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biotechs: Archive

Zacks Equity Research

Mirum's (MIRM) Livmarli Receives FDA Nod for Expanded Use

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

Zacks Equity Research

Allogene's (ALLO) Q4 Loss Narrower Than Expected, Sales Miss

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

Zacks Equity Research

Madrigal (MDGL) Stock Up as FDA Approves First Drug for NASH

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

Zacks Equity Research

Bristol Myers (BMY) Gets FDA Nod for Breyanzi's Label Expansion

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

Zacks Equity Research

Biotech Stock Roundup: AMLX, ACAD Down on Study Data, MRNA, RGLS Gain on Updates & More

Amylyx Pharmaceuticals (AMLX) and Acadia Pharmaceuticals (ACAD) plunged on failure of studies.

REGNPositive Net Change MRNANegative Net Change ACADPositive Net Change AMLXPositive Net Change

Zacks Equity Research

AstraZeneca (AZN) to Acquire Amolyt Pharma for $1.05 Billion

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

Zacks Equity Research

Pfizer (PFE) Gets EU Nod for Expanded Use of Pneumococcal Jab

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

Zacks Equity Research

Pacira's (PCRX) Knee Osteoarthritis Drug Gets FDA's RMAT Tag

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

Zacks Equity Research

NewAmsterdam (NAMS) Doses Patient in HeFH Study, Shares Up

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

Zacks Equity Research

Lexicon (LXRX) Dips on Post Hoc Analysis Data on Sotagliflozin

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

Zacks Equity Research

Allogene (ALLO) Inks Deal With Arbor Bio for CRISPR Technology

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

Zacks Equity Research

Applied Therapeutics (APLT) Surges 124% in a Month: Here's Why

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

Zacks Equity Research

Incyte (INCY) Posts Positive Results on Opzelura From HS Study

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

Zacks Equity Research

Regeneron (REGN) Gets FDA Nod for Praluent Label Extension

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

Zacks Equity Research

Why Moderna (MRNA) Stock Price Was Up 9% on Monday

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

Zacks Equity Research

Acadia (ACAD) Down as Schizophrenia Study on Nuplazid Fails

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

Zacks Equity Research

ASLAN (ASLN) Up 161% on Upbeat Initial Data From Eczema Study

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

Zacks Equity Research

The Zacks Analyst Blog Highlights Legend Biotech, Exact Sciences, Exelixis, Ascendis Pharma and MorphoSys

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

Zacks Equity Research

Novo Nordisk's (NVO) Wegovy Gets FDA Nod to Reduce Heart Risk

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

Benjamin Rains

Bull of the Day: Veeva Systems Inc. (VEEV)

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

Zacks Equity Research

MindMed's (MNMD) Anxiety Drug Gets FDA Breakthrough Therapy Tag

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

Zacks Equity Research

Novo Nordisk (NVO) Up on Upbeat Data From New Obesity Pill Study

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

Zacks Equity Research

Viking (VKTX) Stock Down on Novo Nordisk's Obesity Pill Data

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

Zacks Equity Research

Emergent (EBS) Down 16% on Q4 Earnings Miss, Tops on Sales

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

Zacks Equity Research

Creative Medical (CELZ) Up on Orphan Drug Tag for CELZ-101

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