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Zacks News
Biotech Stock Roundup: IRON, VERV Down on Study Updates, BMYs Drug News & More
by Zacks Equity Research
Disc Medicine, Inc. (IRON) and Verve Therapeutics (VERV) fall on study updates.
Vanda (VNDA) Soars 29.2%: Is Further Upside Left in the Stock?
by Zacks Equity Research
Vanda (VNDA) was a big mover last session on higher-than-average trading volume. The latest trend in earnings estimate revisions might not help the stock continue moving higher in the near term.
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%.
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
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.
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.
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.
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.
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.
Lisata's (LSTA) LSTA1 Gets FDA's RPDD Tag for Osteosarcoma
by Zacks Equity Research
Lisata's (LSTA) lead investigational product candidate, LSTA1, gets Rare Pediatric Disease Designation for treating osteosarcoma. Stock rises.
Spruce Biosciences (SPRB) Falls 86% in a Month: Here's Why
by Zacks Equity Research
Spruce Biosciences' (SPRB) CAHmelia-203 phase IIb study of tildacerfont in adult patients with CAH fails to meet the primary efficacy endpoint.
Cybin (CYBN) Begins Phase II Study on Anxiety Drug, Stock Up
by Kanishka Das
Cybin (CYBN) initiates a phase II proof-of-concept study evaluating CYB004 for the treatment of generalized anxiety disorder. The stock rises 7.2%.
J&J (JNJ) Gets FDA Panel Vote for Carvykti's Expanded Use
by Zacks Equity Research
J&J (JNJ) is looking for expansion of Carvykti's label for the treatment of adult patients with relapsed and lenalidomide-refractory multiple myeloma.
Lexicon (LXRX) Dips on Post Hoc Analysis Data on Sotagliflozin
by Zacks Equity Research
New post hoc analysis of data from Lexicon's (LXRX) phase III study shows improvements in glycemic control when treated with sotagliflozin for type 1 diabetes and chronic kidney disease.
Pfizer's (PFE) Adcetris Meets Survival Goal in Lymphoma Study
by Zacks Equity Research
Pfizer (PFE) plans to seek approval for the eighth indication for Adcetris based on data from the ECHELON-3 study.
Lilly (LLY) Stock Down as FDA Delays Decision on Donanemab
by Zacks Equity Research
The FDA decision on Eli Lilly's (LLY) Alzheimer's candidate, donanemab, was expected in the first quarter of 2024, which has now been delayed.
MindMed's (MNMD) Anxiety Drug Gets FDA Breakthrough Therapy Tag
by Zacks Equity Research
The FDA bestows a breakthrough therapy designation to MindMed's (MNMD) MM120 for treating generalized anxiety disorder. Shares rise more than 50% on the news.
Creative Medical (CELZ) Up on Orphan Drug Tag for CELZ-101
by Zacks Equity Research
Creative Medical's (CELZ) CELZ-101 gets FDA's Orphan Drug designation for preventing allograft rejection in type-I diabetes patients undergoing pancreatic islet cell transplantation. Stock rises.
Vanda (VNDA) Falls on FDA's CRL to Hetlioz sNDA for Insomnia
by Zacks Equity Research
Vanda's (VNDA) supplemental new drug application seeking approval for Hetlioz to treat insomnia gets a complete response letter from the FDA.
Nektar (NKTR) Begins Phase IIb Study Rezpeg in Alopecia Areata
by Zacks Equity Research
The placebo-controlled, phase IIb study will investigate the efficacy and safety of Nektar's (NKTR) rezpeg in patients with severe to very severe alopecia areata.
Nektar (NKTR) Q4 Loss Wider Than Expected, Revenue Beat
by Zacks Equity Research
Nektar (NKTR) reports a wider-than-expected loss in the fourth quarter of 2023 while revenue beat estimates.
Arcturus (ARCT) Stock Surges 73% in 3 Months: Here's Why
by Zacks Equity Research
Arcturus' (ARCT) steady progress with its product candidate, ARCT-032, for the treatment of cystic fibrosis is encouraging.
Puma Biotechnology (PBYI) Q4 Earnings & Revenues Lag Estimates
by Zacks Equity Research
Puma Biotechnology's (PBYI) fourth-quarter 2024 earnings and revenues fall shy of estimates. Stock declines.
Mirum's (MIRM) Q4 Earnings Lag Estimates, Revenues Beat
by Zacks Equity Research
Mirum's (MIRM) earnings fall shy of estimates in the fourth quarter of 2023 while revenues beat the same.