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Aquestive's (AQST) stock rises after meeting primary and secondary goals in the pivotal study of Anaphylm Sublingual Film to treat severe allergic reactions, including anaphylaxis.
Immuneering (IMRX) plunges after multiple Wall Street analysts downgraded the stock on lackluster results from an early-stage study evaluating its lead drug across advanced RAS-mutant solid tumors.
Bristol Myers' (BMY) Abecma gets eight out of 11 votes from the FDA's ODAC for patients with triple-class exposed relapsed or refractory multiple myeloma in earlier lines of therapy.
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.
Allogene's (ALLO) fourth-quarter earnings beat estimates, but sales miss the mark. Management expects operating expenses for 2024 to be around $280 million.
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Novo Nordisk (NVO) announces FDA approval of its application seeking label expansion for Wegovy to reduce the risks of major adverse cardiovascular events.
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.
biotechs: Archive
Aquestive (AQST) Up as Anaphylm Pivotal Study Meets Goals
by Zacks Equity Research
Aquestive's (AQST) stock rises after meeting primary and secondary goals in the pivotal study of Anaphylm Sublingual Film to treat severe allergic reactions, including anaphylaxis.
ACETNegative Net Change ADMANegative Net Change FGENPositive Net Change AQSTNegative Net Change
biotechnology biotechs medical pharmaceuticals
Cybin (CYBN) Begins Phase II Study on Anxiety Drug, Stock Up
by Kanishka Das
Cybin (CYBN) initiates a phase II proof-of-concept study evaluating CYB004 for the treatment of generalized anxiety disorder. The stock rises 7.2%.
VNDANegative Net Change ANIPPositive Net Change ADMANegative Net Change CYBNNegative Net Change
biotechs
Immuneering (IMRX) Plummets 71% in One Week: Here's Why
by Zacks Equity Research
Immuneering (IMRX) plunges after multiple Wall Street analysts downgraded the stock on lackluster results from an early-stage study evaluating its lead drug across advanced RAS-mutant solid tumors.
GSKNegative Net Change ANIPPositive Net Change ADMANegative Net Change IMRXPositive Net Change
biotechs medical
Bristol Myers' (BMY) Abecma Gets ODAC Votes for Label Expansion
by Zacks Equity Research
Bristol Myers' (BMY) Abecma gets eight out of 11 votes from the FDA's ODAC for patients with triple-class exposed relapsed or refractory multiple myeloma in earlier lines of therapy.
BMYNegative Net Change JNJNegative Net Change ADMANegative Net Change TSVTPositive Net Change
biotechnology biotechs pharmaceuticals
New Strong Sell Stocks for March 18th
by Zacks Equity Research
ACNB, AMPH and TRDA have been added to the Zacks Rank #5 (Strong Sell) List on March 18, 2024.
AMPHNegative Net Change ACNBNegative Net Change TRDANegative Net Change
biotechs finance medical
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.
ACETNegative Net Change ADMANegative Net Change FGENPositive Net Change MIRMNegative 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.
GSKNegative Net Change ANIPPositive Net Change ADMANegative Net Change ALLONegative 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 AKRONegative 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).
GSKNegative Net Change BMYNegative Net Change JNJNegative Net Change ADMANegative 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.
REGNNegative Net Change MRNAPositive Net Change RGLSPositive Net Change ACADPositive Net Change AMLXNegative 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.
AZNNegative Net Change ACETNegative Net Change ADMANegative Net Change FGENPositive 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.
GSKNegative Net Change PFENegative Net Change MRKNegative Net Change ADMANegative 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.
ACETNegative Net Change PCRXNegative Net Change ADMANegative Net Change FGENPositive 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.
REGNNegative Net Change ADMANegative Net Change FGENPositive 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.
LXRXNegative Net Change VNDANegative Net Change ANIPPositive Net Change ADMANegative 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.
GSKNegative Net Change ANIPPositive Net Change ADMANegative Net Change ALLONegative 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.
ACETNegative Net Change ADMANegative Net Change FGENPositive Net Change APLTNegative 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.
GSKNegative Net Change INCYNegative Net Change ADMANegative Net Change FGENPositive 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.
REGNNegative Net Change SNYNegative Net Change ADMANegative Net Change FGENPositive 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 MRNAPositive Net Change ANIPPositive Net Change ADMANegative 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.
ACETNegative Net Change ADMANegative Net Change ACADPositive Net Change FGENPositive 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.
REGNNegative Net Change SNYNegative Net Change ADMANegative Net Change ASLNPositive 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 ASNDNegative 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.
NVOPositive Net Change LLYPositive Net Change ACETNegative Net Change FGENPositive 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