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Zacks News
Adverum (ADVM) Completes IND Amendment for Gene Therapy Study
by Zacks Equity Research
Adverum (ADVM) completes IND amendment with the FDA for initiating the phase II LUNA study on its gene therapy candidate, ADVM-022, for treating wet-age-related macular degeneration. Stock up.
Vertex (VRTX) VX-880 Early Study Sees Lifting of Clinical Hold
by Zacks Equity Research
The FDA lifts clinical hold on Vertex's (VRTX) study on VX-880, its stem-cell-derived, fully differentiated islet replacement therapy that could offer a functional cure for type 1 diabetes patients.
Celldex (CLDX) Down on Interim Data From Phase Ib Study in CSU
by Zacks Equity Research
Celldex (CLDX) posts interim data from the phase Ib study evaluating barzolvolimab in patients with moderate to severe chronic spontaneous urticaria. Shares down.
Graybug (GRAY) to Review Strategic Alternatives, Stock Up
by Zacks Equity Research
Graybug's (GRAY) board of directors is set to review strategic options focused on maximizing shareholder value, including a potential sale of the company. Shares rise.
Cybin (CYBN) Up on FDA Clearance of IND for CYB003 in MDD
by Zacks Equity Research
Cybin (CYBN) receives a "may proceed letter" and IND application clearance from the FDA for a phase I/IIa study evaluating CYB003 for potential treatment of major depressive disorder. Shares up.
Kezar (KZR) Doubles on Promising Kidney Disorder Study Data
by Zacks Equity Research
Shares of Kezar (KZR) surge more than 100% during after-hour trading on Jun 27, following a promising data readout from a mid-stage study evaluating zetomipzomib in patients with active lupus nephritis.
uniQure (QURE) Up on Safety Data From Huntington's Disease Study
by Zacks Equity Research
uniQure (QURE) posts safety and biomarker data from the 10 patients enrolled in the lower-dose cohort of its ongoing phase I/II study evaluating AMT-130 for treating Huntington's disease.
Precision BioSciences' (DTIL) Stock Up This Week: Here's Why
by Zacks Equity Research
Shares of Precision BioSciences (DTIL) are up as the company inks a gene-editing deal with Novartis to develop a potentially curative treatment for disorders like sickle cell disease.
Apellis (APLS) Expands Deal for Targeted Complement Therapies
by Zacks Equity Research
Apellis (APLS) expands its current research and development deal with privately held company, Affilogic, to develop targeted complement therapies for delivery into the brain.
Bristol Myers' (BMY) Breyanzi sBLA Receives EMA Validation
by Zacks Equity Research
The EMA validates Bristol Myers' (BMY) type II variation application for the label expansion of Breyanzi for treating relapsed/refractory large B-cell lymphoma after first-line therapy.
FDA Panel Votes Against Acadia (ACAD) sNDA for Nuplazid
by Zacks Equity Research
An FDA advisory committee votes against Acadia's (ACAD) Nuplazid (pimavanserin) for treating hallucinations and delusions associated with Alzheimer's disease psychosis.
Deciphera (DCPH) Up More Than 30% in Past 3 Months: Here's Why
by Zacks Equity Research
Deciphera's (DCPH) Qinlock, approved for treating advanced gastrointestinal stromal tumors, has seen strong uptake since its approval. The recent restructuring initiative is saving costs.
Alnylam's (ALNY) Rare Disease Drug, Amvuttra, Gets FDA Nod
by Zacks Equity Research
The FDA approves Alnylam's (ALNY) Amvuttra (vutrisiran) to treat adult patients with polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis.
ImmunoGen (IMGN) Enters New Collaboration to Boost ADC Pipeline
by Zacks Equity Research
ImmunoGen (IMGN) inks a collaboration deal with privately-held Oxford BioTherapeutics to develop novel antibody-drug conjugates by complementing each other's proprietary technologies.
Immunovant (IMVT) Set on Lead Candidate Batoclimab's Development
by Zacks Equity Research
Immunovant (IMVT) remains focused on developing lead pipeline candidate, batoclimab for treating several types of autoimmune diseases. Lack of other pipeline candidate remains a concern.
Cogent (COGT) Surges on Robust Data from Mastocytosis Study
by Zacks Equity Research
Cogent's (COGT) bezuclastinib achieves robust effectiveness in patients with advanced systemic mastocytosis with a favorable safety and tolerability profile. Stock surges more than 58% on Jun 10.
Aeglea (AGLE) Down on RTF Letter from FDA for Rare Disease Drug
by Zacks Equity Research
Aeglea (AGLE) gets a Refusal to File letter from the FDA related to the biologics license application for pegzilarginase to treat arginase 1 deficiency. Stock down.
Repare (RPTX) Up 20% on Deal With Roche for Solid Tumor Drug
by Zacks Equity Research
Repare Therapeutics (RPTX) signs a licensing agreement with Roche (RHHBY) to develop its lead candidate for solid tumor indications.
Sage (SAGE), Biogen (BIIB) Depression Drug Meets Study Goals
by Zacks Equity Research
Sage Therapeutics (SAGE) and partner Biogen (BIIB) announce positive data from a phase III study, which evaluated zuranolone to treat postpartum depression in women.
Apellis (APLS) Files NDA for Pegcetacoplan in Geographic Atrophy
by Zacks Equity Research
Apellis (APLS) submits a new drug application to the FDA for pegcetacoplan for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration.
Sanofi (SNY) Gets Breakthrough Therapy Tag for Hemophilia A Drug
by Zacks Equity Research
The FDA bestows a Breakthrough Therapy designation to Sanofi's (SNY) efanesoctocog alfa for the treatment of people with hemophilia A.
BioMarin (BMRN) Delays FDA Re-Submission for Hemophilia Drug
by Zacks Equity Research
BioMarin (BMRN) posts follow-up data from a phase I/II study on its gene-therapy candidate for hemophilia A. However, the stock falls 7% as management plans to defer the candidate's BLA filing.
FDA Delays Decision on TGTX's BLA for Multiple Sclerosis Drug
by Zacks Equity Research
The FDA extends PDUFA date by three months on TG Therapeutics' (TGTX) regulatory submission for ublituximab for relapsing multiple sclerosis. Shares fell 14.5% following the announcement.
GSK to Boost Vaccine Portfolio With Affinivax Acquisition
by Zacks Equity Research
GSK signs an agreement to acquire Affinivax, Inc. for a $2.1 billion upfront payment. The company is looking to boost its vaccine pipeline with this acquisition.
Global Blood (GBT) Thrives on Oxbryta, Overdependence a Woe
by Zacks Equity Research
Global Blood's (GBT) Oxbryta is approved for treating sickle cell disease. The recent label expansion nod to Oxbryta is a positive. However, sole dependence on Oxbryta for growth is a concern.