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biotechs: Archive

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FDA Expands J&J's (JNJ) Carvykti Label in Multiple Myeloma

Following the label expansion, J&J's (JNJ) Carvykti is approved as a second-line treatment for adults with relapsed/refractory myeloma. It was initially approved for use as a fifth- or later-line treatment.

BMYPositive Net Change JNJNegative Net Change LEGNPositive Net Change

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How Allogene (ALLO) Stock Stands Out in a Strong Industry

Allogene (ALLO) has seen solid earnings estimate revision activity over the past month, and belongs to a strong industry as well.

ALLONegative Net Change

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MindMed (MNMD) Stock Rises 154% in 3 Months: Here's Why

MindMed's (MNMD) progress with the development of its lead candidate MM120 for treating generalized anxiety disorder has been encouraging, leading the stock to rise during this time.

LGNDPositive Net Change ANIPPositive Net Change ADMAPositive Net Change MNMDNegative Net Change

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Aldeyra (ALDX) Stock Rallies 43% in One Week: Here's Why

Aldeyra (ALDX) rises 43% in one week, driven by plans to initiate a pivotal study to support the resubmission of reproxalap NDA for dry eye disease in the first half of 2024.

ABBVPositive Net Change ADMAPositive Net Change ALDXPositive Net Change FGENNegative Net Change

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Fate Therapeutics (FATE) Surges 86.4% YTD on Pipeline Progress

Fate Therapeutics (FATE) gains 86.4% on encouraging pipeline progress of its cellular immunotherapies for cancer.

ANIPPositive Net Change FATENegative Net Change ADMAPositive Net Change GLPGPositive Net Change

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eFFECTOR Therapeutics (EFTR) Plunges 82% as NSCLC Study Fails

eFFECTOR Therapeutics (EFTR) plunges on disappointing top-line results from the primary analysis of its mid-stage NSCLC study of tomivosertib, following the abandonment of the developmental program.

MRKNegative Net Change ADMAPositive Net Change FGENNegative Net Change EFTRNo Net Change

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Candel (CADL) Up on Upbeat Data From Pancreatic Cancer Study

Candel's (CADL) CAN-2409 demonstrates improvements in estimated median overall survival versus the control group in treating borderline resectable pancreatic ductal adenorcarcinoma. The stock rises.

LGNDPositive Net Change ANIPPositive Net Change ADMAPositive Net Change CADLPositive Net Change

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Gritstone (GRTS) Plummets 58% in a Week: Here's Why

Gritstone (GRTS) plunges after a mid-stage study evaluating its personalized cancer vaccine in certain patients with colorectal cancer failed to achieve its primary endpoint.

LGNDPositive Net Change ANIPPositive Net Change ADMAPositive Net Change GRTSNo Net Change

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Biotech Stock Roundup: IRON, VERV Down on Study Updates, BMYs Drug News & More

Disc Medicine, Inc. (IRON) and Verve Therapeutics (VERV) fall on study updates.

BMYPositive Net Change VNDAPositive Net Change IRONPositive Net Change

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Amylyx (AMLX) Withdraws ALS Drug, Cuts Workforce by 70%

Amylyx (AMLX) makes a formal decision to remove its amyotrophic lateral sclerosis drug from the U.S. and Canadian markets. The company is expected to reduce its workforce by 70%. Its shares are trading up on the news.

ANIPPositive Net Change ADMAPositive Net Change GLPGPositive Net Change AMLXPositive Net Change

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Amarin (AMRN) Up 7% on Intellectual Property Wins in Europe

Amarin (AMRN) secures a new patent for Vazkepa in Europe, which extends its exclusivity for eight more years. It achieves success in defending another patent on the drug against third parties.

LGNDPositive Net Change AMRNPositive Net Change ANIPPositive Net Change ADMAPositive Net Change

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Kodiak (KOD) Counts on Tarcocimab Program Despite Setbacks

Kodiak (KOD) initiates a phase III study evaluating tarcocimab in diabetic retinopathy, which is expected to serve as the basis for a regulatory filing for three eye disease indications.

REGNPositive Net Change BAYRYPositive Net Change ADMAPositive Net Change KODNegative Net Change

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Kintara (KTRA) Stock Soars on Merger Agreement With TuHURA

Kintara (KTRA) inks a definitive merger agreement with TuHURA for an all-stock transaction. It is expected to close in the third quarter of 2024. The stock surges 63.4%.

