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biotechnology: Archive

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Regeneron (REGN), SNY Win FDA Nod for Kevzara Label Expansion

The FDA approves label expansion of Regeneron (REGN) and Sanofi's Kevzara for the treatment of polyarticular juvenile idiopathic arthritis.

REGNPositive Net Change SNYPositive Net Change NERVPositive Net Change ALXOPositive Net Change

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Apellis (APLS) Up on Upbeat GA Data From Long-Term Syfovre Study

Apellis (APLS) rises 3.3% as the treatment of GA patients with Syfovre demonstrates a visual function benefit in a prespecified endpoint at month 36 in a late-stage, long-term extension study.

CGENNo Net Change APLSPositive Net Change ANVSNegative Net Change ALXOPositive Net Change

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Geron (GERN) Wins FDA Approval for Blood Cancer Drug, Stock Up

Geron's (GERN) shares rise on approval of its first drug. The FDA approves imetelstat for the treatment of adult patients with lower-risk MDS with transfusion-dependent anemia.

BMYPositive Net Change GERNPositive Net Change KRYSNegative Net Change ALXOPositive Net Change

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Roche (RHHBY) NSCLC Drug Alecensa Gets EC Nod for Label Expansion

Roche's (RHHBY) Alecensa gets the European Commission's approval as the first and only targeted adjuvant treatment for people with ALK-positive early-stage lung cancer.

RHHBYNegative Net Change NERVPositive Net Change KRYSNegative Net Change ALXOPositive Net Change

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ChromaDex (CDXC) Up as Ataxia Candidate Gets Orphan Drug Tag

ChromaDex (CDXC) rises 12% as the FDA grants the Orphan Drug Designation and the Rare Pediatric Disease Designation to its investigational candidate, NRC, to treat ataxia telangiectasia.

CGENNo Net Change ANVSNegative Net Change ALXOPositive Net Change

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Moderna (MRNA) Submits Updated COVID-19 Jab to FDA for Review

Moderna (MRNA) completes regulatory filing of its Spikevax 2024-2025 formula, targeting the COVID-19 variant JN.1 to the FDA for the upcoming vaccination season.

PFEPositive Net Change MRNANegative Net Change NVAXNegative Net Change ALXOPositive Net Change

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Replimune (REPL) Gains on Positive Data From Melanoma Study

Replimune's (REPL) lead pipeline candidate RP1, in combination with Opdivo, leads to an overall response rate of 33.6% in patients with anti-PD1 failed melanoma. Shares gain.

BMYPositive Net Change KRYSNegative Net Change REPLPositive Net Change ALXOPositive Net Change

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Halozyme (HALO) Raises 2024 Financial Guidance, Stock Up 13%

Halozyme (HALO) gains 13% as it raises its full-year 2024 financial guidance and updates its five-year financial outlook based on the new ENHANZE patent grant in Europe.

JNJPositive Net Change HALOPositive Net Change ANVSNegative Net Change ALXOPositive Net Change

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Biotech Stock Roundup: GSK's Litigation Update, BIIB's Drug Approval & Other Updates

GSK and Biogen (BIIB) are in the spotlight following litigation updates and drug approval, respectively.

GSKPositive Net Change BIIBNegative Net Change AMGNPositive Net Change VKTXNegative Net Change VIRNo Net Change

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Vir Biotechnology (VIR) Up on Positive Data From HDV Study

Vir Biotechnology (VIR) rises on upbeat data from its phase II study evaluating tobevibart and elebsiran for the treatment of people living with chronic hepatitis delta.

NERVPositive Net Change KRYSNegative Net Change VIRNo Net Change ALXOPositive Net Change

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Repare (RPTX) Up 14% as Ovarian Cancer Combo Gets Fast Track Tag

Repare (RPTX) rises 14% as the FDA grants Fast Track designation to its investigational lunresertib/camonsertib combo to treat adult ovarian cancer patients in the United States.

CGENNo Net Change ANVSNegative Net Change RPTXPositive Net Change ALXOPositive Net Change

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Halozyme's (HALO) ENHANZE Product Gets New Patent Grant in EU

Halozyme (HALO) is set to benefit from the new patent grant in the EU, ensuring the protection of its ENHANZE rHuPH20 product in several EU countries until 2029.

JNJPositive Net Change HALOPositive Net Change ANVSNegative Net Change ALXOPositive Net Change

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Annexon (ANNX) Up as Phase III Neuro Disorder Study Meets Goals

Annexon (ANNX) jumps 31% after meeting the primary and key secondary endpoints with the low dose of its lead candidate, ANX005, in the phase III study for Guillain-Barre syndrome.

CGENNo Net Change ANVSNegative Net Change ALXOPositive Net Change ANNXPositive Net Change

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Ocugen (OCGN) Skyrockets 209.6% Year to Date: Heres Why

Ocugen's (OCGN) shares rise significantly in the year-to-date period on positive progress with its promising pipeline candidates.

NERVPositive Net Change KRYSNegative Net Change OCGNNegative Net Change ALXOPositive Net Change

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Bristol Myers (BMY) Reports Positive Data on Breyanzi, Opdivo (Revised)

Bristol Myers (BMY) announces positive data from three studies evaluating CAR T cell therapy Breyanzi (liso-cel) and three updated analyses on studies evaluating Opdivo at ASCO.

BMYPositive Net Change NERVPositive Net Change KRYSNegative Net Change ALXOPositive Net Change

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Denali's (DNLI) Candidate Selected for FDA's START Pilot Program

Denali's (DNLI) DNL126, an investigational enzyme replacement therapy, gets selected for the START Pilot Program, intended to accelerate the development of rare disease therapies.

SNYPositive Net Change BIIBNegative Net Change KRYSNegative Net Change DNLIPositive Net Change

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Bristol Myers (BMY) Reports Positive Data on Breyanzi, Opdivo

Bristol Myers (BMY) announces positive data from three studies evaluating CAR T cell therapy Breyanzi (liso-cel) and three updated analyses on studies evaluating Opdivo at ASCO.

BMYPositive Net Change NERVPositive Net Change KRYSNegative Net Change ALXOPositive Net Change

Neena Mishra

ETFs to Profit from the Weight Loss Drug Boom

The market for GLP-1 drugs could soar to $130 billion by 2030

LLYPositive Net Change NVDAPositive Net Change TSLANegative Net Change HRTSPositive Net Change THNRPositive Net Change OZEMPositive Net Change

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Affimed (AFMD) Soars on Upbeat Follow-Up Data From NSCLC Study

Affimed (AFMD) rallies 69% on positive follow-up efficacy data from its early to mid-stage study of the AFM24/Tecentriq combo therapy to treat heavily-pretreated EGFR wild-type NSCLC patients.

RHHBYNegative Net Change ANVSNegative Net Change ALXOPositive Net Change

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Intellia (NTLA) Up on Upbeat Long-Term Angioedema Study Data

Intellia (NTLA) gains 10% after reporting encouraging long-term efficacy data from the phase I portion of its early to mid-stage study evaluating NTLA-2002 for treating hereditary angioedema.

CGENNo Net Change NTLANegative Net Change ANVSNegative Net Change ALXOPositive Net Change