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biotechs: Archive

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RARE's Bone Disorder Drug Gets FDA's Breakthrough Therapy Tag

Ultragenyx announces that the FDA grants Breakthrough Therapy designation to its investigational osteogenesis imperfecta treatment candidate, setrusumab.

ALNYPositive Net Change CPRXPositive Net Change ANIPNegative Net Change RAREPositive Net Change

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SRRK Stock Soars as Muscle Disease Drug Meets Phase III Study Goal

Scholar Rock stock skyrockets as the late-stage study of the investigational therapy, apitegromab, to treat spinal muscular atrophy meets the primary goal.

CPRXPositive Net Change ANIPNegative Net Change BHVNPositive Net Change SRRKNegative Net Change

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ONCY Stock Up on Regulatory Update From Breast Cancer Program

Oncolytics stock soars as the company seeks an accelerated approval pathway for its lead candidate, pelareorep, to treat a breast cancer indication.

AZNPositive Net Change RHHBYPositive Net Change ONCYPositive Net Change ANIPNegative Net Change

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Exelixis Gains 20.7% in Three Months: Is This the Right Time to Buy?

EXEL stock surges 20.7% on encouraging performance of its lead drug Cabometyx and impressive pipeline progress. We are optimistic about the stock as we believe there is room for growth.

ALNYPositive Net Change BMYPositive Net Change EXELNegative Net Change KRYSNegative Net Change

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Pacira's Exparel Receives Permanent New Product-Specific J-Code

PCRX reports that the CMS has assigned a permanent product-specific J-code for Exparel, which is set to facilitate better insurance coverage for the drug.

PCRXNegative Net Change ANIPNegative Net Change KRYSNegative Net Change FULCPositive Net Change

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RARE's Wilson Disease Candidate Betters Standard Therapy in Study

Ultragenyx reports superior efficacy of UX701 for Wilson disease compared with standard therapy from the Stage 1 cohorts of its pivotal phase I/II/III study.

ANIPNegative Net Change RAREPositive Net Change KRYSNegative Net Change FULCPositive Net Change

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Do Options Traders Know Something About BioMarin (BMRN) Stock We Don't?

Investors need to pay close attention to BioMarin (BMRN) stock based on the movements in the options market lately.

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GILD Grants Right for HIV PrEP Candidate to Six Generic Companies

Gilead signs non-exclusive, royalty-free voluntary licensing agreements with six generic companies to market its investigational medicine, lenacapavir, for HIV Prevention.

GILDNegative Net Change ANIPNegative Net Change KRYSNegative Net Change FULCPositive Net Change

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STTK Discontinues Cancer Program, Plans Workforce Cut, Stock Falls

Shattuck stock plunges as it discontinues the clinical development of SL-172154 for two blood cancer indications and plans to reduce the workforce by 40%.

BMYPositive Net Change ANIPNegative Net Change FULCPositive Net Change STTKPositive Net Change

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Here's Why You Should Add ALNY Stock to Your Portfolio Right Now

Alnylam's Amvuttra and Givlaari sales continue to boost revenues. Its ongoing collaboration deals with RHHBY, NVS and REGN are progressing well.

REGNPositive Net Change ALNYPositive Net Change NVSPositive Net Change RHHBYPositive Net Change

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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.

PFEPositive Net Change MRNAPositive 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.

MRNAPositive 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.

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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 ABBVPositive 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 BMEAPositive 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.

BIIBPositive Net Change VNDANegative Net Change WVEPositive Net Change BHVNPositive Net Change ZVRAPositive 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.

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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.

REGNPositive Net Change SNYPositive Net Change AMGNPositive 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.

CLDXPositive 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.

RHHBYPositive 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.

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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.

GSKPositive Net Change NVSPositive 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 GSKPositive Net Change BIIBPositive 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.

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