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biotechs: Archive

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ARCT Stock Up as Updated COVID-19 Jab Betters PFE & BNTX's Comirnaty

Arcturus stock gains as the company reports that its sa-mRNA COVID-19 vaccine, ARCT-154, shows superior efficacy compared with treatment with Comirnaty.

PFENegative Net Change MRNANegative Net Change ARCTPositive Net Change BNTXPositive Net Change

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MRNA Begins Dosing in Pivotal Study on Norovirus Vaccine

Moderna doses the first participant in a phase III study evaluating its mRNA norovirus vaccine candidate, mRNA-1403, in the United States.

MRNANegative Net Change ANIPNegative Net Change KRYSNegative Net Change FULCPositive Net Change

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SAVA Stock Down on Settling Misleading Alzheimer's Study Data Claims

Casava stock falls as the company agrees to pay a cumulative fine exceeding $40 million to settle misleading claims charges brought against it by the SEC.

ANIPNegative Net Change KRYSNegative Net Change SAVANegative Net Change FULCPositive Net Change

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ABBV's Newly Added Parkinson's Disease Drug Meets Second Study Goal

Data from a late-stage study shows that AbbVie's tavapadon reduced the burden of Parkinson's disease. The drug previously demonstrated efficacy as adjunctive therapy.

ABBVNegative Net Change ADMANegative Net Change KRYSNegative Net Change BVSNegative Net Change

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Bristol Myers Stock Up on FDA Nod for Schizophrenia Treatment

The FDA approves BMY's differentiated schizophrenia treatment for adults and broadens its diverse portfolio. Shares gain.

BMYPositive Net Change ABBVNegative Net Change KRYSNegative Net Change FULCPositive Net Change

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BMEA Stock Up 9% as FDA Lifts Clinical Hold on 2 Diabetes Studies

Biomea stock rises 9% after the FDA lifts clinical hold on two phase I/II studies evaluating the company's lead candidate, BMF-219, for diabetes.

ANIPNegative Net Change KRYSNegative Net Change FULCPositive Net Change BMEANegative Net Change

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Biotech Stock Roundup: BHVN, WVE, ZVRA Stocks Up on Updates, BIIB & UCBs Study Data & More

Biohaven and Zevra are in the spotlight following positive updates on key candidates.

BIIBNegative Net Change VNDANegative Net Change WVEPositive Net Change BHVNNegative Net Change ZVRANegative Net Change

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Pfizer Withdraws Sickle Cell Disease Therapy Oxbryta From Market

PFE's decision is based on clinical data, which suggests that the overall benefit of the drug no longer outweighs the risk in the approved patient population.

PFENegative Net Change ADMANegative Net Change KRYSNegative Net Change BVSNegative Net Change

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AMGN Stock Falls Despite Upbeat Data on Immunology Drugs: Here's Why

Though Amgen reported encouraging results on two immunology drugs, Wall Street expresses skepticism as the data fell short when compared to existing treatments.

REGNNegative Net Change SNYNegative Net Change AMGNNegative Net Change ARGXPositive Net Change

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CLDX Stock Down Despite Upbeat Long-Term Data From Urticaria Study

Celldex stock falls due to safety concerns related to the treatment of urticaria patients with barzolvolimab in a phase II study, despite robust efficacy data.

CLDXNegative Net Change ANIPNegative Net Change KRYSNegative Net Change FULCPositive Net Change

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Roche's Lupus Study for Gazyva Meets Primary & Key Secondary Goals

RHHBY announces meeting primary and key secondary goals in the late-stage study of its lymphoma drug, Gazyva/Gazyvaro, for treating active lupus nephritis.

RHHBYNegative Net Change ANIPNegative Net Change KRYSNegative Net Change FULCPositive Net Change

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TSVT, BMY Discontinue Enrollment in Late-stage Abecma Study

2seventy bio and partner BMY decide to stop enrollment in the late-stage study on Abecma due to growth in the newly diagnosed multiple myeloma treatment space.

REGNNegative Net Change BMYPositive Net Change NVONegative Net Change TSVTNegative Net Change

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Incyte Gains 12.7% Year to Date: How Should You Play the Stock?

