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Zacks News
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.
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.
Evaxion (EVAX) Enrolls First Patient in Phase IIb Melanoma Study
by Zacks Equity Research
Evaxion (EVAX) enrolls the first patient in the phase IIb study evaluating its cancer therapy, EVX-01 in combination with Keytruda, for treating melanoma.
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.
Seagen's (SGEN) Tukysa Gets FDA Priority Review for New Indication
by Zacks Equity Research
FDA grants priority review to Seagen's (SGEN) sNDA for Tukysa in combination with trastuzumab for previously treated HER2-positive metastatic colorectal cancer. A decision is due on Jan 19, 2023.
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.
Blueprint Medicines (BPMC) Rises 68.2% in 3 Months: Here's Why
by Zacks Equity Research
Blueprint Medicines' (BPMC) Ayvakit, approved for treating PDGFRA Exon 18 mutant gastrointestinal stromal tumors, is witnessing strong uptake. The drug's label expansion studies also hold promise.
Apellis (APLS) Up More Than 60% in Past 3 Months: Here's Why
by Zacks Equity Research
Apellis' (APLS) marketed drug, Empaveli, approved for treating paroxysmal nocturnal hemoglobinuria is driving revenues. The drug's label expansion studies also hold promise.
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.
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.
AstraZeneca (AZN) Gets Japan Nod for Expanded Use of 3 Drugs
by Zacks Equity Research
The Japanese Ministry of Health, Labour, and Welfare approved AstraZeneca's (AZN) three marketed drugs, Lynparza, Tagrisso and Ultomiris, for three different indications in Japan.
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.
Novo (NVO) Posts Positive Data From Diabetes Study on CagriSema
by Zacks Equity Research
Novo Nordisk (NVO) completes the phase II study evaluating CagriSema, a combination of semaglutide and cagrilintide for treating type II diabetes.
Axsome (AXSM) Soars on FDA Nod for Depression Drug, Auvelity
by Zacks Equity Research
The FDA approves Axsome's (AXSM) Auvelity extended-release tablets for the treatment of major depressive disorder in adults. This becomes the first approved product for the company. Shares rise.
Blueprint Medicines' (BPMC) Ayvakit Meets Goal in PIONEER Study
by Zacks Equity Research
Blueprint Medicines (BPMC) posts top-line data from part 2 of the PIONEER study evaluating Ayvakit in patients with non-advanced systemic mastocytosis. Shares down.
Horizon (HZNP) Inks Collaboration Deal with Q32 Bio for ADX-914
by Zacks Equity Research
Horizon (HZNP) enters into a collaboration and option agreement with Q32 Bio to develop the latter's ADX-914 for treating autoimmune diseases.
ORIC Stock Plunges on Discontinuation of Oncology Candidate
by Zacks Equity Research
ORIC declines on discontinuation of pipeline candidate ORIC-101 following planned interim analyses of two phase Ib studies.
ORIC Pharmaceuticals (ORIC) in Focus: Stock Moves 6.7% Higher
by Zacks Equity Research
ORIC Pharmaceuticals (ORIC) saw a big move last session, as its shares jumped nearly 7% on the day, amid huge volumes.