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biotechs: Archive
Mirum's (MIRM) Livmarli Receives FDA Nod for Expanded Use
by Zacks Equity Research
Mirum's (MIRM) Livmarli gets FDA approval for label expansion to include the treatment of cholestatic pruritus in patients aged five years and older with PFIC.
ACETPositive Net Change ADMAPositive Net Change FGENNegative Net Change MIRMPositive Net Change
biotechnology biotechs medical pharmaceuticals
Allogene's (ALLO) Q4 Loss Narrower Than Expected, Sales Miss
by Zacks Equity Research
Allogene's (ALLO) fourth-quarter earnings beat estimates, but sales miss the mark. Management expects operating expenses for 2024 to be around $280 million.
GSKPositive Net Change ANIPPositive Net Change ADMAPositive Net Change ALLONo Net Change
biotechs crispr earnings medical
Madrigal (MDGL) Stock Up as FDA Approves First Drug for NASH
by Zacks Equity Research
Madrigal Pharmaceuticals' (MDGL) Rezdiffra (resmetirom) is the first and only medicine approved by the FDA for the treatment of NASH.
LLYPositive Net Change VKTXPositive Net Change MDGLPositive Net Change AKROPositive Net Change
biotechs pharmaceuticals
Bristol Myers (BMY) Gets FDA Nod for Breyanzi's Label Expansion
by Zacks Equity Research
Bristol Myers (BMY) obtains FDA approval for the label expansion of CAR T cell therapy, Breyanzi, for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
GSKPositive Net Change BMYPositive Net Change JNJNegative Net Change ADMAPositive Net Change
biotechnology biotechs medical pharmaceuticals
Biotech Stock Roundup: AMLX, ACAD Down on Study Data, MRNA, RGLS Gain on Updates & More
by Zacks Equity Research
Amylyx Pharmaceuticals (AMLX) and Acadia Pharmaceuticals (ACAD) plunged on failure of studies.
REGNPositive Net Change MRNANegative Net Change ACADPositive Net Change AMLXPositive Net Change
biotechnology biotechs pharmaceuticals
AstraZeneca (AZN) to Acquire Amolyt Pharma for $1.05 Billion
by Zacks Equity Research
AstraZeneca (AZN) enters into an agreement to acquire Amolyt Pharma to strengthen its rare disease pipeline by adding the latter's late-stage hypoparathyroidism treatment candidate, eneboparatide.
AZNPositive Net Change ACETPositive Net Change ADMAPositive Net Change FGENNegative Net Change
biotechnology biotechs medical pharmaceuticals
Pfizer (PFE) Gets EU Nod for Expanded Use of Pneumococcal Jab
by Zacks Equity Research
Following the label expansion, Pfizer's (PFE) 20-valent pneumococcal conjugate vaccine is authorized for use in individuals aged six weeks and older.
GSKPositive Net Change PFENegative Net Change MRKNegative Net Change ADMAPositive Net Change
biotechs medical pharmaceuticals
Pacira's (PCRX) Knee Osteoarthritis Drug Gets FDA's RMAT Tag
by Zacks Equity Research
Pacira (PCRX) receives the FDA's RMAT designation for its gene-therapy product candidate, PCRX-201, which is currently being developed in an early-stage study to treat osteoarthritis of the knee.
ACETPositive Net Change PCRXPositive Net Change ADMAPositive Net Change FGENNegative Net Change
biotechnology biotechs medical pharmaceuticals
NewAmsterdam (NAMS) Doses Patient in HeFH Study, Shares Up
by Zacks Equity Research
NewAmsterdam (NAMS) gains on the initiation of a phase III study evaluating fixed-dose combination of obicetrapib and ezetimibe in patients with HeFH and/or ASCVD.
REGNPositive Net Change ADMAPositive Net Change FGENNegative Net Change NAMSPositive Net Change
biotechnology biotechs pharmaceuticals
Lexicon (LXRX) Dips on Post Hoc Analysis Data on Sotagliflozin
by Zacks Equity Research
New post hoc analysis of data from Lexicon's (LXRX) phase III study shows improvements in glycemic control when treated with sotagliflozin for type 1 diabetes and chronic kidney disease.
LXRXPositive Net Change VNDAPositive Net Change ANIPPositive Net Change ADMAPositive Net Change
biotechs
Allogene (ALLO) Inks Deal With Arbor Bio for CRISPR Technology
by Zacks Equity Research
Allogene (ALLO) intends to combine its next generation AlloCAR T platform with Arbor Biotechnologies' proprietary CRISPR gene therapy technology to develop therapies for autoimmune diseases.
GSKPositive Net Change ANIPPositive Net Change ADMAPositive Net Change ALLONo Net Change
biotechs cell-therapy crispr medical
Applied Therapeutics (APLT) Surges 124% in a Month: Here's Why
by Zacks Equity Research
Applied Therapeutics (APLT) surges 124% in a month due to encouraging updates from two separate developmental programs for govorestat to treat different rare neurological indications.
ACETPositive Net Change ADMAPositive Net Change FGENNegative Net Change APLTPositive Net Change
biotechnology biotechs medical pharmaceuticals
Incyte (INCY) Posts Positive Results on Opzelura From HS Study
by Zacks Equity Research
Incyte's (INCY) Opzelura leads to a significantly greater reduction in abscess and inflammatory nodule (AN) count in HS patients.
