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Zacks News
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.