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biotechs: Archive

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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.

AZNNegative Net Change PFENegative 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.

BMYPositive Net Change KRYSNegative Net Change REPLPositive Net Change ALXONegative 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 HALONegative Net Change ANVSNegative Net Change ALXONegative 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.

GSKNegative Net Change BIIBNegative Net Change AMGNNegative Net Change VKTXPositive Net Change VIRNegative 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.

NERVNegative Net Change KRYSNegative Net Change VIRNegative Net Change ALXONegative 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 HRTXNegative Net Change MRNSPositive Net Change ARQTNegative 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 PFENegative Net Change ABBVPositive Net Change ARQTNegative 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.

CGENNegative Net Change ANVSNegative Net Change RPTXNegative Net Change ALXONegative 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 HALONegative Net Change ANVSNegative Net Change ALXONegative Net Change

Zacks Equity Research

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.

CGENNegative Net Change ANVSNegative Net Change ALXONegative Net Change ANNXNegative 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.

NERVNegative Net Change KRYSNegative Net Change OCGNNegative Net Change ALXONegative 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 NERVNegative Net Change KRYSNegative Net Change ALXONegative 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.

SNYNegative Net Change BIIBNegative Net Change KRYSNegative Net Change DNLINegative 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 NERVNegative Net Change KRYSNegative Net Change ALXONegative 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.

PFENegative Net Change MRNANegative Net Change NVAXNegative 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 AFMDNegative Net Change ANVSNegative Net Change ALXONegative 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.

CGENNegative Net Change NTLANegative Net Change ANVSNegative Net Change ALXONegative 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.

GILDPositive Net Change KRYSNegative Net Change RCUSNegative Net Change ALXONegative Net Change

Zacks Equity Research

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.

SNYNegative Net Change GSKNegative Net Change PFENegative 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 ALXONegative Net Change

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Moderna (MRNA) Secures FDA Nod for mRNA-Based RSV Vaccine

The RSV vaccine is Moderna???s (MRNA) second FDA-approved product. Once the vaccine secures the CDC's recommendation, it will be launched in the 2024-2025 respiratory virus season.

GSKNegative Net Change PFENegative Net Change MRNANegative Net Change

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Novartis (NVS) Reports Positive Long-Term Data on CSU Drug

Novartis (NVS) reports phase III data that confirm sustained efficacy and long-term safety of oral remibrutinib in chronic spontaneous urticaria.

NVSNegative Net Change RHHBYPositive Net Change KRYSNegative Net Change ALXONegative Net Change

Zacks Equity Research

Gilead's (GILD) Urothelial Cancer Study Did Not Meet Its Primary Goal

Gilead Sciences, Inc.'s (GILD) confirmatory TROPiCS-04 study on Trodelvy in locally advanced or metastatic urothelial cancer fails to achieve its primary endpoint.

GILDPositive Net Change ABBVPositive Net Change KRYSNegative Net Change ALXONegative Net Change

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Ultragenyx (RARE) DTX401 Meets Goals in Metabolic Disorder Study

Ultragenyx (RARE) reports meeting primary and secondary endpoints in the late-stage study of its investigational gene therapy, DTX401, to treat glycogen storage disease type Ia.

RARENegative Net Change ENTXNegative Net Change ANVSNegative Net Change ALXONegative Net Change