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Zacks News
Gritstone (GRTS) Plummets 58% in a Week: Here's Why
by Zacks Equity Research
Gritstone (GRTS) plunges after a mid-stage study evaluating its personalized cancer vaccine in certain patients with colorectal cancer failed to achieve its primary endpoint.
Amylyx (AMLX) Withdraws ALS Drug, Cuts Workforce by 70%
by Zacks Equity Research
Amylyx (AMLX) makes a formal decision to remove its amyotrophic lateral sclerosis drug from the U.S. and Canadian markets. The company is expected to reduce its workforce by 70%. Its shares are trading up on the news.
Amarin (AMRN) Up 7% on Intellectual Property Wins in Europe
by Zacks Equity Research
Amarin (AMRN) secures a new patent for Vazkepa in Europe, which extends its exclusivity for eight more years. It achieves success in defending another patent on the drug against third parties.
Kodiak (KOD) Counts on Tarcocimab Program Despite Setbacks
by Zacks Equity Research
Kodiak (KOD) initiates a phase III study evaluating tarcocimab in diabetic retinopathy, which is expected to serve as the basis for a regulatory filing for three eye disease indications.
Merck (MRK) Begins Phase II/II Ovarian Cancer Study on ADC Drug
by Zacks Equity Research
Merck's (MRK) phase II/III study called REJOICE-Ovarian01 study will evaluate the efficacy of raludotatug deruxtecan in patients with platinum-resistant ovarian cancer.
Verve (VERV) Pauses Enrollment in Cholesterol Study, Stock Falls
by Zacks Equity Research
Verve (VERV) stops enrollment in the phase Ib study of gene therapy candidate VERVE-10 to reduce disease-driving low-density lipoprotein cholesterol due to safety issues. Stock plunges on the news.
Vanda (VNDA) Up on FDA Nod for Fanapt in Bipolar I Disorder
by Zacks Equity Research
Vanda (VNDA) announces the FDA's approval of Fanapt for the acute treatment of bipolar I disorder in adults. The stock rises 30.4%.
EMA Accepts Rocket (RCKT) Gene Therapy Filing for Fanconi Anemia
by Zacks Equity Research
The EMA accepts Rocket's (RCKT) regulatory submission seeking approval for RP-L102, a gene therapy for a rare genetic disorder called fanconi anemia that affects the bone marrow.
Evaxion (EVAX) Up on Upbeat Preclinical S. Aureus Vaccine Data
by Zacks Equity Research
Evaxion (EVAX) gains 20% on positive results from the pre-clinical studies of its EVX-B1 vaccine candidate in large non-rodent animals, which is being developed to treat S. aureus infection.
Here's Why Amgen (AMGN) Stock is Outperforming the Industry
by Zacks Equity Research
Amgen (AMGN) expects strong sales growth of products like Tezspire, Evenity and Repatha to make up for lower revenues from oncology biosimilars and Enbrel
Bristol Myers (BMY) Wins EC Nod for Reblozyl Label Expansion
by Zacks Equity Research
Bristol Myers (BMY) receives European Commission's approval for a label expansion of Reblozyl (luspatercept) for another indication.
Disc Medicine (IRON) Down on Mixed Results From AURORA Study
by Zacks Equity Research
Disc Medicine's (IRON) shares lose after a phase II study of bitopertin in patients with erythropoietic protoporphyria does not achieve the key secondary endpoint.
Avalo Therapeutics (AVTX) Surges 270% in a Week: Here's Why
by Zacks Equity Research
Avalo (AVTX) surges on adding a new pipeline drug, which has its origins at Eli Lilly. Alongside the acquisition, it also secured funding to continue operations beyond 2027.
Vertex (VRTX) Moves Kidney Disease Drug to Phase 3 Development
by Zacks Equity Research
Vertex (VRTX) advances inaxaplin to late-stage development. It will evaluate the drug in lower age groups and will enroll patients aged 10 years and older with APOL1-mediated kidney disease.
Solid Biosciences (SLDB) Falls Despite FDA Rare Tag for DMD Drug
by Zacks Equity Research
Solid Biosciences' (SLDB) novel gene-therapy candidate, SGT-003, gets FDA's Rare Pediatric Disease Designation for the treatment of Duchenne muscular dystrophy.
Axsome (AXSM) Begins Solriamfetol Binge Eating Phase III Study
by Zacks Equity Research
Axsome's (AXSM) phase III ENGAGE study is set to evaluate the efficacy and safety of solriamfetol for the treatment of binge eating disorder in adults.
AstraZeneca (AZN) Dato-DXd Breast Cancer BLA Gets FDA Acceptance
by Zacks Equity Research
AstraZeneca's (AZN) BLA is seeking approval of Dato-DXd for previously treated metastatic HR-positive, HER2-negative breast cancer.
AstraZeneca's (AZN) Rare Blood Disorder Drug Gets FDA Nod
by Zacks Equity Research
FDA approves AstraZeneca's (AZN) Voydeya as an add-on to therapy to Ultomiris or Soliris for treating extravascular hemolysis in adult patients with paroxysmal nocturnal hemoglobinuria.
Adma Biologics (ADMA) Suffers a Larger Drop Than the General Market: Key Insights
by Zacks Equity Research
In the most recent trading session, Adma Biologics (ADMA) closed at $6.54, indicating a -0.91% shift from the previous trading day.
Bristol Myers' (BMY) Zeposia Fails Crohn's Disease Study
by Zacks Equity Research
Patients treated with Bristol Myers' (BMY) Zeposia in a phase III study for Crohn's disease did not achieve disease remission.
Kodiak (KOD) Stock Falls on Q4 Earnings Miss, Pipeline in Focus
by Zacks Equity Research
Kodiak (KOD) reports a wider-than-expected loss for fourth-quarter 2023. The company provides updates regarding its pipeline development plans.
Is Adicet Bio (ACET) Outperforming Other Medical Stocks This Year?
by Zacks Equity Research
Here is how Adicet Bio, Inc. (ACET) and Adma Biologics (ADMA) have performed compared to their sector so far this year.
Moderna (MRNA) Posts Pipeline Progress, Secures Blackstone Funding
by Zacks Equity Research
Moderna (MRNA) posts data on three experimental vaccines and intends to advance them to late-stage studies. It also secures $750 million in funding from Blackstone to advance its influenza program.
Apogee (APGE) Stock Rallies 95.6% in a Month: Here's Why
by Zacks Equity Research
Apogee (APGE) surges 95.6% in a month after reporting positive interim results from its phase I study for APG777 to treat AD. The company plans to initiate a phase II study for the same indication.
Syndax (SNDX) Gets FDA Priority Tag for Leukemia Drug NDA
by Zacks Equity Research
Syndax Pharmaceuticals (SNDX) groundbreaking menin inhibitor, revumenib, receives FDA priority review for treating relapsed, refractory acute leukemia.