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Pharma Stock Roundup: FDA Okays PFE & JNJ Drugs, EU Approves ABBV's Migraine Drug
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This week, the FDA approved Pfizer’s (PFE - Free Report) Elrexfio (elranatamab) for relapsed or refractory multiple myeloma (“RRMM”) and J&J’s (JNJ - Free Report) oral combination tablet, Akeega to treat BRCA-positive metastatic castration-resistant prostate cancer (mCRPC). The European Commission approved AbbVie’s (ABBV - Free Report) Aquipta (atogepant) for preventive treatment of migraine in adults. Novartis’ (NVS - Free Report) generics division, Sandoz announced positive data from a phase III study evaluating a biosimilar version of Regeneron Pharmaceuticals’ (REGN - Free Report) Eylea
Recap of the Week’s Most Important Stories
FDA Approves Pfizer’s Elranatamab for Multiple Myeloma: The FDA granted accelerated approval to Pfizer’s BCMA-CD3-targeted agent Elrexfio (elranatamab) for treating heavily pre-treated patients with RRMM). Continued approval of the drug will be based on verification of clinical benefit in a confirmatory study. The FDA’s approval of Elrexfio is based on data from the pivotal phase II MagnetisMM-3 study, which evaluated elranatamab in heavily pretreated patients with RRMM who received Elrexfio as their first BCMA-directed therapy. Data from the study showed early and deep responses and a manageable safety profile for elranatamab. Elranatamab’s marketing authorization application is also under review in the EU.
FDA Approves J&J’s Prostate Cancer Tablet Akeega: The FDA granted approval to J&J’s Akeega, which is a combination of Zejula (niraparib) and abiraterone acetate, plus prednisone in the form of a dual action tablet, for the first-line treatment of adult patients with deleterious or suspected deleterious BRCA-positive mCRPC. The approval of Akeega is based on results from the phase III MAGNITUDE study. Data from the study showed that patients treated with Akeega plus prednisone achieved a reduction of 47% in radiographic progression-free survival compared to abiraterone acetate plus prednisone in patients with BRCA-positive mCRPC. Akeega was approved in the EU in April.
AbbVie’s Atogepant Gets EU Nod for Preventive Treatment of Migraine: The European Commission approved AbbVie’s CGRP receptor antagonist, Aquipta (atogepant) in Europe for prophylaxis (prevention) of migraine in adults who have four or more migraine days per month. This approval was based on results from two pivotal phase III studies, PROGRESS and ADVANCE, evaluating 60 mg dose strength of Aquipta/Qulipta in adult patients with chronic migraine or episodic migraine, respectively.
Atogepant is already approved in the United States as Qulipta for the preventive treatment of both chronic and episodic migraine. With the latest approval in EU, Aquipta has become the first and only once-daily oral CGRP receptor antagonist to be approved for the preventive treatment of both chronic and episodic migraine in the European Union.
Novartis’ Eylea Biosimilar Meets Goal in Study: Novartis unit Sandoz’s phase III study called Mylight, evaluating a biosimilar version of Regeneron’s blockbuster eye drug, Eylea (aflibercept), met its primary efficacy endpoint. It showed no clinically meaningful differences to the reference biologic, Eylea. The study showed therapeutic equivalence in mean change of best corrected visual acuity from baseline to week 8 between the biosimilar aflibercept and Eylea.
Eylea is presently approved to improve visual acuity in patients with neovascular age-related macular degeneration, diabetic macular edema, macular edema secondary to retinal vein occlusion and other specific neovascular retinal diseases. Sandoz plans to launch four key biosimilar products over the next few years, aflibercept being one of them.
The NYSE ARCA Pharmaceutical Index rose 0.08% in the last five trading sessions.
