esbriet is presently approved for the treatment of IPF.
The NYSE ARCA Pharmaceutical Index rose 3.3% 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.
Last week, all the stocks were in the green with Lilly rising the most (8.5%).
In the past six months, Lilly has risen the most (26.1%) while Pfizer declined the most (3.7%).
(See the last pharma stock roundup here: FDA Updates From LLY, GSK, NVS, SNY to Spin-Off API Unit)
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.
Biggest Tech Breakthrough in a Generation
Be among the early investors in the new type of device that experts say could impact society as much as the discovery of electricity. Current technology will soon be outdated and replaced by these new devices. In the process, it’s expected to create 22 million jobs and generate $12.3 trillion in activity.
A select few stocks could skyrocket the most as rollout accelerates for this new tech. Early investors could see gains similar to buying Microsoft in the 1990s. Zacks’ just-released special report reveals 8 stocks to watch. The report is only available for a limited time.
See 8 breakthrough stocks now>>