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Zacks News
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.
Seagen (SGEN) Up More Than 20% in Past 3 Months: Here's Why
by Zacks Equity Research
Seagen (SGEN) is riding on the strong uptake of its marketed drugs that are approved for different cancer indications. Further label expansion of these drugs should boost the top line.
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.
Novartis (NVS) Gets Positive CHMP Opinion for Scemblix in CML
by Zacks Equity Research
The CHMP recommends approval of Novartis' (NVS) Scemblix for treating adult patients with chronic myeloid leukemia. EU also approves label expansion of Cosentyx.
AbbVie's (ABBV) Rinvoq Gets CHMP Nod for New Indication
by Zacks Equity Research
The CHMP recommends approval of AbbVie's (ABBV) Rinvoq for treating adults with active non-radiographic axial spondyloarthritis.
ANI (ANIP) Soars 6.2%: Is Further Upside Left in the Stock?
by Zacks Equity Research
ANI (ANIP) witnessed a jump in share price last session on above-average trading volume. The latest trend in earnings estimate revisions for the stock doesn't suggest further strength down the road.
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.
Exelixis (EXEL) Begins Study on XL092 Combo in Colorectal Cancer
by Zacks Equity Research
Exelixis (EXEL) starts the phase III STELLAR-303 study evaluating XL092 in combination with atezolizumab as compared to regorafenib for treating patients with metastatic colorectal cancer.
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.
Seagen (SGEN) Stock Up on Rumors of Acquisition by Merck
by Zacks Equity Research
Shares of Seagen (SGEN) rise after rumors of a buyout by Merck hit the market. However, a deal is not imminent at the moment.
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.
Addex (ADXN) Terminates Parkinson's-Related Dyskinesia Study
by Zacks Equity Research
Addex (ADXN) terminates the phase IIb/III study evaluating dipraglurant as a potential treatment for dyskinesia associated with Parkinson's disease. Shares fall.
Acadia (ACAD) Up on FDA Briefing Document for Nuplazid sNDA
by Zacks Equity Research
The FDA issues briefing documents related to Acadia's (ACAD) resubmitted sNDA for Nuplazid for treating hallucinations and delusions associated with Alzheimer's disease psychosis. Shares rise.
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.
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.
Alnylam (ALNY) Posts Positive Data From IgA Nephropathy Study
by Zacks Equity Research
Alnylam (ALNY) reports top-line data from a phase II study evaluating its investigational RNAi therapeutic, cemdisiran, for the treatment of immunoglobulin A nephropathy.
Immunovant (IMVT) Sees Wider Q4 Loss, to Study Batoclimab in TED
by Zacks Equity Research
Immunovant's (IMVT) earnings miss estimates in fiscal fourth quarter ended on Mar 31, 2022. The company achieves FDA alignment for phase III study on batoclimab in thyroid eye disease.
Apellis (APLS), Sobi Begin Pegcetacoplan Dosing in Kidney Disease
by Zacks Equity Research
Apellis (APLS) and Sobi dose the first patient in phase III VALIANT study evaluating pegcetacoplan in primary immune-complex membranoproliferative glomerulonephritis and C3 glomerulopathy. Stock up.
Praxis (PRAX) Tanks on Negative Data From Depression Study
by Zacks Equity Research
Praxis (PRAX) posts negative data from the phase II/III Aria study that evaluated PRAX-114 for monotherapy treatment of major depressive disorder. Shares fall.
Global Blood's (GBT) Candidates for SCD Get Two FDA Tags
by Zacks Equity Research
The FDA bestows both orphan drug and rare pediatric disease designations to Global Blood's (GBT) inclacumab and GBT021601 (GBT601) for the treatment of sickle cell disease.