Image: Bigstock
Pharma Stock Roundup: FDA Okays PFE & JNJ Drugs, EU Approves ABBV's Migraine Drug
This week, the FDA approved Pfizer’s (PFE - Free Report) Elrexfio (elranatamab) for relapsed or refractory multiple myeloma (“RRMM”) and J&J’s (JNJ - Free Report) oral combination tablet, Akeega to treat BRCA-positive metastatic castration-resistant prostate cancer (mCRPC). The European Commission approved AbbVie’s (ABBV - Free Report) Aquipta (atogepant) for preventive treatment of migraine in adults. Novartis’ (NVS - Free Report) generics division, Sandoz announced positive data from a phase III study evaluating a biosimilar version of Regeneron Pharmaceuticals’ (REGN - Free Report) Eylea
Recap of the Week’s Most Important Stories
FDA Approves Pfizer’s Elranatamab for Multiple Myeloma: The FDA granted accelerated approval to Pfizer’s BCMA-CD3-targeted agent Elrexfio (elranatamab) for treating heavily pre-treated patients with RRMM). Continued approval of the drug will be based on verification of clinical benefit in a confirmatory study. The FDA’s approval of Elrexfio is based on data from the pivotal phase II MagnetisMM-3 study, which evaluated elranatamab in heavily pretreated patients with RRMM who received Elrexfio as their first BCMA-directed therapy. Data from the study showed early and deep responses and a manageable safety profile for elranatamab. Elranatamab’s marketing authorization application is also under review in the EU.
FDA Approves J&J’s Prostate Cancer Tablet Akeega: The FDA granted approval to J&J’s Akeega, which is a combination of Zejula (niraparib) and abiraterone acetate, plus prednisone in the form of a dual action tablet, for the first-line treatment of adult patients with deleterious or suspected deleterious BRCA-positive mCRPC. The approval of Akeega is based on results from the phase III MAGNITUDE study. Data from the study showed that patients treated with Akeega plus prednisone achieved a reduction of 47% in radiographic progression-free survival compared to abiraterone acetate plus prednisone in patients with BRCA-positive mCRPC. Akeega was approved in the EU in April.
AbbVie’s Atogepant Gets EU Nod for Preventive Treatment of Migraine: The European Commission approved AbbVie’s CGRP receptor antagonist, Aquipta (atogepant) in Europe for prophylaxis (prevention) of migraine in adults who have four or more migraine days per month. This approval was based on results from two pivotal phase III studies, PROGRESS and ADVANCE, evaluating 60 mg dose strength of Aquipta/Qulipta in adult patients with chronic migraine or episodic migraine, respectively.
Atogepant is already approved in the United States as Qulipta for the preventive treatment of both chronic and episodic migraine. With the latest approval in EU, Aquipta has become the first and only once-daily oral CGRP receptor antagonist to be approved for the preventive treatment of both chronic and episodic migraine in the European Union.
Novartis’ Eylea Biosimilar Meets Goal in Study: Novartis unit Sandoz’s phase III study called Mylight, evaluating a biosimilar version of Regeneron’s blockbuster eye drug, Eylea (aflibercept), met its primary efficacy endpoint. It showed no clinically meaningful differences to the reference biologic, Eylea. The study showed therapeutic equivalence in mean change of best corrected visual acuity from baseline to week 8 between the biosimilar aflibercept and Eylea.
Eylea is presently approved to improve visual acuity in patients with neovascular age-related macular degeneration, diabetic macular edema, macular edema secondary to retinal vein occlusion and other specific neovascular retinal diseases. Sandoz plans to launch four key biosimilar products over the next few years, aflibercept being one of them.
The NYSE ARCA Pharmaceutical Index rose 0.08% in the last five trading sessions.
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
Here’s how the eight major stocks performed in the last five trading sessions.
Image Source: Zacks Investment Research
In the last five trading sessions, Merck rose the most (up 3.2%), while Roche declined the most (3.1%).
In the past six months, Lilly has risen the most (63.7%), while Pfizer has declined the most (15.5%).
(See the last pharma stock roundup here: LLY, BAYRY Post Q2 Results, NVO’s Wegovy Cuts Heart Attack Risk)
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.