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Zacks News
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.
Fennec (FENC) Gets CRL From FDA for Pedmark, Stock Down
by Zacks Equity Research
Fennec (FENC) suffers a setback again with a CRL for its new drug application (NDA) for Pedmark. Shares are down in pre-market trading.
Blueprint Medicines (BPMC) Set to Acquire Lengo Therapeutics
by Zacks Equity Research
Blueprint Medicines (BPMC) inks an agreement to acquire privately held Lengo Therapeutics. The company is looking to boost its lung cancer portfolio with this acquisition.
BioCryst (BCRX) Begins Enrollment in PNH Study on BCX9930
by Zacks Equity Research
BioCryst (BCRX) starts patient enrollment in the pivotal REDEEM-2 study evaluating BCX9930 for treating patients with paroxysmal nocturnal hemoglobinuria.
Merck's (MRK) Keytruda Gets Europe Nod for Two Carcinomas
by Zacks Equity Research
Merck's (MRK) Keytruda, in combination with Eisai's Lenvima, gets approval for treating first-line renal cell carcinoma and recurrent endometrial carcinoma in Europe.
Wall Street Analysts See a 60% Upside in Sarepta Therapeutics (SRPT): Can the Stock Really Move This High?
by Zacks Equity Research
The mean of analysts' price targets for Sarepta Therapeutics (SRPT) points to a 59.8% upside in the stock. While this highly sought-after metric has not proven reasonably effective, strong agreement among analysts in raising earnings estimates does indicate an upside in the stock.
Bristol Myers (BMY) Top Drugs Maintain Momentum Amid Competition
by Zacks Equity Research
Bristol Myers' (BMY) performance has been good of late, driven by Revlimid, Eliquis, Opdivo and its new product portfolio amid stiff competition.
4 Reasons Why You Should Add Sarepta (SRPT) to Your Portfolio
by Zacks Equity Research
Sarepta's (SRPT) stock creates a significant opportunity for investors on the back of solid demand for its commercialized drugs and steady progress with its key pipeline candidates.
Gilead Sciences (GILD) Stock Gains 20% YTD: What Lies Ahead?
by Zacks Equity Research
Gilead's (GILD) performance in the year has been pretty good on contribution from Veklury. The company is now focusing on its oncology business as the virology business faces challenges.