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Zacks News
Tharimmune (THAR) Up on Positive Data From Pipeline Candidate
by Zacks Equity Research
Tharimmune (THAR) announces positive data from a phase I study on TH104 and the development timeline in chronic pruritis in primary biliary cholangitis indication.
Arcturus' (ARCT) CF Drug Gets FDA's Orphan Status, Stock Up
by Zacks Equity Research
Arcturus (ARCT) rises 8% as the FDA grants Orphan Drug Designation for its product candidate, ARCT-032, for the treatment of cystic fibrosis.
Acadia (ACAD) Begins Alzheimer's Disease Psychosis Study
by Zacks Equity Research
Acadia (ACAD) initiates a phase II study on ACP-204 in the treatment of Alzheimer's disease psychosis, the first among the three studies planned in the phase II/III clinical program of the candidate.
GSK's Blenrep Combo Meets PFS Endpoint in Head-to-Head Study
by Zacks Equity Research
GSK announces positive data from the DREAMM-7 head-to-head phase III study evaluating Blenrep for second-line treatment of relapsed or refractory multiple myeloma. The study meets its primary endpoint.
Regeneron (REGN), Sanofi's Dupixent Succeeds in 2nd COPD Study
by Zacks Equity Research
Regeneron (REGN) and partner Sanofi (SNY) post positive data from the second COPD study and plan to submit a sBLA to the FDA by the end of 2023.
Theseus (THRX) Up 57% in a Month on Strategic Restructuring Plan
by Zacks Equity Research
Theseus (THRX) gains 57% in a month after announcing plans to conduct a process exploring strategic alternatives to maximize shareholder value. The company cuts its workforce by 72%.
Kiniksa Pharmaceuticals (KNSA) Up 14.7% YTD: Here's How
by Zacks Equity Research
Kiniksa Pharmaceuticals (KNSA) enjoys a good run in the year on the back of solid revenue growth and pipeline updates.
Vertex (VRTX) Gets EU Nod for Kaftrio Use in 2-5 Year Kids
by Zacks Equity Research
The European Commission approves Vertex's (VRTX) Kaftrio for expanded use to treat children aged two to five years with cystic fibrosis.
Regeneron (REGN) Stock Rallies 10% YTD: What Lies Ahead?
by Zacks Equity Research
Regeneron (REGN) shares gain 10% year to date on Eylea HD's approval and Dupixent's momentum. Pipeline progress is impressive as well.
Zacks Industry Outlook Highlights Gilead Sciences, CRISPR Therapeutics, ACADIA Pharmaceuticals, Dynavax and Ligand Pharmaceuticals
by Zacks Equity Research
Gilead Sciences, CRISPR Therapeutics, ACADIA Pharmaceuticals, Dynavax and Ligand Pharmaceuticals are part of the Zacks Industry Outlook article.
Freeline (FRLN) Shares Rise on Merger Agreement With Syncona
by Zacks Equity Research
Freeline Therapeutics (FRLN) is set to be acquired by Syncona Ltd. The transaction is expected to be closed in the first quarter of 2024. Shares rise.
Mesoblast (MESO) Up on Deal With BMT CTN to Develop GVHD Drug
by Zacks Equity Research
Mesoblast (MESO) partners with Blood and Marrow Transplant Clinical Trials Network to develop a pivotal study on its lead candidate, Ryoncil, for acute graft versus host disease. The stock rises 11%.
Immix (IMMX) CAR-T Therapy IND Cleared by FDA, Stock Down
by Zacks Equity Research
The FDA clears Immix's (IMMX) investigational new drug application for BCMA CAR-T cell therapy, NXC-201, to expand clinical studies in relapsed/refractory AL amyloidosis to the United States. Stock falls.
How Much Upside is Left in Ligand (LGND)? Wall Street Analysts Think 90.66%
by Zacks Equity Research
The average of price targets set by Wall Street analysts indicates a potential upside of 90.7% in Ligand (LGND). While the effectiveness of this highly sought-after metric is questionable, the positive trend in earnings estimate revisions might translate into an upside in the stock.
Avita (RCEL) Falls 19% on Lowered 2023 Revenue Guidance
by Zacks Equity Research
Avita's (RCEL) stock declines 19% after the company lowered its total revenue guidance for 2023.
5 Biotech Stocks Likely to Thrive as Industry Prospects Look Bright
by Ekta Bagri
New drug approvals and pipeline progress are likely to help maintain momentum for the Zacks Biomedical and Genetics industry. A strong portfolio and solid pipeline progress position GILD, CRSP, ACAD, DVAX and LGND well amid volatility.
Can-Fite (CANF) Up on Liver Cancer Study Update of Namodenoson
by Zacks Equity Research
Can-Fite (CANF) stock up 7% as the liver cancer patient achieves a complete response and overall survival of 6.9 years upon continued treatment with namodenoson in a phase II study.
Anavex (AVXL) Up 12% on Regulatory Update for Alzheimer's Drug
by Zacks Equity Research
Anavex (AVXL) announces an encouraging regulatory update for its investigational candidate, blarcamesine, in the treatment of Alzheimer's disease. The stock rises 12%.
Bayer (BAYRY) Stops Heart Drug Study Due to Lack of Efficacy
by Zacks Equity Research
Bayer's (BAYRY) phase III cardiovascular drug study is stopped due to low efficacy compared with Eliquis. The company suffers another setback in Roundup Litigation.
Here's Why You May Invest in Puma Biotechnology (PBYI) Stock
by Zacks Equity Research
Here, we discuss some reasons why investing in Puma Biotechnology (PBYI) stock now may turn out to be a more prudent move than ever.
Repare Therapeutics (RPTX) Rises 34% in a Week: Here's Why
by Zacks Equity Research
Repare Therapeutics (RPTX) rises 34% in a week after announcing plans to begin clinal-stage development of two additional candidates, RP-1664 and RP-3467, in 2024 in several solid tumor indications.
Dermata (DRMA) Up on FDA Nod to Begin Pivotal Study of Acne Drug
by Zacks Equity Research
Dermata (DRMA) announces reaching an agreement with the FDA to begin a late-stage pivotal clinical program for its acne treatment candidate, DMT310. The stock rises 7%.
Ardelyx (ARDX) Up on Xphozah's Orphan Tag for Hyperphosphatemia
by Zacks Equity Research
Ardelyx (ARDX) announces that the FDA has granted orphan drug designation to Xphozah for the treatment of pediatric hyperphosphatemia. The stock rises 4%.
SpringWorks (SWTX) Falls Despite Positive Mirdametinib Study Data
by Zacks Equity Research
SpringWorks (SWTX) posts encouraging data from phase IIb study on its MEK inhibitor, mirdametinib for treating neurofibromatosis type 1-associated plexiform neurofibromas. Stock falls.
Chemomab (CMMB) Up on Fast Track Designation to CM-101 for PSC
by Zacks Equity Research
The FDA bestows Fast Track designation to Chemomab's (CMMB) pipeline candidate, CM-101, for the treatment of primary sclerosing cholangitis. Stock rises.