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Zacks News
Cartesian (RNAC) MG Study Meets Goals, Stock Down on Other Updates
by Zacks Equity Research
Cartesian (RNAC) announced that the phase IIb study in MG patients has achieved its primary endpoints. However, the stock nosedives following an equity financing announcement.
Regeneron (REGN), SNY Win EC Approval for Dupixent for COPD
by Zacks Equity Research
Regeneron (REGN) and partner Sanofi get approval for their blockbuster drug Dupixent for the chronic obstructive pulmonary disease indication in the EU.
Roche (RHHBY) Gets Positive CHMP Recommendation for Its Drugs
by Zacks Equity Research
Roche (RHHBY) gets CHMP recommendation for a label expansion of ophthalmology drug Vabysmo (faricimab) and PiaSky (crovalimab) for the treatment of paroxysmal nocturnal haemoglobinuria.
Roche's (RHHBY) Ocrevus Subcutaneous Gets European Commission Nod
by Zacks Equity Research
Roche (RHHBY) obtains approval for the subcutaneous formulation of relapsing multiple sclerosis drug Ocrevus in Europe. In addition, a review of the company's MAA for gene therapy, Elevidys, is also underway.
Bristol Myers' (BMY) Krazati Gets FDA Nod for Colorectal Cancer
by Zacks Equity Research
Bristol Myers (BMY) wins FDA approval for Krazati, in combination with Erbitux, as a targeted treatment option for adult patients with KRASG12C-mutated locally advanced or metastatic colorectal cancer.
Roche (RHHBY), Ascidian Team Up for RNA Exon Editing Therapeutics
by Zacks Equity Research
Roche (RHHBY) gets exclusive, target-specific rights to Ascidian's RNA exon editing technology for undisclosed neurological targets for an initial payment of $42 million.
Roche (RHHBY) Reports Upbeat Data on Columvi From STARGLO Study
by Zacks Equity Research
Roche's (RHHBY) Columvi significantly extends survival in patients with relapsed or refractory diffuse large B-cell lymphoma in the phase III STARGLO study.
Bristol Myers (BMY) Gets FDA Nod for Label Expansion of Augtyro
by Zacks Equity Research
The FDA approves Bristol Myers' (BMY) cancer drug Augtyro for the treatment of adult and pediatric patients aged 12 years and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion.
Shattuck (STTK) Announces Positive Interim Data on Cancer Drug
by Zacks Equity Research
Shattuck (STTK) will now focus on higher-risk myelodysplastic syndromes and TP53 mutant acute myeloid leukemia indications for lead candidate SL-172154, following encouraging interim data from the phase IB dose expansion study.
Ultragenyx (RARE) to Seek Accelerated Nod for Rare Disease Drug
by Zacks Equity Research
Following a fruitful meeting with the FDA, Ultragenyx (RARE) plans to seek accelerated approval for UX111 for the treatment of Sanfilippo syndrome type A.
Ultragenyx (RARE) Posts New Data From Bone Disease Study
by Zacks Equity Research
Ultragenyx's (RARE) pipeline candidate setrusumab shows sustained reductions in fracture rates in patients with osteogenesis imperfecta in new data from the Orbit study.
SAGE's Huntington's Disease Study Meets Primary Endpoint
by Zacks Equity Research
The phase II SURVEYOR study evaluating SAGE's dalzanemdor as a potential treatment for patients with cognition dysfunction caused by Huntington's disease meets its primary endpoint.
Regeneron (REGN), SNY Win FDA Nod for Kevzara Label Expansion
by Zacks Equity Research
The FDA approves label expansion of Regeneron (REGN) and Sanofi's Kevzara for the treatment of polyarticular juvenile idiopathic arthritis.
Roche (RHHBY) NSCLC Drug Alecensa Gets EC Nod for Label Expansion
by Zacks Equity Research
Roche's (RHHBY) Alecensa gets the European Commission's approval as the first and only targeted adjuvant treatment for people with ALK-positive early-stage lung cancer.
AstraZeneca's (AZN) Tagrisso sNDA Gets FDA's Priority Tag
by Zacks Equity Research
The FDA grants priority review to AstraZeneca's (AZN) Tagrisso for treating patients with unresectable, stage III EGFR-mutated lung cancer. A decision is due in the fourth quarter of 2024.
Vir Biotechnology (VIR) Up on Positive Data From HDV Study
by Zacks Equity Research
Vir Biotechnology (VIR) rises on upbeat data from its phase II study evaluating tobevibart and elebsiran for the treatment of people living with chronic hepatitis delta.
Ocugen (OCGN) Skyrockets 209.6% Year to Date: Heres Why
by Zacks Equity Research
Ocugen's (OCGN) shares rise significantly in the year-to-date period on positive progress with its promising pipeline candidates.
Bristol Myers (BMY) Reports Positive Data on Breyanzi, Opdivo (Revised)
by Zacks Equity Research
Bristol Myers (BMY) announces positive data from three studies evaluating CAR T cell therapy Breyanzi (liso-cel) and three updated analyses on studies evaluating Opdivo at ASCO.
Bristol Myers (BMY) Reports Positive Data on Breyanzi, Opdivo
by Zacks Equity Research
Bristol Myers (BMY) announces positive data from three studies evaluating CAR T cell therapy Breyanzi (liso-cel) and three updated analyses on studies evaluating Opdivo at ASCO.
Bristol Myers (BMY) Gets EC Nod for Opdivo Label Expansion
by Zacks Equity Research
Bristol Myers' (BMY) Opdivo combination regimen receives the European Commission's approval for the first-line treatment of unresectable or metastatic urothelial carcinoma.
Corcept (CORT) Rises as Cushing's Syndrome Study Meets Goal
by Zacks Equity Research
Corcept's (CORT) phase III GRACE study, evaluating its lead candidate, relacorilant, for treating patients with Cushing's syndrome, meets the primary endpoint in a randomized withdrawal phase.
Mirum's (MIRM) Livmarli Aids Sales but Overdependence Concerns
by Zacks Equity Research
Mirum's (MIRM) lead drug, Livmarli, continues to generate steady sales. The recent label expansion of the drug should drive sales further. However, overdependence on Livmarli for revenues is a concern.
Candel (CADL) Reports Upbeat Data From Lung Cancer Study
by Zacks Equity Research
Candel's (CADL) CAN-2409 prolongs overall survival in a phase II study for treating patients with advanced non-small cell lung cancer who are non-responsive to immune checkpoint inhibitor therapy.
Cartesian (RNAC) Up as FDA Grants RMAT Tag to Descartes-08
by Zacks Equity Research
The FDA bestows RMAT designation to Cartesian's (RNAC) lead pipeline candidate, Descartes-08, for treating myasthenia gravis. Shares rise.
Esperion's (ESPR) Drugs Get EU Nod for Lowering Heart Risk
by Zacks Equity Research
Esperion's (ESPR) Nilemdo & Nustendi get the European Commission's nod for label expansion based on data from the CLEAR Outcomes study.