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Zacks News
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.
Akebia (AKBA) Up as Vafseo Gets FDA Nod for Anemia Due to CKD
by Zacks Equity Research
Akebia (AKBA) gains during premarket hours on Mar 28 as its key product Vafseo (vadadustat) tablets receive FDA's approval for the treatment of anemia due to chronic kidney disease.
Mesoblast (MESO) to File Pediatric GVHD Drug BLA, Stock Up
by Zacks Equity Research
Mesoblast (MESO) gains as the FDA states that the available phase III data for lead candidate, remestemcel-L, is sufficient to support a regulatory filing for pediatric SR-aGVHD indication.
Praxis (PRAX) Surges on Positive Epilepsy Study Results
by Zacks Equity Research
Praxis (PRAX) reports strong response rates across both study arms in a phase IIa proof of concept study for epilepsy patients with PPR.
Stoke Therapeutics (STOK) Up on Upbeat Dravet Syndrome Study Data
by Zacks Equity Research
Stoke Therapeutics (STOK) gains on meaningful clinical data from STK-001 studies for the treatment of Dravet syndrome.
Merck (MRK) Gets FDA Approval for New PAH Drug Winrevair
by Zacks Equity Research
Merck's (MRK) Winrevair becomes the first novel activin signaling inhibitor approved by the FDA to treat PAH.
Axsome's (AXSM) Narcolepsy Drug Study Meets Primary Goal
by Zacks Equity Research
Data from a late-stage study shows that a five-week treatment with Axsome's (AXSM) experimental narcolepsy drug reduced weekly cataplexy attacks by 83%, compared to 66% for placebo.
Novo Nordisk (NVO) to Buy Cardior to Boost Heart Disease Pipeline
by Zacks Equity Research
Novo Nordisk (NVO) is set to acquire Cardior Pharmaceuticals for 1.025 billion euros to establish a presence in cardiovascular disease.
Regeneron's (REGN) Lymphoma Candidate Rejected by the FDA
by Zacks Equity Research
Regeneron's (REGN) efforts to expand its oncology portfolio get a hit as the FDA refuses to approve the lymphoma drug odronextamab.
AstraZeneca's (AZN) Ultomiris Gets FDA Nod for New Indication
by Zacks Equity Research
FDA approves AstraZeneca's (AZN) Ultomiris for AQP4 Ab+ NMOSD, making it the first and only long-acting C5 complement inhibitor approved for this rare neurological disease.
ANI Pharmaceuticals, Inc. (ANIP) Hits Fresh High: Is There Still Room to Run?
by Zacks Equity Research
ANI (ANIP) is at a 52-week high, but can investors hope for more gains in the future? We take a look at the company's fundamentals for clues.