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Zacks News
Atara Biotherapeutics (ATRA) Reports Q3 Loss, Tops Revenue Estimates
by Zacks Equity Research
Atara Biotherapeutics (ATRA) delivered earnings and revenue surprises of -5.13% and 2.13%, respectively, for the quarter ended September 2022. Do the numbers hold clues to what lies ahead for the stock?
BioMarin (BMRN) Hemophilia Gene Therapy BLA Gets FDA Acceptance
by Zacks Equity Research
If approved, BioMarin's (BMRN) valoctocogene roxaparvovec will become the first gene therapy for treating hemophilia A in the United States. A decision from the FDA is due on Mar 31, 2023.
Acadia (ACAD) Thrives on Nuplazid, Overdependence a Concern
by Zacks Equity Research
Acadia's (ACAD) lead drug, Nuplazid, is approved for treating hallucinations and delusions associated with Parkinson's disease psychosis. Sole dependence on Nuplazid for growth remains an overhang.
Apellis' (APLS) Empaveli Aids Growth, Stiff Competition a Woe
by Zacks Equity Research
Apellis' (APLS) lead drug, Empaveli, is approved for treating paroxysmal nocturnal hemoglobinuria. The drug's label expansion studies hold promise. Stiff competition remains an overhang.
Alnylam (ALNY) Gets FDA Approval for Oxlumo Label Expansion
by Zacks Equity Research
The FDA approves Alnylam's (ALNY) Oxlumo for treating primary hyperoxaluria type 1 to lower urinary oxalate and plasma oxalate levels in pediatric and adult patients.
Allogene (ALLO) Begins Phase II Study on Allogeneic CAR T Therapy
by Zacks Equity Research
Allogene (ALLO) starts the pivotal phase II ALPHA2 study evaluating its allogeneic CAR T therapy, ALLO-501A in patients with relapsed/refractory large B-cell lymphoma.
Acadia (ACAD) Rises More Than 14% in 3 Months: Here's Why
by Zacks Equity Research
Acadia's (ACAD) Nuplazid, approved for treating hallucinations and delusions associated with Parkinson's disease psychosis, is driving revenues. Other candidates are also making good progress.
Horizon (HZNP) Completes Enrollment in Phase IV TED Study
by Zacks Equity Research
Horizon (HZNP) completes enrollment in the phase IV study evaluating Tepezza for the treatment of thyroid eye disease in patients with a low clinical activity score.
Sanofi's (SNY) Dupixent Gets FDA Nod for Prurigo Nodularis
by Zacks Equity Research
The FDA approves Sanofi (SNY) and its partner Regeneron's Dupixent (dupilumab) for the treatment of adult patients with prurigo nodularis.
Merck's (MRK) Keytruda Gets Four New Approvals in Japan
by Zacks Equity Research
The Ministry of Health, Labour and Welfare approves Merck's (MRK) anti-PD-1 therapy, Keytruda, for four new cancer indications in Japan.
Emergent (EBS) Acquires Worldwide Rights to Smallpox Antiviral
by Zacks Equity Research
Emergent (EBS) completes the acquisition of worldwide rights to Tembexa, an FDA-approved smallpox oral antiviral for all ages, from Chimerix.
Alnylam's (ALNY) Rare Disease Drug Amvuttra Gets EC Nod
by Zacks Equity Research
The European Commission approves Alnylam's (ALNY) Amvuttra for treating hereditary transthyretin-mediated (hATTR) amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy.
Pacira (PCRX) Gets Positive CHMP View on Exparel Label Expansion
by Zacks Equity Research
The CHMP gives a positive opinion on Pacira's (PCRX) marketed drug Exparel and recommended a marketing authorization for the product to treat postsurgical pain in children aged six years or older.
Horizon's (HZNP) Phase II Sjogren's Syndrome Study Meets Goal
by Zacks Equity Research
Horizon's (HZNP) phase II study on dazodalibep for treating patients with Sjogren's syndrome meets the primary endpoint.
Acadia's (ACAD) Rett Syndrome Drug NDA Gets FDA Priority Review
by Zacks Equity Research
The FDA accepts and grants priority review to Acadia's (ACAD) NDA for trofinetide to treat Rett syndrome. A decision from the regulatory body is due on Mar 12, 2023.
IVERIC bio (ISEE) Posts Positive Top-Line Data From GA Study
by Zacks Equity Research
IVERIC bio (ISEE) reports positive top-line data from the phase III GATHER2 study, evaluating its investigational candidate, Zimura, for the treatment of geographic atrophy. Stock up.
Gilead's (GILD) Tecartus Gets EC Nod for New Cancer Indication
by Zacks Equity Research
The European Commission approves Gilead's (GILD) CAR T-cell therapy, Tecartus, for treating adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
Immunovant (IMVT) Up More Than 20% in Past 3 Months: Here's Why
by Zacks Equity Research
Immunovant's (IMVT) lead pipeline candidate, batoclimab, is being developed for treating myasthenia gravis, thyroid eye disease and other autoimmune diseases.
Immuneering (IMRX) Files IND for Cancer Candidate IMM-1-104
by Zacks Equity Research
Immuneering (IMRX) files an investigational new drug (IND) application to the FDA to start a phase I/IIa study on IMM-1-104 for the treatment of advanced RAS mutant solid tumors. Stock up.
Sanofi (SNY) Gets FDA Nod for Rare Disease Drug Xenpozyme
by Zacks Equity Research
The FDA approves Sanofi's (SNY) Xenpozyme for treating non-central nervous system (non-CNS) manifestations of acid sphingomyelinase deficiency (ASMD) disease.
Amgen's (AMGN) Lumakras Meets Goal in New Lung Cancer Study
by Zacks Equity Research
Amgen's (AMGN) phase III CodeBreaK 200 study evaluating once-daily oral, Lumakras, for treating KRAS G12C-mutated non-small cell lung cancer meets its primary endpoint.
Deciphera (DCPH) Thrives on Qinlock, Overdependence a Concern
by Zacks Equity Research
Deciphera's (DCPH) Qinlock, approved for treating advanced gastrointestinal stromal tumors, has seen strong uptake since its approval. However, heavy dependence on Qinlock for growth remains a woe.
Alnylam (ALNY) Up More Than 60% in Past 3 Months: Here's Why
by Zacks Equity Research
Alnylam's (ALNY) portfolio of approved drugs is witnessing a strong uptake while its pipeline is progressing well. The recent FDA approval of Amvuttra for a rare disease is a positive.
Aeglea (AGLE) Down on Corporate Restructuring, CEO Steps Down
by Zacks Equity Research
Aeglea (AGLE) announces a corporate restructuring plan to prioritize the development of AGLE-177 for patients living with homocystinuria. The company's current CEO resigns. Stock down.
Horizon (HZNP) Marketed Drugs Aid Growth, Stiff Rivalry a Woe
by Zacks Equity Research
Horizon's (HZNP) portfolio of marketed drugs, including Tepezza and Krystexxa, aid growth. The company is also working on the label expansion of its drugs. However, stiff competition remains a woe.