MRKNegative Net Change LGNDPositive Net Change ANIPPositive Net Change

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Genprex (GNPX) Expands SCLC Study of Key Candidate, Stock Up

Genprex (GNPX) gains 9.5% after expanding clinical study sites in the United States for the early to mid-stage study of lead candidate, Reqorsa, to treat lung cancer patients.

AZNPositive Net Change RHHBYPositive Net Change MRKNegative Net Change GNPXPositive Net Change

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Allakos (ALLK): Strong Industry, Solid Earnings Estimate Revisions

Allakos (ALLK) has seen solid earnings estimate revision activity over the past month, and belongs to a strong industry as well.

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How Adverum (ADVM) Stock Stands Out in a Strong Industry

Adverum (ADVM) has seen solid earnings estimate revision activity over the past month, and belongs to a strong industry as well.

ADVMPositive Net Change

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Vanda (VNDA) Up on FDA Nod for Fanapt in Bipolar I Disorder

Vanda (VNDA) announces the FDA's approval of Fanapt for the acute treatment of bipolar I disorder in adults. The stock rises 30.4%.

LGNDPositive Net Change VNDAPositive Net Change ANIPPositive Net Change ADMAPositive Net Change

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EMA Accepts Rocket (RCKT) Gene Therapy Filing for Fanconi Anemia

The EMA accepts Rocket's (RCKT) regulatory submission seeking approval for RP-L102, a gene therapy for a rare genetic disorder called fanconi anemia that affects the bone marrow.

LGNDPositive Net Change ANIPPositive Net Change ADMAPositive Net Change RCKTNegative Net Change

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Evaxion (EVAX) Up on Upbeat Preclinical S. Aureus Vaccine Data

Evaxion (EVAX) gains 20% on positive results from the pre-clinical studies of its EVX-B1 vaccine candidate in large non-rodent animals, which is being developed to treat S. aureus infection.

ACETPositive Net Change ADMAPositive Net Change FGENNegative Net Change EVAXNegative Net Change

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Here's Why Amgen (AMGN) Stock is Outperforming the Industry

Amgen (AMGN) expects strong sales growth of products like Tezspire, Evenity and Repatha to make up for lower revenues from oncology biosimilars and Enbrel

AMGNPositive Net Change VNDAPositive Net Change ADMAPositive Net Change MORPositive Net Change

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Bristol Myers (BMY) Wins EC Nod for Reblozyl Label Expansion

Bristol Myers (BMY) receives European Commission's approval for a label expansion of Reblozyl (luspatercept) for another indication.

BMYPositive Net Change ANIPPositive Net Change ADMAPositive Net Change GLPGPositive Net Change

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Disc Medicine (IRON) Down on Mixed Results From AURORA Study

Disc Medicine's (IRON) shares lose after a phase II study of bitopertin in patients with erythropoietic protoporphyria does not achieve the key secondary endpoint.

ANIPPositive Net Change ADMAPositive Net Change GLPGPositive Net Change IRONPositive Net Change

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Vertex (VRTX) Moves Kidney Disease Drug to Phase 3 Development

Vertex (VRTX) advances inaxaplin to late-stage development. It will evaluate the drug in lower age groups and will enroll patients aged 10 years and older with APOL1-mediated kidney disease.

VRTXNegative Net Change ANIPPositive Net Change ADMAPositive Net Change CRSPPositive Net Change

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Solid Biosciences (SLDB) Falls Despite FDA Rare Tag for DMD Drug

Solid Biosciences' (SLDB) novel gene-therapy candidate, SGT-003, gets FDA's Rare Pediatric Disease Designation for the treatment of Duchenne muscular dystrophy.

VNDAPositive Net Change ANIPPositive Net Change ADMAPositive Net Change SLDBPositive Net Change

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Axsome (AXSM) Begins Solriamfetol Binge Eating Phase III Study

Axsome's (AXSM) phase III ENGAGE study is set to evaluate the efficacy and safety of solriamfetol for the treatment of binge eating disorder in adults.

JAZZNegative Net Change ANIPPositive Net Change ADMAPositive Net Change AXSMPositive Net Change