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Zacks News
Alnylam (ALNY) Files for Oxlumo Label Expansion in US & EU
by Zacks Equity Research
Alnylam (ALNY) files regulatory applications to the FDA and the EMA, seeking approval for a new indication of Oxlumo for the treatment of advanced primary hyperoxaluria type 1.
Trevena (TRVN) to Begin Clinical Study on Pain Candidate
by Zacks Equity Research
Trevena (TRVN) advances TRV045 into clinical development as a potential treatment for diabetic neuropathic pain. Enrollment in the study is expected to begin in the first quarter of 2022.
Foghorn (FHTX) Surges on Oncology Collaboration With Lilly
by Zacks Equity Research
Foghorn (FHTX) soars following a collaboration with pharma giant Lilly for novel oncology targets.
Bristol-Myers (BMY) Up on Dividend Hike, Share Repurchase
by Zacks Equity Research
Bristol-Myers (BMY) increases its quarterly dividend and announces a share repurchase program. Consequently, the stock gains.
Pfizer (PFE) to Buy Arena, Boost Immuno-Inflammatory Pipeline
by Zacks Equity Research
Pfizer (PFE) signs an agreement to acquire Arena Pharmaceuticals for $6.7 billion in cash. Stock rises.
Forma's (FMTX) Etavopivat Proves Safety Profile in SCD Study
by Zacks Equity Research
Forma's (FMTX) investigational PKR activator, etavopivat significantly improves anemia and red blood cell health in patients with sickle cell disease.
Moderna's (MRNA) Flu Vaccine Data Fails to Impress Investors
by Zacks Equity Research
Moderna's (MRNA) early-stage flu vaccine data seems promising but it fails to meet investors' expectations.
Cytokinetics' (CYTK) Aficamten Gets Breakthrough Therapy Tag
by Zacks Equity Research
The FDA bestows a Breakthrough Therapy status on Cytokinetics' (CYTK) aficamten for the treatment of symptomatic obstructive hypertrophic cardiomyopathy.
Intercept (ICPT) Down on Withdrawal of Application for NASH
by Zacks Equity Research
Intercept (ICPT) withdraws its application seeking approval for OCA for the treatment of liver fibrosis due to nonalcoholic steatohepatitis in the EU. Resultantly, the stock declines.
Aytu BioPharma's (AYTU) AR101 Gets FDA's Orphan Drug Status
by Zacks Equity Research
The FDA bestows an Orphan Drug designation to Aytu BioPharma's (AYTU) AR101 for the treatment of vascular Ehlers-Danlos Syndrome.
Dare's (DARE) Xaciato Gets FDA Nod for Bacterial Vaginosis
by Zacks Equity Research
Dare (DARE) gets FDA approval for Xaciato (clindamycin phosphate) vaginal gel as a treatment for bacterial vaginosis.
Radius (RDUS) Announces Data on Breast Cancer Drug, Abalo-TDS
by Zacks Equity Research
Radius Health (RDUS) provides detailed results on breast cancer drug and from the phase III wearABLe study.
AbbVie's (ABBV) Rinvoq Meets Goals in Crohn's Disease Study
by Zacks Equity Research
AbbVie's (ABBV) Rinvoq achieves primary and key secondary endpoints in the first phase III induction study in patients with Crohn's Disease.
ACADIA's (ACAD) Rett Syndrome Candidate Meets Goal in Study
by Zacks Equity Research
ACADIA's (ACAD) phase III study, evaluating the efficacy and safety of trofinetide in patients with Rett syndrome, meets co-primary endpoints. Shares rise.
Bristol Myers (BMY) sBLA for Reblozyl Gets Priority Review
by Zacks Equity Research
Bristol Myers' (BMY) sBLA seeking label expansion of Reblozyl for the treatment of anemia in adults with non-transfusion dependent (NTD) beta thalassemia gets priority review by the FDA.
Dyne Therapeutics (DYN) Submits IND to FDA for DMD Candidate
by Zacks Equity Research
Dyne Therapeutics (DYN) files an investigational new drug application in the United States for a clinical study on its investigational candidate DYNE-251 to address Duchenne Muscular Dystrophy.
Blueprint Medicines' (BPMC) Ayvakit Aids Growth Amid Rivalry
by Zacks Equity Research
Blueprint Medicines' (BPMC) Ayvakit, which has been approved to treat PDGFRA Exon 18 mutant gastrointestinal stromal tumors, has seen strong uptake since approval. However, stiff competition remains a headwind.
Why Is Sarepta Therapeutics (SRPT) Down 4.4% Since Last Earnings Report?
by Zacks Equity Research
Sarepta Therapeutics (SRPT) reported earnings 30 days ago. What's next for the stock? We take a look at earnings estimates for some clues.
Novartis (NVS) Highlights Growth Profile at its R&D Day
by Zacks Equity Research
Novartis (NVS) throws light on its pipeline progress, key areas of focus and long-term targets at its R&D day. Here, we discuss key highlights from the same.
Glaxo (GSK), Vir COVID Drug Appears Effective Against Omicron
by Zacks Equity Research
Glaxo (GSK) and Vir Biotechnology announce promising pre-clinical data from the study of their antibody candidate, sotrovimab, against mutations found in the Omicron variant.
Ultragenyx (RARE) Begins Dosing in Phase I/II Study of UX053
by Zacks Equity Research
Ultragenyx (RARE) doses the first patient in a phase I/II study evaluating its investigational mRNA candidate, UX053, for treating glycogen storage disease type III.
Amgen (AMGN) Kyprolis Gets FDA Nod for Use With Darzalex Faspro
by Zacks Equity Research
Amgen (AMGN) gets FDA nod for the label expansion of Kyprolis in combination with Darzalex Faspro and dexamethasone for treating patients with multiple myeloma at first or subsequent relapse.
Vertex (VRTX) Up on Kidney Disease Drug's Success in Phase II
by Zacks Equity Research
Vertex's (VRTX) APOL1 inhibitor, VX-147, led to a significant reduction in protein in urine in a phase II study in APOL1-mediated FSGS, a severe kidney disorder.
Merck (MRK) Vaxneuvance sBLA for Pediatrics Gets Priority Review
by Zacks Equity Research
Merck (MRK) is seeking label expansion for Vaxneuvance for use in pediatric patients aged six weeks through 17 years for the prevention of invasive pneumococcal disease. A decision is expected by on Apr 1, 2022.
Deciphera (DCPH) to Prioritize Key Pipeline Drugs, Cut Jobs
by Zacks Equity Research
Deciphera (DCPH) announces a corporate restructuring plan to prioritize development of vimseltinib and DCC-3116, streamline commercial operations and reduce workforce by almost 35%. Shares rise.