Though INCY's performance in the year so far has been good, increasing competition for Jakafi is a concern. We advise investors to wait and watch before turning positive.

GSKNegative Net Change NVSNegative Net Change INCYPositive Net Change

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Biogen's Lupus Candidate Meets Key Goals in Phase III Study

The phase III PHOENYCS GO study evaluating BIIB and UCB's drug candidate, dapirolizumab pegol, for treating systemic lupus erythematosus meets the primary endpoint.

AZNPositive Net Change GSKNegative Net Change BIIBNegative Net Change ANIPNegative Net Change

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Eli Lilly Secures Approval for Alzheimer's Drug Kisunla in Japan

Japan is the second major market where LLY's Kisunla has been approved. The drug was first approved in the United States in July 2024.

BIIBNegative Net Change LLYNegative Net Change PRTANegative Net Change SAVANegative Net Change

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WVE Stock Soars on Upbeat Efficacy Data From Muscle Disease Study

Wave Life Sciences stock soars 53% on positive interim data from a mid-stage study showing superior efficacy of investigational DMD drug, WVE-N531.

ANIPNegative Net Change WVEPositive Net Change KRYSNegative Net Change FULCPositive Net Change

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Regeneron Stock Down on Court Ruling for Amgen's Biosimilar of Eylea

A federal judge rejected Regeneron's request for a preliminary injunction against Amgen in its lawsuit for Eylea's biosimilar.

REGNNegative Net Change RHHBYNegative Net Change AMGNNegative Net Change BAYRYNegative Net Change

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BHVN Stock Up as Rare Neurological Disease Study Meets Primary Goal

The pivotal BHV4157-206-RWE study evaluating Biohaven's pipeline candidate, troriluzole, for treating spinocerebellar ataxia meets its primary endpoint.

ANIPNegative Net Change BHVNNegative Net Change KRYSNegative Net Change FULCPositive Net Change

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VTYX Stock Rises on Strategic Equity Investment Deal With SNY

Ventyx stock climbs 7% on signing a $27 million strategic investment agreement with Sanofi in exchange for granting exclusive rights to VTX3232.

SNYNegative Net Change NVONegative Net Change LLYNegative Net Change VTYXNegative Net Change

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Regeneron, SNY's Dupixent Get CHMP Recommendation for Label Expansion

REGN and SNY get positive CHMP opinion on the label expansion of Dupixent in the EU for eosinophilic esophagitis in children down to 1 year of age.

REGNNegative Net Change SNYNegative Net Change RHHBYNegative Net Change

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Apellis Stock Down as Eye Drug Faces Third CHMP Rejection in the EU

APLS stock falls as the CHMP confirms its June 2024 negative opinion on the regulatory filing for intravitreal pegcetacoplan to treat GA in the EU.

ILMNNegative Net Change KRYSNegative Net Change APLSNegative Net Change FULCPositive Net Change

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NVO Stock Down on Unsatisfactory Data From Mid-Stage Obesity Study

Novo Nordisk stock falls 5.5% on unsatisfactory safety and efficacy data from a mid-stage study of investigational obesity candidate, monlunabant.

NVONegative Net Change LLYNegative Net Change VKTXNegative Net Change CRBPNegative Net Change

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EMA Committee Endorses AbbVie's Elahere in Ovarian Cancer

If approved, this will be the first regulatory approval for ABBV's Elahere in the European Union.

AZNPositive Net Change PFENegative Net Change MRKPositive Net Change ABBVNegative Net Change

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Sanofi's Sarclisa Gets FDA Nod for Expanded Use in Multiple Myeloma

This latest FDA decision marks the first approval for SNY's Sarclisa as a first-line treatment for multiple myeloma patients.

REGNNegative Net Change SNYNegative Net Change BMYPositive Net Change JNJNegative Net Change

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Longboard Stock Soars on FDA Designations for Epilepsy Drug

The FDA grants orphan drug and rare pediatric disease designations to LBPH's lead pipeline drug for the treatment of Dravet Syndrome.

ILMNNegative Net Change KRYSNegative Net Change BVSNegative Net Change LBPHPositive Net Change