New drug approvals and regular pipeline updates have grabbed focus in the biotech sector this week.
Recap of the Week’s Most Important Stories
:
Pipeline Update From Regeneron
:
Regeneron Pharmaceuticals, Inc
.
REGN
and partner Sanofi announced that the phase III study (CUPID STUDY B) evaluating blockbuster asthma drug Dupixent (dupilumab) in patients with chronic spontaneous urticaria (CSU) will be stopped. The LIBERTY-CUPID pivotal program was initiated in 2020 with an accelerated direct-to-phase III strategy. Dupixent did not reach statistical significance in interim analysis despite numeric improvements observed across key endpoints in this phase III study in patients refractory to omalizumab. Hence, the study will be stopped 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 in connection with global sales of Dupixent and Kevzara.
Regeneron currently carries a Zacks Rank #3 (Hold). You can see
the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
.
Sage, Biogen Report Data
:
Sage Therapeutics, Inc.
SAGE
, and
Biogen
Inc
.
BIIB
announced
that the CORAL study on zuranolone in patients with major depressive disorder (MDD) met the trial endpoints. The CORAL study compared zuranolone 50 mg co-initiated with standard-of-care antidepressant versus standard of care antidepressant co-initiated with placebo. Zuranolone 50 mg co-initiated with a standard of care antidepressant showed a statistically significant reduction in depressive symptoms at day three. The CORAL study also met its key secondary endpoint, with zuranolone co-initiated with a standard of care antidepressant demonstrating a statistically significant improvement in depressive symptoms compared to antidepressant co-initiated with placebo over the two-week treatment period.
However, Sage stock was down after the release of CORAL study data. Investors were not much encouraged with the data and concerned over the drug’s efficacy over the long term, raising questions about whether it can be approved.
Agios’ Drug Gets FDA Approval
:
Agios Pharmaceuticals, Inc
.
AGIO
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, lifelong hemolytic anemia. The approval was based on successful ACTIVATE and ACTIVATE-T studies, which demonstrate the impact of mitapivat in significantly improving hemolysis and anemia in PK deficiency. The drug was reviewed by the FDA under Priority Review and was previously granted orphan drug designation. The drug is also under review 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
.
ATRA
were down after the company reported Memorial Sloan Kettering Cancer Center’s (MSK) notification to the FDA of a fatal serious adverse event (SAE) associated with a patient treated in the ongoing phase I MSK-conducted dose-escalation clinical study of autologous mesothelin CAR T, ATA2271. Consequently, MSK has voluntarily paused enrollment of new patients in the study on a temporary basis. ATA2271 is a next-generation, autologous chimeric antigen receptor (CAR) T-cell therapy targeting mesothelin currently under clinical investigation in patients with malignant pleural mesothelioma. The single case involved a patient with a history of multiple malignancies and other comorbidities undergoing treatment for advanced, recurrent mesothelioma.
Atara also announced that the stoppage in ATA2271 study enrollment does not impact the IND-enabling work currently underway to advance ATA3271, a separate, off-the-shelf, allogeneic CAR-T therapy targeting mesothelin using next-generation PD1DNR and 1XX CAR technologies for patients with advanced mesothelioma.
Performance
Medical – Biomedical and Genetics Industry 5YR % Return
The Nasdaq Biotechnology Index has lost 4.64% in the past four trading sessions. Among the biotech giants, Regeneron has lost 4.33% during the period. Over the past six months, shares of Vertex have soared 16.03%. (See the last biotech stock roundup here:
Biotech Stock Roundup: Biotech Stock Roundup: BDSI Surges on Merger Deal, SGEN Down on Outlook & More
)
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What’s Next in Biotech?
Stay tuned for more pipeline and regulatory updates, along with earnings updates.
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