For immediate release
Chicago, IL – February 24, 2022 – Zacks.com announces the list of stocks featured in the analyst blog. Every day, Zacks Equity Research analysts discuss the latest news and events impacting stocks and financial markets. Stocks recently featured in the blog include: Regeneron Pharmaceuticals, Inc. REGN, Sage Therapeutics, Inc. SAGE, Biogen BIIB, Agios Pharmaceuticals, Inc. AGIO and Atara Biotherapeutics, Inc. ATRA.
Here are highlights from Wednesday’s analyst blog:
Biotech Stock Roundup: SAGE, ATRA, AGIO and More
New drug approvals and regular pipeline updates have captured the attention in the biotech industry this week.
Recap of the most important stories of the week:
Regeneron pipeline update: Regeneron Pharmaceuticals, Inc.. and its partner Sanofi announced the termination of the phase III study (CUPID STUDY B) evaluating the blockbuster asthma drug Dupixent (dupilumab) in patients with chronic spontaneous urticaria (CSU). The LIBERTY-CUPID pivotal program was initiated in 2020 with an accelerated strategy of moving directly into phase III.
Dupixent did not reach statistical significance in the interim analysis despite the numerical improvements observed on the primary endpoints of this phase III study in omalizumab-refractory patients. Therefore, the study will be terminated due to futility.
Regeneron has a collaboration agreement with Sanofi for drugs like Dupixent and Kevzara. While sales of these drugs are recorded by Sanofi, Regeneron records its share of profits/losses related to worldwide sales of Dupixent and Kevzara.
Regeneron currently wears a Zacks Rank #3 (Hold). You can see the full list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Sage, Biogen report data: Sage Therapeutics, Inc. and biogenic announced that the CORAL study of zuranolone in patients with major depressive disorder (MDD) met the trial endpoints. The CORAL study compared zuranolone 50 mg co-initiated with a standard antidepressant versus a standard antidepressant co-initiated with placebo.
Zuranolone 50 mg co-initiated with a standard antidepressant showed a statistically significant reduction in depressive symptoms by day three. The CORAL study also met its key secondary endpoint, zuranolone co-initiated with a standard antidepressant demonstrating a statistically significant improvement in depressive symptoms compared to the antidepressant co-initiated with placebo during the two week treatment.
However, the sage stock was down after the CORAL study data was released. Investors were not very encouraged by the data and concerned about the drug’s long-term effectiveness, raising questions about whether it can be approved.
Agios’ drug gets FDA approval: Agios Pharmaceuticals, Inc.. announced that the FDA has approved Pyrukynd (mitapivat) in the United States for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency, a rare, debilitating and lifelong hemolytic anemia. The approval was based on the successful completion of the ACTIVATE and ACTIVATE-T studies, which demonstrate the impact of mitapivat on significantly improving hemolysis and anemia in PK deficiency.
The drug has been reviewed by the FDA under a priority review and previously received orphan drug designation. The drug is also being reviewed by the European Medicines Agency as a potential treatment for adults with PK deficiency, and Agios expects a regulatory decision in the EU by the end of 2022. .
Atara Down on Study Update: Shares of Atara Biotherapeutics, Inc.. were down after the company reported Memorial Sloan Kettering Cancer Center (MSK) notification to the FDA of a fatal serious adverse event (SAE) associated with a patient treated in the Phase I clinical study dose escalation conducted by MSK on autologous CAR T mesothelin, ATA2271. Therefore, MSK has voluntarily temporarily suspended the recruitment of new patients into the study.
ATA2271 is a next-generation mesothelin-targeting chimeric antigen receptor (CAR) autologous T-cell therapy currently under clinical investigation in patients with malignant pleural mesothelioma. The only case involved a patient with a history of multiple malignancies and other comorbidities under treatment for advanced and recurrent mesothelioma.
Atara also announced that the discontinuation of recruitment for the ATA2271 study does not impact the IND work currently underway to advance ATA3271, a distinct, off-the-shelf allogeneic CAR-T therapy targeting mesothelin. using next-generation PD1DNR and 1XX CAR technologies for patients with advanced mesothelioma.
Medical – Biomedical and genetic industry % return over 5 years
The Nasdaq Biotechnology Index has lost 4.64% over the past four trading sessions. Among the biotech giants, Regeneron lost 4.33% over the period. Over the past six months, shares of Vertex have climbed 16.03%. (See the latest roundup of biotech stocks here: Biotech Stock Roundup: Biotech Stock Roundup: BDSI Rises on Merger Deal, SGEN Falls on Outlook and More)
What’s next in biotechnology?
Stay tuned for more pipeline and regulatory updates, as well as revenue updates.
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Regeneron Pharmaceuticals, Inc. (REGN): Free Stock Analysis Report
Biogen Inc. (BIIB): Free Stock Analysis Report
Agios Pharmaceuticals, Inc. (AGIO): Free Stock Analysis Report
Sage Therapeutics, Inc. (SAGE): Free Stock Analysis Report
Atara Biotherapeutics, Inc. (ATRA): Free Stock Analysis Report
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