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Zacks News
ImmunityBio (IBRX) Gains 17% in the Past Week: Here's Why
by Zacks Equity Research
ImmunityBio (IBRX) rises 17% in the past week as it announces insurance coverage as well as the treatment of the first patients with its newly approved bladder cancer immunotherapy, Anktiva.
AbbVie (ABBV) Parkinson's Candidate Faces 2nd FDA Rejection
by Zacks Equity Research
AbbVie (ABBV) issues the second CRL for Parkinson's disease medicine, ABBV-951, based on some observations on inspection of one of its third-party manufacturing facilities.
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.
Novo Nordisk (NVO) to Invest $4.1B in Clayton Facility Expansion
by Zacks Equity Research
Novo Nordisk (NVO) plans to invest $4.1 billion in order to expand its Clayton facility with a second manufacturing plant, boosting capacity for injectable treatments and creating 1,000 new jobs.
Alnylam (ALNY) Soars as Heart Disease Drug Study Meets Goals
by Zacks Equity Research
Alnylam (ALNY) soars as its phase III study, seeking to expand Anvuttra's label to include the treatment of ATTR amyloidosis with cardiomyopathy, achieves primary and all secondary endpoints.
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.
Intra-Cellular's (ITCI) Caplyta Boosts Sales, Dependence a Woe
by Zacks Equity Research
Intra-Cellular (ITCI) is witnessing strong Caplyta sales, driven by an increasing prescription rate. However, the company is heavily dependent on Caplyta sales for growth, which is a concern.
Gilead (GILD) Up as Twice-Yearly HIV Shot Prevents Infection
by Zacks Equity Research
Gilead's (GILD) twice-yearly, subcutaneous lenacapavir has demonstrated its potential as a new tool to help prevent HIV infections with zero infections and 100% efficacy. Shares gain.
JAZZ Falls as Suvecaltamide Tremor Study Fails to Meet Goals
by Zacks Equity Research
JAZZ shares are down 5% as it fails to achieve statistical significance on the primary and key secondary endpoint in a mid-stage tremor study on suvecaltamide.
Should You Hold Kodiak Sciences (KOD) Stock in Your Portfolio?
by Zacks Equity Research
Kodiak Sciences (KOD) is evaluating its lead candidate, tarcocimab, in a late-stage study for diabetic retinopathy, which is expected to support a regulatory filing for three eye disease indications.
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.
Terns (TERN) Gains 13.6% YTD: Will the Momentum Continue?
by Zacks Equity Research
Terns Pharmaceuticals, Inc. (TERN) outperforms the industry year to date on encouraging pipeline progress of its oncology candidate.
Day One (DAWN) In-Licenses MabCare Cancer Candidate, Stock Up
by Zacks Equity Research
Day One (DAWN) gains 11% on in-licensing exclusive worldwide rights to MabCare???s MTX-13, which is set to begin clinical studies for adult and pediatric solid tumor indications.
Intra-Cellular (ITCI) Up as Second Depression Study Meets Goals
by Zacks Equity Research
Intra-Cellular (ITCI) gains 10% after achieving key goals in the second late-stage study evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for the treatment of MDD.
Aerovate (AVTE) Down as Lead Drug Fails to Meet PAH Study Goals
by Zacks Equity Research
Aerovate's (AVTE) shares plunge 93% as its lead candidate, AV-101, fails to meet the primary and secondary endpoints in the phase IIb/III study to treat pulmonary arterial hypertension patients.
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.
Editas (EDIT) Reports Upbeat New Data From Reni-Cel Studies
by Zacks Equity Research
Editas (EDIT) reports positive new safety and efficacy data from the RUBY and EdiTHAL studies evaluating its investigational gene therapy, reni-cel, for SCD and TDT, respectively.
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.
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.
Apellis (APLS) Up on Upbeat GA Data From Long-Term Syfovre Study
by Zacks Equity Research
Apellis (APLS) rises 3.3% as the treatment of GA patients with Syfovre demonstrates a visual function benefit in a prespecified endpoint at month 36 in a late-stage, long-term extension study.
Geron (GERN) Wins FDA Approval for Blood Cancer Drug, Stock Up
by Zacks Equity Research
Geron's (GERN) shares rise on approval of its first drug. The FDA approves imetelstat for the treatment of adult patients with lower-risk MDS with transfusion-dependent anemia.
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.
ChromaDex (CDXC) Up as Ataxia Candidate Gets Orphan Drug Tag
by Zacks Equity Research
ChromaDex (CDXC) rises 12% as the FDA grants the Orphan Drug Designation and the Rare Pediatric Disease Designation to its investigational candidate, NRC, to treat ataxia telangiectasia.
Moderna (MRNA) Submits Updated COVID-19 Jab to FDA for Review
by Zacks Equity Research
Moderna (MRNA) completes regulatory filing of its Spikevax 2024-2025 formula, targeting the COVID-19 variant JN.1 to the FDA for the upcoming vaccination season.