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Zacks News
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.
GSK Gets FDA Nod for Measles, Mumps & Rubella Vaccine, Priorix
by Zacks Equity Research
The FDA approves GSK's Priorix vaccine for active immunization for the prevention of measles, mumps and rubella in individuals aged 12 months and older.
Immunic (IMUX) Falls as Phase II Ulcerative Colitis Study Fails
by Zacks Equity Research
Immunic's (IMUX) phase II CALDOSE-1 study, evaluating vidofludimus calcium in patients with moderate-to-severe ulcerative colitis, fails to meet primary endpoint. Stock down.
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.
Precision BioSciences (DTIL) Reports Q1 Loss, Misses Revenue Estimates
by Zacks Equity Research
Precision BioSciences (DTIL) delivered earnings and revenue surprises of 20.69% and 33.66%, respectively, for the quarter ended March 2022. Do the numbers hold clues to what lies ahead for the stock?
ProQR (PRQR) Reports Q1 Loss, Tops Revenue Estimates
by Zacks Equity Research
ProQR (PRQR) delivered earnings and revenue surprises of 12% and 16.39%, respectively, for the quarter ended March 2022. Do the numbers hold clues to what lies ahead for the stock?
Precision BioSciences (DTIL) Stock Sinks As Market Gains: What You Should Know
by Zacks Equity Research
In the latest trading session, Precision BioSciences (DTIL) closed at $2.09, marking a -0.95% move from the previous day.
Precision BioSciences (DTIL) Reports Q4 Loss, Misses Revenue Estimates
by Zacks Equity Research
Precision BioSciences (DTIL) delivered earnings and revenue surprises of 20.83% and 23.10%, respectively, for the quarter ended December 2021. Do the numbers hold clues to what lies ahead for the stock?