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biotechs: Archive

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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.

RHHBYPositive Net Change NERVPositive Net Change KRYSPositive Net Change ALXOPositive Net Change

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Biogen (BIIB) & Eisai's Leqembi sBLA Gets FDA Acceptance

FDA accepts Biogen's (BIIB) partner Eisai's sBLA for a maintenance intravenous dosing version of Alzheimer's drug Leqembi. The final FDA decision is expected on Jan 25, 2025.

BIIBPositive Net Change LLYPositive Net Change PRTAPositive 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.

CGENPositive 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 MRNAPositive Net Change NVAXPositive Net Change ALXOPositive Net Change

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AbbVie's (ABBV) Ovarian Cancer Therapy Meets Study Goal

Data from a mid-stage study shows that treatment with AbbVie's (ABBV) Elahere achieves an objective response rate of almost 52% in certain heavily pre-treated patients with ovarian cancer.

AZNPositive Net Change PFEPositive Net Change MRKPositive Net Change ABBVPositive 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.

BMYNegative Net Change KRYSPositive 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 BIIBPositive Net Change AMGNNegative Net Change VKTXPositive Net Change VIRPositive 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 KRYSPositive Net Change VIRPositive Net Change ALXOPositive Net Change

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Amgen's (AMGN) Uplizna Meets Study Goal for Rare Disease

Data from a late-stage study shows that treatment with Amgen's (AMGN) Uplizna achieves a statistically significant reduction in the risk of flares in patients with IgG4-RD, a rare disease.

AMGNNegative Net Change HRTXPositive Net Change MRNSPositive Net Change ARQTPositive Net Change

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AbbVie (ABBV) Starts Late-Stage Study on Multiple Myeloma Drug

The late-stage study will evaluate AbbVie's (ABBV) experimental antibody to treat patients with relapsed/refractory multiple myeloma who have received at least two lines of prior therapy.

JNJPositive Net Change PFEPositive Net Change ABBVPositive Net Change ARQTPositive 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.

CGENPositive 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.

CGENPositive Net Change ANVSNegative Net Change ALXOPositive Net Change ANNXPositive Net Change

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Viking (VKTX) Falls 10% Despite Upbeat NASH Study Results

Viking Therapeutics (VKTX) reports promising 52-week treatment data from a mid-stage study on its experimental NASH drug. However, shares drop as management did not provide any info on future plans.

VKTXPositive Net Change IONSNegative Net Change MDGLPositive Net Change AKROPositive 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 KRYSPositive Net Change OCGNNo 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.

BMYNegative Net Change NERVPositive Net Change KRYSPositive 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 BIIBPositive Net Change KRYSPositive 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.

BMYNegative Net Change NERVPositive Net Change KRYSPositive Net Change ALXOPositive Net Change

Sundeep Ganoria

FDA Panel to Consider Updating COVID-19 Jabs for New Virus Strains

An FDA panel meeting is scheduled on Jun 5 to consider if COVID-19 vaccines should be updated to target the WHO-recommended JN.1 variant or the KP.2 variant which is the currently dominating strain in the country.

PFEPositive Net Change MRNAPositive Net Change NVAXPositive 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.

RHHBYPositive 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.

CGENPositive Net Change NTLAPositive Net Change ANVSNegative Net Change ALXOPositive Net Change

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Gilead (GILD), RCUS Announce Data From Colorectal Cancer Study

Gilead (GILD) and partner Arcus Biosciences (RCUS) present data from metastatic colorectal cancer and gastrointestinal cancer study.

GILDNegative Net Change KRYSPositive Net Change RCUSPositive Net Change ALXOPositive Net Change

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GSK Stock Dips on Delaware Court Ruling for Zantac Litigation

GSK shares decline more than 7% in pre-market trading on Monday in response to an unfavorable ruling by a state court in Delaware in the Zantac litigation.

SNYPositive Net Change GSKPositive Net Change PFEPositive Net Change

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AbbVie (ABBV) Skyrizi Gets CHMP Nod for Ulcerative Colitis in EU

AbbVie (ABBV) announces that the EMA's CHMP issued a positive opinion on its regulatory filing seeking label expansion for the immunology drug, Skyrizi, to treat UC.

ABBVPositive Net Change ENTXNegative Net Change ANVSNegative Net Change ALXOPositive Net Change