GSKPositive Net Change INCYNegative Net Change ADMAPositive Net Change FGENNegative Net Change
biotechnology biotechs pharmaceuticals
Regeneron (REGN) Gets FDA Nod for Praluent Label Extension
by Zacks Equity Research
Regeneron (REGN) obtains FDA approval for Praluent as an adjunct to diet and other LDL-C, lowering therapies to include pediatric patients aged eight and older with HeFH.
REGNPositive Net Change SNYPositive Net Change ADMAPositive Net Change FGENNegative Net Change
biotechnology biotechs pharmaceuticals
Why Moderna (MRNA) Stock Price Was Up 9% on Monday
by Zacks Equity Research
Moderna (MRNA) surges amid initiation reports of a phase II/III study on Merck-partnered experimental cancer therapy to treat patients with cutaneous squamous cell carcinoma, a form of skin cancer.
MRKNegative Net Change MRNANegative Net Change ANIPPositive Net Change ADMAPositive Net Change
biotechs medical messenger-rna pharmaceuticals vaccines
Acadia (ACAD) Down as Schizophrenia Study on Nuplazid Fails
by Zacks Equity Research
Acadia (ACAD) tumbles after its late-stage study on pimavanserin to treat negative symptoms of schizophrenia fails to achieve the primary goal with statistical significance.
ACETPositive Net Change ADMAPositive Net Change ACADPositive Net Change FGENNegative Net Change
biotechnology biotechs medical pharmaceuticals
ASLAN (ASLN) Up 161% on Upbeat Initial Data From Eczema Study
by Zacks Equity Research
ASLAN (ASLN) rises on upbeat initial data from a phase II study of eblasakimab in patients with eczema, who have previously been treated with Dupixent but did not achieve an adequate response.
REGNPositive Net Change SNYPositive Net Change ADMAPositive Net Change ASLNNegative Net Change
biotechnology biotechs medical pharmaceuticals
The Zacks Analyst Blog Highlights Legend Biotech, Exact Sciences, Exelixis, Ascendis Pharma and MorphoSys
by Zacks Equity Research
Legend Biotech, Exact Sciences, Exelixis, Ascendis Pharma and MorphoSys are part of the Zacks top Analyst Blog.
EXELPositive Net Change EXASPositive Net Change ASNDPositive Net Change MORPositive Net Change LEGNPositive Net Change
biotechs
Novo Nordisk's (NVO) Wegovy Gets FDA Nod to Reduce Heart Risk
by Zacks Equity Research
Novo Nordisk (NVO) announces FDA approval of its application seeking label expansion for Wegovy to reduce the risks of major adverse cardiovascular events.
NVONegative Net Change LLYPositive Net Change ACETPositive Net Change FGENNegative Net Change
biotechnology biotechs medical pharmaceuticals
Bull of the Day: Veeva Systems Inc. (VEEV)
by Benjamin Rains
VEEV stock has doubled the Zacks Tech sector in 2024 to retake some key moving averages. Yet Veeva trades 33% below its all-time highs as the wider tech sector looks a little overheated in the short term.
VEEVPositive Net Change
biotechs pharmaceuticals tech-stocks
MindMed's (MNMD) Anxiety Drug Gets FDA Breakthrough Therapy Tag
by Zacks Equity Research
The FDA bestows a breakthrough therapy designation to MindMed's (MNMD) MM120 for treating generalized anxiety disorder. Shares rise more than 50% on the news.
VNDAPositive Net Change ANIPPositive Net Change ADMAPositive Net Change MNMDPositive Net Change
biotechs
Novo Nordisk (NVO) Up on Upbeat Data From New Obesity Pill Study
by Zacks Equity Research
Novo Nordisk (NVO) stock rises as it presents encouraging efficacy data on a new investigational oral obesity pill, amycretin, at its Capital Markets Day.
NVONegative Net Change LLYPositive Net Change AMGNPositive Net Change VKTXPositive Net Change
biotechnology biotechs medical pharmaceuticals
Viking (VKTX) Stock Down on Novo Nordisk's Obesity Pill Data
by Zacks Equity Research
Viking Therapeutics (VKTX) falls as VK2735's placebo-adjusted mean weight loss after 13 weeks of treatment in a phase II study appears similar to Novo Nordisk's amycretin in a phase I study.
NVONegative Net Change LLYPositive Net Change AMGNPositive Net Change VKTXPositive Net Change
biotechs pharmaceuticals
Emergent (EBS) Down 16% on Q4 Earnings Miss, Tops on Sales
by Zacks Equity Research
Emergent (EBS) reports mixed earnings for fourth-quarter 2023. The company signs a forbearance agreement with its lenders, effective till April 2023-end.
GSKPositive Net Change EBSNegative Net Change ANIPPositive Net Change ADMAPositive Net Change
biotechs earnings medical vaccines
Creative Medical (CELZ) Up on Orphan Drug Tag for CELZ-101
by Zacks Equity Research
Creative Medical's (CELZ) CELZ-101 gets FDA's Orphan Drug designation for preventing allograft rejection in type-I diabetes patients undergoing pancreatic islet cell transplantation. Stock rises.
VNDAPositive Net Change ANIPPositive Net Change ADMAPositive Net Change CELZNegative Net Change
biotechs