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biotechs: Archive
Roche (RHHBY) NSCLC Drug Alecensa Gets EC Nod for Label Expansion
by Zacks Equity Research
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
biotechnology biotechs medical pharmaceuticals
Biogen (BIIB) & Eisai's Leqembi sBLA Gets FDA Acceptance
by Zacks Equity Research
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
biotechs
ChromaDex (CDXC) Up as Ataxia Candidate Gets Orphan Drug Tag
by Zacks Equity Research
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
biotechnology biotechs medical pharmaceuticals
Moderna (MRNA) Submits Updated COVID-19 Jab to FDA for Review
by Zacks Equity Research
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
biotechnology biotechs medical pharmaceuticals
AbbVie's (ABBV) Ovarian Cancer Therapy Meets Study Goal
by Zacks Equity Research
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
biotechs medical pharmaceuticals
Replimune (REPL) Gains on Positive Data From Melanoma Study
by Zacks Equity Research
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
biotechnology biotechs medical pharmaceuticals
Halozyme (HALO) Raises 2024 Financial Guidance, Stock Up 13%
by Zacks Equity Research
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
biotechnology biotechs medical pharmaceuticals
Biotech Stock Roundup: GSK's Litigation Update, BIIB's Drug Approval & Other Updates
by Zacks Equity Research
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
biotechnology biotechs medical pharmaceuticals
Vir Biotechnology (VIR) Up on Positive Data From HDV Study
by Zacks Equity Research
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
biotechnology biotechs medical pharmaceuticals
Amgen's (AMGN) Uplizna Meets Study Goal for Rare Disease
by Zacks Equity Research
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
biotechs medical pharmaceuticals
AbbVie (ABBV) Starts Late-Stage Study on Multiple Myeloma Drug
by Zacks Equity Research
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
biotechs medical pharmaceuticals
Repare (RPTX) Up 14% as Ovarian Cancer Combo Gets Fast Track Tag
by Zacks Equity Research
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
biotechnology biotechs medical pharmaceuticals
Halozyme's (HALO) ENHANZE Product Gets New Patent Grant in EU
by Zacks Equity Research
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
biotechnology biotechs medical pharmaceuticals
Annexon (ANNX) Up as Phase III Neuro Disorder Study Meets Goals
by Zacks Equity Research
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
biotechnology biotechs medical pharmaceuticals
Viking (VKTX) Falls 10% Despite Upbeat NASH Study Results
by Zacks Equity Research
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
biotechs medical pharmaceuticals
Ocugen (OCGN) Skyrockets 209.6% Year to Date: Heres Why
by Zacks Equity Research
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
biotechnology biotechs medical pharmaceuticals
Bristol Myers (BMY) Reports Positive Data on Breyanzi, Opdivo (Revised)
by Zacks Equity Research
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
biotechnology biotechs medical pharmaceuticals
Denali's (DNLI) Candidate Selected for FDA's START Pilot Program
by Zacks Equity Research
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
biotechnology biotechs pharmaceuticals
Bristol Myers (BMY) Reports Positive Data on Breyanzi, Opdivo
by Zacks Equity Research
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
biotechnology biotechs medical pharmaceuticals
FDA Panel to Consider Updating COVID-19 Jabs for New Virus Strains
by Sundeep Ganoria
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
biotechs medical messenger-rna pharmaceuticals vaccines
Affimed (AFMD) Soars on Upbeat Follow-Up Data From NSCLC Study
by Zacks Equity Research
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
biotechnology biotechs medical pharmaceuticals
Intellia (NTLA) Up on Upbeat Long-Term Angioedema Study Data
by Zacks Equity Research
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
biotechnology biotechs medical pharmaceuticals
Gilead (GILD), RCUS Announce Data From Colorectal Cancer Study
by Zacks Equity Research
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
biotechnology biotechs medical pharmaceuticals
GSK Stock Dips on Delaware Court Ruling for Zantac Litigation
by Zacks Equity Research
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
biotechs
AbbVie (ABBV) Skyrizi Gets CHMP Nod for Ulcerative Colitis in EU
by Zacks Equity Research
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
biotechnology biotechs medical pharmaceuticals